Label: ZOFRAN- ondansetron 4mg tablet, film coated

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

Drug Label Information

Updated October 1, 2021

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  • Dosage and Administration Section

    2 DOSAGE AND ADMINISTRATION

    2.1 Dosage

    The recommended dosage regimens for adult and pediatric patients are described in Table 1 and Table 2, respectively.

    Corresponding doses of ondansetron tablets, ondansetron orally disintegrating tablets and ondansetron oral solution may be used interchangeably.

    Table 1: Adult Recommended Dosage Regimen for Prevention of Nausea and Vomiting
    Indication
    Dosage Regimen
    Highly Emetogenic Cancer Chemotherapy
    A single 24 mg dose administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin greater than or equal to 50 mg/m2
    Moderately Emetogenic Cancer Chemotherapy
    8 mg administered 30 minutes before the start of chemotherapy, with a subsequent 8 mg dose 8 hours after the first dose.

    Then administer 8 mg twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
    Radiotherapy
    For total body irradiation: 8 mg administered 1 to 2 hours before each fraction of radiotherapy each day.

    For single high-dose fraction radiotherapy to the abdomen: 8 mg administered 1 to 2 hours before radiotherapy, with subsequent 8 mg doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

    For daily fractionated radiotherapy to the abdomen: 8 mg administered 1 to 2 hours before radiotherapy, with subsequent 8 mg doses every 8 hours after the first dose for each day radiotherapy is given.
    Postoperative
    16 mg administered 1 hour before induction of anesthesia.

    Table 2: Pediatric Recommended Dosage Regimen for Prevention of Nausea and Vomiting
    Indication
    Dosage Regimen
    Moderately Emetogenic Cancer Chemotherapy
    12 to 17 years of age: 8 mg administered 30 minutes before the start of chemotherapy, with a subsequent 8 mg dose 8 hours after the first dose.

    Then administer 8 mg twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

    4 to 11 years of age: 4 mg administered 30 minutes before the start of chemotherapy, with a subsequent 4 mg dose 4 and 8 hours after the first dose.

    Then administer 4 mg three times a day for 1 to 2 days after completion of chemotherapy.

    2.2 Dosage in Hepatic Impairment

    In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), do not exceed a total daily dose of 8 mg [see USE IN SPECIFIC POPULATIONS (8.6), CLINICAL PHARMACOLOGY (12.3)].

  • Indications and Usage Section

    1 INDICATIONS AND USAGE

    Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with:

    highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2
    initial and repeat courses of moderately emetogenic cancer chemotherapy
    radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen

    Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.

  • Contraindications Section

    4 CONTRAINDICATIONS

    Ondansetron tablets are contraindicated in patients:

    known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation [see ADVERSE REACTIONS (6.2)]
    receiving concomitant apomorphine due to the risk of profound hypotension and loss of consciousness

  • Principal Display Panel

    Ondasetron 4mg Tablet

  • INGREDIENTS AND APPEARANCE
    ZOFRAN 
    ondansetron 4mg tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80425-0072(NDC:65862-187)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONDANSETRON HYDROCHLORIDE (UNII: NMH84OZK2B) (ONDANSETRON - UNII:4AF302ESOS) ONDANSETRON4 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize6mm
    FlavorImprint Code F;91
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0072-510 in 1 BOTTLE; Type 0: Not a Combination Product07/31/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07853907/31/2007
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0072)