Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
MOXIFLOXACIN HYDROCHLORIDE (UNII: C53598599T) (MOXIFLOXACIN - UNII:U188XYD42P)
Lake Erie Medical DBA Quality Care Products LLC
MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN 400 mg
PRESCRIPTION DRUG
New Drug Application
AVELOX- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AVELOX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AVELOX. INITIAL U.S. APPROVAL: 1999 WARNING: FLUOROQUINOLONES, INCLUDING AVELOX , ARE ASSOCIATED WITH AN INCREASED RISK OF TENDINITIS AND TENDON RUPTURE IN ALL AGES. THIS RISK IS FURTHER INCREASED IN OLDER PATIENTS USUALLY OVER 60 YEARS OF AGE, IN PATIENTS TAKING CORTICOSTEROID DRUGS, AND IN PATIENTS WITH KIDNEY, HEART OR LUNG TRANSPLANTS _[SEE WARNINGS AND_ _PRECAUTIONS (5.1)]_. FLUOROQUINOLONES, INCLUDING AVELOX, MAY EXACERBATE MUSCLE WEAKNESS IN PERSONS WITH MYASTHENIA GRAVIS. AVOID AVELOX IN PATIENTS WITH KNOWN HISTORY OF MYASTHENIA GRAVIS _[SEE WARNINGS AND PRECAUTIONS_ _(5.2).]_ To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX and other antibacterial drugs, AVELOX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1) RECENT MAJOR CHANGES Boxed Warning 02/11 Warnings and Precautions (5.2, 5.6) 02/11, 10/11 INDICATIONS AND USAGE AVELOX is a fluoroquinolone antibacterial indicated for treating infections in adults ≥ 18 years of age caused by designated, susceptible bacteria. (1, 12.4) Acute Bacterial Sinusitis (1.1) Acute Bacterial Exacerbation of Chronic Bronchitis (1.2) Community Acquired Pneumonia (1.3) Skin and Skin Structure Infections: Uncomplicated (1.4) and Complicated (1.5) Complicated Intra-Abdominal Infections (1.6) DOSAGE AND ADMINISTRATION TYPE OF INFECTION DOSE EVERY 24 HO URS DURATIO N (DAYS) Acute Bacterial Sinusitis (1.1) 400 mg 10 Acute Bacterial Exacerbation of Chronic Bronchitis (1.2) 400 mg 5 Community Acquired Pneumonia (1.3) 400 mg 7-14 Uncomplicated Skin and Skin Structure Infections (SSSI) (1.4) 400 mg 7 Complicated SSSI (1.5) 400 mg 7-21 Complicated Intra-Abdominal Infections (1.6) Aqra d-dokument sħiħ