Prescription Drugs

CLINICAL PHARMACOLOGY The exact mechanism by which erythromycin reduces lesions of acne vulgaris is not fully known; however, the effect appears to be due in part to the antibacterial activity of the drug. Microbiology: Erythromycin appears to inhibit protein synthesis in susceptible organisms by reversibly binding to ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. Antagonism has been demonstrated between erythromycin, lincomycin, chloramphenicol, and clindamycin.

EMGEL (erythromycin) ® TOPICAL GEL USP 2% Rx Only For Dermatologic Use Only-Not for Ophthalmic Use DESCRIPTION EMGEL (erythromycin) Topical Gel contains erythromycin. Erythromycin is a macrolide antibiotic obtained from cultures of Streptomyces erythreus. Erythromycin has the empirical formula C 37 H 67 NO 13 and a molecular weight of 733.94. It has the following structural formula: EMGEL Topical Gel contains erythromycin, USP 2% (20 mg/g) with SD 40-2 alcohol 77%, propylene glycol, and hydroxypropyl cellulose.

INDICATIONS EMGEL (erythromycin) Topical Gel is indicated for the topical treatment of acne vulgaris. DOSAGE AND ADMINISTRATION Apply sparingly as a thin layer to affected area(s) twice a day, in the morning and the evening, after the skin has been thoroughly washed with soap and water and patted dry. The hands should be washed after application. If there has been no improvement after 6 to 8 weeks, or if the condition becomes worse, treatment should be discontinued, and the physician should be reconsulted. Spread the medication lightly rather than rubbing it in. HOW SUPPLIED ERYGEL® (Erythromycin Topical Gel USP) 2% is supplied in plastic tubes in the following sizes: 30g - NDC 0259-4312-30 and 60 g - NDC 0259-4312-60. Note: FLAMMABLE. Keep away from heat and flame. Store and dispense in original container. Keep tube tightly closed. Store between 15° and 25°C (59° and 77°F). Manufactured for: Merz Pharmaceuticals, Greensboro, NC 27410 70-2057-00 Rev 10/01

OVERDOSE No Information Provided. CONTRAINDICATIONS EMGEL (erythromycin) Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components.

SIDE EFFECTS The most common adverse reaction reported with EMGEL (erythromycin) Topical Gel was burning. The following have been reported occasionally: peeling, dryness, itching, erythema, and oiliness. Irritation of the eyes and tenderness of the skin have also been reported with the topical use of erythromycin. A generalized urticarial reaction, which was possibly related to the use of erythromycin and required systemic steroid therapy, has been reported. DRUG INTERACTIONS No Information Provided.

WARNINGS Pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis". After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis. PRECAUTIONS General: For topical use only; not for ophthalmic use. Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. Avoid contact with eyes and all mucous membranes. The use of antibiotic agents may be associated with the overgrowth of antibiotic-resistant organisms. If this occurs, discontinue use and take appropriate measures. Carcinogenesis, Mutagenesis, Impairment of Fertility: No animal studies have been performed to evaluate carcinogenic and mutagenic potential or effects on fertility of topical erythromycin. However, long-term (2-year) oral studies in rats with erythromycin ethylsuccinate and erythromycin base did not provide evidence of tumorigenicity. There was no apparent effect on male or female fertility in rats fed erythromycin (base) at levels up to 0.25% of diet. Pregnancy: Teratogenic effects: Pregnancy Category B: There was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25% of diet) prior to and during mating, during gestation and through weaning of two successive litters. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed. Erythromycin has been reported to cross the placental barrier in humans, but fetal plasma levels are generally low. Nursing Mothers: It is not known whether erythromycin is excreted in human milk after topical application. However, erythromycin is excreted in human milk following oral and parenteral erythromycin administration. Therefore, caution should be exercised when erythromycin is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children have not been established.