LEVOFLOXACIN tablet 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:

DIRECT RX

INN (International Name):

LEVOFLOXACIN

Composition:

LEVOFLOXACIN ANHYDROUS 750 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. 1.1 Nosocomial Pneumonia 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)]. 1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen Levofloxacin is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [

Product summary:

16.1 Levofloxacin Tablets, USP •Levofloxacin Tablets USP, 250 mg are pink colored, capsule shaped, biconvex, film coated tablets debossed with '25' on one side and 'I' on the other side. •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. •Levofloxacin Tablets USP, 750 mg are white colored, capsule shaped, biconvex, film coated tablets debossed with '18' on one side and 'I' on the other side. 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
DIRECT RX
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Revised: 8/2023
Document Id: 02579894-261f-6c6d-e063-6294a90abbf1
34391-3
Set id: 4f40d5fa-ebcc-516c-e054-00144ff8d46c
Version: 7
Effective Time: 20230807
DIRECT RX

Summary of Product characteristics

LEVOFLOXACIN- LEVOFLOXACIN TABLET
LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
DIRECT RX
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LEVOFLOXACIN
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON
RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND
EXACERBATION OF MYASTHENIA GRAVISWARNING: SERIOUS ADVERSE
REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL
NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF
MYASTHENIA GRAVIS
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON
RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND
EXACERBATION OFMYASTHENIA GRAVIS
• Fluoroquinolones, including levofloxacin, have been associated
with disabling and
potentially irreversible serious adverse reactions that have occurred
together [see
Warnings and Precautions (5.1)], including:
o Tendinitis and tendon rupture [see Warnings and Precautions (5.2)]
o Peripheral neuropathy [see Warnings and Precautions (5.3)]
o Central nervous system effects [see Warnings and Precautions (5.4)]
Discontinue levofloxacin immediately and avoid the use of
fluoroquinolones,
including levofloxacin, in patients who experience any of these
serious adverse
reactions [see Warnings and Precautions (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 [see Warnings and Precautions (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 [see Indications and Usage
(1.12)]
o Acute bacterial exacerbation of chronic bronchitis [see Indications
and Usage
(1.13)]
o Acute bacterial sinusitis [see Indications and Usage (1.14)].
Levofloxacin tablets are indicated for the treatment of adults (≥18
years of age) with
mild, moderate, a