Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
MUPIROCIN (UNII: D0GX863OA5) (MUPIROCIN - UNII:D0GX863OA5)
Advanced Rx Pharmacy of Tennessee, 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. 8.1 Pregnancy 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 indi
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: 80425-0254-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
MUPIROCIN- MUPIROCIN OINTMENT ADVANCED RX PHARMACY OF TENNESSEE, LLC ---------- MUPIROCIN 2% OINTMENT 1. INDICATIONS AND USAGE 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) 2. DOSAGE AND ADMINISTRATION For Topical Use Only. 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. Cover the treated area with gauze dressing if desired. Re-evaluate patients not showing a clinical response within 3 to 5 days. Mupirocin ointment is not for intranasal, ophthalmic, or other mucosal use [see WARNINGS AND PRECAUTIONS (5.2, 5.6)]. 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 in a water-miscible ointment base supplied in 15-gram, 22-gram and 30-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 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 th Belgenin tamamını okuyun