Contraindications : התוויות נגד

4.3    Contraindications
Hypersensitivity to sertindole or any of the excipients.

Sertindole is contraindicated in patients with known uncorrected hypokalaemia, and those with known uncorrected hypomagnesaemia.

Sertindole is contraindicated in patients with a history of clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia, or bradycardia (<50 beats per minute).
Furthermore, sertindole should not be initiated in patients with congenital long QT syndrome or a family history of this disease, or in patients with known acquired QT interval prolongation (QTc above 450 msec in males and 470 msec in females).

Sertindole is contraindicated in patients receiving drugs known to significantly prolong the QT interval. Relevant classes include:
-      class Ia and III antiarrhythmics (e.g. quinidine, amiodarone, sotalol, dofetilide) -      some antipsychotics (e.g. thioridazine)
-      some macrolides (e.g. erythromycin)
-      some antihistamines (e.g. terfenadine, astemizole)
-      some quinolone antibiotics (e.g. gatifloxacin, moxifloxacin).

The above list is not exhaustive and other individual drugs known to significantly increase QT interval (e.g. cisapride, lithium) are also contraindicated.

Co-administration of sertindole is contraindicated with drugs known to potently inhibit hepatic cytochrome P450 3A enzymes (see section 4.5). Relevant classes include: -     systemic treatment with ‘azole’ antifungal agents (e.g. ketoconazole, itraconazole) -     some macrolide antibiotics (e.g. erythromycin, clarithromycin)
-     HIV protease inhibitors (e.g. indinavir)
-     Some calcium channel blockers (e.g. diltiazem, verapamil ).

The above list is not exhaustive and other individual drugs known to potently inhibit CYP3A enzymes (e.g. cimetidine) are also contraindicated.

Sertindole is contraindicated in patients with severe hepatic impairment.