Product Information
Registration Status: ActiveSIN13446P
ONDANSETRON SANDOZ 8MG TABLET is approved to be sold in Singapore with effective from 2008-04-16. It is marketed by NOVARTIS (SINGAPORE) PTE LTD, with the registration number of SIN13446P.
This product contains Ondansetron 8mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.
This product is manufactured by Novartis (Bangladesh) LTD in BANGLADESH.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties. [PubChem]
Indication
For the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, postoperation, and radiation. Also used for the treatment of postoperative nausea and vomiting.
Mechanism of Action
Ondansetron is a selective serotonin 5-HT3 receptor antagonist. The antiemetic activity of the drug is brought about through the inhibition of 5-HT3 receptors present both centrally (medullary chemoreceptor zone) and peripherally (GI tract). This inhibition of 5-HT3 receptors in turn inhibits the visceral afferent stimulation of the vomiting center, likely indirectly at the level of the area postrema, as well as through direct inhibition of serotonin activity within the area postrema and the chemoreceptor trigger zone.
Pharmacokinetics
- Absorption
- Ondansetron is well absorbed after oral administration and undergoes limited first-pass metabolism.
- Distribution
- Metabolism
- Hepatic
- Elimination
Clearance
* 0.38 L/h/kg [Normal Adult Volunteers (19-40 yrs)] * 0.32 L/h/kg [Normal Adult Volunteers (61-74 yrs)] * 0.26 L/h/kg [Normal Adult Volunteers (>=75 yrs)]
Toxicity
Low blood pressure and fainting, sudden blindness, severe constipation
Active Ingredient/Synonyms
Ondansetron | Ondansetron |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.