Posology : מינונים

4.2   Posology and method of administration

Posology
Hypercholesterolaemia and/or Coronary Heart Disease (with ACS History) The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with ATOZET.

The dose range of ATOZET is 10/10 mg/day through 10/80 mg/day. The typical dose is 10/10 mg once a day. The patient’s low-density lipoprotein cholesterol (LDL-C) level, coronary heart disease risk status, and response to current cholesterol-lowering therapy should be considered when starting therapy or adjusting the dose.

The dose of ATOZET should be individualised based on the known efficacy of the various dose strengths of ATOZET (see section 5.1, Table 4) and the response to the current cholesterol-lowering therapy. Adjustment of dose should be made at intervals of 4 weeks or more.

Homozygous Familial Hypercholesterolaemia
The dose of ATOZET in patients with homozygous FH is 10/10 to 10/80 mg daily. ATOZET may be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

Co-administration with other medicines
Dosing of ATOZET should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.

In patients taking hepatitis C antiviral agents elbasvir/grazoprevir concomitantly with ATOZET, the dose of ATOZET should not exceed 10/20 mg/day (see sections 4.4 and 4.5).

Elderly
No dose adjustment is required for older patients (see section 5.2).

Paediatric population
The safety and efficacy of ATOZET in children has not been established (see section 5.2). No data are available.

Hepatic impairment
ATOZET should be used with caution in patients with hepatic impairment (see sections 4.4 and 5.2).
ATOZET is contraindicated in patients with active liver disease (see section 4.3).

Renal impairment
No dose adjustment is required for renally impaired patients (see section 5.2).
Method of administration
ATOZET is for oral administration. ATOZET can be administered as a single dose at any time of the day, with or without food.