WARLINE-600 TAB

PHARMACOLOGY

PHARMACOKINETICS:

• Absorption: Owing to hepatic first-pass metabolism, its bioavailability is only about 60%.
• Distribution: Plasma protein binding of ondansetron 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: Ondansetron 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 ondansetron elimination half-life was 4.0 hours, and there was no difference in the multidose pharmacokinetics over a 4-day period.

INDICATIONS:

• Prevention of nausea and vomiting associated with highly emetogenic chemotherapy, including cisplatin ≥50mg/m2.
• Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic 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 post-op nausea and vomiting.