Bactroban Nasal (Mupirocin Calcium Ointment) Drug Information: Side Effects and Drug Interactions

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May 25, 2012

Bactroban Nasal

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What are noninfectious, common rashes localized to a particular anatomical area?

Common, noninfectious rashes are listed below. Since these conditions are not caused by infectious organisms, it is reasonable to attempt to treat them with over-the-counter 1% hydrocortisone cream for a week or so prior to seeking medical attention.

Seborrheic dermatitis: Seborrheic dermatitis is the single most common rash affecting adults. It produces a red, scaling eruption that characteristically affects the scalp, forehead, brows, cheeks, and external ears.

Atopic dermatitis: Atopic dermatitis, often called eczema, is a common disorder of childhood which produces red, itchy, weeping rashes on the inner aspects of the elbows and in back of the knees as well as the cheeks, neck, wrists, and ankles. It is commonly found in patients who also have asthma and hay fever.

Contact dermatitis: Contact dermatitis is a rash that i...

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SIDE EFFECTS

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 Less than 1% of domestic or foreign subjects and patients in clinical trials were withdrawn due to adverse events.

The most frequently reported adverse events in foreign clinical trials were as follows: rhinitis (1.0%), taste perversion (0.8%), pharyngitis (0.5%).

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) (n=210)
Headache	9%
Rhinitis	6%
Respiratory disorder, including upper respiratory tract congestion	5%
Pharyngitis	4%
Taste perversion	3%
Burning/stinging	2%
Cough	2%
Pruritus	1%

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.

DRUG INTERACTIONS

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.