Emistat® Tablet 8 mg: Each tablet contains Ondansetron Hydrochloride USP 10 mg, equivalent to Ondansetron 8 mg.
Emistat® FT 8 mg: Each tablet contains Ondansetron Hydrochloride USP 10 mg, equivalent to Ondansetron 8 mg.
Emistat® FT 4 mg: Each tablet contains Ondansetron Hydrochloride USP 5 mg, equivalent to Ondansetron 4 mg.
Emistat® 8 mg/4 mL Injection: Each ampoule 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.
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 |
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. |
Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes. |
|
Adults |
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 |
Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes |
|
Radiotherapy-Induced Nausea and Vomiting |
|||
|
Patient Group |
8mg Tablet/FT |
4mg FT |
Injection |
|
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, |
Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes. |
|
Postoperative Nausea and Vomiting |
|||
|
Patient Group |
8mg Tablet/FT |
4mg FT |
Injection |
|
Adults |
16 mg given as two 8 mg Tablets |
16 mg (given as four 4 mg FT) |
4 mg |
|
Pediatrics (>40 kg) |
- |
- |
4 mg |
|
Pediatrics (40 kg) |
- |
- |
0.1 mg/kg |
Contraindicated in patients with known hypersensitivity to the drug or any of its components.
Concomitant use with apomorphine.
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.
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).
The potential for clinically significant drug interactions with Ondansetron appears to be low.
Chemotherapy-Induced Nausea and Vomiting
Pediatric Patients (6 months to 18 years)
Three doses of 0.15 mg/kg, up to a maximum of 16 mg per dose, administered orally or intravenously over 15 minutes.
Adults
Initial Dose: 8 mg orally, 1–2 hours before chemotherapy.
Follow-up Dose: 8 mg orally every 8 hours for up to 5 days after a course of chemotherapy.
Radiotherapy-Induced Nausea and Vomiting
Adults
Initial Dose: 8 mg orally, 1–2 hours before radiotherapy.
Follow-up Dose: 8 mg orally every 8 hours for up to 5 days.
Postoperative Nausea and Vomiting
Adults
4 mg orally or intravenously.
Pediatrics
0.1 mg/kg intravenously for patients weighing >40 kg.
Store at a temperature not exceeding 30ºC in a dry place. Protect from light.
Emistat® Tablet 8 mg: Each box contains 5x10's tablets in blister pack.
Emistat® FT 8 mg: Each box contains 3x10's flash tablets in Alu-Alu blister pack.
Emistat® FT 4 mg: Each box contains 3x10's flash tablets in Alu-Alu blister pack.
Emistat® 8 mg/4 mL Injection: Each box contains 2x5's ampoules in blister pack.
Emistat® oral solution: Each pack contains 50 ml oral solution in PET bottle with 5 ml spoon and 1.25 ml dropper.
