AVOID CONTACT WITH THE EYES. Application of BACTROBAN NASAL (mupirocin calcium ointment) to the eye under testing conditions has caused severe symptoms such as burning and tearing. These symptoms resolved within days to weeks after discontinuation of the ointment.

In the event of a sensitization or severe local irritation from BACTROBAN NASAL (mupirocin calcium ointment) , usage should be discontinued.

General: As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi. (See DOSAGE AND ADMINISTRATION.)

Pregnancy

Teratogenic Effects

Pregnancy 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/m² 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 (mupirocin calcium ointment) is administered to a nursing woman.

Pediatric Use

Safety in children under the age of 12 years has not been established. (See CLINICAL PHARMACOLOGY.)

Last reviewed on RxList: 12/9/2008
This monograph has been modified to include the generic and brand name in many instances.