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General The use of antimicrobial agents may be associated with the overgrowth of nonsusceptible organisms including fungi; in such a case, antibiotic administration should be stopped and appropriate measures taken.

Information for Patients Avoid contaminating the tip of container with material from the eye, fingers, or other source.

Carcinogenesis, Mutagenesis, Impairment of Fertility Two year oral studies conducted in rats with erythromycin did not provide evidence of tumorigenicity. Mutagenicity studies have not been conducted. No evidence of impaired fertility or harm to the fetus that appeared related to erythromycin was reported in these studies.

Pregnancy Pregnancy Category B Reproduction studies have been performed in rats, mice, and rabbits using erythromycin and its various salts and esters, at doses that were several multiples of the usual human dose. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, the erythromycins should be used during pregnancy only if clearly needed.

Nursing Mothers Caution should be exercised when erythromycin is administered to a nursing woman.

Pediatric Use See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION .

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