MUPIROCIN- mupirocin ointment
Glenmark Pharmaceuticals Inc., USA
1 INDICATIONS AND USAGE
Mupirocin ointment is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes).
2 DOSAGE AND ADMINISTRATION
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For Topical Use Only.
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Apply a small amount of mupirocin ointment, with a cotton swab or gauze pad, to the affected area 3 times daily for up to 10 days.
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Cover the treated area with gauze dressing if desired.
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Re-evaluate patients not showing a clinical response within 3 to 5 days.
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Mupirocin ointment is not for intranasal, ophthalmic, or other mucosal use [see Warnings and Precautions (5.2, 5.6)].
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Do not apply mupirocin ointment concurrently with any other lotions, creams or ointments [see Clinical Pharmacology (12.3)].
3 DOSAGE FORMS AND STRENGTHS
Each gram of mupirocin ointment contains 20 mg mupirocin USP in a water-miscible ointment base supplied in 22-gram tubes.
4 CONTRAINDICATIONS
Mupirocin ointment is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment.
5 WARNINGS AND PRECAUTIONS
Click here to enter Warnings and Precautions
5.1 Severe Allergic Reactions
Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash, have been reported in patients treated with formulations of mupirocin, including mupirocin ointment [see Adverse Reactions (6.2)].
5.2 Eye Irritation
Avoid contact with the eyes. In case of accidental contact, rinse well with water.
5.3 Local Irritation
In the event of a sensitization or severe local irritation from mupirocin ointment, usage should be discontinued, and appropriate alternative therapy for the infection instituted.
5.4 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.
If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
5.5 Potential for Microbial Overgrowth
As with other antibacterial products, prolonged use of mupirocin ointment may result in overgrowth of nonsusceptible microorganisms, including fungi [see Dosage and Administration (2)].
5.6 Risk Associated with Mucosal Use
Mupirocin ointment is not formulated for use on mucosal surfaces. Intranasal use has been associated with isolated reports of stinging and drying. A separate formulation, � Bactroban (mupirocin calcium) nasal ointment, is available for intranasal use.
5.7 Risk of Polyethylene Glycol Absorption
Polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys. In common with other polyethylene glycol-based ointments, mupirocin ointment should not be used in conditions where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment.
5.8 Risk Associated with Use at Intravenous Sites
Mupirocin ointment should not be used with intravenous cannulae or at central intravenous sites because of the potential to promote fungal infections and antimicrobial resistance.
6 ADVERSE REACTIONS
The following adverse reactions are discussed in more detail in other sections of the labeling:
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Severe Allergic Reactions [see Warnings and Precautions (5.1)]
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Eye Irritation [see Warnings and Precautions (5.2)]
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Local Irritation [see Warnings and Precautions (5.3)]
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Clostridium difficile -Associated Diarrhea [see Warnings and Precautions (5.4)]
6.1 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.
The following local adverse reactions were reported by at least 1% of subjects in connection with the use of mupirocin ointment in clinical trials: burning, stinging, or pain in 1.5% of subjects; itching in 1% of subjects. Rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate were reported in less than 1% of subjects.
