granisetron hydrochloride

FDA Drug Profile — Granisol

Drug Details

Generic Name
granisetron hydrochloride
Brand Names
Granisol
Application Number
ANDA219282
Sponsor
Intra-Sana Laboratories
NDC Codes
1
Dosage Forms
SOLUTION
Routes
ORAL
Active Ingredients
GRANISETRON HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Granisetron hydrochloride injection, is a serotonin-3 (5-HT 3 ) receptor antagonist indicated for: The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. The prevention and treatment of postoperative nausea and vomiting in adults. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided during the postoperative period, granisetron hydrochloride injection is recommended even where the incidence of postoperative nausea and/or vomiting is low. Granisetron hydrochloride injection, is a serotonin-3 (5-HT 3 ) receptor antagonist indicated for: Prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. ( 1 ) Prevention and treatment of postoperative nausea and vomiting in adults. ( 1 )