|Pharmacy UpdateMarch/April 1998In This Issue*Amphotericin B Formulations
*Intravenous (I.V.) Amphotericin
B Administration Guidelines (Table 1)

*Susceptibility of Common NIH
Microorganisms

*Did You Know

*Formulary Update

Drug Information Service
Pharmacy Department
Warren G. Magnuson Clinical Center
National Institutes of Health
Bethesda, Maryland 20892-1196
Charles E. Daniels, Ph.D.
Chief, Pharmacy DepartmentEditor-in-ChiefKarim Anton Calis, Pharm.D., M.P.H.
Coordinator, Drug Information Service, and Endocrinology Clinical Pharmacy
Specialist[email protected]Associate EditorAmy M. Heck, Pharm.D.
Specialized Resident in Drug Information Practice and Pharmacotherapy[email protected]Archives

Amphotericin
B Formulations

Amphotericin B remains the drug
of choice for many fungal infections. However, intravenous administration
of amphotericin B deoxycholate is often complicated by both infusion-related
adverse reactions (e.g., fever, chills, rigors, nausea, vomiting, hypotension,
and rarely hypertension) and systemic toxicities (e.g., nephrotoxicity,
acidosis, hypokalemia, hypomagnesemia, and anemia). Symptomatic support
with medications such as antipyretics and antihistamines can often ease
the discomfort associated with infusion-related reactions. The incidence
and severity of nephrotoxicity associated with the amphotericin B deoxycholate
preparation can be minimized by adequate saline hydration in patients who
can tolerate increased fluid intake. Amphotericin B administration guidelines
were recently developed by the Antimicrobials Subcommittee and were approved
by the Pharmacy and Therapeutics (P&T) Committee (see Table 1).

Several lipid formulations of amphotericin
B have recently been approved for use in the United States. These formulations
appear to be less nephrotoxic than conventional amphotericin B, but the
cost of therapy is significantly higher (see Table 2). In patients in whom
conventional amphotericin B therapy is contraindicated or not well tolerated,
the newer products are encouraging alternatives. However, there are few
studies that directly compare the relative safety and efficacy of these
new lipid products.

Two lipid formulations of amphotericin
B were recently approved by the P&T Committee for use at the NIH Clinical
Center: Abelcet® (amphotericin B lipid complex ABLC) and
AmBisome® (liposomal amphotericin B). Use of these agents
requires approval from the NIAID or NCI Infectious Diseases Services.

Upon recommending approval of these
amphotericin B lipid formulations, the P&T Committee issued the following
statements:

*Current
data suggest that lipid formulations of amphotericin B are effective but
less toxic in comparison to conventional amphotericin B.

*To
date, there are no comparative data by which to evaluate the relative efficacy,
safety, and tolerability of the various lipid formulations of amphotericin
B (compared to other lipid formulations).

*Lipid
formulations of amphotericin B are substantially more expensive than conventional
amphotericin B.

*Conventional
amphotericin B is indicated as initial therapy for the treatment of invasive
fungal infections.

*Both
Abelcet® and AmBisome® are indicated as second-line
therapy for treatment of invasive fungal infections in patients who are
intolerant of or refractory to conventional antifungal therapy.

*Both
conventional amphotericin B and AmBisome® are indicated
as initial empirical antifungal therapy for neutropenic patients with persistent
fever who are unresponsive to broad-spectrum antibiotics.

*Pharmacoeconomic
studies are currently under way to clarify the role of lipid formulations
of amphotericin B in the management of invasive fungal infections.Table
1. Clinical Center Amphotericin B Deoxycholate Administration Guidelines
Indications
First-line therapy for most systemic
mycoses, especially in immunocompromised hosts

Empiric therapy in febrile neutropenic
patients unresponsive to antibacterial therapy

Oropharyngeal or esophageal candidiasis
refractory to topical antifungals and oral azole therapyAdverse Reactions

Infusion Related:

Fever, chills, rigors, and hypotension;
rarely
hypertension, nausea, vomiting, and anorexia

Thrombophlebitis (if given through
a peripheral line)Non-Infusion Related:

Nephrotoxicity (azotemia and renal
tubular acidosis are dose and duration dependent)

Renal electrolyte wasting (K+,
Mg++, and HCO3-)

Normochromic, normocytic anemiaSuggested Dosages for Selected Systemic
Mycoses

Aspergillosis 1.0 - 1.5 mg/kg/day

Blastomycosis 0.4 - 0.6 mg/kg/day

Candidiasis 0.3 - 1.0 mg/kg/day
(oroesophageal)
0.5 - 1.0 mg/kg/day
(other sites)

Coccidioidomycosis 0.5 - 1.0 mg/kg/day

Cryptococcosis 0.5 - 1.0 mg/kg/day
(may use with flucy-
tosine 100 mg/kg/day)

Fusariosis 1.0 - 1.5 mg/kg/day

Histoplasmosis 0.5 - 0.7 mg/kg/day

Mucormycosis 0.5 - 1.5 mg/kg/dayAdministration

Test dose:

Not necessaryDose Escalation (over 2-3 days):

Not necessary; may reduce infusion-related
adverse effects during the first few days

Not recommended for patients with
serious or life-threatening infectionsInfusion Solution:

Always dilute in dextrose 5% in
water (incompatible with solutions containing sodium chloride)

Final concentrations:

0.1 mg/ml if infused through a peripheral
line
1.4 mg/ml if infused through a central lineInfusion Rate:

Over 2 - 4 hours
Note: use of in-line filter is not recommendedMonitoring During Infusion

Vital signs every 30 minutes during
the first dose, then every 1-2 hours with subsequent doses

Monitor for infusion-related symptoms
throughout administration period

Review signs and symptoms of infusion-related
reactions with patient before administration of first dose

Management of Infusion-Related
Reactions
For immediate response in managing
rigors:

Meperidine given by slow I.V. injection
over at least 5 minutes

Adults: 25-50 mg

Children: 1-1.5 mg/kgFever:

Adults: acetaminophen 500-1000
mg p.o. or 650 mg suppository

Children: dose according to weight
and agePre-Medication (after previous
infusion-related reaction):

Acetaminophen 650 mg p.o. (or suppository)
with or without diphenhydramine (25-50 mg p.o. or I.V. or 0.75-1.25 mg/kg
p.o. or I.V. in pediatric patients) 30 minutes prior to start of infusionIf symptoms persist despite pre-medication:

Hydrocortisone 25-50 mg (10-25
mg in pediatric patients) prior to infusion or added to amphotericin B
solutionFor preventing thrombophlebitis
and infusion-site discomfort when peripheral line is used:

Heparin 100-500 units added to
amphotericin B solutionPrevention of Nephrotoxicity

Saline Hydration or Sodium Loading
(3-6 mEq of Na+/kg):

Hydration with one liter of 0.9%
NaCl solution prior to amphotericin B infusion may reduce incidence and/or
severity of nephrotoxicity

For patients with prolonged therapy,
continuous hydration for up to one week after therapy may be necessary

Alternatively, continuous I.V.
or oral hydration can be used throughout the day (with equivalent amounts
of sodium)

Saline hydration should be given
with caution to patients with cardiac compromise and to those who develop
hypertension during amphotericin B infusion

Saline hydration should not be
given to patients with end-stage renal diseaseManagement of K+, Mg++,
and HCO3- Loss

K+, Mg++,
and HCO3- renal wasting usually becomes apparent
during the first week of therapy and continues throughout treatment course;
aggressive replacement is necessary

Intravenous potassium (acetate
or chloride), and magnesium sulfate can be added to hydration fluid

Oral supplementation can be given
if tolerated

Electrolytes and renal function
should be monitored after completion of therapy

Continued hydration or electrolyte
supplementation may be necessary in some casesUp to Top

Percent Susceptibility
of Common NIH Microorganisms

Concentration
(μg/ml)

Ps. aeruginosa
- CF
"(61) a,e"

Ps. aeruginosa
Non-CF
"(105) a,f"

Stenotrophomonas
maltophilia
(33) b

Staphylococcus
aureus
(221) a

Staphylococcus
epidermidis
(214) a

Enterococcus
faecalis
(131) a

Enterococcus
faecium
(26) bAmikacin

16

68

89

9

99

100

-

-Ampicillin

8

- d

-

-

-

-

98

35Amox./clavulan.

4/2

-

-

-

91

34

-

-Aztreonam

8

72

65

-

-

-

-

-Cefazolin

8

-

-

-

91

34

-

-Cefoxitin

8

-

-

-

-

-

-

-Ceftazidime

8

84

79

48

-

-

-

-Ceftriaxone

8

-

-

-

91

33

-

-Ciprofloxacin

1

57

86

33

90

55

76

15Clindamycin

2

-

-

-

92

60

-

-Erythromycin

0.5

-

-

-

70

29

-

-Gentamicin

4

54

75

-

93

70

-

-Imipenem

4

74

85

-

91

33

99

38Oxacillin

2

-

-

-

91

34

-

-Penicillin

0.12

-

-

-

10

12

-

-Piperacillin

64

88

88

26

-

-

-

-Rifampin

1

-

-

-

98

87

-

-Tobramycin

4

87

96

-

-

-

-

-Trimeth./sulfa.

2/38

-

-

91

92

65

-

-Vancomycin

4

-

-

-

100

100

95

65Gent./Pen. syn.

500

-

-

-

-

-

96

69Nitrofurantoin *

32

-

-

-

-

-

100

60Up to Top

Concentration
(μg/ml)

Escherichia
coli
(191) a

Klebsiella
pneumoniae (97) a

Enterobacter
cloacae
(46) b

Citrobacter
freundii
(18) b

Serratia
marcescens
(35) b

Acinetobacter
baumannii
(35) cAmikacin

16

100

98

100

100

100

97Ampicillin

8

60

-

-

-

-

-Amox./clavulan.

8/4

91

98

-

-

-

-Aztreonam

8

97

93

91

89

94

-Cefazolin

8

86

94

-

-

-

-Cefoxitin

8

95

96

-

-

-

-Ceftazidime

8

97

94

96

83

94

89Ceftriaxone

8

97

94

87

78

100

71Cefuroxime

8

95

90

-

-

-

-Ciprofloxacin

1

98

96

93

94

94

83Gentamicin

4

94

96

93

100

100

91Imipenem

4

100

99

96

100

100

100Piperacillin

16

64

63

87

83

100

83Tobramycin

4

95

96

93

100

100

89Trimeth./sulfa.

2/38

81

95

91

59

100

80Nitrofurantoin *

32

99

65

-

100

-

-Sulfamethox. *

256

64

70

100

44

-

-Tetracycline *

4

73

90

96

67

-

-Data from CC isolates.
Number in parentheses is number of isolates tested.
a. January 1, 1996 through December 31, 1996.
b. January 1, 1996 through May 31, 1997.
c. January 1, 1994 through May 31, 1997.
d. Dashes indicate antibiotics not recommended for use against given organism.
e.Pseudomonas aeruginosa
isolates from cystic fibrosis patients.
f.Pseudomonas aeruginosa isolates from non-cystic fibrosis patients.
* For treatment of urinary tract infections only; data are for levels achievable
in urine only.
Clinical Center, National Institutes of Health, Rev. 6/97Up to Top

Table 2. Comparison
of Amphotericin B Products

Product

Amphotericin B
deoxycholate(Fungizone®)Bristol-Myers Squibb

Liposomal
amphotericin B(AmBisome®)Nexstar/Fujisawa

Amphotericin B
lipid complex(Abelcet®)Liposome Co.

Amphotericin B
colloidal dispersion(Amphotec®)SequusComposition

deoxycholate

hydrogenated soy,
phosphatidylcholine,
cholesterol, diastearoyl phosphatidylglycerol

dimyristoyl
phosphatidylcholine
dimyristoyl phosphatidylglycerol

cholesteryl
sulfateMol % Ampho B

34%

10%

50%

50%Diameter

< 400 nm

80 nm

1600-11,000 nm

122 nmStructure

micelles

spherical

lipid ribbon

lipid discUsual Dose

1 mg/kg/day

5 mg/kg/day

5 mg/kg/day

5 mg/kg/dayDaily Cost*

$6.00

$826.00

$281.00

$252.00*Cost based on Federal
Supply Schedule for a 70-kg patientUp to Top

Formulary
Update
The Pharmacy and Therapeutics Committee recently approved
the following formulary actions:

Additions:

*Tiagabine (Gabatril®), an antiepileptic agent

*Terbinafine (Lamisil®), an oral antifungal agent
for the treatment of onychomycosis

*Amphotericin B lipid complex (Abelcet®), with
use restricted to the Infectious Diseases Services

*Liposomal amphotericin B (AmBisome®), with use
restricted to the Infectious Diseases Services

*Valacyclovir (Valtrex®), an antiviral agent.

*Amiodarone injection 50 mg/mL

*Diazepam rectal gel.Editor's NoteWe wish to thank Alice Pau, Pharm.D. (Table
1) and Stacey Henning, R.Ph. (Table 2) for their contributions to this
issue of Pharmacy Update.Drug Information
Service*Patient-specific pharmacotherapy evaluations and recommendations* Comprehensive
information about medications, biologics, and nutrients* Critical
evaluation of drug therapy literature* Assistance
with study design, protocol development, and clinical trial drug safety
monitoring* Parenteral
nutrition assessment and monitoring301-496-2407Pager 104-2619-7
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                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      | Pharmacy UpdateMarch/April 1998                                  | In This Issue*Amphotericin B Formulations
*Intravenous (I.V.) Amphotericin
B Administration Guidelines (Table 1)

*Susceptibility of Common NIH
Microorganisms

*Did You Know

*Formulary Update

Drug Information Service
Pharmacy Department
Warren G. Magnuson Clinical Center
National Institutes of Health
Bethesda, Maryland 20892-1196
Charles E. Daniels, Ph.D.
Chief, Pharmacy DepartmentEditor-in-ChiefKarim Anton Calis, Pharm.D., M.P.H.
Coordinator, Drug Information Service, and Endocrinology Clinical Pharmacy
Specialist[email protected]Associate EditorAmy M. Heck, Pharm.D.
Specialized Resident in Drug Information Practice and Pharmacotherapy[email protected]Archives | Amphotericin
B Formulations

Amphotericin B remains the drug
of choice for many fungal infections. However, intravenous administration
of amphotericin B deoxycholate is often complicated by both infusion-related
adverse reactions (e.g., fever, chills, rigors, nausea, vomiting, hypotension,
and rarely hypertension) and systemic toxicities (e.g., nephrotoxicity,
acidosis, hypokalemia, hypomagnesemia, and anemia). Symptomatic support
with medications such as antipyretics and antihistamines can often ease
the discomfort associated with infusion-related reactions. The incidence
and severity of nephrotoxicity associated with the amphotericin B deoxycholate
preparation can be minimized by adequate saline hydration in patients who
can tolerate increased fluid intake. Amphotericin B administration guidelines
were recently developed by the Antimicrobials Subcommittee and were approved
by the Pharmacy and Therapeutics (P&T) Committee (see Table 1).

Several lipid formulations of amphotericin
B have recently been approved for use in the United States. These formulations
appear to be less nephrotoxic than conventional amphotericin B, but the
cost of therapy is significantly higher (see Table 2). In patients in whom
conventional amphotericin B therapy is contraindicated or not well tolerated,
the newer products are encouraging alternatives. However, there are few
studies that directly compare the relative safety and efficacy of these
new lipid products.

Two lipid formulations of amphotericin
B were recently approved by the P&T Committee for use at the NIH Clinical
Center: Abelcet® (amphotericin B lipid complex ABLC) and
AmBisome® (liposomal amphotericin B). Use of these agents
requires approval from the NIAID or NCI Infectious Diseases Services.

Upon recommending approval of these
amphotericin B lipid formulations, the P&T Committee issued the following
statements:

*Current
data suggest that lipid formulations of amphotericin B are effective but
less toxic in comparison to conventional amphotericin B.

*To
date, there are no comparative data by which to evaluate the relative efficacy,
safety, and tolerability of the various lipid formulations of amphotericin
B (compared to other lipid formulations).

*Lipid
formulations of amphotericin B are substantially more expensive than conventional
amphotericin B.

*Conventional
amphotericin B is indicated as initial therapy for the treatment of invasive
fungal infections.

*Both
Abelcet® and AmBisome® are indicated as second-line
therapy for treatment of invasive fungal infections in patients who are
intolerant of or refractory to conventional antifungal therapy.

*Both
conventional amphotericin B and AmBisome® are indicated
as initial empirical antifungal therapy for neutropenic patients with persistent
fever who are unresponsive to broad-spectrum antibiotics.

*Pharmacoeconomic
studies are currently under way to clarify the role of lipid formulations
of amphotericin B in the management of invasive fungal infections. |                                    | Table
1. Clinical Center Amphotericin B Deoxycholate Administration Guidelines
Indications
First-line therapy for most systemic
mycoses, especially in immunocompromised hosts

Empiric therapy in febrile neutropenic
patients unresponsive to antibacterial therapy

Oropharyngeal or esophageal candidiasis
refractory to topical antifungals and oral azole therapyAdverse Reactions

Infusion Related:

Fever, chills, rigors, and hypotension;
rarely
hypertension, nausea, vomiting, and anorexia

Thrombophlebitis (if given through
a peripheral line)Non-Infusion Related:

Nephrotoxicity (azotemia and renal
tubular acidosis are dose and duration dependent)

Renal electrolyte wasting (K+,
Mg++, and HCO3-)

Normochromic, normocytic anemiaSuggested Dosages for Selected Systemic
Mycoses

Aspergillosis 1.0 - 1.5 mg/kg/day

Blastomycosis 0.4 - 0.6 mg/kg/day

Candidiasis 0.3 - 1.0 mg/kg/day
(oroesophageal)
0.5 - 1.0 mg/kg/day
(other sites)

Coccidioidomycosis 0.5 - 1.0 mg/kg/day

Cryptococcosis 0.5 - 1.0 mg/kg/day
(may use with flucy-
tosine 100 mg/kg/day)

Fusariosis 1.0 - 1.5 mg/kg/day

Histoplasmosis 0.5 - 0.7 mg/kg/day

Mucormycosis 0.5 - 1.5 mg/kg/dayAdministration

Test dose:

Not necessaryDose Escalation (over 2-3 days):

Not necessary; may reduce infusion-related
adverse effects during the first few days

Not recommended for patients with
serious or life-threatening infectionsInfusion Solution:

Always dilute in dextrose 5% in
water (incompatible with solutions containing sodium chloride)

Final concentrations:

0.1 mg/ml if infused through a peripheral
line
1.4 mg/ml if infused through a central lineInfusion Rate:

Over 2 - 4 hours
Note: use of in-line filter is not recommendedMonitoring During Infusion

Vital signs every 30 minutes during
the first dose, then every 1-2 hours with subsequent doses

Monitor for infusion-related symptoms
throughout administration period

Review signs and symptoms of infusion-related
reactions with patient before administration of first dose

Management of Infusion-Related
Reactions
For immediate response in managing
rigors:

Meperidine given by slow I.V. injection
over at least 5 minutes

Adults: 25-50 mg

Children: 1-1.5 mg/kgFever:

Adults: acetaminophen 500-1000
mg p.o. or 650 mg suppository

Children: dose according to weight
and agePre-Medication (after previous
infusion-related reaction):

Acetaminophen 650 mg p.o. (or suppository)
with or without diphenhydramine (25-50 mg p.o. or I.V. or 0.75-1.25 mg/kg
p.o. or I.V. in pediatric patients) 30 minutes prior to start of infusionIf symptoms persist despite pre-medication:

Hydrocortisone 25-50 mg (10-25
mg in pediatric patients) prior to infusion or added to amphotericin B
solutionFor preventing thrombophlebitis
and infusion-site discomfort when peripheral line is used:

Heparin 100-500 units added to
amphotericin B solutionPrevention of Nephrotoxicity

Saline Hydration or Sodium Loading
(3-6 mEq of Na+/kg):

Hydration with one liter of 0.9%
NaCl solution prior to amphotericin B infusion may reduce incidence and/or
severity of nephrotoxicity

For patients with prolonged therapy,
continuous hydration for up to one week after therapy may be necessary

Alternatively, continuous I.V.
or oral hydration can be used throughout the day (with equivalent amounts
of sodium)

Saline hydration should be given
with caution to patients with cardiac compromise and to those who develop
hypertension during amphotericin B infusion

Saline hydration should not be
given to patients with end-stage renal diseaseManagement of K+, Mg++,
and HCO3- Loss

K+, Mg++,
and HCO3- renal wasting usually becomes apparent
during the first week of therapy and continues throughout treatment course;
aggressive replacement is necessary

Intravenous potassium (acetate
or chloride), and magnesium sulfate can be added to hydration fluid

Oral supplementation can be given
if tolerated

Electrolytes and renal function
should be monitored after completion of therapy

Continued hydration or electrolyte
supplementation may be necessary in some casesUp to Top

Percent Susceptibility
of Common NIH Microorganisms

Concentration
(μg/ml)

Ps. aeruginosa
- CF
"(61) a,e"

Ps. aeruginosa
Non-CF
"(105) a,f"

Stenotrophomonas
maltophilia
(33) b

Staphylococcus
aureus
(221) a

Staphylococcus
epidermidis
(214) a

Enterococcus
faecalis
(131) a

Enterococcus
faecium
(26) bAmikacin

16

68

89

9

99

100

-

-Ampicillin

8

- d

-

-

-

-

98

35Amox./clavulan.

4/2

-

-

-

91

34

-

-Aztreonam

8

72

65

-

-

-

-

-Cefazolin

8

-

-

-

91

34

-

-Cefoxitin

8

-

-

-

-

-

-

-Ceftazidime

8

84

79

48

-

-

-

-Ceftriaxone

8

-

-

-

91

33

-

-Ciprofloxacin

1

57

86

33

90

55

76

15Clindamycin

2

-

-

-

92

60

-

-Erythromycin

0.5

-

-

-

70

29

-

-Gentamicin

4

54

75

-

93

70

-

-Imipenem

4

74

85

-

91

33

99

38Oxacillin

2

-

-

-

91

34

-

-Penicillin

0.12

-

-

-

10

12

-

-Piperacillin

64

88

88

26

-

-

-

-Rifampin

1

-

-

-

98

87

-

-Tobramycin

4

87

96

-

-

-

-

-Trimeth./sulfa.

2/38

-

-

91

92

65

-

-Vancomycin

4

-

-

-

100

100

95

65Gent./Pen. syn.

500

-

-

-

-

-

96

69Nitrofurantoin *

32

-

-

-

-

-

100

60Up to Top

Concentration
(μg/ml)

Escherichia
coli
(191) a

Klebsiella
pneumoniae (97) a

Enterobacter
cloacae
(46) b

Citrobacter
freundii
(18) b

Serratia
marcescens
(35) b

Acinetobacter
baumannii
(35) cAmikacin

16

100

98

100

100

100

97Ampicillin

8

60

-

-

-

-

-Amox./clavulan.

8/4

91

98

-

-

-

-Aztreonam

8

97

93

91

89

94

-Cefazolin

8

86

94

-

-

-

-Cefoxitin

8

95

96

-

-

-

-Ceftazidime

8

97

94

96

83

94

89Ceftriaxone

8

97

94

87

78

100

71Cefuroxime

8

95

90

-

-

-

-Ciprofloxacin

1

98

96

93

94

94

83Gentamicin

4

94

96

93

100

100

91Imipenem

4

100

99

96

100

100

100Piperacillin

16

64

63

87

83

100

83Tobramycin

4

95

96

93

100

100

89Trimeth./sulfa.

2/38

81

95

91

59

100

80Nitrofurantoin *

32

99

65

-

100

-

-Sulfamethox. *

256

64

70

100

44

-

-Tetracycline *

4

73

90

96

67

-

-Data from CC isolates.
Number in parentheses is number of isolates tested.
a. January 1, 1996 through December 31, 1996.
b. January 1, 1996 through May 31, 1997.
c. January 1, 1994 through May 31, 1997.
d. Dashes indicate antibiotics not recommended for use against given organism.
e.Pseudomonas aeruginosa
isolates from cystic fibrosis patients.
f.Pseudomonas aeruginosa isolates from non-cystic fibrosis patients.
* For treatment of urinary tract infections only; data are for levels achievable
in urine only.
Clinical Center, National Institutes of Health, Rev. 6/97Up to Top

Table 2. Comparison
of Amphotericin B Products

Product

Amphotericin B
deoxycholate(Fungizone®)Bristol-Myers Squibb

Liposomal
amphotericin B(AmBisome®)Nexstar/Fujisawa

Amphotericin B
lipid complex(Abelcet®)Liposome Co.

Amphotericin B
colloidal dispersion(Amphotec®)SequusComposition

deoxycholate

hydrogenated soy,
phosphatidylcholine,
cholesterol, diastearoyl phosphatidylglycerol

dimyristoyl
phosphatidylcholine
dimyristoyl phosphatidylglycerol

cholesteryl
sulfateMol % Ampho B

34%

10%

50%

50%Diameter

< 400 nm

80 nm

1600-11,000 nm

122 nmStructure

micelles

spherical

lipid ribbon

lipid discUsual Dose

1 mg/kg/day

5 mg/kg/day

5 mg/kg/day

5 mg/kg/dayDaily Cost*

$6.00

$826.00

$281.00

$252.00*Cost based on Federal
Supply Schedule for a 70-kg patient | Indications
First-line therapy for most systemic
mycoses, especially in immunocompromised hosts

Empiric therapy in febrile neutropenic
patients unresponsive to antibacterial therapy

Oropharyngeal or esophageal candidiasis
refractory to topical antifungals and oral azole therapyAdverse Reactions

Infusion Related:

Fever, chills, rigors, and hypotension;
rarely
hypertension, nausea, vomiting, and anorexia

Thrombophlebitis (if given through
a peripheral line)Non-Infusion Related:

Nephrotoxicity (azotemia and renal
tubular acidosis are dose and duration dependent)

Renal electrolyte wasting (K+,
Mg++, and HCO3-)

Normochromic, normocytic anemiaSuggested Dosages for Selected Systemic
Mycoses

Aspergillosis 1.0 - 1.5 mg/kg/day

Blastomycosis 0.4 - 0.6 mg/kg/day

Candidiasis 0.3 - 1.0 mg/kg/day
(oroesophageal)
0.5 - 1.0 mg/kg/day
(other sites)

Coccidioidomycosis 0.5 - 1.0 mg/kg/day

Cryptococcosis 0.5 - 1.0 mg/kg/day
(may use with flucy-
tosine 100 mg/kg/day)

Fusariosis 1.0 - 1.5 mg/kg/day

Histoplasmosis 0.5 - 0.7 mg/kg/day

Mucormycosis 0.5 - 1.5 mg/kg/dayAdministration

Test dose:

Not necessaryDose Escalation (over 2-3 days):

Not necessary; may reduce infusion-related
adverse effects during the first few days

Not recommended for patients with
serious or life-threatening infectionsInfusion Solution:

Always dilute in dextrose 5% in
water (incompatible with solutions containing sodium chloride)

Final concentrations:

0.1 mg/ml if infused through a peripheral
line
1.4 mg/ml if infused through a central lineInfusion Rate:

Over 2 - 4 hours
Note: use of in-line filter is not recommendedMonitoring During Infusion

Vital signs every 30 minutes during
the first dose, then every 1-2 hours with subsequent doses

Monitor for infusion-related symptoms
throughout administration period

Review signs and symptoms of infusion-related
reactions with patient before administration of first dose | Management of Infusion-Related
Reactions
For immediate response in managing
rigors:

Meperidine given by slow I.V. injection
over at least 5 minutes

Adults: 25-50 mg

Children: 1-1.5 mg/kgFever:

Adults: acetaminophen 500-1000
mg p.o. or 650 mg suppository

Children: dose according to weight
and agePre-Medication (after previous
infusion-related reaction):

Acetaminophen 650 mg p.o. (or suppository)
with or without diphenhydramine (25-50 mg p.o. or I.V. or 0.75-1.25 mg/kg
p.o. or I.V. in pediatric patients) 30 minutes prior to start of infusionIf symptoms persist despite pre-medication:

Hydrocortisone 25-50 mg (10-25
mg in pediatric patients) prior to infusion or added to amphotericin B
solutionFor preventing thrombophlebitis
and infusion-site discomfort when peripheral line is used:

Heparin 100-500 units added to
amphotericin B solutionPrevention of Nephrotoxicity

Saline Hydration or Sodium Loading
(3-6 mEq of Na+/kg):

Hydration with one liter of 0.9%
NaCl solution prior to amphotericin B infusion may reduce incidence and/or
severity of nephrotoxicity

For patients with prolonged therapy,
continuous hydration for up to one week after therapy may be necessary

Alternatively, continuous I.V.
or oral hydration can be used throughout the day (with equivalent amounts
of sodium)

Saline hydration should be given
with caution to patients with cardiac compromise and to those who develop
hypertension during amphotericin B infusion

Saline hydration should not be
given to patients with end-stage renal diseaseManagement of K+, Mg++,
and HCO3- Loss

K+, Mg++,
and HCO3- renal wasting usually becomes apparent
during the first week of therapy and continues throughout treatment course;
aggressive replacement is necessary

Intravenous potassium (acetate
or chloride), and magnesium sulfate can be added to hydration fluid

Oral supplementation can be given
if tolerated

Electrolytes and renal function
should be monitored after completion of therapy

Continued hydration or electrolyte
supplementation may be necessary in some cases |                               | Concentration
(μg/ml)       | Ps. aeruginosa
- CF
"(61) a,e" | Ps. aeruginosa
Non-CF
"(105) a,f" | Stenotrophomonas
maltophilia
(33) b | Staphylococcus
aureus
(221) a | Staphylococcus
epidermidis
(214) a | Enterococcus
faecalis
(131) a | Enterococcus
faecium
(26) b | Amikacin | 16 | 68         | 89 | 9   | 99 | 100 | - | - | Ampicillin | 8  | - d             | -   | - | - | - | 98 | 35 | Amox./clavulan. | 4/2 | -         | - | -  | 91 | 34 | - | - | Aztreonam | 8 | 72        | 65 | - | - | - | -  | -  | Cefazolin | 8 | -         | - | - | 91 | 34 | - | - | Cefoxitin | 8 | -           | - | -  | -  | -  | - | - | Ceftazidime | 8 | 84          | 79 | 48 | - | - | -  | -  | Ceftriaxone | 8 | -             | - | -  | 91 | 33 | -  | -  | Ciprofloxacin | 1  | 57          | 86 | 33 | 90 | 55 | 76 | 15 | Clindamycin | 2 | -            | -   | - | 92 | 60 | -  | -  | Erythromycin | 0.5 | -          | - | -  | 70 | 29 | -  | -  | Gentamicin | 4 | 54       | 75 | -  | 93 | 70 | -  | -  | Imipenem | 4  | 74        | 85 | - | 91 | 33 | 99 | 38 | Oxacillin | 2 | -          | -    | - | 91 | 34 | -  | -  | Penicillin | 0.12 | -            | -  | -  | 10 | 12 | - | - | Piperacillin | 64 | 88       | 88 | 26 | - | - | -  | -  | Rifampin | 1 | -          | - | -  | 98 | 87 | - | - | Tobramycin | 4 | 87              | 96   | - | - | -  | -  | -  | Trimeth./sulfa. | 2/38 | -          | - | 91 | 92 | 65 | -   | -   | Vancomycin | 4  | -               | -   | - | 100 | 100 | 95 | 65 | Gent./Pen. syn. | 500 | -                | -  | - | - | - | 96 | 69 | Nitrofurantoin * | 32 | - | -                     | -                        | -                            | -                           | 100                         | 60                         |                                | Concentration
(μg/ml) | Escherichia
coli
(191) a | Klebsiella
pneumoniae (97) a | Enterobacter
cloacae
(46) b | Citrobacter
freundii
(18) b | Serratia
marcescens
(35) b | Acinetobacter
baumannii
(35) c | Amikacin | 16         | 100 | 98 | 100 | 100 | 100 | 97 | Ampicillin | 8               | 60  | -  | -  | - | - | - | Amox./clavulan. | 8/4       | 91 | 98 | -  | -  | -  | -  | Aztreonam | 8         | 97 | 93 | 91 | 89 | 94 | - | Cefazolin | 8         | 86 | 94 | -  | - | - | - | Cefoxitin | 8           | 95 | 96 | -  | -  | -  | -  | Ceftazidime | 8           | 97 | 94 | 96 | 83 | 94 | 89  | Ceftriaxone | 8          | 97 | 94 | 87 | 78 | 100 | 71 | Cefuroxime | 8             | 95 | 90 | -  | -  | -  | -  | Ciprofloxacin | 1          | 98 | 96 | 93 | 94 | 94  | 83  | Gentamicin | 4        | 94 | 96  | 93 | 100 | 100 | 91  | Imipenem | 4            | 100 | 99 | 96 | 100 | 100 | 100 | Piperacillin | 16         | 64 | 63 | 87 | 83 | 100 | 83  | Tobramycin | 4               | 95   | 96 | 93 | 100 | 100 | 89  | Trimeth./sulfa. | 2/38             | 81 | 95 | 91 | 59 | 100 | 80 | Nitrofurantoin * | 32             | 99  | 65 | -  | 100 | -  | - | Sulfamethox. * | 256            | 64 | 70 | 100 | 44 | -  | - | Tetracycline * | 4                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | 73      | 90                                                          | 96                                                  | 67                                                 | -                                                    | -           | Data from CC isolates.
Number in parentheses is number of isolates tested.
a. January 1, 1996 through December 31, 1996.
b. January 1, 1996 through May 31, 1997.
c. January 1, 1994 through May 31, 1997.
d. Dashes indicate antibiotics not recommended for use against given organism.
e.Pseudomonas aeruginosa
isolates from cystic fibrosis patients.
f.Pseudomonas aeruginosa isolates from non-cystic fibrosis patients.
* For treatment of urinary tract infections only; data are for levels achievable
in urine only.
Clinical Center, National Institutes of Health, Rev. 6/97 | Product                                                                              | Amphotericin B
deoxycholate(Fungizone®)Bristol-Myers Squibb      | Liposomal
amphotericin B(AmBisome®)Nexstar/Fujisawa | Amphotericin B
lipid complex(Abelcet®)Liposome Co. | Amphotericin B
colloidal dispersion(Amphotec®)Sequus | Composition | deoxycholate | hydrogenated soy,
phosphatidylcholine,
cholesterol, diastearoyl phosphatidylglycerol | dimyristoyl
phosphatidylcholine
dimyristoyl phosphatidylglycerol | cholesteryl
sulfate | Mol % Ampho B | 34%            | 10%    | 50%       | 50%      | Diameter  | < 400 nm     | 80 nm      | 1600-11,000 nm | 122 nm      | Structure   | micelles    | spherical   | lipid ribbon | lipid disc | Usual Dose | 1 mg/kg/day | 5 mg/kg/day | 5 mg/kg/day                                                | 5 mg/kg/day | Daily Cost* | $6.00 | $826.00 | $281.00 | $252.00 | *Cost based on Federal
Supply Schedule for a 70-kg patient | Up to Top | Formulary
Update
The Pharmacy and Therapeutics Committee recently approved
the following formulary actions:

Additions:

*Tiagabine (Gabatril®), an antiepileptic agent

*Terbinafine (Lamisil®), an oral antifungal agent
for the treatment of onychomycosis

*Amphotericin B lipid complex (Abelcet®), with
use restricted to the Infectious Diseases Services

*Liposomal amphotericin B (AmBisome®), with use
restricted to the Infectious Diseases Services

*Valacyclovir (Valtrex®), an antiviral agent.

*Amiodarone injection 50 mg/mL

*Diazepam rectal gel.
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                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | Pharmacy UpdateMarch/April 1998                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
|In This Issue*Amphotericin B Formulations
*Intravenous (I.V.) Amphotericin
B Administration Guidelines (Table 1)

*Susceptibility of Common NIH
Microorganisms

*Did You Know

*Formulary Update

Drug Information Service
Pharmacy Department
Warren G. Magnuson Clinical Center
National Institutes of Health
Bethesda, Maryland 20892-1196
Charles E. Daniels, Ph.D.
Chief, Pharmacy DepartmentEditor-in-ChiefKarim Anton Calis, Pharm.D., M.P.H.
Coordinator, Drug Information Service, and Endocrinology Clinical Pharmacy
Specialist[email protected]Associate EditorAmy M. Heck, Pharm.D.
Specialized Resident in Drug Information Practice and Pharmacotherapy[email protected]Archives                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | Amphotericin
B Formulations

Amphotericin B remains the drug
of choice for many fungal infections. However, intravenous administration
of amphotericin B deoxycholate is often complicated by both infusion-related
adverse reactions (e.g., fever, chills, rigors, nausea, vomiting, hypotension,
and rarely hypertension) and systemic toxicities (e.g., nephrotoxicity,
acidosis, hypokalemia, hypomagnesemia, and anemia). Symptomatic support
with medications such as antipyretics and antihistamines can often ease
the discomfort associated with infusion-related reactions. The incidence
and severity of nephrotoxicity associated with the amphotericin B deoxycholate
preparation can be minimized by adequate saline hydration in patients who
can tolerate increased fluid intake. Amphotericin B administration guidelines
were recently developed by the Antimicrobials Subcommittee and were approved
by the Pharmacy and Therapeutics (P&T) Committee (see Table 1).

Several lipid formulations of amphotericin
B have recently been approved for use in the United States. These formulations
appear to be less nephrotoxic than conventional amphotericin B, but the
cost of therapy is significantly higher (see Table 2). In patients in whom
conventional amphotericin B therapy is contraindicated or not well tolerated,
the newer products are encouraging alternatives. However, there are few
studies that directly compare the relative safety and efficacy of these
new lipid products.

Two lipid formulations of amphotericin
B were recently approved by the P&T Committee for use at the NIH Clinical
Center: Abelcet® (amphotericin B lipid complex ABLC) and
AmBisome® (liposomal amphotericin B). Use of these agents
requires approval from the NIAID or NCI Infectious Diseases Services.

Upon recommending approval of these
amphotericin B lipid formulations, the P&T Committee issued the following
statements:

*Current
data suggest that lipid formulations of amphotericin B are effective but
less toxic in comparison to conventional amphotericin B.

*To
date, there are no comparative data by which to evaluate the relative efficacy,
safety, and tolerability of the various lipid formulations of amphotericin
B (compared to other lipid formulations).

*Lipid
formulations of amphotericin B are substantially more expensive than conventional
amphotericin B.

*Conventional
amphotericin B is indicated as initial therapy for the treatment of invasive
fungal infections.

*Both
Abelcet® and AmBisome® are indicated as second-line
therapy for treatment of invasive fungal infections in patients who are
intolerant of or refractory to conventional antifungal therapy.

*Both
conventional amphotericin B and AmBisome® are indicated
as initial empirical antifungal therapy for neutropenic patients with persistent
fever who are unresponsive to broad-spectrum antibiotics.

*Pharmacoeconomic
studies are currently under way to clarify the role of lipid formulations
of amphotericin B in the management of invasive fungal infections.
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                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
|Table
1. Clinical Center Amphotericin B Deoxycholate Administration Guidelines
Indications
First-line therapy for most systemic
mycoses, especially in immunocompromised hosts

Empiric therapy in febrile neutropenic
patients unresponsive to antibacterial therapy

Oropharyngeal or esophageal candidiasis
refractory to topical antifungals and oral azole therapyAdverse Reactions

Infusion Related:

Fever, chills, rigors, and hypotension;
rarely
hypertension, nausea, vomiting, and anorexia

Thrombophlebitis (if given through
a peripheral line)Non-Infusion Related:

Nephrotoxicity (azotemia and renal
tubular acidosis are dose and duration dependent)

Renal electrolyte wasting (K+,
Mg++, and HCO3-)

Normochromic, normocytic anemiaSuggested Dosages for Selected Systemic
Mycoses

Aspergillosis 1.0 - 1.5 mg/kg/day

Blastomycosis 0.4 - 0.6 mg/kg/day

Candidiasis 0.3 - 1.0 mg/kg/day
(oroesophageal)
0.5 - 1.0 mg/kg/day
(other sites)

Coccidioidomycosis 0.5 - 1.0 mg/kg/day

Cryptococcosis 0.5 - 1.0 mg/kg/day
(may use with flucy-
tosine 100 mg/kg/day)

Fusariosis 1.0 - 1.5 mg/kg/day

Histoplasmosis 0.5 - 0.7 mg/kg/day

Mucormycosis 0.5 - 1.5 mg/kg/dayAdministration

Test dose:

Not necessaryDose Escalation (over 2-3 days):

Not necessary; may reduce infusion-related
adverse effects during the first few days

Not recommended for patients with
serious or life-threatening infectionsInfusion Solution:

Always dilute in dextrose 5% in
water (incompatible with solutions containing sodium chloride)

Final concentrations:

0.1 mg/ml if infused through a peripheral
line
1.4 mg/ml if infused through a central lineInfusion Rate:

Over 2 - 4 hours
Note: use of in-line filter is not recommendedMonitoring During Infusion

Vital signs every 30 minutes during
the first dose, then every 1-2 hours with subsequent doses

Monitor for infusion-related symptoms
throughout administration period

Review signs and symptoms of infusion-related
reactions with patient before administration of first dose

Management of Infusion-Related
Reactions
For immediate response in managing
rigors:

Meperidine given by slow I.V. injection
over at least 5 minutes

Adults: 25-50 mg

Children: 1-1.5 mg/kgFever:

Adults: acetaminophen 500-1000
mg p.o. or 650 mg suppository

Children: dose according to weight
and agePre-Medication (after previous
infusion-related reaction):

Acetaminophen 650 mg p.o. (or suppository)
with or without diphenhydramine (25-50 mg p.o. or I.V. or 0.75-1.25 mg/kg
p.o. or I.V. in pediatric patients) 30 minutes prior to start of infusionIf symptoms persist despite pre-medication:

Hydrocortisone 25-50 mg (10-25
mg in pediatric patients) prior to infusion or added to amphotericin B
solutionFor preventing thrombophlebitis
and infusion-site discomfort when peripheral line is used:

Heparin 100-500 units added to
amphotericin B solutionPrevention of Nephrotoxicity

Saline Hydration or Sodium Loading
(3-6 mEq of Na+/kg):

Hydration with one liter of 0.9%
NaCl solution prior to amphotericin B infusion may reduce incidence and/or
severity of nephrotoxicity

For patients with prolonged therapy,
continuous hydration for up to one week after therapy may be necessary

Alternatively, continuous I.V.
or oral hydration can be used throughout the day (with equivalent amounts
of sodium)

Saline hydration should be given
with caution to patients with cardiac compromise and to those who develop
hypertension during amphotericin B infusion

Saline hydration should not be
given to patients with end-stage renal diseaseManagement of K+, Mg++,
and HCO3- Loss

K+, Mg++,
and HCO3- renal wasting usually becomes apparent
during the first week of therapy and continues throughout treatment course;
aggressive replacement is necessary

Intravenous potassium (acetate
or chloride), and magnesium sulfate can be added to hydration fluid

Oral supplementation can be given
if tolerated

Electrolytes and renal function
should be monitored after completion of therapy

Continued hydration or electrolyte
supplementation may be necessary in some casesUp to Top

Percent Susceptibility
of Common NIH Microorganisms

Concentration
(μg/ml)

Ps. aeruginosa
- CF
"(61) a,e"

Ps. aeruginosa
Non-CF
"(105) a,f"

Stenotrophomonas
maltophilia
(33) b

Staphylococcus
aureus
(221) a

Staphylococcus
epidermidis
(214) a

Enterococcus
faecalis
(131) a

Enterococcus
faecium
(26) bAmikacin

16

68

89

9

99

100

-

-Ampicillin

8

- d

-

-

-

-

98

35Amox./clavulan.

4/2

-

-

-

91

34

-

-Aztreonam

8

72

65

-

-

-

-

-Cefazolin

8

-

-

-

91

34

-

-Cefoxitin

8

-

-

-

-

-

-

-Ceftazidime

8

84

79

48

-

-

-

-Ceftriaxone

8

-

-

-

91

33

-

-Ciprofloxacin

1

57

86

33

90

55

76

15Clindamycin

2

-

-

-

92

60

-

-Erythromycin

0.5

-

-

-

70

29

-

-Gentamicin

4

54

75

-

93

70

-

-Imipenem

4

74

85

-

91

33

99

38Oxacillin

2

-

-

-

91

34

-

-Penicillin

0.12

-

-

-

10

12

-

-Piperacillin

64

88

88

26

-

-

-

-Rifampin

1

-

-

-

98

87

-

-Tobramycin

4

87

96

-

-

-

-

-Trimeth./sulfa.

2/38

-

-

91

92

65

-

-Vancomycin

4

-

-

-

100

100

95

65Gent./Pen. syn.

500

-

-

-

-

-

96

69Nitrofurantoin *

32

-

-

-

-

-

100

60Up to Top

Concentration
(μg/ml)

Escherichia
coli
(191) a

Klebsiella
pneumoniae (97) a

Enterobacter
cloacae
(46) b

Citrobacter
freundii
(18) b

Serratia
marcescens
(35) b

Acinetobacter
baumannii
(35) cAmikacin

16

100

98

100

100

100

97Ampicillin

8

60

-

-

-

-

-Amox./clavulan.

8/4

91

98

-

-

-

-Aztreonam

8

97

93

91

89

94

-Cefazolin

8

86

94

-

-

-

-Cefoxitin

8

95

96

-

-

-

-Ceftazidime

8

97

94

96

83

94

89Ceftriaxone

8

97

94

87

78

100

71Cefuroxime

8

95

90

-

-

-

-Ciprofloxacin

1

98

96

93

94

94

83Gentamicin

4

94

96

93

100

100

91Imipenem

4

100

99

96

100

100

100Piperacillin

16

64

63

87

83

100

83Tobramycin

4

95

96

93

100

100

89Trimeth./sulfa.

2/38

81

95

91

59

100

80Nitrofurantoin *

32

99

65

-

100

-

-Sulfamethox. *

256

64

70

100

44

-

-Tetracycline *

4

73

90

96

67

-

-Data from CC isolates.
Number in parentheses is number of isolates tested.
a. January 1, 1996 through December 31, 1996.
b. January 1, 1996 through May 31, 1997.
c. January 1, 1994 through May 31, 1997.
d. Dashes indicate antibiotics not recommended for use against given organism.
e.Pseudomonas aeruginosa
isolates from cystic fibrosis patients.
f.Pseudomonas aeruginosa isolates from non-cystic fibrosis patients.
* For treatment of urinary tract infections only; data are for levels achievable
in urine only.
Clinical Center, National Institutes of Health, Rev. 6/97Up to Top

Table 2. Comparison
of Amphotericin B Products

Product

Amphotericin B
deoxycholate(Fungizone®)Bristol-Myers Squibb

Liposomal
amphotericin B(AmBisome®)Nexstar/Fujisawa

Amphotericin B
lipid complex(Abelcet®)Liposome Co.

Amphotericin B
colloidal dispersion(Amphotec®)SequusComposition

deoxycholate

hydrogenated soy,
phosphatidylcholine,
cholesterol, diastearoyl phosphatidylglycerol

dimyristoyl
phosphatidylcholine
dimyristoyl phosphatidylglycerol

cholesteryl
sulfateMol % Ampho B

34%

10%

50%

50%Diameter

< 400 nm

80 nm

1600-11,000 nm

122 nmStructure

micelles

spherical

lipid ribbon

lipid discUsual Dose

1 mg/kg/day

5 mg/kg/day

5 mg/kg/day

5 mg/kg/dayDaily Cost*

$6.00

$826.00

$281.00

$252.00*Cost based on Federal
Supply Schedule for a 70-kg patient                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | Indications
First-line therapy for most systemic
mycoses, especially in immunocompromised hosts

Empiric therapy in febrile neutropenic
patients unresponsive to antibacterial therapy

Oropharyngeal or esophageal candidiasis
refractory to topical antifungals and oral azole therapyAdverse Reactions

Infusion Related:

Fever, chills, rigors, and hypotension;
rarely
hypertension, nausea, vomiting, and anorexia

Thrombophlebitis (if given through
a peripheral line)Non-Infusion Related:

Nephrotoxicity (azotemia and renal
tubular acidosis are dose and duration dependent)

Renal electrolyte wasting (K+,
Mg++, and HCO3-)

Normochromic, normocytic anemiaSuggested Dosages for Selected Systemic
Mycoses

Aspergillosis 1.0 - 1.5 mg/kg/day

Blastomycosis 0.4 - 0.6 mg/kg/day

Candidiasis 0.3 - 1.0 mg/kg/day
(oroesophageal)
0.5 - 1.0 mg/kg/day
(other sites)

Coccidioidomycosis 0.5 - 1.0 mg/kg/day

Cryptococcosis 0.5 - 1.0 mg/kg/day
(may use with flucy-
tosine 100 mg/kg/day)

Fusariosis 1.0 - 1.5 mg/kg/day

Histoplasmosis 0.5 - 0.7 mg/kg/day

Mucormycosis 0.5 - 1.5 mg/kg/dayAdministration

Test dose:

Not necessaryDose Escalation (over 2-3 days):

Not necessary; may reduce infusion-related
adverse effects during the first few days

Not recommended for patients with
serious or life-threatening infectionsInfusion Solution:

Always dilute in dextrose 5% in
water (incompatible with solutions containing sodium chloride)

Final concentrations:

0.1 mg/ml if infused through a peripheral
line
1.4 mg/ml if infused through a central lineInfusion Rate:

Over 2 - 4 hours
Note: use of in-line filter is not recommendedMonitoring During Infusion

Vital signs every 30 minutes during
the first dose, then every 1-2 hours with subsequent doses

Monitor for infusion-related symptoms
throughout administration period

Review signs and symptoms of infusion-related
reactions with patient before administration of first dose                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | Management of Infusion-Related
Reactions
For immediate response in managing
rigors:

Meperidine given by slow I.V. injection
over at least 5 minutes

Adults: 25-50 mg

Children: 1-1.5 mg/kgFever:

Adults: acetaminophen 500-1000
mg p.o. or 650 mg suppository

Children: dose according to weight
and agePre-Medication (after previous
infusion-related reaction):

Acetaminophen 650 mg p.o. (or suppository)
with or without diphenhydramine (25-50 mg p.o. or I.V. or 0.75-1.25 mg/kg
p.o. or I.V. in pediatric patients) 30 minutes prior to start of infusionIf symptoms persist despite pre-medication:

Hydrocortisone 25-50 mg (10-25
mg in pediatric patients) prior to infusion or added to amphotericin B
solutionFor preventing thrombophlebitis
and infusion-site discomfort when peripheral line is used:

Heparin 100-500 units added to
amphotericin B solutionPrevention of Nephrotoxicity

Saline Hydration or Sodium Loading
(3-6 mEq of Na+/kg):

Hydration with one liter of 0.9%
NaCl solution prior to amphotericin B infusion may reduce incidence and/or
severity of nephrotoxicity

For patients with prolonged therapy,
continuous hydration for up to one week after therapy may be necessary

Alternatively, continuous I.V.
or oral hydration can be used throughout the day (with equivalent amounts
of sodium)

Saline hydration should be given
with caution to patients with cardiac compromise and to those who develop
hypertension during amphotericin B infusion

Saline hydration should not be
given to patients with end-stage renal diseaseManagement of K+, Mg++,
and HCO3- Loss

K+, Mg++,
and HCO3- renal wasting usually becomes apparent
during the first week of therapy and continues throughout treatment course;
aggressive replacement is necessary

Intravenous potassium (acetate
or chloride), and magnesium sulfate can be added to hydration fluid

Oral supplementation can be given
if tolerated

Electrolytes and renal function
should be monitored after completion of therapy

Continued hydration or electrolyte
supplementation may be necessary in some cases |                                                                  | Concentration
(μg/ml)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | Ps. aeruginosa
- CF
"(61) a,e"                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | Ps. aeruginosa
Non-CF
"(105) a,f"  | Stenotrophomonas
maltophilia
(33) b                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      | Staphylococcus
aureus
(221) a                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | Staphylococcus
epidermidis
(214) a                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | Enterococcus
faecalis
(131) a | Enterococcus
faecium
(26) b | Amikacin                       | 16                                | 68                                  | 89                            | 9                                  | 99                            | 100                         | -        | -  | Ampicillin | 8  | - d | -  | -   | - | - | 98         | 35 | Amox./clavulan. | 4/2 | - | - | - | 91 | 34 | -               | -   | Aztreonam | 8 | 72 | 65 | -  | - | - | -         | - | Cefazolin | 8  | - | - | - | 91 | 34 | -         | - | Cefoxitin | 8 | - | -  | -  | - | - | -         | - | Ceftazidime | 8 | 84 | 79 | 48 | - | - | -           | - | Ceftriaxone | 8  | -  | - | - | 91 | 33 | -           | - | Ciprofloxacin | 1 | 57 | 86 | 33 | 90 | 55 | 76            | 15 | Clindamycin | 2  | -  | -  | -  | 92 | 60 | -           | - | Erythromycin | 0.5 | - | -  | -  | 70 | 29 | -            | -   | Gentamicin | 4 | 54 | 75 | -  | 93 | 70 | -          | - | Imipenem | 4  | 74 | 85 | -  | 91 | 33 | 99       | 38 | Oxacillin | 2  | - | -  | -  | 91 | 34 | -         | - | Penicillin | 0.12 | - | -  | -  | 10 | 12 | -          | -    | Piperacillin | 64 | 88 | 88 | 26 | - | - | -            | -  | Rifampin | 1  | -  | - | - | 98 | 87 | -        | - | Tobramycin | 4 | 87 | 96 | -  | - | - | -          | - | Trimeth./sulfa. | 2/38 | - | - | 91 | 92 | 65 | -               | -    | Vancomycin | 4 | -  | -  | -  | 100 | 100 | 95         | 65 | Gent./Pen. syn. | 500 | - | -   | -   | -  | -  | 96              | 69  | Nitrofurantoin * | 32 | - | - | - | -  | -  | 100              | 60 |   | Concentration
(μg/ml) | Escherichia
coli
(191) a | Klebsiella
pneumoniae (97) a | Enterobacter
cloacae
(46) b | Citrobacter
freundii
(18) b | Serratia
marcescens
(35) b | Acinetobacter
baumannii
(35) c | Amikacin              | 16                       | 100                          | 98                          | 100                         | 100                        | 100                            | 97       | Ampicillin | 8   | 60 | -   | -   | -   | -  | -          | Amox./clavulan. | 8/4 | 91 | 98 | - | - | - | -               | Aztreonam | 8  | 97 | 93 | 91 | 89 | 94 | -         | Cefazolin | 8  | 86 | 94 | -  | -  | - | -         | Cefoxitin | 8  | 95 | 96 | - | - | - | -         | Ceftazidime | 8  | 97 | 94 | 96 | 83 | 94 | 89          | Ceftriaxone | 8  | 97 | 94 | 87 | 78 | 100 | 71          | Cefuroxime | 8  | 95 | 90 | -  | -   | -  | -          | Ciprofloxacin | 1  | 98 | 96 | 93 | 94 | 94 | 83            | Gentamicin | 4  | 94 | 96 | 93 | 100 | 100 | 91         | Imipenem | 4  | 100 | 99 | 96  | 100 | 100 | 100      | Piperacillin | 16  | 64 | 63 | 87  | 83  | 100 | 83           | Tobramycin | 4  | 95 | 96 | 93 | 100 | 100 | 89         | Trimeth./sulfa. | 2/38 | 81 | 95 | 91  | 59  | 100 | 80              | Nitrofurantoin * | 32 | 99 | 65 | -  | 100 | -  | -                | Sulfamethox. * | 256 | 64 | 70 | 100 | 44 | - | -              | Tetracycline * | 4  | 73 | 90  | 96 | 67 | - | -              | Data from CC isolates.
Number in parentheses is number of isolates tested.
a. January 1, 1996 through December 31, 1996.
b. January 1, 1996 through May 31, 1997.
c. January 1, 1994 through May 31, 1997.
d. Dashes indicate antibiotics not recommended for use against given organism.
e.Pseudomonas aeruginosa
isolates from cystic fibrosis patients.
f.Pseudomonas aeruginosa isolates from non-cystic fibrosis patients.
* For treatment of urinary tract infections only; data are for levels achievable
in urine only.
Clinical Center, National Institutes of Health, Rev. 6/97 | Product | Amphotericin B
deoxycholate(Fungizone®)Bristol-Myers Squibb | Liposomal
amphotericin B(AmBisome®)Nexstar/Fujisawa | Amphotericin B
lipid complex(Abelcet®)Liposome Co. | Amphotericin B
colloidal dispersion(Amphotec®)Sequus | Composition | deoxycholate                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | hydrogenated soy,
phosphatidylcholine,
cholesterol, diastearoyl phosphatidylglycerol | dimyristoyl
phosphatidylcholine
dimyristoyl phosphatidylglycerol | cholesteryl
sulfate                                 | Mol % Ampho B                                      | 34%                                                  | 10%         | 50%          | 50%                                                                                  | Diameter                                                         | < 400 nm            | 80 nm         | 1600-11,000 nm | 122 nm | Structure | micelles | spherical | lipid ribbon | lipid disc | Usual Dose     | 1 mg/kg/day | 5 mg/kg/day | 5 mg/kg/day | 5 mg/kg/day | Daily Cost*  | $6.00      | $826.00    | $281.00     | $252.00     | *Cost based on Federal
Supply Schedule for a 70-kg patient
|Indications
First-line therapy for most systemic
mycoses, especially in immunocompromised hosts

Empiric therapy in febrile neutropenic
patients unresponsive to antibacterial therapy

Oropharyngeal or esophageal candidiasis
refractory to topical antifungals and oral azole therapyAdverse Reactions

Infusion Related:

Fever, chills, rigors, and hypotension;
rarely
hypertension, nausea, vomiting, and anorexia

Thrombophlebitis (if given through
a peripheral line)Non-Infusion Related:

Nephrotoxicity (azotemia and renal
tubular acidosis are dose and duration dependent)

Renal electrolyte wasting (K+,
Mg++, and HCO3-)

Normochromic, normocytic anemiaSuggested Dosages for Selected Systemic
Mycoses

Aspergillosis 1.0 - 1.5 mg/kg/day

Blastomycosis 0.4 - 0.6 mg/kg/day

Candidiasis 0.3 - 1.0 mg/kg/day
(oroesophageal)
0.5 - 1.0 mg/kg/day
(other sites)

Coccidioidomycosis 0.5 - 1.0 mg/kg/day

Cryptococcosis 0.5 - 1.0 mg/kg/day
(may use with flucy-
tosine 100 mg/kg/day)

Fusariosis 1.0 - 1.5 mg/kg/day

Histoplasmosis 0.5 - 0.7 mg/kg/day

Mucormycosis 0.5 - 1.5 mg/kg/dayAdministration

Test dose:

Not necessaryDose Escalation (over 2-3 days):

Not necessary; may reduce infusion-related
adverse effects during the first few days

Not recommended for patients with
serious or life-threatening infectionsInfusion Solution:

Always dilute in dextrose 5% in
water (incompatible with solutions containing sodium chloride)

Final concentrations:

0.1 mg/ml if infused through a peripheral
line
1.4 mg/ml if infused through a central lineInfusion Rate:

Over 2 - 4 hours
Note: use of in-line filter is not recommendedMonitoring During Infusion

Vital signs every 30 minutes during
the first dose, then every 1-2 hours with subsequent doses

Monitor for infusion-related symptoms
throughout administration period

Review signs and symptoms of infusion-related
reactions with patient before administration of first dose                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | Management of Infusion-Related
Reactions
For immediate response in managing
rigors:

Meperidine given by slow I.V. injection
over at least 5 minutes

Adults: 25-50 mg

Children: 1-1.5 mg/kgFever:

Adults: acetaminophen 500-1000
mg p.o. or 650 mg suppository

Children: dose according to weight
and agePre-Medication (after previous
infusion-related reaction):

Acetaminophen 650 mg p.o. (or suppository)
with or without diphenhydramine (25-50 mg p.o. or I.V. or 0.75-1.25 mg/kg
p.o. or I.V. in pediatric patients) 30 minutes prior to start of infusionIf symptoms persist despite pre-medication:

Hydrocortisone 25-50 mg (10-25
mg in pediatric patients) prior to infusion or added to amphotericin B
solutionFor preventing thrombophlebitis
and infusion-site discomfort when peripheral line is used:

Heparin 100-500 units added to
amphotericin B solutionPrevention of Nephrotoxicity

Saline Hydration or Sodium Loading
(3-6 mEq of Na+/kg):

Hydration with one liter of 0.9%
NaCl solution prior to amphotericin B infusion may reduce incidence and/or
severity of nephrotoxicity

For patients with prolonged therapy,
continuous hydration for up to one week after therapy may be necessary

Alternatively, continuous I.V.
or oral hydration can be used throughout the day (with equivalent amounts
of sodium)

Saline hydration should be given
with caution to patients with cardiac compromise and to those who develop
hypertension during amphotericin B infusion

Saline hydration should not be
given to patients with end-stage renal diseaseManagement of K+, Mg++,
and HCO3- Loss

K+, Mg++,
and HCO3- renal wasting usually becomes apparent
during the first week of therapy and continues throughout treatment course;
aggressive replacement is necessary

Intravenous potassium (acetate
or chloride), and magnesium sulfate can be added to hydration fluid

Oral supplementation can be given
if tolerated

Electrolytes and renal function
should be monitored after completion of therapy

Continued hydration or electrolyte
supplementation may be necessary in some cases                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
|                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | Concentration
(μg/ml)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | Ps. aeruginosa
- CF
"(61) a,e"                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | Ps. aeruginosa
Non-CF
"(105) a,f"                                | Stenotrophomonas
maltophilia
(33) b                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | Staphylococcus
aureus
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epidermidis
(214) a | Enterococcus
faecalis
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faecium
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                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
|Trimeth./sulfa.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         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                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
|Nitrofurantoin *                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 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                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | 65                                                               | -                                                                                                                                                                                                                                                                                     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                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
|Sulfamethox. *                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          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                                                                                                                                                                                                                                                                                                                                                                                                           | -                                  | -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
|Tetracycline *                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   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                                                                                                                                                                                                                                                                                                                                                                                                           | -                                  | -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
|Data from CC isolates.
Number in parentheses is number of isolates tested.
a. January 1, 1996 through December 31, 1996.
b. January 1, 1996 through May 31, 1997.
c. January 1, 1994 through May 31, 1997.
d. Dashes indicate antibiotics not recommended for use against given organism.
e.Pseudomonas aeruginosa
isolates from cystic fibrosis patients.
f.Pseudomonas aeruginosa isolates from non-cystic fibrosis patients.
* For treatment of urinary tract infections only; data are for levels achievable
in urine only.
Clinical Center, National Institutes of Health, Rev. 6/97                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
|Product                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | Amphotericin B
deoxycholate(Fungizone®)Bristol-Myers Squibb                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | Liposomal
amphotericin B(AmBisome®)Nexstar/Fujisawa                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Amphotericin B
lipid complex(Abelcet®)Liposome Co.               | Amphotericin B
colloidal dispersion(Amphotec®)Sequus                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
|Composition                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             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                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | hydrogenated soy,
phosphatidylcholine,
cholesterol, diastearoyl phosphatidylglycerol                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | dimyristoyl
phosphatidylcholine
dimyristoyl phosphatidylglycerol | cholesteryl
sulfate                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
|Mol % Ampho B                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    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                                                                                                                                                                                                                                                                                                                                                                                                         
|Diameter                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         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                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | 1600-11,000 nm                                                   | 122 nm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
|Structure                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        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                                                                                                                                                                                                                                                                                                                                                                                                         
|Usual Dose                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | 1 mg/kg/day                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | 5 mg/kg/day                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | 5 mg/kg/day                                                      | 5 mg/kg/day                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
|Daily Cost*                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      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                                                                                                                                                                                                                                                                                                                                                                                                         
|*Cost based on Federal
Supply Schedule for a 70-kg patient                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
|Up to Top                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | Formulary
Update
The Pharmacy and Therapeutics Committee recently approved
the following formulary actions:

Additions:

*Tiagabine (Gabatril®), an antiepileptic agent

*Terbinafine (Lamisil®), an oral antifungal agent
for the treatment of onychomycosis

*Amphotericin B lipid complex (Abelcet®), with
use restricted to the Infectious Diseases Services

*Liposomal amphotericin B (AmBisome®), with use
restricted to the Infectious Diseases Services

*Valacyclovir (Valtrex®), an antiviral agent.

*Amiodarone injection 50 mg/mL

*Diazepam rectal gel.