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:

Janssen Pharmaceuticals, Inc.

INN (International Name):

levofloxacin

Composition:

levofloxacin anhydrous 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LEVAQUIN® is indicated in adult patients 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)] . LEVAQUIN® is indicated in adult patients 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 , Klebsiella pneumoniae , Moraxella catarrhalis , Chlamydophila pneumoniae , Legionella pneumophila , or Mycoplasma pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.2)] . MDRSP isolates are is

Product summary:

LEVAQUIN® Tablets are supplied as 250, 500, and 750 mg capsule-shaped, coated tablets. LEVAQUIN® Tablets are packaged in bottles in the following configurations: LEVAQUIN® Tablets should be stored at 15° to 30°C (59° to 86°F) in well-closed containers.

Authorization status:

New Drug Application

Patient Information leaflet

Janssen Pharmaceuticals, Inc.
----------
This Medication Guide has been approved by the U.S.
Food and Drug Administration
Revised: 06/2020
MEDICATION GUIDE
LEVAQUIN® (Leave ah kwin)
(levofloxacin)
tablets
What is the most important information I should know about LEVAQUIN?
LEVAQUIN, 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
LEVAQUIN, you should stop taking
LEVAQUIN 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 LEVAQUIN.
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 LEVAQUIN 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
LEVAQUIN.
•
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 LEVAQUIN 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 with other tendons. You may need a different
antibiotic that is not a
fluoroquinolone to treat your infection.
•
Tendon rupture can happen while you are taking or after you have
finished taking LEVAQUIN.
Tendon ruptures can happen within hours or days of taking LEVAQUIN and
have

Summary of Product characteristics

LEVAQUIN- LEVOFLOXACIN TABLET, FILM COATED
JANSSEN PHARMACEUTICALS, INC.
----------
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) 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 LEVAQUIN , HAVE BEEN ASSOCIATED WITH
DISABLING AND POTENTIALLY
IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT HAVE OCCURRED TOGETHER
(5.1), INCLUDING:
TENDINITIS AND TENDON RUPTURE (5.2)
PERIPHERAL NEUROPATHY (5.3)
CENTRAL NERVOUS SYSTEM EFFECTS (5.4)
DISCONTINUE LEVAQUIN IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES, INCLUDING LEVAQUIN , IN
PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE REACTIONS (5.1)
FLUOROQUINOLONES, INCLUDING LEVAQUIN , MAY EXACERBATE MUSCLE WEAKNESS
IN PATIENTS WITH MYASTHENIA
GRAVIS. AVOID LEVAQUIN IN PATIENTS WITH A KNOWN HISTORY OF MYASTHENIA
GRAVIS _[SEE WARNINGS AND_
_PRECAUTIONS (5.5)]_.
BECAUSE FLUOROQUINOLONES, INCLUDING LEVAQUIN , HAVE BEEN ASSOCIATED
WITH SERIOUS ADVERSE REACTIONS
(5.1–5.15), RESERVE LEVAQUIN FOR USE IN PATIENTS WHO HAVE NO
ALTERNATIVE TREATMENT OPTIONS FOR THE
FOLLOWING INDICATIONS:
UNCOMPLICATED URINARY TRACT INFECTION (1.12)
ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS (1.13)
ACUTE BACTERIAL SINUSITIS (1.14)
RECENT MAJOR CHANGES
Indications and Usage, Oral solution and Injection Dosage Forms
Removed (1)
7/2018
Dosage and Administration, Oral Solution and Injection Dosage Forms
Removed (2)
7/2018
Warnings and Precautions, Central Nervous System Effects (5.4)
10/2018
Warnings and Precautions, Risk of Aortic Aneurysm and Dissection (5.9)
5/2019
Warnings and Precautions, Blood Glucose Disturbances (5.13)
10/2018
INDICATIONS AND USAGE
LEVAQUIN is a fluoroquinolone