INDICATIONS AND USAGE
To reduce the development of drug-resistant
bacteria and maintain the effectiveness of ERYTHROCIN STEARATE Filmtab
tablets and other antibacterial drugs, ERYTHROCIN STEARATE Filmtab
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.
ERYTHROCIN STEARATE tablets are indicated in the treatment
of infections caused by susceptible strains of the designated microorganisms
in the diseases listed below:
Upper respiratory tract infections of mild to moderate degree caused
by Streptococcus pyogenes; Streptococcus
pneumoniae
; Haemophilus influenzae (when
used concomitantly with adequate doses of sulfonamides, since many
strains of H. influenzae are not susceptible to the
erythromycin concentrations ordinarily achieved).
(See appropriate
sulfonamide labeling for prescribing information.)
Lower respiratory tract infections of mild to moderate
severity caused by Streptococcus pyogenes or Streptococcus pneumoniae.
Listeriosis caused by Listeria monocytogenes.
Respiratory tract infections due to Mycoplasma pneumoniae.
Skin and skin structure infections of mild to moderate severity caused
by Streptococcus pyogenes or Staphylococcus
aureus (resistant staphylococci may emerge during treatment).
Pertussis (whooping cough) caused by Bordetella pertussis.
Erythromycin is effective in eliminating
the organism from the nasopharynx of infected individuals, rendering
them noninfectious.
Some clinical studies suggest that erythromycin
may be helpful in the prophylaxis of pertussis in exposed susceptible
individuals.
Diphtheria: Infections
due to Corynebacterium diphtheriae, as an adjunct
to antitoxin, to prevent establishment of carriers and to eradicate
the organism in carriers.
Erythrasma:
In the treatment of infections due to Corynebacterium minutissimum.
Intestinal amebiasis caused
by Entamoeba histolytica (oral erythromycins only).
Extraenteric amebiasis requires treatment with other agents.
Acute Pelvic Inflammatory Disease Caused
by Neisseria gonorrhoeae: Erythrocin Lactobionate-I.V.
(erythromycin lactobionate for injection, USP) followed by erythromycin
base orally, as an alternative drug in treatment of acute pelvic inflammatory
disease caused by N. gonorrhoeae
in female patients
with a history of sensitivity to penicillin.
Patients should have
a serologic test for syphilis before receiving erythromycin as treatment
of gonorrhea and a follow-up serologic test for syphilis after 3 months.
Erythromycins are Indicated for Treatment
of the Following Infections Caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital
infections during pregnancy.
When tetracyclines are contraindicated
or not tolerated, erythromycin is indicated for the treatment of uncomplicated
urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis.
When tetracyclines are contraindicated or not tolerated, erythromycin
is indicated for the treatment of nongonococcal urethritis caused
by Ureaplasma urealyticum.
Primary syphilis caused by Treponema pallidum.
Erythromycin (oral forms only) is an alternative choice of treatment
for primary syphilis in patients allergic to the penicillins.
In
treatment of primary syphilis, spinal fluid should be examined before
treatment and as part of the follow-up after therapy.
Legionnaires' Disease caused by Legionella
pneumophila.
Although no controlled clinical efficacy studies
have been conducted, in vitro and limited preliminary
clinical data suggest that erythromycin may be effective in treating
Legionnaires' Disease.
Prophylaxis
Prevention of Initial
Attacks of Rheumatic Fever
Penicillin is considered by the American Heart Association to be
the drug of choice in the prevention of initial attacks of rheumatic
fever (treatment of Streptococcus pyogenes infections
of the upper respiratory tract e.g., tonsillitis, or pharyngitis).3
Erythromycin is indicated for the treatment of penicillin-allergic
patients. The therapeutic dose should be administered for ten days.
Prevention of Recurrent
Attacks of Rheumatic Fever
Penicillin or sulfonamides are considered by the American Heart Association
to be the drugs of choice in the prevention of recurrent attacks of
rheumatic fever.
In patients who are allergic to penicillin and sulfonamides,
oral erythromycin is recommended by the American Heart Association
in the long-term prophylaxis of streptococcal pharyngitis (for the
prevention of recurrent attacks of rheumatic fever).3