Emistat® Tablet 8 mg: Each tablet contains Ondansetron Hydrochloride USP 10 mg, equivalent to Ondansetron 8 mg.
Emistat® oral solution: Each pack contains 50 ml oral solution in PET bottle with 5 ml spoon and 1.25 ml dropper.
Emistat is a selective 5-hydroxytryptamine-3 (5-HT3) receptor antagonist with anti-emetic activity.
Ondansetron is a serotonin subtype 3 (5-HT3) receptor antagonist indicated for:
• Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
• Prevention and treatment of postoperative nausea and vomiting.
• Prevention of radiotherapy-induced nausea and vomiting.
• Dosage and Administration
• Use in Specific Populations
Chemotherapy-Induced Nausea and Vomiting
Patient Group
8mg Tablet/FT
4mg FT
Injection
Pediatric patients (6
months to 18 years)
Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.
Adults
Initial Dose: 8 mg orally 1 to 2 hours before radiotherapy. Post Radiotherapy: 8 mg orally every 8 hours for up to 5 days after a course of treatment
Three 0.15 mg/kg doses,
up to a maximum of 16
mg per dose.
Three 0.15 mg/kg doses, up to a
maximum of 16 mg per dose, infused
intravenously over 15 minutes.
Postoperative Nausea and Vomiting
16 mg given as two 8 mg Tablets
16 mg (given as four 4 mg FT)
4 mg
Pediatrics (>40 kg)
0.1 mg/kg
The potential for clinically significant drug interactions with Ondansetron appears to be low.
Contraindicated in patients with known hypersensitivity to the drug or any of its components.
Concomitant use with apomorphine.
Chemotherapy-induced nausea and vomiting (7% incidence): Diarrhea, headache, and fever.
Postoperative nausea and vomiting:
Adults: Headache (10% incidence).
Pediatric patients (1–24 months): Diarrhea (2% incidence).
Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported, even without prior hypersensitivity to other selective 5-HT3 receptor antagonists.
QT prolongation occurs in a dose-dependent manner.
Store at a temperature not exceeding 30ºC in a dry place. Protect from light.