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:

NuCare Pharmaceuticals, Inc.

INN (International Name):

LEVOFLOXACIN

Composition:

LEVOFLOXACIN ANHYDROUS 500 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 is 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 is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including  multi-drug-resistant

Product summary:

Levofloxacin Tablets USP, 500 mg are orange colored, capsule shaped, biconvex, film coated tablets debossed with '26' on one side and 'I' on the other side. They are supplied in Bottles of 7 NDC 68071-3166-7 Blister of 10 NDC 68071-3166-1 Bottles of 14 NDC 68071-3166-4 Bottles of 20 NDC 68071-3166-2 Bottles of 30 NDC 68071-3166-3 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
NuCare Pharmaceuticals, Inc.
----------
17 PATIENT COUNSELING
INFORMATION
Advise the patient to read the FDA-Approved Medication Guide ( 17.6)
17.1 SERIOUS ADVERSE REACTIONS
Advise patients to stop taking levofloxacin if they experience an
adverse reaction and to call their
healthcare provider for advice on completing the full course of
treatment with another antibacterial drug.
Inform patients of the following serious adverse reactions that have
been associated with levofloxacin or
other fluoroquinolone use:
•
Disabling and Potentially Irreversible Serious Adverse Reactions That
May Occur Together:
Inform patients that disabling and potentially irreversible serious
adverse reactions, including
tendinitis and tendon rupture, peripheral neuropathies, and central
nervous system effects, have
been associated with use of levofloxacin and may occur together in the
same patient. Inform
patients to stop taking levofloxacin immediately if they experience an
adverse reaction and to call
their healthcare provider.
•
Tendinitis and Tendon Rupture: Instruct patients to contact their
healthcare provider if they
experience pain, swelling, or inflammation of a tendon, or weakness or
inability to use one of their
joints; rest and refrain from exercise; and discontinue levofloxacin
treatment. Symptoms may be
irreversible. The risk of severe tendon disorder with fluoroquinolones
is higher in older patients
usually over 60 years of age, in patients taking corticosteroid drugs,
and in patients with kidney,
heart or lung transplants.
•
Peripheral Neuropathies: Inform patients that peripheral neuropathies
have been associated with
levofloxacin use, symptoms may occur soon after initiation of therapy
and may be irreversible. If
symptoms of peripheral neuropathy including pain, burning, tingling,
numbness and/or weakness
develop, immediately discontinue levofloxacin and tell them to contact
their physician.
•
Central Nervous System Effects (for example, convulsions, dizziness,
light

Summary of Product characteristics

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
NUCARE 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 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 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)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of levofloxacin and other antibacterial
drugs, levofloxacin should be used only to treat or prevent infections
that are proven or strongly suspected to be caused
by bacteria ( 1.15).
RECENT MAJOR CHANGES
Boxed Warning 06/2016
Indications and Usage ( 1) 06/2016
Dosage and Administration (