Product Information
Registration Status: ActiveSIN14912P
APO-LEVETIRACETAM TABLET 1000MG is approved to be sold in Singapore with effective from 2015-12-22. It is marketed by PHARMAFORTE SINGAPORE PTE LTD, with the registration number of SIN14912P.
This product contains Levetiracetam 1000mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.
This product is manufactured by APOTEX INC. (TORONTO) in CANADA,APOTEX INC. (WESTON) (Primary Packager) in INDIA, andApotex Research Pvt. Ltd. (Primary Packager) in AUSTRALIA.
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
Levetiracetam is an anticonvulsant medication used to treat epilepsy. Levetiracetam may selectively prevent hypersynchronization of epileptiform burst firing and propagation of seizure activity. Levetiracetam binds to the synaptic vesicle protein SV2A, which is thought to be involved in the regulation of vesicle exocytosis. Although the molecular significance of levetiracetam binding to synaptic vesicle protein SV2A is not understood, levetiracetam and related analogs showed a rank order of affinity for SV2A which correlated with the potency of their antiseizure activity in audiogenic seizure-prone mice.
Indication
Used as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
Mechanism of Action
The precise mechanism(s) by which levetiracetam exerts its antiepileptic effect is unknown. The antiepileptic activity of levetiracetam was assessed in a number of animal models of epileptic seizures. Levetiracetam did not inhibit single seizures induced by maximal stimulation with electrical current or different chemoconvulsants and showed only minimal activity in submaximal stimulation and in threshold tests. Protection was observed, however, against secondarily generalized activity from focal seizures induced by pilocarpine and kainic acid, two chemoconvulsants that induce seizures that mimic some features of human complex partial seizures with secondary generalization. Levetiracetam also displayed inhibitory properties in the kindling model in rats, another model of human complex partial seizures, both during kindling development and in the fully kindled state. The predictive value of these animal models for specific types of human epilepsy is uncertain. Levetiracetam is thought to stimulate synaptic vesicle protein 2A (SV2A), inhibiting neurotransmitter release.
Pharmacokinetics
- Absorption
- Rapidly and almost completely absorbed after oral administration (99%). Peak plasma concentrations occurring in about an hour following oral administration in fasted subjects.
- Distribution
- Metabolism
- The major metabolic pathway of levetiracetam (24% of dose) is an enzymatic hydrolysis of the acetamide group. No CYP450 metabolism detected.
- Elimination
Clearance
* 0.96 mL/min/kg
Toxicity
Side effects include aggression, agitation, coma, drowsiness, reduced consciousness, slowed breathing
Active Ingredient/Synonyms
Levetiracetam | Levetiracetame | Levetiracetamum | Levitiracetam | Levetiracetam |
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.