Description
Primary Hypercholesterolaemia: EZETROL administered alone, or with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.
EZETROL, administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia.
Prevention of Cardiovascular Events: EZETROL, administered with a statin, is indicated to reduce the risk of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or need for revascularization), in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS).
Homozygous Familial Hypercholesterolaemia (HoFH): EZETROL, administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).
Homozygous Sitosterolaemia (Phytosterolaemia): EZETROL is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.
EZETROL may be administered with a statin (in patients with primary hypercholesterolemia) or with fenofibrate (in patients with mixed hyperlipidemia) for incremental effect.
When initiating lipid lowering treatment, which includes EZETROL 10 mg Tablets and a statin in combination, the indicated usual initial dose of that particular statin should be used or the already established higher statin dose should be continued.
If the statin dose is to be increased for the first time or further, the dosage instructions of that particular statin should be followed (such as dose increase only after at least 4 weeks of regular use of the combination without any change).
The stepwise increase of the statin dose in combination treatment results in a relatively small additional decrease of LDL-C, but increases the risk of dose-related adverse events of the statin.
