Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
MUPIROCIN (UNII: D0GX863OA5) (MUPIROCIN - UNII:D0GX863OA5)
RPK Pharmaceuticals, Inc.
TOPICAL
Mupirocin ointment 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 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 population is unknown. The esti
Product: 53002-9852 NDC: 53002-9852-1 22 g in a TUBE
Abbreviated New Drug Application
MUPIROCIN- MUPIROCIN OINTMENT RPK 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 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 up to 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 22-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 quantities of polyethylene glycol is Prečítajte si celý dokument