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RILUTEK TABLET 50mg

Product Information

Registration Status: Active

SIN09426P

RILUTEK TABLET 50mg is approved to be sold in Singapore with effective from 1997-07-31. It is marketed by SANOFI-AVENTIS SINGAPORE PTE LTD, with the registration number of SIN09426P.

This product contains Riluzole 50mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.

This product is manufactured by Sanofi Winthrop Industrie in FRANCE.

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
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Description

A glutamate antagonist (receptors, glutamate) used as an anticonvulsant (anticonvulsants) and to prolong the survival of patients with amyotrophic lateral sclerosis. Riluzole is marketed as Rilutek by Sanofi.

Indication

For the treatment of amyotrophic lateral sclerosis (ALS, Lou Gehrig's Disease)

Mechanism of Action

The mode of action of riluzole is unknown. Its pharmacological properties include the following, some of which may be related to its effect: 1) an inhibitory effect on glutamate release (activation of glutamate reuptake), 2) inactivation of voltage-dependent sodium channels, and 3) ability to interfere with intracellular events that follow transmitter binding at excitatory amino acid receptors.

Pharmacokinetics

Absorption
Riluzole is well-absorbed (approximately 90%), with average absolute oral bioavailability of about 60% (CV=30%). A high fat meal decreases absorption, reducing AUC by about 20% and peak blood levels by about 45%.
Distribution
Metabolism
Riluzole is extensively metabolized to six major and a number of minor metabolites, which have not all been identified to date. Metabolism is mostly hepatic, consisting of cytochrome P450–dependent hydroxylation and glucuronidation. CYP1A2 is the primary isozyme involved in N-hydroxylation; CYP2D6, CYP2C19, CYP3A4, and CYP2E1 are considered unlikely to contribute significantly to riluzole metabolism in humans.
Elimination

Active Ingredient/Synonyms

Riluzol | Riluzole | Riluzolum | Riluzole |


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

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