NU-LAMOTRIGINE TABLET

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

LAMOTRIGINE

Tillgänglig från:

NU-PHARM INC

ATC-kod:

N03AX09

INN (International namn):

LAMOTRIGINE

Dos:

25MG

Läkemedelsform:

TABLET

Sammansättning:

LAMOTRIGINE 25MG

Administreringssätt:

ORAL

Enheter i paketet:

100/500

Receptbelagda typ:

Prescription

Terapiområde:

MISCELLANEOUS ANTICONVULSANTS

Produktsammanfattning:

Active ingredient group (AIG) number: 0127134003; AHFS:

Bemyndigande status:

CANCELLED (UNRETURNED ANNUAL)

Tillstånd datum:

2018-03-28

Produktens egenskaper

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