Labor and Delivery
The effect of erythromycin on labor and delivery is unknown.
Erythromycin is excreted in human milk.
Caution should be exercised when erythromycin is administered to
a nursing woman.
See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.
Elderly patients, particularly those with
reduced renal or hepatic function, may be at increased risk for developing
erythromycin-induced hearing loss. (See ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION).
Elderly patients may be more susceptible to the development
of torsades de pointes arrhythmias than younger patients. (See ADVERSE REACTIONS).
patients may experience increased effects of oral anticoagulant therapy
while undergoing treatment with erythromycin. (See PRECAUTIONS — Drug Interactions).
Erythrocin Stearate Filmtab ® Tablets (250 mg) contain 56.7 mg (2.5
mEq) of sodium and 5.0 mg (0.1 mEq) of potassium per tablet.
Erythrocin Stearate Filmtab ® Tablets (500
mg) contain no sodium and 7.0 mg (0.2 mEq) of potassium per tablet.
The geriatric population may respond with
a blunted natriuresis to salt loading. This may be clinically important
with regard to such diseases as congestive heart failure.
most frequent side effects of oral erythromycin preparations are gastrointestinal
and are dose-related. They include nausea, vomiting, abdominal pain,
diarrhea and anorexia. Symptoms of hepatitis, hepatic dysfunction
and/or abnormal liver function test results may occur. (See WARNINGS.)
Onset of pseudomembranous
colitis symptoms may occur during or after antibacterial treatment.
Erythromycin has been associated with QT prolongation and ventricular
arrhythmias, including ventricular tachycardia and torsades de pointes.
Allergic reactions ranging from urticaria
to anaphylaxis have occurred. Skin reactions ranging from mild eruptions
to erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal
necrolysis have been reported rarely.
There have been rare reports of pancreatitis and convulsions.
There have been isolated reports of reversible
hearing loss occurring chiefly in patients with renal insufficiency
and in patients receiving high doses of erythromycin.
In case of overdosage, erythromycin should
be discontinued. Overdosage should be handled with the prompt elimination
of unabsorbed drug and all other appropriate measures should be instituted.
Erythromycin is not removed by peritoneal
dialysis or hemodialysis.
DOSAGE AND ADMINISTRATION
Optimal serum levels of erythromycin are reached when ERYTHROCIN
STEARATE (erythromycin stearate) is taken in the fasting state or
immediately before meals.
The usual dosage is 250 mg every 6 hours;
or 500 mg every 12 hours. Dosage may be increased up to 4 g per day
according to the severity of the infection. However, twice-a-day
dosing is not recommended when doses larger than 1 g daily are administered.
Age, weight, and severity of the infection
are important factors in determining the proper dosage. The usual
dosage is 30 to 50 mg/kg/day, in equally divided doses. For more
severe infections this dosage may be doubled but should not exceed
4 g per day.
In the treatment of streptococcal infections
of the upper respiratory tract (e.g., tonsillitis or pharyngitis),
the therapeutic dosage of erythromycin should be administered for
at least ten days.
Heart Association suggests a dosage of 250 mg of erythromycin orally,
twice a day in long-term prophylaxis of streptococcal upper respiratory
tract infections for the prevention of recurring attacks of rheumatic
fever in patients allergic to penicillin and sulfonamides.3
Conjunctivitis of the
Newborn Caused by Chlamydia trachomatis
Oral erythromycin suspension 50 mg/kg/day
in 4 divided doses for at least 2 weeks.3
Pneumonia of Infancy
Caused by Chlamydia trachomatis
Although the optimal duration of therapy
has not been established, the recommended therapy is oral erythromycin
suspension 50 mg/kg/day in 4 divided doses for at least 3 weeks.
During Pregnancy Due to Chlamydia trachomatis
Although the optimal dose and duration
of therapy have not been established, the suggested treatment is 500
mg of erythromycin by mouth four times a day or two erythromycin 333
mg tablets orally every 8 hours on an empty stomach for at least 7
days. For women who cannot tolerate this regimen, a decreased dose
of one erythromycin 500 mg tablet orally every 12 hours, one 333 mg
tablet orally every 8 hours or 250 mg by mouth four times a day should
be used for at least 14 days.5
For Adults With Uncomplicated
Urethral, Endocervical, or Rectal Infections Caused by Chlamydia
trachomatis , When Tetracycline is Contraindicated or Not
500 mg of
erythromycin by mouth four times a day or two 333 mg tablets orally
every 8 hours for at least 7 days.5
For Patients With Nongonococcal
Urethritis Caused by Ureaplasma urealyticum When
Tetracycline is Contraindicated or Not Tolerated
500 mg of erythromycin by mouth four times
a day or two 333 mg tablets orally every 8 hours for at least seven
30 to 40 g given in divided doses over
a period of 10 to 15 days.
Acute Pelvic Inflammatory
Disease Caused by N. gonorrhoeae
500 mg Erythrocin Lactobionate-I.V. (erythromycin
lactobionate for injection, USP) every 6 hours for 3 days, followed
by 500 mg of erythromycin base orally every 12 hours, or 333 mg of
erythromycin base orally every 8 hours for 7 days.
500 mg every 12 hours, 333 mg every 8 hours
or 250 mg every 6 hours for 10 to 14 days.
30 to 50 mg/kg/day in divided doses for
10 to 14 days.
Although optimal dosage and duration have
not been established, doses of erythromycin utilized in reported clinical
studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14
Although optimal dosage has not been established,
doses utilized in reported clinical data were 1 to 4 g daily in divided
ERYTHROCIN STEARATE Filmtab Tablets (erythromycin
stearate tablets, USP) are supplied in the following strengths and
Filmtab, 250 mg pink tablets imprinted with the corporate Abbott
“A” logo and the Abbo-Code designation ES:
Bottles of 100………………………………………………………..(NDC 0074-6346-20)
Bottles of 500………………………………………………………..(NDC 0074-6346-53)
STEARATE Filmtab, 500 mg pink tablets imprinted with the corporate Abbott “A” logo and the Abbo-Code designation ET:
Bottles of 100……………………………………………………….(NDC 0074-6316-13)
Store below 86°F (30°C).
- National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria
that Grow Aerobically , Third Edition. Approved Standard
NCCLS Document M7-A3, Vol. 13, No. 25 NCCLS, Villanova , PA, December
- National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests , Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13,
No. 24 NCCLS, Villanova , PA, December 1993.
- Committee on Rheumatic Fever, Endocarditis, and Kawasaki
Disease of the Council on Cardiovascular Disease in the Young, the
American Heart Association: Prevention of Rheumatic Fever. Circulation. 78(4):1082-1086, October 1988.
- Honein, M.A., et. al.: Infantile hypertrophic pyloric stenosis
after pertussis prophylaxis with erythromycin: a case review and
cohort study. The Lancet 1999;354 (9196):2101-5.
- Data on file, Abbott Laboratories.
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