Ondansetron 8 MG Disintegrating Tablet
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/m 2 • 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 are also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron orally disintegrating tablets are a 5-HT 3 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/m 2 . ( 1 ) • nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. ( 1 ) • nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. ( 1 ) • postoperative nausea and/or vomiting. ( 1 )
Mylan Pharmaceuticals Inc.
ROUND WHITE M 734
M 734 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
ONDANSETRON Orally Disintegrating Tablets, USP are available containing 4 mg or 8 mg of
ONDANSETRON, USP. The 4 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and 732 on the other side. They are available as follows: NDC 0378-7732-93 bottles of 30 tablets The 8 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and 734 on the other side. They are available as follows: NDC 0378-7734-97 bottles of 10 tablets NDC 0378-7734-93 bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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