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:

REMEDYREPACK INC.

INN (International Name):

LEVOFLOXACIN

Composition:

LEVOFLOXACIN ANHYDROUS 750 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levofloxacin tablets are 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)] . Levofloxacin tablets are 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

Product summary:

Levofloxacin Tablets USP, 250 mg are terra pink colored capsule shaped, biconvex film-coated tablets, debossed with ‘13’ on one side and ‘T’ on the other side. Bottles of 50                                      NDC 65862-536-50 Bottles of 1,000                                 NDC 65862-536-99 10 x 10 Unit-dose Tablets                  NDC 65862-536-10 Levofloxacin Tablets USP, 500 mg are peach colored capsule shaped, biconvex film-coated tablets, debossed with ‘12’ on one side and ‘T’ on the other side. Bottles of 50                                      NDC 65862-537-50 Bottles of 1,000                                 NDC 65862-537-99 10 x 10 Unit-dose Tablets                  NDC 65862-537-10 Levofloxacin Tablets USP, 750 mg are white capsule shaped, biconvex film-coated tablets, debossed with ‘11’ on one side and ‘T’ on the other side. Bottles of 20                                     NDC 65862-538-20 Bottles of 500                                   NDC 65862-538-05 10 x 10 Unit-dose Tablets                 NDC 65862-538-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in well-closed containers.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
REMEDYREPACK INC.
----------
MEDICATION GUIDE
Levofloxacin Tablets USP
(lee'' voe flox' a sin)
What is the most important information I should know about
levofloxacin tablets?
Levofloxacin tablets, 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
tablets. 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
tablets are 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)
•
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 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 levofloxacin
tablets. Tendon ruptures can happen with

Summary of Product characteristics

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
REMEDYREPACK 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
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: • TENDINITIS AND TENDON RUPTURE ( 5.2) • PERIPHERAL NEUROPATHY ( 5.3) • CENTRAL NERVOUS SYSTEM EFFECTS ( 5.4)
DISCONTINUE LEVOFLOXACIN 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 5.15), RESERVE LEVOFLOXACIN 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
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
Levofloxacin tablets are a fluoroquinolone antibacterial indicated in
adults (18 years of age and older) with infections c