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Reproduction studies were performed in rats with mupirocin administered subcutaneously at doses up to 40 times the human intranasal dose (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 Text Continues Below
Category B. Reproduction studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 65 and 130 times, respectively, the human intranasal dose (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 Nasal is administered to a nursing woman. Pediatric Use Safety in children under the age of 12 years has not been established. (See CLINICAL PHARMACOLOGY.) Page: << Prev | 1 | 2
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