Label: ZAFIRLUKAST tablet, film coated

  • NDC Code(s): 59651-291-60, 59651-292-60
  • Packager: Aurobindo Pharma Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 1, 2023

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  • DESCRIPTION
    Zafirlukast is a synthetic, selective peptide leukotriene receptor antagonist (LTRA), with the chemical name ...
  • CLINICAL PHARMACOLOGY
    Mechanism of Action: Zafirlukast is a selective and competitive receptor antagonist of leukotriene D4 and E4 (LTD4 and LTE4), components of slow-reacting substance of anaphylaxis (SRSA) ...
  • INDICATIONS AND USAGE
    Zafirlukast tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.
  • CONTRAINDICATIONS
    Zafirlukast tablets are contraindicated in patients who are hypersensitive to zafirlukast or any of its inactive ingredients. Zafirlukast tablets are contraindicated in patients with hepatic ...
  • WARNINGS
    Hepatotoxicity: Cases of life-threatening hepatic failure have been reported in patients treated with zafirlukast. Cases of liver injury without other attributable cause have been reported from ...
  • PRECAUTIONS
    Information for Patients: Patients should be told that a rare side effect of zafirlukast is hepatic dysfunction, and to contact their physician immediately if they experience symptoms of ...
  • ADVERSE REACTIONS
    Adults and Children 12 years of age and older - The safety database for zafirlukast consists of more than 4000 healthy volunteers and patients who received zafirlukast, of which 1723 were ...
  • OVERDOSAGE
    No deaths occurred at oral zafirlukast doses of 2000 mg/kg in mice (approximately 210 times the maximum recommended daily oral dose in adults and children on a mg/m2 basis), 2000 mg/kg in rats ...
  • DOSAGE AND ADMINISTRATION
    Because food can reduce the bioavailability of zafirlukast, zafirlukast tablets should be taken at least 1 hour before or 2 hours after meals. Adults and Children 12 years of age and ...
  • HOW SUPPLIED
    Zafirlukast Tablets 10 mg, are white, round, biconvex, film-coated tablets debossed with “1” on one side and “B” on other side ...
  • PATIENT INFORMATION
    ZAFIRLUKAST TABLETS - (za FIR loo kast) Read the Patient Information leaflet before you start taking zafirlukast tablets and each time you get a refill. There may be new information. This ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg - (60 Tablets Bottle)
    NDC 59651-291-60 - Rx only - Zafirlukast Tablets - 10 mg - DISPENSE IN THE ORIGINAL AIRTIGHT - CONTAINER. AUROBINDO                                             60 Tablets
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg - (60 Tablets Bottle)
    NDC 59651-292-60 - Rx only - Zafirlukast Tablets - 20 mg - DISPENSE IN THE ORIGINAL AIRTIGHT - CONTAINER. AUROBINDO                                             60 Tablets
  • INGREDIENTS AND APPEARANCE
    Product Information