Posology : מינונים

4.2    Posology and method of administration
Sertindole is administered orally once daily with or without meals. In patients where sedation is required, a benzodiazepine may be co-administered.


Note: ECG monitoring is required before and during treatment with sertindole; see section 4.4.
Clinical studies have shown that sertindole prolongs the QT interval to a greater extent than some other antipsychotics. Sertindole should therefore only be used for patients intolerant to at least one other antipsychotic agent.

Prescribing physicians should comply fully with the required safety measures: see sections 4.3 and 4.4.


Titration
All patients should be started on sertindole 4 mg/day. The dose should be increased by increments of 4 mg after 4-5 days on each dose until the optimal daily maintenance dose, within the range of
12-20 mg, is reached. Due to the α 1 -blocking activity of sertindole, symptoms of postural hypotension may occur during the initial dose-titration period. A starting dose of 8 mg or a rapid increase in dose carries a significantly increased risk of postural hypotension.

Maintenance
Dependent on individual patient response, the dose may be increased to 20mg/day. Only in exceptional cases should the maximum dose of 24 mg be considered, as clinical trials have not demonstrated consistently improved efficacy above 20 mg and QT prolongation may be increased at the upper end of the dose range.

The blood pressure of the patients should be monitored during titration and early maintenance treatment.

Elderly
A pharmacokinetic study showed no difference between young and elderly subjects. However, only limited clinical trial data exist for patients greater than 65 years of age. Treatment should only be initiated after a thorough cardiovascular examination. Slower titration and lower maintenance doses may be appropriate in elderly patients (see section 4.4).

Children and adolescents under the age of 18
Serdolect is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.

Reduced renal function
Sertindole can be given at the usual dosage to patients with renal impairment (see section 4.3). The pharmacokinetics of sertindole is not affected by haemodialysis.

Reduced hepatic function
Patients with mild/moderate hepatic impairment require slower titration and a lower maintenance dose.

Re-titration of sertindole in patients for whom treatment has previously been discontinued When restarting sertindole treatment in patients who have had an interval of less than one week without sertindole, re-titration of sertindole is not required and their maintenance dose can be re-introduced. Otherwise the recommended titration schedule should be followed. An ECG should be taken prior to re-titration of sertindole.

Switching from other antipsychotics
Treatment with sertindole can be initiated according to the recommended titration schedule concomitantly with cessation of other oral antipsychotics. For patients treated with depot antipsychotics, sertindole is initiated in place of the next depot injection