LEVAQUIN levofloxacin tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

LEVOFLOXACIN

Composition:

LEVOFLOXACIN 500 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

LEVAQUIN - LEVOFLOXACIN TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVAQUIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LEVAQUIN.
LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED FOR ORAL USE
LEVAQUIN (LEVOFLOXACIN) SOLUTION FOR ORAL USE
LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION, CONCENTRATE FOR
INTRAVENOUS USE
LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
WARNING :
FLUOROQUINOLONES, INCLUDING LEVAQUIN , ARE ASSOCIATED WITH AN
INCREASED RISK OF TENDINITIS AND TENDON
RUPTURE IN ALL AGES. THIS RISK IS FURTHER INCREASED IN OLDER PATIENTS
USUALLY OVER 60 YEARS OF AGE, IN PATIENTS
TAKING CORTICOSTEROID DRUGS, AND IN PATIENTS WITH KIDNEY, HEART OR
LUNG TRANSPLANTS [_SEE WARNINGS AND_
_PRECAUTIONS (5.1)_].
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of LEVAQUIN and other
antibacterial drugs, LEVAQUIN should be used only to treat or prevent
infections that are proven or strongly suspected
to be caused by bacteria.
RECENT MAJOR CHANGES
Warnings and Precautions
Tendinopathy and Tendon Rupture (5.1)
9/2008
INDICATIONS AND USAGE
LEVAQUIN 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)
Acute bacterial sinusitis (1.4)
Acute bacterial exacerbation of chronic bronchitis (1.5)
Skin and skin structure infections: complicated (1.6) and
uncomplicated (1.7)
Chronic bacterial prostatitis (1.8)
Urinary tract infections: complicated (1.9, 1.10) and uncomplicated
(1.12)
Acute pyelonephritis (1.11)
Inhalational anthrax, post-exposure (1.13). Not tested in humans for
post-exposure prevention of inhalational anthrax;
plasma concentrations are likely to predict efficacy (14.9)
DOSAGE AND ADMINISTRATION
Dosage in patients with normal renal function (