מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVETIRACETAM
UNIMED SDN BHD
LEVETIRACETAM
10 x 10 tablet Tablets; 10 x 10 tablet Tablets
Hetero Labs Limited
LETRAM 250 (Levetiracetam Tablets 250 Mg) LETRAM 500 (Levetiracetam Tablets 500 Mg) DESCRIPTION AND COMPOSITION: LETRAM 250 (Levetiracetam Tablets 250 Mg): Blue coloured, oblong shaped, scored film coated tablets debossed with ‘H’ on one side and ‘87’ on other side. Each film-coated tablet contains 250 mg of Levetiracetam. LETRAM 500 (Levetiracetam Tablets 500 Mg): Yellow coloured, oblong shaped, scored, film coated tablets debossed with ‘H’ on one side and ‘88’ on other side. Each film-coated tablet contains 500 mg of Levetiracetam. PHARMACODYNAMICS 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. _ _ _Mechanism of action _ The mechanism of action of Levetiracetam still remains to be fully elucidated but appears to be different from the mechanisms of current antiepileptic medicinal products. _ _ _Pharmacodynamics effects _ Levetiracetam induces seizure protection in a broad range of animal models of partial and primary generalized seizures without having pro-convulsant effect. The primary metabolite is inactive. In man, activity in both partial and generalized epilepsy conditions (epileptiform discharge/photoparoxysmal response) has confirmed the broad spectrum of the preclinical pharmacological profile. _ _ PHARMACOKINETICS Levetiracetam is a highly soluble and permeable compound. The pharmacokinetic profile is linear and time-independent with low intra- and inter-subject variability. There is no modification of the clearance after repeated administration. There is no evidence for any relevant gender, race or circadian variability. The pharmacokinetic profile is comparable in healthy volunteers and in patients with epilepsy. Due to its complete and linear absorption, plasma levels can be predicted from the oral dose of Levetiracetam expressed as mg/kg bodyweight. Therefore there is no need for plasma level monitoring of Levetiracetam. A significant correlat קרא את המסמך השלם