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Erythrocin Stearate

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Erythrocin Stearate

Erythrocin Stearate

INDICATIONS

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ERYTHROCIN STEARATE (erythromycin stearate tablets) 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 (erythromycin stearate tablets) 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' Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, Disease caused by in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating

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

DOSAGE AND ADMINISTRATION

Optimal serum levels of erythromycin are reached when ERYTHROCIN STEARATE (erythromycin stearate tablets) (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, 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 (erythromycin stearate tablets) Filmtab, 250 mg pink tablets imprinted with the corporate logo a and the Abbo-Code designation ES:

Bottles of 100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (NDC 0074-6346-20)
Bottles of 500 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (NDC 0074-6346-53)
Bottles of 1000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (NDC 0074-6346-19)
ABBO-PAC® unit dose strip packages of 100 tablets . . . . . . . . (NDC 0074-6346-38)

ERYTHROCIN STEARATE (erythromycin stearate tablets) Filmtab, 500 mg pink tablets imprinted with the corporate logo a and the Abbo-Code designation ET:

Bottles of 100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (NDC 0074-6316-13)

Recommended Storage: Store below 86°F

Abbott Laboratories, North Chicago, IL 60064, USA. . Revised: September, 2003. FDA revision date: 12/1/1998

REFERENCES

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.

5. Data on file, Abbott Laboratories.

Last reviewed on RxList: 9/10/2008
This monograph has been modified to include the generic and brand name in many instances.

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