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Emgel Warnings, Precautions, Pregnancy, Nursing, Abuse - Erythromycin

Emgel Warnings, Precautions, Pregnancy, Nursing, Abuse - Erythromycin

WARNINGS

No Information Provided.

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: 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.

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