Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
MUPIROCIN (UNII: D0GX863OA5) (MUPIROCIN - UNII:D0GX863OA5)
BIOMES PHARMACEUTICALS LLC
MUPIROCIN
MUPIROCIN 20 mg in 1 g
PRESCRIPTION DRUG
Abbreviated New Drug Application
MUPIROCIN- MUPIROCIN OINTMENT BIOMES PHARMACEUTICALS 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 USP, 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 The most frequent adverse reactions (at least 1%) were burning, stinging or pain, and itching. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BIOMES PHARMACEUTICALS LLC., AT 1-517-507-5222 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 3/2016 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 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) Ointment: Each gram contains 20 mg mupirocin USP in a water-miscible ointment base supplied in 22-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 f Baca dokumen lengkapnya