Vomidyl

Composition

Vomidyl tablet: Each tablet contains Ondansetron Hydrochloride Dihydrate USP 9.976 mg equivalent to Ondansetron 8 mg.

Indications and Usage

Ondansetron is a serotonin subtype 3 (5-HT3) receptor antagonist 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 and Administration

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

Use in Specific Population

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.

Contraindication

  • Contraindicated in patients known to have hypersensitive to the drug or     any of its components. • Concomitant use of apomorphine.

Precaution

  • Hypersensitivity reactions, including anaphylaxsis and bronchospasm,     have been reported with or without known hypersensitivity to other     selective 5-HT3 receptor antagonists

Adverse Reaction

The most common adverse reactions in Chemotherapy-induced nausea and 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%).

Drug Interaction

The potential for clinically significant drug interactions with Ondansetron appears to be low.

Storage

Keep out of the reach of children. Keep below 30°C, protect from light.

How supplied

Vomidyl tablet: Each box contains 3x10’s tablet in blister pack.