SABRIL Film-coated tablet Ref.[9296] Active ingredients: Vigabatrin

Sabril treatment may only be initiated by a specialist in epileptology, neurology or paediatric neurology. Follow-up should be arranged under supervision of a specialist in epileptology, neurology or paediatric neurology.

Posology

Sabril is for oral administration once or twice daily and may be taken before or after meals.

If the control of epilepsy is not clinically significantly improved after an adequate trial, vigabatrin treatment should not be continued. Vigabatrin should be gradually withdrawn under close medical supervision.

Adults

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 (see also sections 5.1 and 5.2).

Paediatric population

Resistant partial epilepsy

The recommended starting dose in neonates, children and adolescents is 40mg/kg/day. Maintenance recommendations in relation to bodyweight are:

Bodyweight:

10 to 15kg: 0.5-1g/day
15 to 30kg: 1-1.5g/day
30 to 50kg: 1.5-3g/day
>50kg: 2-3g/day

The maximum recommended dose in each of these categories should not be exceeded.

Monotherapy for infantile spasms (West’s Syndrome)

The recommended starting dose is 50mg/kg/day. This may be titrated over a period of one week if necessary. Doses of up to 150mg/kg/day have been used with good tolerability.

Older people and patients with renal impairment

Since vigabatrin is eliminated via the kidney, caution should be exercised when administering the drug to the older people and more particularly in patients with creatinine clearance less than 60 ml/min. Adjustment of dose or frequency of administration should 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).

Symptoms

Vigabatrin overdose has been reported. When provided, doses most commonly were between 7.5 to 30g; however, ingestions up to 90g have been reported. Nearly half of the cases involved multiple drug ingestions. When reported, the most common symptoms included drowsiness or coma. Other less frequently reported symptoms included vertigo, headache, psychosis, respiratory depression or apnea, bradycardia, hypotension, agitation, irritability, confusion, abnormal behaviour, and speech disorder. None of the overdoses resulted in death.

Management

There is no specific antidote. The usual supportive measures should be employed. Measures to remove unabsorbed drug should be considered. Activated charcoal has been shown to not significantly adsorb vigabatrin in an in vitro study. The effectiveness of hemodialysis in the treatment of vigabatrin overdose is unknown. In isolated case reports in renal failure patients receiving therapeutic doses of vigabatrin, hemodialysis reduced vigabatrin plasma concentrations by 40% to 60%.

Shelf life: 36 months.

This medicinal product does not require any special storage conditions.

Clear colourless PVC-aluminium blisters of 10 film-coated tablets or

Opaque blue PVC-aluminium blisters of 10 film-coated tablets.

Each blister pack contains 30, 50, 60, 100 or 200 tablets.

Not all pack sizes may be marketed.

No special requirements.