Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
MOXIFLOXACIN HYDROCHLORIDE (UNII: C53598599T) (MOXIFLOXACIN - UNII:U188XYD42P)
PD-Rx Pharmaceuticals, Inc.
MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN 400 mg
PRESCRIPTION DRUG
New Drug Application
AVELOX- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED PD-RX PHARMACEUTICALS, INC. ---------- 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. AVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLETS, FOR ORAL USE AVELOX (MOXIFLOXACIN HYDROCHLORIDE) INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1999 WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRIAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRIAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS FLUOROQUINOLONES, INCLUDING AVELOX, HAVE BEEN ASSOCIATED WITH DISABLING AND POTENTIALLY IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT HAVE OCCURRED TOGETHER (5.1) INCLUDING: TENDINITIS AND TENDON RUPTURE ( 5.2) PERIPHERAL NEUROPATHY ( 5.3) CENTRAL NERVOUS SYSTEM EFFECTS ( 5.4) DISCONTINUE AVELOX IMMEDIATELY AND AVOID THE USE OF FLUOROQUINOLONES, INCLUDING AVELOX, IN PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE REACTIONS ( 5.1) FLUOROQUINOLONES, INCLUDING AVELOX, MAY EXACERBATE MUSCLE WEAKNESS IN PATIENTS WITH MYASTHENIA GRAVIS. AVOID AVELOX IN PATIENTS WITH KNOWN HISTORY OF MYASTHENIA GRAVIS ( 5.5). BECAUSE FLUOROQUINOLONES, INCLUDING AVELOX, HAVE BEEN ASSOCIATED WITH SERIOUS ADVERSE REACTIONS ( 5.1–5.13), RESERVE AVELOX FOR USE IN PATIENTS WHO HAVE NO ALTERNATIVE TREATMENT OPTIONS FOR THE FOLLOWING INDICATIONS: ACUTE BACTERIAL SINUSITIS ( 1.6) ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS ( 1.7) RECENT MAJOR CHANGES 1. Boxed Warning 7/2016 1. Indications and Usage ( 1.6, 1.7) 7/2016 1. Dosage and Administration ( 2.1) 7/2016 2. Warnings and Precautions ( 5.1) 7/2016 INDICATIONS AND USAGE AVELOX is a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and o Przeczytaj cały dokument