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:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

LEVOFLOXACIN

Composition:

LEVOFLOXACIN ANHYDROUS 500 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 pneumophil

Product summary:

Levofloxacin, USP is supplied as 250 mg, 500 mg and 750 mg capsule-shaped, coated tablets.  Levofloxacin tablets, USP are packaged in bottles and in unit-dose blister strips in the following configurations: Levofloxacin tablets, USP should be stored at 20º to 25ºC (68º to 77°F); excursions permitted to 15º to 30ºC (59º to 86°F) in well-closed containers.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
PD-Rx Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Medication Guide
Levofloxacin Tablets
(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 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)
•
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 rupt

Summary of Product characteristics

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
PD-RX PHARMACEUTICALS, 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:
o TENDINITIS AND TENDON RUPTURE ( 5.2)
o PERIPHERAL NEUROPATHY ( 5.3)
o 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- 5.15), 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
• 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) 05/2019
• Warnings and Precautions,-