Posology : מינונים

4.2 Posology and method of administration

Posology
The dosage must be established and monitored by the doctor on an individual basis. The maintenance dose is about 5 to 10 mg/kg body weight/day. It should be built up step-wise (tapered in) over a one-week period. Ospolot 200 mg film-coated tablets have a dividing groove.
Due to the short half-life of sulthiame, the daily dose should as far as possible be spread over three single doses. If the daily dose is spread over the day in this way, constant plasma levels are to be expected after five to six days. Therapeutic plasma concentrations of sulthiame have not yet been determined.

Method of administration
The film-coated tablets should be swallowed whole (unchewed) with plenty of liquid (approx. one glass of water), as far as possible spread over 3 single doses.
A change from another medication or from combination treatment should be done gradually.
Ospolot® should not be discontinued abruptly. A paediatric neurologist experienced in treating epilepsy should decide on dose adjustment, the duration of treatment and discontinuation on an individual basis.
If therapy is not successful, treatment with sulthiame should be discontinued after about one to two months.

It is recommendable to monitor the blood count, liver enzymes and renal function parameters before treatment with Ospolot®, then at weekly intervals in the first month of treatment, and thereafter at monthly intervals. After six months of treatment, two to four checks per year are sufficient.