国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)
Apotheca Inc.
LEVOFLOXACIN
LEVOFLOXACIN ANHYDROUS 750 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
16.1 Levofloxacin Tablets, USP Levofloxacin tablets, USP 750 mg are white colored, capsule shaped, biconvex, debossed ‘ML 64´ on one side and plain on other side. They are supplied as follows; NDC 12634-674-00 Bottles of 10 NDC 12634-674-01 Bottles of 100 NDC 12634-674-09 Bottles of 35 NDC 12634-674-12 Bottles of 120 NDC 12634-674-18 Bottles of 180 NDC 12634-674-40 Bottles of 40 NDC 12634-674-42 Bottles of 42 NDC 12634-674-45 Bottles of 45 NDC 12634-674-50 Bottles of 50 NDC 12634-674-52 Blister Pack of 12 NDC 12634-674-54 Blister Pack of 14 NDC 12634-674-57 Blister Pack of 20 NDC 12634-674-59 Blister Pack of 30 NDC 12634-674-60 Bottles of 60 NDC 12634-674-61 Blister Pack of 10 NDC 12634-674-63 Blister Pack of 3 NDC 12634-674-66 Blister Pack of 6 NDC 12634-674-67 Blister Pack of 7 NDC 12634-674-69 Blister Pack of 9 NDC 12634-674-71 Bottles of 30 NDC 12634-674-74 Bottles of 24 NDC 12634-674-78 Bottles of 28 NDC 12634-674-79 Bottles of 25 NDC 12634-674-80 Bottles of 20 NDC 12634-674-81 Bottles of 21 NDC 12634-674-82 Bottles of 12 NDC 12634-674-84 Bottles of 14 NDC 12634-674-85 Bottles of 15 NDC 12634-674-90 Bottles of 90 NDC 12634-674-91 Blister Pack of 1 NDC 12634-674-92 Bottles of 2 NDC 12634-674-93 Bottles of 3 NDC 12634-674-94 Bottles of 4 NDC 12634-674-95 Bottles of 5 NDC 12634-674-96 Bottles of 6 NDC 12634-674-97 Bottles of 7 NDC 12634-674-98 Bottles of 8 NDC 12634-674-99 Bottles of 9 Levofloxacin tablets, USP should be stored at 20° to 25°C (68°to 77°F); excursions permitted to 15°to 30°C (59°to 86°F) in well-closed containers.
Abbreviated New Drug Application
Apotheca Inc. ---------- . Revised: 1/2017 Document Id: 47533163-35dc-00ae-e054-00144ff8d46c Set id: 47079bd9-8d75-0c03-e054-00144ff8d46c Version: 2 Effective Time: 20170126 Apotheca Inc. 阅读完整的文件
LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED APOTHECA INC. ---------- 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 阅读完整的文件