Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
MOXIFLOXACIN HYDROCHLORIDE (UNII: C53598599T) (MOXIFLOXACIN - UNII:U188XYD42P)
Physicians Total Care, Inc.
MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN 400 mg
ORAL
PRESCRIPTION DRUG
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. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. AVELOX Tablets and IV are indicated for the treatment of adults (≥ 18 years of age) with infections caused by susceptible strains of the designated microorganisms in the conditions listed below [see Dosage and Administration (2) and Use In Specific Populations (8.5)]. Culture and Susceptibility Testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin
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 54868-4367-5, bottles of 2 tablets; NDC 54868-4367-0, bottles of 5 tablets; NDC 54868-4367-3, bottles of 7 tablets; NDC 54868-4367-1, bottles of 10 tablets; NDC 54868-4367-4, bottles of 14 tablets; NDC 54868-4367-2, bottles of 30 tablets. Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature] . Avoid high humidity.
New Drug Application
AVELOX - MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED Physicians Total Care, Inc. ---------- MEDICATION GUIDE AVELOX® (AV-eh-locks) (moxifloxacin hydrochloride) Tablets AVELOX® IV (AV-eh-locks) (moxifloxacin hydrochloride) Injection Solution for IV 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 side effects that may be serious or even cause death. If you get any of the following serious side effects, 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) • Call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation. Stop taking AVELOX until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area. The most comm Pročitajte cijeli dokument
AVELOX - MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED PHYSICIANS TOTAL CARE, 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. 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) 400 mg 5-14 No dosa Pročitajte cijeli dokument