Posology : מינונים

4.2      Posology and method of administration
Sabrilan treatment may only be initiated by a specialist in epiletology, neurology or pediatric neurology.
Follow up should be arranged under supervision of a specialist in epileptology, neurology or paediatric neurology.

Posology

Sabrilan is intended for oral administration once or twice daily and may be taken before or after meals. The tablets should be swallowed with half a glass of water.

If there is no clinically significant improvement in epileptic symptoms following well-conducted initial treatment, Sabrilan should not be continued. Sabrilan should gradually be withdrawn under close medical supervision.
Tablets are not suitable for children under the age of 6 years, because of the risk of false passage.
Adults
Maximal efficacy is usually obtained with a daily dose of 2 to 3 g. A starting dose of 1 g daily should be added to the patient's current anti-epileptic drug regimen. The daily dose should then be increased in 0.5 g increments at weekly intervals depending on clinical response and tolerability. The maximum recommended dose is 3g/ day.

No direct correlation exists between the plasma concentrations and the efficacy. The duration of the effect of the drug is dependent on the rate of GABA-Transaminase resynthesis rather than plasma drug concentrations (see Section 5.1 and 5.2).

Children
The recommended starting dose in children is 40 mg/kg/day. Recommendations in relation to bodyweight for maintenance treatment are as follows:

Bodyweight        Dosage
10-15 kg          0.5-1 g/day
15-30 kg          1-1.5 g/day
30-50 kg          1.5-3 g/day
> 50 kg           2-3 g/day

The maximum recommended dose in each of these bodyweight categories must not be exceeded.
Elderly subjects and patients with renal insufficiency
Since vigabatrin is eliminated via the kidney, caution should be exercised when administering the drug to the elderly and more particularly in patients with creatinine clearance less than 60 ml/min. Adjustment of dose or frequency of administration must be considered. Such patients may respond to a lower maintenance dose.
Patients should be monitored for undesirable effects such as sedation or confusion (see Sections 4.4 and 4.8).