Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED NDC:17856-0112-1 in a SYRINGE of 1 OINTMENTS; MUPIROCIN OINTMENT image description
- HOW SUPPLIED NDC:17856-0112-1 in a SYRINGE of 1 OINTMENTS
- MUPIROCIN OINTMENT image description
Overview
Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, NF) consisting of polyethylene glycol 400 and polyethylene glycol 3350. Mupirocin is a naturally occurring antibiotic. The chemical name is ( )-(2 ,3 ,4 ,5 )-5-[(2 ,3 ,4 ,5 )-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2 -pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C H O and the molecular weight is 500.62. E S R R S S S S S H 26 44 9 The chemical structure is: CHEMICAL STRUCTURE
Indications & Usage
Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to: and . S. aureus S. pyogenes
Dosage & Administration
A small amount of Mupirocin Ointment USP, 2% should be applied to the affected area 3 times daily. The area treated may be covered with a gauze dressing if desired. Patients not showing a clinical response within 3 to 5 days should be re-evaluated.
Warnings & Precautions
WARNINGS Avoid contact with the eyes. In case of accidental contact, rinse well with water. In the event of sensitization or severe local irritation from Mupirocin Ointment USP, 2%, usage should be discontinued. - associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including mupirocin, 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 . Clostridium difficile C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing isolates of 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 two months after the administration of antibacterial agents. C. difficile C. difficile If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of , and surgical evaluation should be instituted as clinically indicated. C. difficile C. difficile
Contraindications
This drug is contraindicated in patients with known hypersensitivity to any of the constituents of the product.
Adverse Reactions
The following local adverse reactions have been reported in connection with the use of mupirocin ointment USP, 2%: 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 in less than 1% of subjects. Systemic allergic reactions, including anaphylaxis, urticaria, angioedema and generalized rash have been reported in patients treated with mupirocin formulations.
Drug Interactions
- Drug Interactions The effect of the concurrent application of Mupirocin Ointment USP, 2% and other drug products has not been studied.
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