EZETIMIBE MA (Medreich Australia Pty Ltd)

Adults ( greater than or equal to 18 Years)

Primary Hypercholesterolaemia

Ezetimibe 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.

Homozygous Familial Hypercholesterolaemia (HoFH)

Ezetimibe, administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).

Homozygous Sitosterolaemia (Phytosterolaemia)

Ezetimibe is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.

Prevention of Cardiovascular Disease

Ezetimibe, is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see Clinical Trials).

Children and Adolescents 10-17 Years

(pubertal status: boys Tanner Stage II and above and girls who are at least one year post-menarche)

Heterozygous Familial Hypercholesterolaemia (HeFH)

Ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:

Patients not appropriately controlled with a statin or ezetimibe alone

Patients already treated with a statin and ezetimibe,

Homozygous Familial Hypercholesterolaemia (HoFH)

Ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis).