Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
levofloxacin (UNII: 6GNT3Y5LMF) (levofloxacin - UNII:6GNT3Y5LMF)
Physicians Total Care, Inc.
levofloxacin
levofloxacin 250 mg
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectiveness of LEVAQUIN® and other antibacterial drugs, LEVAQUIN® 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. LEVAQUIN® Tablets/Injection and Oral Solution are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed in this section. LEVAQUIN® Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). Culture and susceptibility testing Appropriate culture and
LEVAQUIN® Tablets are supplied as 250, 500, and 750 mg capsule-shaped, coated tablets. LEVAQUIN® Tablets are packaged in bottles and in unit-dose blister strips in the following configurations: 250 mg tablets are terra cotta pink and are imprinted: "LEVAQUIN" on one side and "250" on the other side. LEVAQUIN® Tablets should be stored at 15° to 30°C (59° to 86°F) in well-closed containers. LEVAQUIN® Tablets are manufactured for PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., Raritan, NJ 08869 by Janssen Ortho LLC, Gurabo, Puerto Rico 00778. Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK 74146
New Drug Application
LEVAQUIN - LEVOFLOXACIN TABLET, FILM COATED Physicians Total Care, Inc. ---------- MEDICATION GUIDE LEVAQUIN® [Leave ah kwin] (levofloxacin) 250 mg Tablets, 500 mg Tablets, and 750 mg Tablets And LEVAQUIN® (levofloxacin) Oral Solution, 25 mg/mL And LEVAQUIN® (levofloxacin) Injection, for Intravenous Use And LEVAQUIN® (levofloxacin in 5% dextrose) Injection, for Intravenous Use Read the Medication Guide that comes with LEVAQUIN® 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 LEVAQUIN®? LEVAQUIN® belongs to a class of antibiotics called fluoroquinolones. LEVAQUIN® 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 LEVAQUIN®. • Tendon rupture or swelling of the tendon (tendinitis). • Tendons are tough cords of tissue that connect muscles to bones. • Pain, swelling, tears, and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites can happen in people of all ages who take fluoroquinolone antibiotics, including LEVAQUIN®. The risk of getting tendon problems is higher if you: • are over 60 years of age • are taking steroids (corticosteroids) • have had a kidney, heart or lung transplant. • Swelling of the tendon (tendinitis) and tendon rupture (breakage) have also happened in patients who take fluoroquinolones who do not have the above risk factors. • Other reasons for tendon ruptures 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 takin Läs hela dokumentet
LEVAQUIN - LEVOFLOXACIN TABLET, FILM COATED PHYSICIANS TOTAL CARE, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEVAQUIN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVAQUIN. LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED FOR ORAL USE LEVAQUIN (LEVOFLOXACIN) SOLUTION FOR ORAL USE LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION, CONCENTRATE FOR INTRAVENOUS USE LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1996 WARNING: FLUOROQUINOLONES, INCLUDING LEVAQUIN , 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 LEVAQUIN , MAY EXACERBATE MUSCLE WEAKNESS IN PERSONS WITH MYASTHENIA GRAVIS. AVOID LEVAQUIN IN PATIENTS WITH A KNOWN HISTORY OF MYASTHENIA GRAVIS _[SEE Warnings and_ _Precautions (5.2)]_. To reduce the development of drug-resistant bacteria and maintain the effectiveness of LEVAQUIN and other antibacterial drugs, LEVAQUIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1) RECENT MAJOR CHANGES Warnings and Precautions Exacerbation of myasthenia gravis (5.2) 01/2011 INDICATIONS AND USAGE LEVAQUIN is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) Acute bacterial sinusitis (1.4) Acute bacterial exacerbation of chronic bronchitis (1.5) Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) Chronic bacterial prostatitis (1.8) Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) Acute pyelonephritis (1.11) Inhalational anthrax, post-exposure (1.13). Not te Läs hela dokumentet