LEVOFLOXACIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aidarex Pharmaceuticals LLC

INN (International Name):

LEVOFLOXACIN

Composition:

LEVOFLOXACIN ANHYDROUS 250 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. Levofloxacintablets 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. 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 Micr

Product summary:

Levofloxacin Tablets are supplied as 250, 500, and 750 mg capsule-shaped, coated tablets. Levofloxacin Tablets are packaged in bottles and in unit-dose blister strips in the following configurations: ●  250 mg tablets are pink and are debossed: "W" on one side and "544" on the other side. ●  500 mg tablets are peach and are debossed: "W" on one side and "545" on the other side ●  750 mg tablets are white and are debossed: "W" on one side and "547" on the other side Storage Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Keep the container closed tightly.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LEVOFLOXACIN- LEVOFLOXACIN TABLET
Aidarex Pharmaceuticals LLC
----------
MEDICATION GUIDE
LEVOFLOXACIN TABLETS
250 mg, 500 mg and 750 mg
Read this Medication Guide before you start taking levofloxacin 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, a
fluoroquinolone antibiotic, can cause serious side effects. Some of
these serious side effects could result
in death.
If you have any of the following serious side effects while you take
levofloxacin tablets, 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 are higher if you:
o are over 60 years of age
o are taking steroids (corticosteroids)
o 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:
o physical activity or exercise
o kidney failure
o 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 and swelling is the

Summary of Product characteristics

LEVOFLOXACIN- LEVOFLOXACIN TABLET
AIDAREX PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVOFLOXACIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LEVOFLOXACIN.
LEVOFLOXACIN TABLETS
INITIAL U.S. APPROVAL: 1996
WARNING:
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED 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 MUSCLE
WEAKNESS IN PERSONS WITH MYASTHENIA
GRAVIS. AVOID LEVOFLOXACIN TABLETSIN PATIENTS WITH A KNOWN HISTORY OF
MYASTHENIA GRAVIS [SEE WARNINGS AND
PRECAUTIONS (5.2)].
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)
RECENT MAJOR CHANGES
Indications and Usage
● Plague (1.14) 04/2012
Dosage and Administration
● Dosage in Adult Patients with Normal Renal Function (2.1) 04/2012
● Dosage in Pediatric Patients (2.2) 04/2012
Warnings and Precautions
● Musculoskeletal Disorders in Pediatric Patients and Arthropathic
Effects in Animals
(5.10) 04/2012
● Increased intracranial pressure (pseudotumor cerebri) (5.6)
10/2011
INDICATIONS AND USAGE
Levofloxacin 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)
Chro