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ZOFRAN (ondansetron hydrochloride) Label

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZOFRAN TABLETS, ZOFRAN ODT, and ZOFRAN ORAL SOLUTION safely and effectively. See full prescribing information for ZOFRAN TABLETS, ZOFRAN ODT, and ZOFRAN ORAL SOLUTION. ZOFRAN (ondansetron hydrochloride) tablets, for oral use ZOFRAN ODT (ondansetron) orally disintegrating tablets ZOFRAN (ondansetron hydrochloride) oral solution Initial Approval: 1991 ----------------------------INDICATIONS AND USAGE --------------------------- ZOFRAN is a 5- HT3 receptor antagonist indicated for the prevention of: nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2.

16 mg administered 1 hour before induction of anesthesia. Reference ID: 4011596 . 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

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