LEVOFLOXACIN- 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:

American Health Packaging

INN (International Name):

LEVOFLOXACIN

Composition:

LEVOFLOXACIN ANHYDROUS 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levofloxacin tablets 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 are indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible 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 anti-pseudomonal β-lactam is recommended [see CLINICAL STUDIES ( 14.1)]. Levofloxacin tablets are indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Kle

Product summary:

Levofloxacin tablets USP are supplied as 250, 500, and 750 mg coated tablets. Levofloxacin tablets USP are packaged in the following configurations: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
American Health Packaging
----------
8248101/0617
MEDICATION GUIDE
Levofloxacin (LEE-voe-FLOX-a-sin) Tablets USP
Rx Only
Read this Medication Guide before you start taking levofloxacin
tablets 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 can happen at the same time and could result in death.
If you have any of the following serious side effects while you take
levofloxacin tablets, you should stop
taking levofloxacin tablets immediately and get medical help right
away.
1.Tendon rupture or swelling of the tendon (tendinitis).
•
Tendon problems can happen in people of all ages who take
levofloxacin. Tendons are tough
cords of tissue that connect muscles to bones.
Some tendon problems include pain, swelling, tears, and swelling 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 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.
•
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)
•
Stop taking levofloxacin tablets immediately and get medical help
right away at the first sign of
tendon pain, swelling or inflammation. Avoid exercise and using the
affected area.
The most common area of pain and swelling is the Achilles tendon at
the back of your ankle. This can
also happen wit

Summary of Product characteristics

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
----------
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 TABLET, FILM COATED 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 TABLETS 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 TO 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)
RECENT MAJOR CHANGES
Boxed Warning 6/2016
Indications and Usage ( 1) 6/2016
Dosage and Administration ( 2) 2/2017
Warnings and Precautions ( 5) 2/2017
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 Acqu