国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)
Wockhardt Limited
LEVOFLOXACIN
LEVOFLOXACIN 250 mg
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets 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. Levofloxacin tablets are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Culture and susceptibility testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Mic
Levofloxacin Tablets are supplied as 250, 500, and 750 mg capsule-shaped, coated tablets. Levofloxacin Tablets are packaged in bottles and in unit-dose blister strips in the following configurations: ● 250 mg tablets are pink and are debossed: "W" on one side and "544" on the other side. ● 500 mg tablets are peach and are debossed: "W" on one side and "545" on the other side ● 750 mg tablets are white and are debossed: "W" on one side and "547" on the other side Storage Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Keep the container closed tightly.
Abbreviated New Drug Application
LEVOFLOXACIN- LEVOFLOXACIN TABLET Wockhardt Limited ---------- MEDICATION GUIDE LEVOFLOXACIN TABLETS 250 mg, 500 mg and 750 mg Read this Medication Guide before you start taking levofloxacin 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 levofloxacin tablets? Levofloxacin, a fluoroquinolone antibiotic, can cause serious side effects. Some of these serious side effects could result in death. If you have any of the following serious side effects while you take levofloxacin tablets, get medical help right away. Talk with your healthcare provider about whether you should continue to take levofloxacin tablets. 1. Tendon rupture or swelling of the tendon (tendinitis). ● Tendon problems can happen in people of all ages who take levofloxacin tablets. Tendons are tough cords of tissue that connect muscles to bones. Some tendon problems 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 levofloxacin tablets are higher if you: o are over 60 years of age o are taking steroids (corticosteroids) o 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 levofloxacin tablets. ● Other reasons that can increase your risk of tendon problems can include: o physical activity or exercise o kidney failure o 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 levofloxacin tablets until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area. The most common area of pain and swelling is the Achilles 阅读完整的文件
LEVOFLOXACIN- LEVOFLOXACIN TABLET WOCKHARDT LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEVOFLOXACIN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVOFLOXACIN. LEVOFLOXACIN TABLETS INITIAL U.S. APPROVAL: 1996 WARNING: _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, 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 LEVOFLOXACIN, MAY EXACERBATE MUSCLE WEAKNESS IN PERSONS WITH MYASTHENIA GRAVIS. AVOID LEVOFLOXACIN TABLETSIN 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 levofloxacin and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1) RECENT MAJOR CHANGES Indications and Usage ● Plague (1.14) 04/2012 Dosage and Administration ● Dosage in Adult Patients with Normal Renal Function (2.1) 04/2012 ● Dosage in Pediatric Patients (2.2) 04/2012 Warnings and Precautions ● Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals (5.10) 04/2012 ● Increased intracranial pressure (pseudotumor cerebri) (5.6) 10/2011 INDICATIONS AND USAGE Levofloxacin 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 bacter 阅读完整的文件