Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)
Proficient Rx LP
LEVOFLOXACIN
LEVOFLOXACIN ANHYDROUS 500 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 andSusceptibility 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 available as follows: 500 mg are available as peach-colored, film-coated, oval-shaped tablets, debossed with “TEVA” on one side and “7292” on the other, in bottles of 10. 750 mg are available as white to off-white, film-coated, oval-shaped tablets, debossed with “TEVA” on one side and “7293” on the other, in bottles of 5 and 10. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED Proficient Rx LP ---------- MEDICATION GUIDE LEVOFLOXACIN [lee voe FLOX a sin] TABLETS Read this Medication Guide before you start taking levofloxacin tablets 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 tablets, 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 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 levofloxacin tablets. • 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 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 p Izlasiet visu dokumentu
LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED PROFICIENT RX LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEVOFLOXACIN TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVOFLOXACIN TABLETS. LEVOFLOXACIN TABLETS FOR ORAL USE INITIAL U.S. APPROVAL: 1996 TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE EFFECTIVENESS OF LEVOFLOXACIN AND OTHER ANTIBACTERIAL DRUGS, LEVOFLOXACIN SHOULD BE USED ONLY TO TREAT OR PREVENT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA. 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 MUSCLEWEAKNESS IN PERSONS WITH MYASTHENIA GRAVIS. AVOID LEVOFLOXACIN INPATIENTS WITH A KNOWN HISTORY OF MYASTHENIA GRAVIS [_SEE WARNINGS AND_ _PRECAUTIONS (_5.2 )]. RECENT MAJOR CHANGES Warnings and Precautions • INDICATIONS AND USAGE Levofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (≥ 18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). • • • • • • • • • DOSAGE AND ADMINISTRATION • TYPE OF INFECTION DOSE EVERY 24 HOURS DURATION (DAYS) Nosocomial Pneumonia (1.1) 750 mg 7 to 14 Community Acquired Pneumonia (1.2) 500 mg 7 to 14 Community Acquired Pneumonia (1.3) 750 mg 5 Acute Bacterial Sinusitis (1.4) 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis (1.5) 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) (1.6) 750 mg 7 to 14 Uncomplicated SSSI (1.7) 500 mg 7 to 10 Chronic Bacterial Prostatitis (1.8) 500 mg 28 Peripheral Neuropathy (5. Izlasiet visu dokumentu