Label: ZOFRAN- ondansetron 4mg tablet, orally disintegrating

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

Drug Label Information

Updated December 4, 2020

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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)].

    2.3 Administration Instructions for Ondansetron Orally Disintegrating Tablets

    Do not attempt to push ondansetron orally disintegrating tablets through the foil backing. With dry hands, remove the tablet from the bottle or PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  • Indications and Usage Section

    1 INDICATIONS AND USAGE

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

  • Principal Display Panel

    Ondasetron 4mg ODT

  • INGREDIENTS AND APPEARANCE
    ZOFRAN 
    ondansetron 4mg tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80425-0113(NDC:65862-390)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONDANSETRON (UNII: 4AF302ESOS) (ONDANSETRON - UNII:4AF302ESOS) ONDANSETRON4 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize5mm
    FlavorGUARANA, STRAWBERRYImprint Code 5;E
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0113-260 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09046904/12/2010
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0113)