LEVOFLOXACIN- levofloxacin tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)

Tilgjengelig fra:

NuCare Pharmaceuticals, Inc.

INN (International Name):

LEVOFLOXACIN

Sammensetning:

LEVOFLOXACIN ANHYDROUS 250 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 parainf

Produkt oppsummering:

16.1 Levofloxacin Tablets, USP Levofloxacin tablets, USP are supplied as 250, capsule-shaped, coated tablets. Levofloxacin tablets, USP are packaged in bottles and in unit-dose blister strips in the following configurations: Levofloxacin tablets, USP 250 mg are pink coloured, capsule shaped, biconvex, debossed ML 62 on one side and plain on other side. bottles of 3 NDC 68071-3051-3 Levofloxacin tablets, USP should be stored at 20º to 25ºC (68º to 77°F); excursions permitted to 15º to 30ºC (59º to 86°F) in well-closed containers.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

NuCare Pharmaceuticals, Inc.
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Revised: 3/2017
Document Id: 4ab7ad0e-a303-1d9f-e054-00144ff8d46c
Set id: 4ab7ad0e-a302-1d9f-e054-00144ff8d46c
Version: 1
Effective Time: 20170314
NuCare Pharmaceuticals, Inc.

Preparatomtale

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
NUCARE PHARMACEUTICALS, INC.
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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) 06/201