Preparation
Onasia 8 mg tablet: Each film-coated tablet contains Ondansetron BP 8 mg.
Onasia 50 ml oral solution: Each 5 ml contains Ondansetron Hydrochloride BP equivalent to Ondansetron 4 mg.
Indication
1. Nausea-vomiting associated with gastroenteritis
2. Nausea-vomiting associated with pregnancy
3. Prevention of postoperative nausea and vomiting
4. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy
5. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy
6. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen or daily fractions to the abdomen
Contraindication
Ondansetron is contraindicated for patients known to have hypersensitivity to the drug.
Dosage & Administration
Postoperative nausea and vomiting: The recommended dose is 16 mg as two 8 mg Onasia® tablets 1 hour before induction of anesthesia.
Chemotherapy induced nausea and vomiting:
a. For highly emetogenic cancer chemotherapy:
The recommended adult oral dose is three 8 mg Onasia tablets administered 30 minutes before the start of single day highly emetogenic chemotherapy. Geriatric use same as the general population.
b. For moderately emetogenic cancer chemotherapy: The recommended adult oral dose is one 8 mg Onasia tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose and Onasia 8 mg tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
Side Effect
Generally Ondansetron is well tolerated. However few side effects including headache, diarrhoea, fatigue, dizziness and constipation may be seen after Ondansetron is administered.
Precaution
Cross-reactive hypersensitivity has been reported between different 5-HT3 antagonists. Depending on dose, Ondansetron prolongs the QT interval. Ondansetron is not effective in preventing motion-induced nausea and vomiting
Drug Interaction
The following drugs should be used with caution when concomitantly used with Ondansetron: Phenytoin, Carbamazepine, Rifampicin & Tramadol.
Use Children
The intravenous formulation of Ondansetron is FDA approved for use in pediatric patients as young as 1 month; the oral formulations are approved in pediatric patients 4 years of age and older
Use Pregnancy Lactation
Pregnancy: Pregnancy category B.
Nursing mother: 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.
Packaging
Onasia 8 mg Tablet: Each box contains 3x10 tablets in blister pack.
Onasia 50 ml oral solution: Each bottle contains 50 ml oral solution.
Storage
Store below 30 °c. Protect from light and moisture. Keep all medicines out of the reach of children.