البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
MUPIROCIN CALCIUM (UNII: RG38I2P540) (MUPIROCIN - UNII:D0GX863OA5)
Cardinal Health
MUPIROCIN CALCIUM
MUPIROCIN 20 mg in 1 g
PRESCRIPTION DRUG
New Drug Application
BACTROBAN- MUPIROCIN CALCIUM OINTMENT CARDINAL HEALTH ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BACTROBAN NASAL OINTMENT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BACTROBAN NASAL OINTMENT. BACTROBAN (MUPIROCIN CALCIUM) NASAL OINTMENT INITIAL U.S. APPROVAL: 1995 INDICATIONS AND USAGE BACTROBAN nasal ointment is an antibacterial drug indicated for the eradication of nasal colonization with methicillin- resistant _Staphylococcus aureus_ (MRSA) in adult and pediatric patients (aged 12 years and older) and healthcare workers as part of a comprehensive infection control program to reduce the risk of infection among patients at high risk of MRSA infection during institutional outbreaks of infections with this microorganism_._ (1) Limitations of Use (1) • • DOSAGE AND ADMINISTRATION • • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • ADVERSE REACTIONS • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT 1-888-825-5249 OR FDA AT 1-800- FDA-1088 OR www.fda.gov/medwatch. SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 2/2016 There are insufficient data at this time to establish that this product is safe and effective as part of an intervention program to prevent autoinfection of high-risk patients from their own nasal colonization with _Staphylococcus aureus_ _(S. aureus)_. There are insufficient data at this time to recommend use of BACTROBAN nasal ointment for general prophylaxis of any infection in any patient population. For Intranasal Use Only. (2) Apply approximately one-half of the ointment from the single-use tube into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days. (2) After application, close the nostrils by pressing together and releasing the sides of the nose repetitively for approximately 1 minute to spread the ointment throughout the nares. (2) Dis اقرأ الوثيقة كاملة