EMDAR Injection

PHARMACOLOGY

1. Pharmacokinetics: -

Absorption: Owing to hepatic first-pass metabolism, its bioavailability is only about 60%.

Distribution: Plasma protein binding of ondensetron as measured in vitro was 70% to 76%, over the Pharmacologic concentration range of 10 to 500 ng/mL. Circulating drug also distributes into erythrocytes.

Metabolism: Ondensetron is extensively metabolized in humans, with approximately 5% of a radiolabeled dose recovered as the parent compound from the urine. The primary metabolic pathway is hydroxylation on the indole ring followed by subsequent glucuronide or sulfate conjugation.

Elimination: In adult cancer patients, the mean ondensetron elimination half-life was 4.0 hours, and there was no difference in the multidose pharmacokinetics over a 4-day period.

INDICATION: - Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin  50 mg/ Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy .

Prevention of nausea and vomiting associated with radiotherapy in patients receiving total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.

Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for 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 postoperatively,