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Fertility studies were performed in rats with mupirocin administered subcutaneously at doses up to 49 times a human topical dose of 1 gram/ day (approximately 20 mg mupirocin per day) on a mg/ m 2 basis and revealed no evidence of impaired fertility from mupirocin sodium. Pregnancy Teratogenic Effects Pregnancy Category B Text Continues Below
Teratology studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 78 and 154 times, respectively, a human topical dose of 1 gram/ day (approximately 20 mg mupirocin per day) on a mg/ m 2 basis and revealed no evidence of harm to the fetus due to mupirocin. 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 during pregnancy only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Bactroban Cream is administered to a nursing woman. Pediatric Use The safety and effectiveness of Bactroban Cream have been established in the age groups 3 months to 16 years. Use of Bactroban Cream in these age groups is supported by evidence from adequate and well-controlled studies of Bactroban Cream in adults with additional data from 93 pediatric patients studied as part of the pivotal trials in adults. (See CLINICAL STUDIES section.) Geriatric Use In two well-controlled studies, 30 patients over 65 years old were treated with Bactroban Cream. No overall difference in the efficacy or safety of Bactroban Cream was observed in this patient population when compared to that observed in younger patients. Page: << Prev | 1 | 2
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