ondansetron hydrochloride
Drug Details
- Generic Name
- ondansetron hydrochloride
- Brand Names
- ondansetron, ondansetron hydrochloride, Ondansetron
- Application Number
- ANDA076183
- Sponsor
- Cardinal Health 107, LLC
- NDC Codes
- 15
- Dosage Forms
- TABLET, FILM COATED, INJECTION, INJECTION, SOLUTION, SOLUTION
- Routes
- ORAL, INTRAMUSCULAR, INTRAVENOUS
- Active Ingredients
- ONDANSETRON HYDROCHLORIDE
Indications and Usage
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/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 tablets are also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron 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)