Maa: Etelä-Afrikka
Kieli: englanti
Lähde: South African Health Products Regulatory Authority (SAHPRA)
Dr-reddy
LAMITOR –25 (tablets) LAMITOR –50 (tablets) LAMITOR –100 (tablets) SCHEDULING STATUS: S3 8007547-6513 PROPRIETARY NAME (and dosage form): LAMITOR –25 (tablets) LAMITOR –50 (tablets) LAMITOR –100 (tablets) COMPOSITION LAMITOR –25: Each tablet contains 25 mg lamotrigine . LAMITOR –50: Each tablet contains 50 mg lamotrigine. LAMITOR –100: Each tablet contains 100 mg lamotrigine. PHARMACOLOGICAL CLASSIFICATION A.2.5 Antiepileptics PHARMACOLOGICAL ACTION Lamotrigine blocks voltage-sensitive sodium channels, thereby stabilising neuronal membranes and inhibiting neurotransmitter release, principally that of glutamate, an excitatory amino acid which is thought to play a key role in the generation of epileptic seizures. Pharmacokinetics Lamotrigine is rapidly and completely absorbed from the gut. The absorption is unaffected by food. The time to peak concentration is 1,4 to 4,8 hours. The mean elimination half-life is 25 +10 hours and the pharmacokinetic profile is linear up to 450 mg, the highest single dose tested. The half-life of lamotrigine is affected by concomitant use of enzyme- inducing drugs such as phenytoin, carbamazepine, phenobarbital or primidone with a mean value of approximately 14 hours. The half-life of lamotrigine increases to approximately 59 hours when co-administered with valproic acid alone (see DOSAGE AND DIRECTIONS FOR USE). Following multiple administration of lamotrigine (150 mg twice daily) there is modest induction of its own metabolism, resulting in a 25% decrease in the elimination half-life at steady state. Lamotrigine is moderately (55%) bound to plasma proteins. Clearance adjusted for bodyweight is higher in children aged 12 years and under than in adults, with the highest values in children under 5 years. The half-lif Lue koko asiakirja