Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
Mupirocin (UNII: D0GX863OA5) (Mupirocin - UNII:D0GX863OA5)
Preferred Pharmaceuticals, Inc.
Mupirocin
Mupirocin 20 mg in 1 g
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. Risk Summary There are insufficient human data to establish whether there is a drug-associated risk with mupirocin ointment in pregnant women. Systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin ointment [see Clinical Pharmacology (12.3)] . No developmental toxicity was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses of 160 mg per kg per day or 40 mg per kg per day, respectively (22 and 11 times the human topical dose based on calculations of dose divided by the entire body surface area). The estimated background risk of major birth defects and miscarriages for the indicated popu
Each gram of mupirocin ointment contains 20 mg mupirocin in a water-miscible ointment base. Mupirocin Ointment USP, 2% is supplied as follows: 22 g tube NDC 68788-9152-2 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
MUPIROCIN- MUPIROCIN OINTMENT PREFERRED PHARMACEUTICALS, INC. ---------- 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 • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • • • • ADVERSE REACTIONS • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TARO PHARMACEUTICALS U.S.A., INC., AT 1-866-923-4914 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 11/2019 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) Ointment: Each gram contains 20 mg mupirocin in a water-miscible ointment base supplied in 15-gram, 22-gram and 30-gram tubes. (3) Known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. (4) 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 Olvassa el a teljes dokumentumot