Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVETIRACETAM
SM PHARMACEUTICALS SDN. BHD.
LEVETIRACETAM
10x10 Tablets
SM PHARMACEUTICALS SDN. BHD.
_Consumer Medication Information Leaflet (RiMUP) _ LEVISAT 500MG FILM COATED TABLET Levetiracetam 500mg Film Coated Tablet _ _ ______________________________________________________________________________________________________________ _______________________________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. WHAT LEVISAT 500MG FIM COATED TABLET IS USED FOR 2. HOW LEVISAT500MG FILM COATED TABLET WORKS 3. BEFORE YOU TAKE LEVISAT 500MG FILM COATED TABLET 4. HOW TO TAKE LEVISAT 500MG FILM COATED TABLET 5. WHILE YOU ARE USING LEVISAT 500MG FILM COATED TABLET 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF LEVISAT 500MG FILM COATED TABLET 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION 11. RIMUP SERIAL NUMBER. WHAT LEVISAT 500MG FILM COATED TABLET IS USED FOR • on its own in adults and adolescents from 16 years of age with a certain typeof newly diagnosed epilepsy. Epilepsy is acondition where the patients haverepeated fits (seizures). Levetiracetam isused for the epilepsy form in which thefits initially affect only one side of thebrain, but could thereafter extend tolarger areas on both sides of the brain(partial onset seizures with or withoutsecondary generalization). Levisat hasbeen given to you by your doctor toreduce the number of fits. • as an add-on to other antiepileptic medicines to treat: - partial onset seizures with or without secondary generalization in adults and children from 4 years of age with epilepsy. - myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy - primary generalized tonic-clonic seizures (major fits, including loss of consciousness) in adults and children from 12 years of age with Idiopathic Generalized Epilepsy. LEVISAT 500MG FILM COATED TABLET WORKS Levisat is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). BEFORE YOU TAKE LEVIAT 500MG FILM COATED T Baca dokumen lengkap
SM PHARMACEUTICALS SDN BHD LEVISAT 500MG FILM COATED TABLET DESCRIPTION: Yellow colored, oblong-shaped biconvex film coated tablet, debossed with “L” and “U” on either side of break line on one side and “X02” on the other side. COMPOSITION: Each film coated tablet contains: Levetiracetam 500 mg ACTIONS AND MODE OR MECHANISMS OF ACTION: MECHANISMS OF ACTION: The mechanism of action of levetiracetam still remains to be fully elucidated. Clinical efficacy and safety Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalization in adults, adolescents and children from 4 years of age with epilepsy. PHARMACOLOGY (SUMMARY OF PHARMACODYNAMICS AND PHARMACOKINETICS): PHARMACODYNAMICS Pharmacotherapeutic group: antiepileptics, other antiepileptics. The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α - ethyl-2-oxo-1-pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances. PHARMACOKINETICS Levetiracetam is a highly soluble and permeable compound. The pharmacokinetic profile is linear with low intra- and inter-subject variability. There is no modification of the clearance after repeated administration. ABSORPTION Levetiracetam is rapidly absorbed after oral administration. Oral absolute bioavailability is close to 100 %. Peak plasma concentrations (C max ) are achieved at 1.3 hours after dosing. Steady-state is achieved after two days of a twice daily administration schedule. The extent of absorption is dose- independent and is not altered by food. DISTRIBUTION Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins (< 10 %). METABOLISM Levetiracetam is not extensively metabolized in humans. The major metabolic pathway (24 % of the dose) is an enzymatic hydrolysis of the acetamide group. Production of the primary metabolite, UCB L057, is not supported by liver cytochrome P 450 isoforms. Hydrolysis of the acetamide group was measurable in a large number of tissues including b Baca dokumen lengkap