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Clinical Trials: In clinical trials, 210 domestic and 2,130 foreign adult subjects/patients received BACTROBAN NASAL (mupirocin calcium ointment) ointment. Less than 1% of domestic or foreign subjects and patients in clinical trials were withdrawn due to adverse events.
In domestic clinical trials, 17% (36/210) of adults treated with BACTROBAN NASAL ointment reported adverse events thought to be at least possibly drug-related. The incidence of adverse events that were reported in at least 1% of adults enrolled in domestic clinical trials were as follows:
ADVERSE EVENTS ( ≥ 1% INCIDENCE)-ADULTS IN US TRIALS
|% of Subjects/Patients Experiencing Event
BACTROBAN NASAL (mupirocin calcium ointment)
|Respiratory disorder, including upper respiratory tract congestion||5%|
The following events thought possibly drug-related were reported in less than 1% of adults enrolled in domestic clinical trials: Blepharitis, diarrhea, dry mouth, ear pain, epistaxis, nausea, and rash.
All adequate and well-controlled clinical trials have been performed using BACTROBAN NASAL (mupirocin calcium ointment) ointment, 2% in 1 arm and the vehicle ointment in the other arm of the study. No adequate and well-controlled safety data are available from direct, head-to-head comparative studies of this product and other products for this indication.
Read the Bactroban Nasal (mupirocin calcium ointment) Side Effects Center for a complete guide to possible side effects
The effect of the concurrent application of intranasal mupirocin calcium and other intranasal products has not been studied. Until further information is known, mupirocin calcium ointment, 2% should not be applied concurrently with any other intranasal products. Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals to evaluate carcinogenic potential of mupirocin calcium have not been conducted.
Results of the following studies performed with mupirocin calcium or mupirocin sodium in vitro and in vivo did not indicate a potential for mutagenicity: Rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks, Salmonella reversion test (Ames), Escherichia coli mutation assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice.
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/m2 basis and revealed no evidence of impaired fertility from mupirocin sodium.
Last reviewed on RxList: 12/9/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Bactroban Nasal Information
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