Sertindole

What it is and how it works

Sertindole is an antagonist at dopamine D2, serotonin 5-HT2A and 5-HT2C, and alpha1-adrenergic receptors, with relative selectivity for limbic dopamine neurones. This produces antipsychotic effects with a low incidence of extrapyramidal symptoms.

Indications

Schizophrenia, as second-line treatment in patients intolerant of at least one other antipsychotic, with restrictions owing to cardiac risk.

Dosage and administration (summary)

Taken orally once daily, starting at 4 mg and increased by 4 mg every 4–5 days to a usual maintenance dose of 12–20 mg daily (maximum 24 mg daily), with ECG monitoring.

Contraindications

Known QT prolongation or congenital long-QT syndrome, clinically significant cardiovascular disease, uncorrected hypokalaemia or hypomagnesaemia, severe hepatic impairment, and concomitant drugs that prolong the QT interval or strongly inhibit CYP3A4 or CYP2D6.

Warnings and precautions

Sertindole prolongs the QT interval and may cause serious ventricular arrhythmias; obtain an ECG before and during treatment and stop if QTc exceeds 500 ms. Orthostatic hypotension, nasal congestion, reduced ejaculatory volume and weight gain may occur; elderly patients with dementia have increased mortality with antipsychotics.

Pregnancy

Not recommended in pregnancy.

Storage and supply

Store below 25 °C.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.