Label: LEVOFLOXACIN- levofloxacin tablet, film coated

  • NDC Code(s): 31722-721-31, 31722-721-32, 31722-721-50, 31722-722-31, view more
  • Packager: Camber Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 14, 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 ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    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  (5.1 to  5.15)], 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)].

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  • 1 INDICATIONS AND USAGE
    1.1 Nosocomial Pneumonia - Levofloxacin tablets are 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 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    •   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 ...
  • 4 CONTRAINDICATIONS
    Levofloxacin tablets are 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, USP are synthetic antibacterial agents for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the ...
  • 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 ...
  • 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, 250 mg are pink colored, capsule shaped, biconvex, film coated tablets debossed with '25' on one side and 'I' on the other side. They are supplied in -    Bottles ...
  • 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 ...
  • SPL MEDGUIDE SECTION
    Levofloxacin - (LEE-voe-FLOX-a-sin)  Tablets USP -   What is the most important information I should know about levofloxacin tablets ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    250 mg 50s Label: 500 mg 50s Label: 750 mg 20s Label:
  • INGREDIENTS AND APPEARANCE
    Product Information