Label: LEVOFLOXACIN tablet, film coated

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

Drug Label Information

Updated August 7, 2024

If you are a consumer or patient please visit this version.

  • 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- 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)].

    Close
  • 1 INDICATIONS AND USAGE
    1.1Nosocomial Pneumonia - Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible S - taphylococcus 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 white colored, modified capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘279’ on other side.  Levofloxacin tablets USP, 500 ...
  • 4 CONTRAINDICATIONS
    Levofloxacin tablets are contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [ seeWarningsandPrecautions (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 ...
  • 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 or ...
  • 11 DESCRIPTION
    Levofloxacin tablets are synthetic antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Levofloxacin is a member of the fluoroquinolone class of antibacterial agents [ seeMicrobiology - (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 white colored, modified capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘279’ on other side and are supplied - Cartons of 100 ...
  • 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 ...
  • MEDICATION GUIDE
    MEDICATION GUIDE  - Levofloxacin Tablets USP, 250 mg, 500 mg and 750 mg -   (lee'' voe flox' a sin) What is the most important information I should know about levofloxacin ...
  • Package/Label Display Panel
    MAJOR® PHARMACEUTICALS - NDC 0904-6351-61 - Unit Dose - Once-a-day - LEVOFLOXACIN TABLETS - 250 mg - PHARMACIST: DISPENSE WITH - MEDICATION GUIDE - Rx only - 100 TABLETS
  • Package/Label Display Panel
    MAJOR® PHARMACEUTICALS - NDC 0904-6352-61 - Unit Dose - Once-a-day - LEVOFLOXACIN TABLETS - 500 mg - PHARMACIST: DISPENSE WITH - MEDICATION GUIDE - Rx only - 100 TABLETS
  • Package/Label Display Panel
    MAJOR® PHARMACEUTICALS - NDC 0904-6353-61 - Unit Dose - Once-a-day - LEVOFLOXACIN TABLETS - 750 mg - PHARMACIST: DISPENSE WITH - MEDICATION GUIDE - Rx only - 100 TABLETS
  • INGREDIENTS AND APPEARANCE
    Product Information