Composition
Vomidyl tablet: Each film coated tablet contains Ondansetron Hydrochloride Dihydrate USP 9.976 mg equivalent to Ondansetron 8 mg.
Pharmacology
Ondansetron is a serotonin subtype 3 (5-HT3) receptor antagonist with anti-emetic activity.
Indication
Ondansetron is indicated:
• Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
• Prevention and treatment of post-operative nausea and vomiting.
• Prevention of radiotherapy induced nausea and vomiting.
Dosage & administration
Contra-indication
• Contraindicated in patients known to have hypersensitive to the drug or any of its components.
• Concomitant use of apomorphine.
|
Chemotherapy-Induced Nausea and Vomiting |
|
|
Patient Group |
Tablet |
|
Pediatric patients (6 months to 18 years) |
Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose. |
|
Adults |
Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose. |
|
Radiot herapy-Induced Nausea and Vomiting |
|
|
Patient Group |
Tablet |
|
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. |
|
Post operative Nausea and Vomiting |
|
|
Patient Group |
Tablet |
|
Adults |
16 mg given as two 8 mg Tablets |
Warning & precaution
Hypersensitivity reactions, including anaphylaxsis and bronchospasm, have been reported with or without known hypersensitivity to other selective 5-HT3 receptor antagonists.
Side effects
The most common adverse reactions in Chemotherapy -induced nausea & vomiting (incidence 7%) are diarrhea, headache and fever.
The most common adverse reactions postoperative nausea and vomiting in adults is headache (incidence 10%), and in pediatric patients aged 1 to 24 months is diarrhea (incidence 2%).
Use in pregnancy & lactation
Pregnancy: Pregnancy Category B
Nursing Mothers: Ondansetron is excreted in the breast milk of rats. It is not known whether Ondansetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ondansetron is administered to a nursing woman.
Geriatric Use: Dose adjustment is not needed in patients over the age of 65.
Hepatic impairment: A total daily dose of 8 mg should not be exceeded (patients with severe hepatic impairment).
Renal Impairment: No dosage adjustment is recommended.
Use in children & adolescents
Pediatric patients (6 months to 18 years) three 0.15 mg/kg doses, up to a maximum of 16 mg.
Drug interaction
The potential for clinically significant drug interactions with Ondansetron appears to be low.
Overdose
There is no specific antidote for Ondansetron overdose.
Storage
Keep out of the reach of children. Keep below 30°C, protect from light.
Packing
Vomidyl tablet: Each box contains 3x10's tablet in blister pack.
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