LEVOFLOXACIN tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Aidarex Pharmaceuticals LLC

INN (International Adı):

LEVOFLOXACIN

Kompozisyon:

LEVOFLOXACIN ANHYDROUS 500 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

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

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

Aidarex Pharmaceuticals LLC
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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

Ürün özellikleri

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
AIDAREX PHARMACEUTICALS LLC
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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) 06/2016
Warnings and