Active Ingredient: Vigabatrin
Vigabatrin is indicated in infants and children from 1 month to less than 7 years of age for treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
1 - 3 g
From 0.5 To 1.5 g 2 time(s) per day every day
1 g
Maximal efficacy is usually seen in the 2-3g/day range. A starting dose of 1g daily should be added to the patient’s current antiepileptic medicinal product regimen. The daily dose should then be titrated in 0.5g increments at weekly intervals depending on clinical response and tolerability. The highest recommended dose is 3g/day.
No direct correlation exists between the plasma concentration and the efficacy. The duration of the effect of the medicinal product is dependent on the rate of GABA transaminase resynthesis rather than the concentration of the drug in the plasma.
Vigabatrin is for oral or gastric use and may be taken before or after meals. Gastric administration should be used for children who cannot swallow, but can be fed by enteral route.
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