Resistant partial epilepsy (focal onset seizures)

Active Ingredient: Vigabatrin

Indication for Vigabatrin

Population group: only infants (40 days - 1 year old) , children (1 year - 12 years old)

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:

40 mg/kg in 2 divided doses daily

Route of admnistration

Oral

Defined daily dose

40 - 40 mg per kg of body weight

Dosage regimen

From 20 To 20 mg per kg of body weight 2 time(s) per day every day

Detailed description

The recommended starting dose is 40 mg/kg/day.

Maintenance recommendations in relation to bodyweight are:

Bodyweight:

  • 10 to 15 kg: 0.5 to 1 g/day
  • 15 to 30 kg: 1 to 1.5 g/day

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 Vigabatrin should be gradually withdrawn under close medical supervision.

Dosage considerations

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.

Active ingredient

Vigabatrin

Vigabatrin is a selective irreversible inhibitor of GABA transaminase, the enzyme responsible for the breakdown of GABA (gamma aminobutyric acid). Vigabatrin increases the concentration of GABA, the major inhibitory neurotransmitter in the brain.

Read more about Vigabatrin

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