EMGEL 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.
EMGEL Topical Gel contains erythromycin, USP 2% (20 mg/g) with SD 40-2 alcohol 77%, propylene glycol, and hydroxypropyl cellulose.
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 Topical Gel is indicated for the topical treatment of acne vulgaris.
EMGEL Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components.
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: Animal studies to evaluate carcinogenic and mutagenic potential or effects on fertility have not been performed with erythromycin.
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) before 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 topically applied erythromycin is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness in children have not been established.
The most common adverse reaction reported with EMGEL 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.
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.
EMGEL 2% Topical Gel is supplied in plastic bottles containing 27 g (NDC 0173-0440-01) and 50 g (NDC 0173-0440-02).
Note: FLAMMABLE: Keep away from heat and flame.
Keep bottle tightly closed. Store at room temperature.
Manufactured for Glaxo Wellcome Inc.
Research Triangle Park, NC 27709
by DPT Laboratories, Inc., San Antonio, TX 78215