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
40 - 40 mg per kg of body weight
From 20 To 20 mg per kg of body weight 2 time(s) per day every day
The recommended starting dose is 40 mg/kg/day.
Maintenance recommendations in relation to bodyweight are:
Bodyweight:
Number of soluble tablets according to body weight and starting dose in resistant partial epilepsy:
| Body weight (kg) | Starting dose of 40 mg/kg/day |
|---|---|
| 3 | 0.5 × 100 mg tablet morning |
| 0.5 × 100 mg tablet evening | |
| 4 | 0.5 × 100 mg tablet morning |
| 1 × 100 mg tablet evening | |
| 5 | 1 × 100 mg tablet morning |
| 1 × 100 mg tablet evening | |
| 6 | 1 × 100 mg tablet morning |
| 1.5 × 100 mg tablet evening | |
| 7 | 1.5 × 100 mg tablet morning |
| 1.5 × 100 mg tablet evening | |
| 8 | 1.5 × 100 mg tablet morning |
| 2 × 100 mg tablet evening | |
| 10 | 2 × 100 mg tablet morning |
| 2 × 100 mg tablet evening | |
| 13 | 2.5 × 100 mg tablet morning |
| 2.5 × 100 mg tablet evening | |
| 15 | 3 × 100 mg tablet morning |
| 3 × 100 mg tablet evening | |
| 17 | 3.5 × 100 mg tablet morning |
| 3.5 × 100 mg tablet evening | |
| 19 | 3.5 × 100 mg tablet morning |
| 4 × 100 mg tablet evening | |
| 22 | 4.5 × 100 mg tablet morning |
| 4.5 × 100 mg tablet evening | |
| 25 | 1 × 500 mg tablet morning |
| 1 × 500 mg tablet evening | |
| 28 | 1 × 500 mg tablet morning |
| 1 × 500 mg και 1 × 100 mg tablet evening | |
| 30 | 1 × 500 mg και 1 × 100 mg tablet morning |
| 1 × 500 mg και 1 × 100 mg tablet evening |
Vigabatrin is for oral or gastric administration twice daily and may be taken before or after meals.
The maximum recommended dose should not be exceeded.
If control of epilepsy is not clinically significantly improved after an adequate treatment course, vigabatrin treatment should be discontinued. Vigabatrin should be gradually withdrawn under close medical supervision.
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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