Erythrocin Stearate (Page 4 of 5)

Labor and Delivery

The effect of erythromycin on labor and delivery is unknown.

Nursing Mothers

Erythromycin is excreted in human milk. Caution should be exercised when erythromycin is administered to a nursing woman.

Pediatric Use

See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.

Geriatric Use

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).

Elderly 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.

ADVERSE REACTIONS

The 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. (See WARNINGS.)

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.

OVERDOSAGE

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.

Adults

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.

Children

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.

The American 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.

Urogenital Infections 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 Tolerated

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 days.5

Primary Syphilis

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.

Intestinal Amebiasis

Adults

500 mg every 12 hours, 333 mg every 8 hours or 250 mg every 6 hours for 10 to 14 days.

Children

30 to 50 mg/kg/day in divided doses for 10 to 14 days.

Pertussis

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 days.

Legionnaires’ Disease

Although optimal dosage has not been established, doses utilized in reported clinical data were 1 to 4 g daily in divided doses.

HOW SUPPLIED

ERYTHROCIN STEARATE Filmtab Tablets (erythromycin stearate tablets, USP) are supplied in the following strengths and packages.

ERYTHROCIN STEARATE 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)

ERYTHROCIN 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)

Recommended Storage

Store below 86°F (30°C).

REFERENCES

  1. 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 1993.
  2. 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.
  3. 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.
  4. 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.
  5. Data on file, Abbott Laboratories.

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