MUPIROCIN

2 DOSAGE AND ADMINISTRATION For Topical Use Only. Apply a small amount of mupirocin cream, with a cotton swab or gauze pad, to the affected area 3 times daily for 10 days. Cover the treated area with gauze dressing if desired. Re-evaluate patients not showing a clinical response within 3 to 5 days.

6 )]. 3 )]. For Topical Use Only. ( 2 ) Apply a small amount of mupirocin cream, with a cotton swab or gauze pad, to the affected area 3 times daily for 10 days. ( 2 ) Re-evaluate patients not showing a clinical response within 3 to 5 days.

( 2 ) Not for intranasal, ophthalmic, or other mucosal use. ( 2 )

4 )] The most frequent adverse reactions (at least 1%) were headache, rash, and nausea. gov/medwatch . 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In 2 randomized, double‑blind, double‑dummy trials, 339 subjects were treated with topical mupirocin cream plus oral placebo. 3%) subjects. 1%). Other adverse reactions which occurred in less than 1% of subjects were: abdominal pain, burning at application site, cellulitis, dermatitis, dizziness, pruritus, secondary wound infection, and ulcerative stomatitis.

In a supportive trial in the treatment of secondarily infected eczema, 82 subjects were treated with mupirocin cream. 4%), and 1 report each of abdominal pain, bleeding secondary to eczema, pain secondary to eczema, hives, dry skin, and rash.

2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following reactions have been identified during postmarketing use of mupirocin cream. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.

These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal relationship to mupirocin cream. 1 )] .

5 WARNINGS AND PRECAUTIONS Severe Allergic Reactions: Anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients treated with formulations of mupirocin, including mupirocin cream. 1 ) Eye Irritation: Avoid contact with eyes.

2 ) Local Irritation: Discontinue in the event of sensitization or severe local irritation. 3 ) Clostridium difficile -Associated Diarrhea (CDAD): If diarrhea occurs, evaluate patients for CDAD. 4 ) Potential for Microbial Overgrowth: Prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi.

5 ) Risk Associated with Mucosal Use: Mupirocin cream is not formulated for use on mucosal surfaces. A separate formulation, BACTROBAN nasal ointment, is available for intranasal use. 2 )] . 2 Eye Irritation Avoid contact with the eyes.

In case of accidental contact, rinse well with water. 3 Local Irritation In the event of a sensitization or severe local irritation from mupirocin cream, usage should be discontinued, and appropriate alternative therapy for the infection instituted.

4 Clostridium difficile -Associated Diarrhea Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.

difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.

4 CONTRAINDICATIONS Mupirocin cream is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin cream. Known hypersensitivity to mupirocin or any of the excipients of mupirocin cream.

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