Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)
Aidarex Pharmaceuticals LLC
LEVOFLOXACIN
LEVOFLOXACIN ANHYDROUS 500 mg
ORAL
PRESCRIPTION DRUG
Levofloxacin tablets, USP 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 tablets, USP are indicated for the treatment of nosocomial pneumonia due to methicillinsusceptible 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 antipseudomonal β-lactam is recommended [see Clinical Studies (14.1) ]. Levofloxacin tablets, USP are indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus , Streptococcus pneumoniae (including multidrug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainflue
16.1 Levofloxacin Tablets, USP Levofloxacin tablets, USP are supplied as 500 mg capsule-shaped, coated tablets. Levofloxacin tablets, USP are packaged in bottles in the following configurations: 5 Tablets in a bottle - 53217-0199-05 7 Tablets in a bottle - 53217-0199-07 30 Tablets in a bottle - 53217-0199-30 20 Tablets in a bottle - 53217-0199-20 14 Tablets in a bottle - 53217-0199-14 10 Tablets in a bottle - 53217-0199-10 Repackaged by Aidarex Pharmaceuticals LLC, Corona, CA 92880
Abbreviated New Drug Application
Aidarex Pharmaceuticals LLC ---------- . Revised: 10/2016 Document Id: 74cc896f-4abf-4b52-8b7d-068d4ec072da Set id: c3fc47ed-008f-4dba-96ee-27d17db0c680 Version: 4 Effective Time: 20161031 Aidarex Pharmaceuticals LLC Perskaitykite visą dokumentą
LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED 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: o TENDINITIS AND TENDON RUPTURE (5.2) o PERIPHERAL NEUROPATHY (5.3) o 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: o UNCOMPLICATED URINARY TRACT INFECTION (1.12) o ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS (1.13) o ACUTE BACTERIAL SINUSITIS (1.14) 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 (1.15). RECENT MAJOR CHANGES Boxed Warning 06/2016 Indications and Usage (1) 06/2016 Dosage and Administration (2) 06/2016 Warnings and Perskaitykite visą dokumentą