NU-LAMOTRIGINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LAMOTRIGINE

Available from:

NU-PHARM INC

ATC code:

N03AX09

INN (International Name):

LAMOTRIGINE

Dosage:

100MG

Pharmaceutical form:

TABLET

Composition:

LAMOTRIGINE 100MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTICONVULSANTS

Product summary:

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

Authorization status:

CANCELLED (UNRETURNED ANNUAL)

Authorization date:

2018-03-28

Summary of Product characteristics

0
PRODUCT MONOGRAPH
NU-LAMOTRIGINE
LAMOTRIGINE TABLETS
25, 100 AND 150 MG TABLETS
ANTIEPILEPTIC
NU-PHARM INC.
DATE OF PREPARATION:
50 MURAL ST., UNITS 1 & 2
September 29, 2009
RICHMOND HILL, ONTARIO
L4B 1E4
CONTROL#: 132852
1
PRODUCT MONOGRAPH
NU-LAMOTRIGINE
Lamotrigine Tablets
25, 100 and 150 mg
THERAPEUTIC CLASSIFICATION
Antiepileptic
THIS PRODUCT DOES NOT HAVE DOSAGE STRENGTHS SMALL ENOUGH TO INITIATE
TREATMENT IN
CHILDREN UNDER 12 YEARS OF AGE.
DO NOT EXCEED THE RECOMMENDED INITIAL DOSE AND SUBSEQUENT DOSE
ESCALATIONS OF NU-
LAMOTRIGINE (LAMOTRIGINE). MORE RAPID INITIAL TITRATION HAS BEEN
ASSOCIATED WITH AN
INCREASED INCIDENCE OF SERIOUS DERMATOLOGICAL REACTIONS (SEE
WARNINGS).
ACTIONS 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 (_i.e._ glutamate and
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
2
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 and intellectual capacity), behaviour and fine
co-ordination have been seen
with lamotrigine treatment in these patients.
Studies have also been conducted using lamotrigine monothe