Label: LEVOFLOXACIN tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 20, 2024

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  • 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 ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)
    • Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions ...

    WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA 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)], 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)].
    Close
  • 1 INDICATIONS AND USAGE
    1.1 Nosocomial Pneumonia - Levofloxacin tablet is indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Dosage of Levofloxacin Tablets in Adult Patients with Creatinine Clearance ≥ 50 mL/minute - The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Levofloxacin tablets, USP are white to off white, modified capsule-shaped, biconvex and film-coated - • 250 mg tablets, debossed with logo of ‘ZC55’ on one side and plain on other side - • 500 mg ...
  • 4 CONTRAINDICATIONS
    Levofloxacin tablet is contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions (5.3)].
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects - Fluoroquinolones ...
  • 6 ADVERSE REACTIONS
    The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: •   Disabling and Potentially Irreversible Serious Adverse ...
  • 7 DRUG INTERACTIONS
    7.1 Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins - While the chelation by divalent cations is less marked than with other fluoroquinolones, concurrent administration of ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Published information from case reports, case control studies and observational studies on levofloxacin administered during pregnancy have not identified any ...
  • 10 OVERDOSAGE
    In the event of an acute overdosage, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis ...
  • 11 DESCRIPTION
    Levofloxacin tablets are synthetic antibacterial agents for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Levofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology (12.4)]. 12.3 Pharmacokinetics - The mean ±SD pharmacokinetic ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In a lifetime bioassay in rats, levofloxacin exhibited no carcinogenic potential following daily dietary administration for 2 years ...
  • 14 CLINICAL STUDIES
    14.1 Nosocomial Pneumonia - Adult patients with clinically and radiologically documented nosocomial pneumonia were enrolled in a multicenter, randomized, open-label study comparing intravenous ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Levofloxacin Tablets USP, 500 mg are white to off white, modified capsule-shaped, biconvex, film-coated tablets debossed with logo of 'ZC56' on one side and plain on other side and are supplied ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Serious Adverse Reactions - Advise patients to stop taking levofloxacin if they experience an adverse reaction and ...
  • MEDICATION GUIDE
    MEDICATION GUIDE - Levofloxacin (lee" voe flox' a sin) Tablets, USP - What is the most important information I should know about levofloxacin tablets? Levofloxacin, a ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 72578-099 - Levofloxacin Tablets USP, 500 mg - Rx only
  • INGREDIENTS AND APPEARANCE
    Product Information