1 INDICATIONS AND USAGE
Ciprofloxacin tabletsare a fluoroquinolone antibacterial indicated in adults (18 years of age and older)with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated:
Skin and Skin Structure Infections (
1.1)
Bone and Joint Infections (
1.2)
Complicated Intra-Abdominal Infections (
1.3)
Infectious Diarrhea (
1.4)
Typhoid Fever (Enteric Fever) (
1.5)
Uncomplicated Cervical and Urethral Gonorrhea (
1.6)
Inhalational Anthrax post-exposure in adult and pediatric patients (
1.7)
Plague in adult and pediatric patients (
1.8)
Chronic Bacterial Prostatitis (
1.9)
Lower Respiratory Tract Infections (
1.10)
Acute Exacerbation of Chronic Bronchitis
Urinary Tract Infections (
1.11)
Urinary Tract Infections (UTI)
Acute Uncomplicated Cystitis
Complicated UTI and Pyelonephritis in Pediatric Patients
Acute Sinusitis (
1.12)
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other antibacterial drugs, ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (
1.13)
1.1 Skin and Skin Structure Infections
Ciprofloxacin tablets areindicated in adult patients for treatment of skin and skin structure infections caused by
Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillinsusceptible
Staphylococcus aureus, methicillin-susceptible
Staphylococcus epidermidis, or
Streptococcus pyogenes.
1.2 Bone and Joint Infections
Ciprofloxacin tablets areindicated in adult patients for treatment of bone and joint infections caused by
Enterobacter cloacae, Serratia marcescens, or
Pseudomonas aeruginosa.
1.3 Complicated Intra-Abdominal Infections
Ciprofloxacin tablets areindicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by
Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or
Bacteroides fragilis.
1.4 Infectious Diarrhea
Ciprofloxacin tablets areindicated in adult patients for treatment of infectious diarrhea caused by
Escherichia coli (enterotoxigenic isolates),
Campylobacter jejuni, Shigella boydii
,
Shigella dysenteriae, Shigella flexneri or
Shigella sonnei
when antibacterial therapy is indicated.
Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.
1.5 Typhoid Fever (Enteric Fever)
Ciprofloxacin tablets areindicated in adult patients for treatment of typhoid fever (enteric fever
) caused by
Salmonella typhi. The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated.
1.6 Uncomplicated Cervical and Urethral Gonorrhea
Ciprofloxacin tablets areindicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to
Neisseria gonorrhoeae [see Warnings and Precautions
(5.17)
].
1.7 Inhalational Anthrax (Post-Exposure)
Ciprofloxacin tablets areindicated in adults and pediatric patients from birth to 17 years of age for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized
Bacillus anthracis.
Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.
1 Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001
[
s
ee Clinical Studies
(14.2)
]
.
1.8 Plague
Ciprofloxacin tablets areindicated for treatment of plague, including pneumonic and septicemic plague, due to
Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. Efficacy studies of ciprofloxacin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only
[see Clinical Studies
(14.3)
].
1.9 Chronic Bacterial Prostatitis
Ciprofloxacin tablets are indicatedin adultpatientsfortreatmentofchronicbacterialprostatitis caused by
Esc
h
er
i
ch
i
a co
l
i
or
P
ro
t
eus
m
i
ra
b
i
l
i
s.
1.10Lower Respiratory Tract Infections
Ciprofloxacin tablets are indicatedin adultpatientsfortreatmentoflower respiratorytractinfectionscausedby
Esche
r
i
c
h
i
a
co
l
i
,
Kl
eb
s
i
e
l
l
a
pneu
m
o
n
i
ae, E
n
t
e
roba
c
t
er
c
l
oa
c
ae, P
r
o
t
e
us
mi
ra
b
i
l
i
s,
Pseudo
m
on
a
s aeru
g
i
nos
a
,
H
ae
m
op
h
il
u
s
i
n
fl
u
enz
a
e,
H
ae
m
op
h
i
l
us
p
a
ra
i
n
fl
u
enz
a
e, or
S
t
re
p
t
oc
oc
cus
p
n
eu
m
on
i
a
e.
Ciprofloxacin tablets are notadrugoffirstchoicein thetreatmentofpresumed orconfirmed pneumoniasecondaryto
S
t
re
p
t
o
c
occ
u
s
pn
e
u
m
on
i
a
e.
Ciprofloxacin tablets are indicatedforthetreatmentofacuteexacerbationsofchronicbronchitis (AECB)caused by
M
or
a
xe
l
l
a
ca
t
a
rrh
a
l
i
s.
Becausefluoroquinolones,includingciprofloxacin tablets, havebeen associated with seriousadverse reactions
[see
W
arn
i
ngs
and P
r
eca
u
t
i
ons
(
5.1
to
5.16
)
]
andforsomepatientsAECBisself-limiting, reserveciprofloxacin tabletsfor treatmentofAECBin patientswho haveno alternativetreatmentoptions
.
1.11 Urinary Tract Infections
U
r
i
na
r
y
Tr
a
ct
I
n
f
ec
t
i
o
n
s
i
n
Adu
l
t
s
Ciprofloxacin tablets are indicatedin adultpatients fortreatmentofurinarytractinfectionscaused by
Esche
r
i
c
h
i
a c
o
l
i,
K
l
eb
s
i
e
ll
a
p
neu
m
o
n
i
ae,
E
n
t
eroba
c
t
e
r
c
l
oac
a
e,
S
e
rr
a
ti
a
m
arce
s
cen
s,
Pr
o
t
eus
m
i
r
a
b
i
l
i
s,
P
ro
v
i
de
n
c
i
a re
t
t
ge
r
i,
M
or
g
an
e
ll
a
m
o
rg
a
n
ii,
C
i
t
roba
c
t
e
r
ko
s
e
r
i,
Ci
t
r
obac
t
er
f
re
u
nd
i
i,
P
s
eudo
m
o
nas
a
e
rug
i
nosa, methicillin-susceptible
S
t
a
p
hy
l
o
c
occ
u
s
e
p
i
d
e
r
m
i
d
i
s,
S
t
aphy
l
o
co
c
cus
s
apro
p
hy
t
i
c
u
s, or
E
n
t
e
roco
c
cus
f
aec
a
l
i
s.
Acu
t
e
U
n
co
m
p
l
i
c
a
t
ed
C
ys
ti
ti
s
Ciprofloxacin tablets are indicatedin adultfemalepatients fortreatmentofacuteuncomplicated cystitiscaused by
Esche
r
i
c
h
i
a
co
l
i
or
S
t
a
ph
y
l
ococc
u
s
sa
p
rop
h
y
t
i
cu
s
.
Becausefluoroquinolones,includingciprofloxacin tablets, havebeen associated with seriousadverse reactions
[
see Wa
r
n
i
n
g
s
and
P
r
e
ca
u
ti
o
n
s
(
5.1
to
5.16
)
]andforsomepatientsacuteuncomplicated cystitisisself-limiting, reserveciprofloxacin tabletsfortreatmentofacuteuncomplicated cystitisin patientswho haveno alternativetreatment options.
C
o
m
p
li
c
a
t
e
d
U
r
i
n
ary
T
ra
c
t
I
n
f
ec
t
i
on
a
nd P
y
e
l
o
n
eph
r
i
t
i
s
i
n Pe
d
i
a
t
r
i
c
Pa
t
i
e
n
t
s
Ciprofloxacin tablets are indicatedin pediatricpatientsaged oneto 17 yearsofage fortreatmentofcomplicated urinary tractinfections(cUTI)andpyelonephritisdueto
E
s
ch
e
r
i
c
h
i
a
c
o
l
i
[
s
ee
U
s
e
i
n
Spe
c
i
f
i
c
Pop
u
l
a
ti
o
ns
(8.4)
].
Although effective in clinicaltrials, ciprofloxacin is notadrugof firstchoiceinthepediatricpopulation dueto an increasedincidenceofadversereactionscomparedto controls, includingreactionsrelatedtojoints and/orsurroundingtissues
.
Ciprofloxacin, likeotherfluoroquinolones,isassociated witharthropathyand histopathologicalchangesin weight-bearingjointsof juvenileanimals
[see
W
arn
i
ngs
and
P
rec
a
u
t
i
ons
(5.13)
, Adverse
Rea
c
t
i
ons
(6.1)
,
U
se
i
n
S
pe
c
i
f
i
c
P
o
pu
l
a
ti
o
ns
(8.4)
and
N
on
c
l
i
n
i
c
a
l
To
x
i
c
o
l
ogy
(13.2)
]
.
1.12 Acute Sinusitis
Ciprofloxacin tablets are indicatedin adultpatientsfortreatmentofacutesinusitiscaused by
H
a
e
m
oph
i
l
us
i
n
f
l
ue
n
zae, S
t
re
p
t
o
c
occ
u
s
pn
e
u
m
on
i
a
e,
or
M
ora
x
e
l
l
a c
a
t
a
rrh
a
l
i
s.
Because fluoroquinolones, including ciprofloxacin tablets, have been associated with serious adverse reactions
[see
Warnings
and Precautions (
5.1
to
5.16)]
and for some patients acute sinusitis is self-limiting, reserve ciprofloxacin tablets for treatment of acute sinusitis in patients who have no alternative treatment options.
1.13 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other antibacterial drugs, ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with ciprofloxacin tablets may be initiated before results of these tests are known; once results become available appropriate therapy should be continued.
As with other drugs, some isolates of
Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ciprofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.