LEVOFLOXACIN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

H.J. Harkins Company, Inc.

INN (International Name):

LEVOFLOXACIN

Composition:

LEVOFLOXACIN 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets 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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Levofloxacin tablets are indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed in this section. Culture and susceptibility testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Cli

Product summary:

Levofloxacin tablets are available as follows: 250 mg are available as terra cotta pink, film-coated, oval-shaped tablets, debossed with “TEVA” on one side and “7291” on the other, in bottles of 50. 500 mg are available as peach-colored, film-coated, oval-shaped tablets, debossed with “TEVA” on one side and “7292” on the other, in bottles of 50. 750 mg are available as white to off-white, film-coated, oval-shaped tablets, debossed with “TEVA” on one side and “7293” on the other, in bottles of 50. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LEVOFLOXACIN - LEVOFLOXACIN TABLET, FILM COATED
H.J. Harkins Company, Inc.
----------
MEDICATION GUIDE
LEVOFLOXACIN TABLETS
Read the Medication Guide that comes with levofloxacin tablets before
you start taking them and each
time you get a refill. There may be new information. This Medication
Guide does not take the place of
talking to your healthcare provider about your medical condition or
your treatment.
What is the most important information I should know about
levofloxacin tablets?
Levofloxacin tablets belong to a class of antibiotics called
fluoroquinolones. Levofloxacin tablets can
cause side effects that may be serious or even cause death. If you get
any of the following serious side
effects, get medical help right away. Talk with your healthcare
provider about whether you should
continue to take levofloxacin tablets.
1.
Tendon rupture or swelling of the tendon (tendinitis).
•
Tendon problems can happen in people of all ages who take levofloxacin
tablets. Tendons
are tough cords of tissue that connect muscles to bones.
•
Some tendon problems include pain, swelling, tears, and inflammation
of tendons
including the back of the ankle (Achilles), shoulder, hand, or other
tendon sites.
•
The risk of getting tendon problems while you take levofloxacin
tablets is higher if you:
•
are over 60 years of age
•
are taking steroids (corticosteroids)
•
have had a kidney, heart or lung transplant.
•
Tendon problems can happen in people who do not have the above risk
factors when they
take levofloxacin tablets. Other reasons that can increase your risk
of tendon problems can
include:
•
physical activity or exercise
•
kidney failure
•
tendon problems in the past, such as in people with rheumatoid
arthritis (RA).
•
Call your healthcare provider right away at the first sign of tendon
pain, swelling or
inflammation. Stop taking levofloxacin tablets until tendinitis or
tendon rupture has been
ruled out by your healthcare provider. Avoid exercise and using the
affected area. The
most common area of pain a

Summary of Product characteristics

LEVOFLOXACIN - LEVOFLOXACIN TABLET, FILM COATED
H.J. HARKINS COMPANY, 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
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF LEVOFLOXACIN AND
OTHER ANTIBACTERIAL DRUGS, LEVOFLOXACIN SHOULD BE USED ONLY TO TREAT
OR PREVENT INFECTIONS THAT ARE PROVEN OR
STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA.
WARNING:
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, 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)_].
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, MAY EXACERBATE
MUSCLEWEAKNESS IN PERSONS WITH MYASTHENIA
GRAVIS. AVOID LEVOFLOXACIN INPATIENTS WITH A KNOWN HISTORY OF
MYASTHENIA GRAVIS [_SEE WARNINGS AND_
_PRECAUTIONS (5.2)_]_._
RECENT MAJOR CHANGES
Warnings and Precautions
Exacerbation of myasthenia gravis (5.2) 01/2011
Increased intracranial pressure (pseudotumor
cerebri) (5.6) 08/2011
INDICATIONS AND USAGE
Levofloxacin tablets are 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 concentrati