Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)
Aidarex Pharmaceuticals LLC
LEVOFLOXACIN
LEVOFLOXACIN ANHYDROUS 750 mg
ORAL
PRESCRIPTION DRUG
Levofloxacin 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. Levofloxacin is indicated for the treatment of nosocomial pneumonia due to methicillin susceptible Staphylococcus aureus , Pseudomonas aeruginosa , Serratia marcescens , Escherichia coli , Klebsiella pneumoniae , Haemophilus influenzae , or Streptococcus pneumoniae . Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see Clinical Studies (14.1)] . Levofloxacin is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus , Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae , Haemophilus parainfluenzae , Klebsie
Levofloxacin tablets, USP Levofloxacin tablet, USP supplied as 750 mg oval-shaped, coated tablets. • 750 mg tablets are White, oval, biconvex, film coated tablets, debossed 750 on one side and "C287" on the other side, – bottles of 5 Tablets (NDC 53217-0318-05) – bottles of 7 Tablets (NDC 53217-0318-07) – bottles of 10 Tablets (NDC 53217-0318-10) – bottles of 30 Tablets (NDC 53217-0318-30) Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required). Store at 20º - 25ºC (68º - 77ºF) [See USP Controlled Room Temperature]. Repackaged by: Aidarex Pharmaceuticals, LLC Corona, CA 92880
Abbreviated New Drug Application
LEVOFLOXACIN- LEVOFLOXACIN TABLET Aidarex Pharmaceuticals LLC ---------- MEDICATION GUIDE LEVOFLOXACIN TABLETS, USP [LEE-voe-FLOX-a-sin] Read the 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, a fluoroquinolone antibiotic, can cause serious side effects. Some of these serious side effects can happen at the same time and could result in death. If you have any of the following serious side effects while you take levofloxacin tablets, you should stop taking levofloxacin tablets immediately and get medical help right away. 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 tendons 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) • Stop taking levofloxacin tablets immediately and get medical help right away at the first sign of tendon pain, swelling or inflammation. Stop taking levofloxacin tablets, USP until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area. Přečtěte si celý dokument
LEVOFLOXACIN- LEVOFLOXACIN TABLET AIDAREX PHARMACEUTICALS LLC ---------- 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 WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, 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 LEVOFLOXACIN IMMEDIATELY AND AVOID THE USE OF FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, IN PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE REACTIONS (5.1) FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, MAY EXACERBATE MUSCLE WEAKNESS IN PATIENTS WITH MYASTHENIA GRAVIS. AVOID LEVOFLOXACIN IN PATIENTS WITH A KNOWN HISTORY OF MYASTHENIA GRAVIS [SEE WARNINGS AND PRECAUTIONS (5.5)]. BECAUSE FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN HAVE BEEN ASSOCIATED WITH SERIOUS ADVERSE REACTIONS (5.1-5.14), RESERVE LEVOFLOXACIN FOR USE IN PATIENTS WHO HAVE NO ALTERNATIVE TREATMENT OPTIONS FOR THE FOLLOWING INDICATIONS: UNCOMPLICATED URINARY TRACT INFECTION (1.12) ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS (1.13) ACUTE BACTERIAL SINUSITIS (1.14) RECENT MAJOR CHANGES Boxed Warning 6/2016 Indications and Usage (1) 6/2016 Dosage and Administration (2) 6/2016 Warnings and Precautions (5) 6/2016 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) Skin and Skin Structure Infections: Complicated (1 Přečtěte si celý dokument