ZOFRAN TABLET 8mg

Product Information

Registration Status: Active

ZOFRAN 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.

Ondansetron

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.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank