Posology : מינונים

4.2    Posology and method of administration
Posology
The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with Ezetrol.

Route of administration is oral. The recommended dose is one Ezetrol 10 mg tablet daily. Ezetrol can be administered at any time of the day, with or without food.

When Ezetrol is added to a statin, either the indicated usual initial dose of that particular statin or the already established higher statin dose should be continued. In this setting, the dosage instructions for that particular statin should be consulted.


Co-administration with bile acid sequestrants
Dosing of Ezetrol should occur either ≥ 2 hours before or ≥ 4 hours after administration of a bile acid sequestrant.
Older people
No dosage adjustment is required for elderly patients (see section 5.2).

Paediatric population
Initiation of treatment must be performed under review of a specialist.

Adolescents ≥ 10 : The safety and efficacy of ezetimibe in adolescents aged 10 to 17 years has not been established. Current available data are described in sections 4.4, 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.

When Ezetrol is administered with a statin, the dosage instructions for the statin, in adolescents should be consulted.

Children < 10 years: The safety and efficacy of Ezetimibe in children aged < 10 years has not been established.

Patients with hepatic impairment
No dosage adjustment is required in patients with mild hepatic impairment (Child-Pugh score 5 to 6).
Treatment with Ezetrol is not recommended in patients with moderate (Child-Pugh score 7 to 9) or severe (Child-Pugh score > 9) liver dysfunction. (see sections 4.4 and 5.2).

Patients with renal impairment
No dosage adjustment is required for renally impaired patients (see section 5.2).