Product Information
Registration Status: ActiveZOFRAN TABLET 8mg is approved to be sold in Singapore with effective from 1990-10-16. It is marketed by NOVARTIS (SINGAPORE) PTE LTD, with the registration number of SIN05133P.
This product contains Ondansetron 10mg EQV to 8mg Ondansetron in the form of TABLET, FILM-COATED. It is approved for ORAL use.
This product is manufactured by Aspen Bad Oldesloe GmbH in GERMANY.
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.
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.