Osetron Tablet: Each tablet contains Ondansetron 8mg as Hydrochloride USP.
Osetron Injection: Each ml contains Ondansetron 2mg as Hydrochloride USP.
Osetron Syrup: Each 5ml syrup contains Ondansetron 4mg as Hydrochloride USP.
Osetron ® is a selective 5-HT 3 serotonin receptor antagonist. 5-HT 3 serotonin receptors are present both peripherally on vagal nerve terminals and centrally in chemoreceptor trigger zone. During chemotherapy and postoperative period; excessive serotonin secrets from the enterochromaffin cells of the small intestine. The released serotonin stimulates the 5-HT 3 serotonin receptors of the vagal nerve terminals and chemoreceptor trigger zone which initiate vomiting reflex. Ondansetron is indicated for the prevention of chemotherapy & radiotherapy induced nausea and vomiting. It also prevents the postoperative nausea and vomiting.
The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used.
Adults:
Emetogenic chemotherapy and radiotherapy (injection, tablets, syrup): Single dose of Osetron ® 8 mg injection slow IV immediately before treatment, or 8 mg tablet / 10 ml syrup twice a day. First dose 30 min before chemotherapy, next dose 8 hours later. To protect against delayed emesis, 8 mg tablet / 10 ml oral solution twice a day for 1-2 days after chemotherapy.
Highly emetogenic chemotherapy: Single dose 8 mg injection slow IV infusion over at least 15 min immediately before treatment. Higher doses up to max 32 mg in 24 hours. Delayed emesis: 8 mg twice a day up to 5 days.
Post-operative nausea and vomiting: 4 mg IM or slow IV single dose (up to 8 mg).
Children (>=12 years): Same as adults.
Children (4 to 11 years): 0.15 mg/kg IV injection 15 min before treatment, followed by 4 mg tablet or 5 ml solution 2-3 times daily for 1-2 days.
Children (1 month to 12 years, post-op): 0.1 mg/kg slow IV up to max 4 mg.
Preparation: Dilute IV injection in 50 ml of 5% Dextrose or 0.9% NaCl.
Hepatic impairment: Max daily dose of 8 mg infused over 15 minutes.
Apomorphine co-administration causes profound hypotension and loss of consciousness (contraindicated); drugs that prolong the QT interval (antiarrhythmics, macrolides) increase ventricular arrhythmia risk; CYP3A4 inducers (phenytoin, carbamazepine) decrease ondansetron levels.
Ondansetron is contraindicated for patients known to have hypersensitivity to the Ondansetron or to any of its ingredient.
Common: Headache, diarrhea, fatigue, dizziness, constipation.
Overdose
There is no specific antidote for Ondansetron overdose. If overdose is occurred, symptomatic and supportive therapy should be given as appropriate.
Category B. Conflicting data regarding oral clefts in 1st trimester; use for severe hyperemesis gravidarum only when other therapies fail. Lactation: Excreted in animal milk; caution advised.
Store below 30°C in a cool, dry place. Protect from light and moisture. Keep out of reach of children.