FYCOMPA FILM-COATED TABLET 10MG

Product Information

Registration Status: Active

FYCOMPA FILM-COATED TABLET 10MG is approved to be sold in Singapore with effective from 2014-12-09. It is marketed by EISAI (SINGAPORE) PTE LTD, with the registration number of SIN14620P.

This product contains Perampanel 10mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.

This product is manufactured by Eisai Manufacturing Ltd. in UNITED KINGDOM.

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.

Perampanel

Description

Perampanel is a noncompetitive AMPA glutamate receptor antagonist. It is marketed under the name Fycompa™ and is indicated as an adjunct in patients over 12 years old for the treatment of partial-onset seizures that may or may not occur with generalized seizures. The FDA label includes an important black-boxed warning of serious or life-threatening behavioral and psychiatric reactions in patients taking Fycompa™.

Indication

Used in patients over 12 years old for the treatment of partial-onset seizures that may or may not occur with generalized seizures.

Mechanism of Action

The exact mechanism of action of perampanel in seizures is not yet determined, but it is known that perampanel decreases neuronal excitation by non-competitive ihibition of the AMPA receptor.

Pharmacokinetics

Absorption
After oral adminitration, perampanel is absorbed rapidly and completely.
Distribution
The volume of distribution of perampanel was not quantified.
Metabolism
Perampanel is highly metabolized by CYP3A4 and/or CYP3A5 primary oxidation and by sequential glucuronidation.
Elimination

Clearance

In healthy patients, perampanel has a clearance of about 12 mL/min.

Toxicity

The FDA label includes an important warning of serious or life-threatening behavioral and psychiatric adverse reactions including aggression, hostility, irritability, anger, and homicidal thoughts in patients taking perampanel.

Active Ingredient/Synonyms

3-(2-Cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one | perampanel | pérampanel | Perampanelum | Perampanel |


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