Posology : מינונים

4.2.    Posology and method of administration
In female children, female adolescents, women of childbearing potential and pregnant women Depalept should be initiated and supervised by a specialist experienced in the management of epilepsy. Treatment should only be initiated if other treatments are ineffective or not tolerated (see Section 4.4 and Section 4.6) and the benefit and risk should be carefully reconsidered at regular treatment reviews. Preferably Depalept should be prescribed as monotherapy and at the lowest effective dose, if possible as a prolonged release formulation. The daily dose should be divided into at least two single doses.
In view of the dosage strength this medicinal product is for use in adults and children weighing over than 17 kg only.
Depalept 500 mg and Depalept 200 mg enteric coated tablets are not suitable for children under the age of 6 years (risk of choking).

Posology
The mean dosage is 20 -30 mg/kg per day. However, if seizures are not brought under control at this dosage it may be increased and patients must be closely monitored.

− In children, the usual dosage is about 30 mg/kg per day in divided doses.
− In adults and adolscents, the usual dosage is 20 to 30 mg/kg per day in divided dose.
− In elderly patients, the dosage should be determined based on the control of seizures.
The daily dosage should determined based on age and body weight, however, the significant variations in inter-individual sensitivity to valproate must be taken into account.
No clear correlation between the daily dose, serum levels and the therapeutic effect has been established: the dosage should be determined on the basis of the clinical response.
Determination of valproic acid plasma levels should be considered along with clinical monitoring when control of seizures is not achieved or when adverse effects are suspected. The effective therapeutic range is usually between 40 and 100 mg/L (300 to 700 μmol/L).

Patients with renal insufficiency
It may be necessary to decrease the dosage in patients with renal insufficiency, and it may be necessary to increase the dosage in patients on dialysis. Sodium valproate is dialysable (see section 4.9). Dosage should be adjusted according to clinical monitoring of the patient (see section 4.4).

Method of administration.

Oral use.
The daily dose is to be administrered as 2 or 3 divided doses, preferably during meals: • as 2 divided doses in patients under 1 year of age,
• as 3 divided doses in patients over 1 year of age.
The solution is to be ingested after diluting in a small quantity of non-fizzy drink.
Administer only the oral solution with the syringe for oral administration supplied in the box and the syrup with the measuring cup supplied in the box.

Initiation of Depalept therapy (oral administration):
• If the patient is already being treated and is taking other antiepileptics, begin administering sodium valproate gradually, to reach the optimal dose in approximately two weeks, then reduce the concomitant treatments if necessary on the basis of treatment efficacy.
• If the patient is not taking any other antiepileptics, the dosage should preferably be increased step- wise every 2 or 3 days, in order to reach the optimal dose in approximately one week.
• If necessary, combination treatment with other antiepileptics should be instituted gradually (see 4.5 Interaction with other medicinal products and other forms of interaction).
• Liver function tests should be performed before starting treatment (see Section 4.3) and then periodically for the first 6 months, particularly in patients at risk (see Section 4.4).
• Blood tests (complete blood count including platelets, bleeding time and coagulation parameters) are recommended prior to treatment, then after 15 days and at the end of treatment, and also before any surgery, and in the event of hematomas or spontaneous bleeding (see Section 4.8).
• In patients with renal insufficiency, elevated circulating valproic acid concentrations in the blood should be taken into account and the dosage should be reduced accordingly.