Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
Mupirocin (UNII: D0GX863OA5) (Mupirocin - UNII:D0GX863OA5)
Lake Erie Medical DBA Quality Care Products LLC
TOPICAL
PRESCRIPTION DRUG
Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes) . Mupirocin ointment is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. Pregnancy Category B. There are no adequate and well-controlled studies of mupirocin ointment in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Developmental toxicity studies have been performed with mupirocin administered subcutaneously to rats and rabbits at doses up to 160 mg per kg per day in both species. This dose is 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) based on body surface area. There was no evidence of fetal harm due to mupirocin. It is not known whether this drug is excreted in human milk. Because many drugs a
Mupirocin Ointment USP, 2% is supplied as follows: 55700-069-22 22g Each gram of mupirocin ointment contains 20 mg mupirocin in a water-miscible ointment base. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
MUPIROCIN- MUPIROCIN OINTMENT LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MUPIROCIN OINTMENT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MUPIROCIN OINTMENT. MUPIROCIN OINTMENT, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1987 INDICATIONS AND USAGE Mupirocin ointment is an RNA synthetase inhibitor antibacterial indicated for the topical treatment of impetigo due to susceptible isolates of _Staphylococcus aureus_ and _Streptococcus pyogenes_. (1) DOSAGE AND ADMINISTRATION For Topical Use Only. (2) Apply a small amount of mupirocin ointment, 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) DOSAGE FORMS AND STRENGTHS Ointment: Each gram contains 20 mg mupirocin in a water-miscible ointment base supplied in 15 gram, 22 gram and 30 gram tubes. (3) CONTRAINDICATIONS Known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. (4) WARNINGS AND PRECAUTIONS Severe Allergic Reactions: Anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients treated with formulations of mupirocin, including mupirocin ointment. (5.1) Eye Irritation: Avoid contact with eyes. (5.2) Local Irritation: Discontinue in the event of sensitization or severe local irritation. (5.3) _Clostridium difficile-_Associated Diarrhea (CDAD): If diarrhea occurs, evaluate patients for CDAD. (5.4) Potential for Microbial Overgrowth: Prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi. (5.5) Risk Associated with Mucosal Use: Mupirocin ointment is not formulated for use on mucosal surfaces. A separate formulation, mupirocin nasal ointment, is available for intranasal use. (5.6) Risk of Polyethylene Glycol Absorption: Mupirocin ointment should not be used where absorption of large Olvassa el a teljes dokumentumot