Pharmacology: Seton (Ondansetron) is a potent, highly selective 5-HT3(Serotonin) receptor antagonist. Due to antagonism of 5-HT3(Serotonin) receptor on neurons located both in the central and peripheral nervous system, it inhibits the triggering of vomiting reflex. It has proven to be highly efficacious in the treatment of chemotherapy and radiotherapy induced nausea and vomiting.

Indications:

• Prevention and treatment of nausea and vomiting induced by cytostatic chemotherapy.
• Prevention and treatment of nausea and vomiting associated with radiotherapy.
• Prevention of post-operative nausea and vomiting. 

Dosage & Administration
Prevention of chemotherapy induced nausea and vomiting:

Adults- Tablet and Oral Solution: The recommended adult oral dosage of Seton (Ondansetron) is 24mg given as three 8mg tablets in highly emetogenic chemotherapy. In case of moderately emetogenic chemotherapy, the oral dose is one 8mg tablet or 10ml of oral solution given twice daily.

Pediatric Patients- Tablet and Oral Solution: For pediatric patients 4 through 11 years of age, the dosage is one 4mg Seton(Ondansetron) tablet or 5ml of oral solution should be administered 3 times a day for 1 to 2 days after completion of chemotherapy.

Radiotherapy induced nausea and vomiting: Adult- Tablet and Oral Solution: the recommended oral dosage is one 8mg Seton(Ondansetron) tablet or 10ml of oral solution given 3 times daily.

Post-operative nausea and vomiting (PONV): Adult- Tablet and Oral Solution: the recommended dosage si 16mg given as two 8mg Seton(Ondansetron) tablets or 20ml of oral solution 1hour before induction of anesthesia.

Dosage adjustment for patients with impaired hepatic function: Tablet and Oral solution: The total daily dose of 8mg should not be exceeded.

Side Effect: The major side effects are constipation, headache and diarrhea but they are mild to moderate in nature. In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ondansetron. Sensation of warmth or flushing, hiccup, occasional alterations of liver enzymes, hypersensitivity reactions, involuntary movements, seizures, chest pain, arrhythmias, hypotension and bradycardia are also reported.

Contraindications: Contraindicated in patients with a history of hypersensitivity to Ondansetron and other selective 5-HT3 receptor antagonists.
Precautions: It should be used cautiously in case of moderate or severe hepatic impairment. It is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction.
Pregnancy and Lactation: Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. It is not known whether Ondansetron is excreted in human milk. Caution should be exercised when Ondansetron is administered to nursing women.
Drug Interactions: Seton(Ondansetron) is metabolized by hepatic cytochrome P-450 metabolizing enzymes. So, inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of Ondansetron. 
 Packaging: Seton 8 Tablet: Each box contains 3 x 10 tablets in blister pack. Each film-coated tablet contains Ondansetron Hydrochloride Dihydrate USP equivalent to Ondansetron 8mg.

Pharmaceutical Precaution: Store at below 25 0C. Protect from light, heat and moisture.
Warning: Keep out of the reach of children.
Manufactured by:
Delta Pharma Limited
Pakundia, Kishoreganj, Bangladesh.