Infantile spasms (West's syndrome)

Active Ingredient: Vigabatrin

Indication for Vigabatrin

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

Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for treatment in monotherapy of infantile spasms (West’s syndrome).

For this indication, competent medicine agencies globally authorize below treatments:

25-150 mg/kg in 2 divided doses daily

Route of admnistration

Oral

Defined daily dose

25 - 150 mg per kg of body weight

Dosage regimen

From 12.5 To 75 mg per kg of body weight 2 time(s) per day every day

Loading dose

50 mg per kg of body weight

Detailed description

Monotherapy for infantile spasms (West’s Syndrome) The recommended starting dose is 50 mg/kg/day. Subsequent dosing can be titrated by 25 mg/kg/day increments every 3 days up to the maximum recommended dose of 150 mg/kg/day.

Number of soluble tablets according to body weight, starting dose and dose increment in infantile spasms:

Body weight (kg) Starting dose of 50 mg/kg/dayProposed doses for first titration step (75 mg/kg/day) (Day 3)Proposed doses for second titration step (100 mg/kg/day) (Day 6)
3 0.5 × 100 mg tablet morning1.0 × 100 mg tablet morning1.5 × 100 mg tablet morning
1 × 100 mg tablet evening1.5 × 100 mg tablet evening1.5 × 100 mg tablet evening
4 1 × 100 mg tablet morning1.5 × 100 mg tablet morning2 × 100 mg tablet morning
1 × 100 mg tablet evening1.5 × 100 mg tablet evening2 × 100 mg tablet evening
5 1 × 100 mg tablet morning1.5 × 100 mg tablet morning2.5 × 100 mg tablet morning
1.5 × 100 mg tablet evening2 × 100 mg tablet evening2.5 × 100 mg tablet evening
6 1.5 × 100 mg tablet morning2 × 100 mg tablet morning3 × 100 mg tablet morning
1.5 × 100 mg tablet evening2.5 × 100 mg tablet evening3 × 100 mg tablet evening
7 1.5 × 100 mg tablet morning2.5 × 100 mg tablet morning3.5 × 100 mg tablet morning
2 × 100 mg tablet evening2.5 × 100 mg tablet evening3.5 × 100 mg tablet evening
8 2 × 100 mg tablet morning3 × 100 mg tablet morning4 × 100 mg tablet morning
2 × 100 mg tablet evening3 × 100 mg tablet evening4 × 100 mg tablet evening
9 2 × 100 mg tablet morning3.5 × 100 mg tablet morning4.5 × 100 mg tablet morning
2.5 × 100 mg tablet evening3.5 × 100 mg tablet evening4.5 × 100 mg tablet evening
10 0.5 × 500 mg tablet morning0.5 × 500 mg tablet morning1 × 500 mg tablet morning
0.5 × 500 mg tablet evening1 × 500 mg tablet evening1 × 500 mg tablet evening
11 2.5 × 100 mg tablet morning4 × 100 mg tablet morning1 × 500 mg tablet morning
3 × 100 mg tablet evening4 × 100 mg tablet evening1 × 500 mg και 1 × 100 mg tablet evening
12 3 × 100 mg tablet morning4.5 × 100 mg tablet morning1 × 500 mg και 1 × 100 mg tablet morning
3 × 100 mg tablet evening4.5 × 100 mg tablet evening1 × 500 mg και 1 × 100 mg tablet evening
13 3 × 100 mg tablet morning4.5 × 100 mg tablet morning1 × 500 mg και 1 × 100 mg tablet morning
3.5 × 100 mg tablet evening1 × 500 mg tablet evening1 × 500 mg και 2 × 100 mg tablet evening
14 3.5 × 100 mg tablet morning1 × 500 mg tablet morning1 × 500 mg και 2 × 100 mg tablet morning
3.5 × 100 mg tablet evening1 × 500 mg tablet evening1 × 500 mg και 2 × 100 mg tablet evening
15 0.5 × 500 mg tablet morning1 × 500 mg tablet morning1.5 × 500 mg tablet morning
1 × 500 mg tablet evening1 × 500 mg και 1 × 100 mg tablet evening1.5 × 500 mg tablet evening
16 4 × 100 mg tablet morning1 × 500 mg και 1 × 100 mg tablet morning1 × 500 mg και 3 × 100 mg tablet morning
4 × 100 mg tablet evening1 × 500 mg και 1 × 100 mg tablet evening1 × 500 mg και 3 × 100 mg tablet evening

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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