资料单张
ASPEN LAMOTRIGINE 25 mg TABLETS
ASPEN LAMOTRIGINE 50 mg TABLETS
ASPEN LAMOTRIGINE 100 mg TABLETS
ASPEN LAMOTRIGINE 200 mg TABLETS
SCHEDULING STATUS:
S3
PROPRIETARY NAME
(and dosage form):
ASPEN LAMOTRIGINE 25 mg TABLETS
ASPEN LAMOTRIGINE 50 mg TABLETS
ASPEN LAMOTRIGINE 100 mg TABLETS
ASPEN LAMOTRIGINE 200 mg TABLETS
COMPOSITION
Each tablet contains:
ASPEN LAMOTRIGINE 25 mg TABLETS –
Lamotrigine
25 mg
ASPEN LAMOTRIGINE 50 mg TABLETS –Lamotrigine 50 mg
ASPEN LAMOTRIGINE 100 mg TABLETS –Lamotrigine 100 mg
ASPEN LAMOTRIGINE 200 mg TABLETS –Lamotrigine 200 mg
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 major role in
the generation of epileptic seizures.
Pharmacokinetics
Lamotrigine is well 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
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