RATIO-LAMOTRIGINE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

LAMOTRIGINE

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

N03AX09

INN (Διεθνής Όνομα):

LAMOTRIGINE

Δοσολογία:

100MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

LAMOTRIGINE 100MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

MISCELLANEOUS ANTICONVULSANTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0127134001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2016-12-05

Αρχείο Π.Χ.Π.

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