Country: Канада
Језик: Енглески
Извор: Health Canada
LAMOTRIGINE
TEVA CANADA LIMITED
N03AX09
LAMOTRIGINE
150MG
TABLET
LAMOTRIGINE 150MG
ORAL
60
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0127134006; AHFS:
CANCELLED POST MARKET
2016-12-05
PRODUCT MONOGRAPH RATIO-LAMOTRIGINE (lamotrigine) 25, 100 and 150 mg Tablets Antiepileptic Teva Canada Limited Date of Revision: 30 Novopharm Court November 6, 2014 Toronto, Ontario Canada M1B 2K9 Control No.: 178540 2 PRODUCT MONOGRAPH DO NOT EXCEED THE RECOMMENDED INITIAL DOSE AND SUBSEQUENT DOSE ESCALATIONS OF RATIO- LAMOTRIGINE. MORE RAPID INITIAL TITRATION HAS BEEN ASSOCIATED WITH AN INCREASED INCIDENCE OF SERIOUS DERMATOLOGICAL REACTIONS (SEE WARNINGS). RATIO-LAMOTRIGINE lamotrigine (25, 100 and 150 mg Tablets) ANTIEPILEPTIC ACTION AND CLINICAL PHARMACOLOGY Lamotrigine is a drug of the phenyltriazine class chemically unrelated to existing antiepileptic drugs (AEDs). Lamotrigine is thought to act at voltage-sensitive sodium channels to stabilize neuronal membranes and inhibit the release of excitatory amino acid neurotransmitters (e.g. glutamate, aspartate) that are thought to play a role in the generation and spread of epileptic seizures. CLINICAL TRIALS In adult placebo-controlled clinical studies, lamotrigine has been shown to be effective in reducing seizure frequency and the number of days with seizures when added to existing antiepileptic drug therapy in adult patients with partial seizures, with or without generalized tonic-clonic seizures, that are not satisfactorily controlled. The effectiveness of lamotrigine adjunctive therapy has also been shown in pediatric and adult patients with Lennox-Gastaut syndrome. A significant reduction in major motor seizures, drop attacks, and tonic-clonic seizures were seen following lamotrigine treatment compared with placebo treated patients. Improvements in cognitive skills (speech, nonverbal communication, alertness, attention, intellectual capacity), behaviour, and fine coordination have been seen with lamotrigine treatment in these patients. Studies have also been conducted using lamotrigine monotherapy in adult patients (n = 443) newly diagnosed with epilepsy (partial seizures, with or without secondary generalization or primary generalized tonic clonic). Resu Прочитајте комплетан документ