Country: United States
Language: English
Source: NLM (National Library of Medicine)
MOXIFLOXACIN HYDROCHLORIDE (UNII: C53598599T) (MOXIFLOXACIN - UNII:U188XYD42P)
Bayer HealthCare Pharmaceuticals Inc.
MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN 400 mg in 250 mL
INTRAVENOUS
PRESCRIPTION DRUG
AVELOX is indicated in adult patients for the treatment of Community Acquired Pneumonia caused by susceptible isolates of Streptococcus pneumoniae (including multi-drug resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Clinical Studies (14.3)] . MDRSP isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [MIC] ≥ 2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. AVELOX is indicated in adult patients for the treatment of Uncomplicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes [see Clinical Studies (14.4)]. AVELOX is indicated in adult patients for the treatment of Complicated Skin and Skin
AVELOX (moxifloxacin hydrochloride) tablets are available as oblong, dull red film-coated tablets containing 400 mg moxifloxacin. The tablet is coded with the word “BAYER” on one side and “M400” on the reverse side. NDC Code 50419-530-01 Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature] . Avoid high humidity. AVELOX (moxifloxacin hydrochloride) in sodium chloride injection is available in ready-to-use 250 mL flexible bags containing 400 mg of moxifloxacin in 0.8% saline. The flexibag is not made with natural rubber latex. No further dilution of this preparation is necessary. NDC Code 50419-537-01 Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature] . Do not refrigerate – product precipitates upon refrigeration.
New Drug Application
AVELOX- MOXIFLOXACIN HYDROCHLORIDE INJECTION, SOLUTION AVELOX- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED Bayer HealthCare Pharmaceuticals Inc. ---------- MEDICATION GUIDE FDA-Approved Medication Guide MEDICATION GUIDE AVELOX® (AV-eh-locks) (moxifloxacin hydrochloride) Tablets AVELOX® (AV-eh-locks) (moxifloxacin hydrochloride) Injection Solution for Intravenous use Read the Medication Guide that comes with AVELOX® before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is the most important information I should know about AVELOX? AVELOX belongs to a class of antibiotics called fluoroquinolones. AVELOX can cause serious side effects that can happen at the same time and could result in death. If you get any of the following serious side effects, you should stop taking AVELOX and get medical help right away. Talk with your healthcare provider about whether you should continue to take AVELOX. 1. Tendon rupture or swelling of the tendon (tendinitis). • Tendon problems can happen in people of all ages who take AVELOX. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include: • Pain, swelling, tears and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites. • The risk of getting tendon problems while you take AVELOX is higher if you: • Are over 60 years of age • Are taking steroids (corticosteroids) • Have had a kidney, heart or lung transplant • Tendon problems can happen in people who do not have the above risk factors when they take AVELOX. • Other reasons that can increase your risk of tendon problems can include: • Physical activity or exercise • Kidney failure • Tendon problems in the past, such as in people with rheumatoid arthritis (RA). • Stop taking AVELOX immediately and call your healthcare provider right away a Read the complete document
AVELOX- MOXIFLOXACIN HYDROCHLORIDE INJECTION, SOLUTION AVELOX- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED BAYER HEALTHCARE 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 • • • ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS (1.7) RECENT MAJOR CHANGES INDICATIONS AND USAGE AVELOX is a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below: • • • • • • To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX and other antibacterial 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 Read the complete document