Ezetimibe

Primary Hypercholesterolaemia Ezetimibe Tabletsco-administered with an HMG-CoA reductase inhibitor (statin) is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia who are not appropriately controlled with a statin alone.

Ezetimibe Tablets monotherapy is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia in whom a statin is considered inappropriate or is not tolerated.

1) in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) when added to ongoing statin therapy or initiated concomitantly with a statin. Homozygous Familial Hypercholesterolaemia (HoFH) Ezetimibe Tablets co-administered with a statin, is indicated as adjunctive therapy to diet for use in patients with HoFH.

g. LDL apheresis). Homozygous Sitosterolaemia (Phytosterolaemia) Ezetimibe Tablets is indicated as adjunctive therapy to diet for use in patients with homozygous familial sitosterolaemia.

TEVA-EZETIMIBE (Ezetimibe Tablets) is indicated as an adjunct to lifestyle changes, including diet, when the response to diet and other non-pharmacological measures alone has been inadequate. Primary Hypercholesterolemia TEVA-EZETIMIBE, administered alone or with an HMG-CoA reductase inhibitor (statin), is indicated for: • the reduction of elevated total cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG) and • to increase high density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hypercholesterolemia.

TEVA-EZETIMIBE, administered in combination with fenofibrate, is indicated for: • the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia. Homozygous Familial Hypercholesterolemia (HoFH) TEVA-EZETIMIBE, administered with a statin, is indicated for: • the reduction of elevated total-C and LDL-C levels in patients with HoFH as an adjunct to treatments such as LDL apheresis or if such treatments are not possible.

1 INDICATIONS AND USAGE Ezetimibe tablets are indicated: • In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).

• In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. • In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia.

• In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia.