Indication*

Oral Heterozygous Familial Hypercholesterolaemia, Mixed Dyslipidaemia, Primary Hypercholesterolaemia, Homozygous Familial Hypercholesterolaemia, Prophylaxis of Cardiovascular events in High-risk patients.

Directions for Use*

(Oral Heterozygous Familial Hypercholesterolaemia,) Children: Dose is individual according to baseline LDL-C levels, the goal of therapy, and patient response. As an adjunct to diet: 10-17 years Initially, 10 mg daily; may be adjusted according to response at intervals of at least 4 weeks. Usual range: 10-20 mg once daily. (Mixed Dyslipidaemia, Primary Hypercholesterolaemia) Adult: Dose is individualized according to baseline LDL-Cholesterol (LDL-C) levels, the goal of therapy, and patients response. As an adjunct to diet: Usual initial dose: 10 mg or 20 mg once daily; patients who require >45% reduction in LDL-C may initiate at 40 mg once daily. Usual range: 10-80 mg once daily. Max: 80 mg once daily. Evaluate lipid levels within 2-4 weeks after initiation and or upon titration, then adjust dose accordingly. (Homozygous Familial Hypercholesterolaemia) Adult: Dose is individualized according to baseline LDL-C levels, the goal of therapy, and patient response. As an adjunct to other lipid-lowering treatments (e.g. LDL apheresis): 10-80 mg daily. (Prophylaxis of Cardiovascular events in high-risk patients) Adult: Dose is individualized according to baseline LDL-C levels, the goal of therapy, and patient response. Primary prevention: Initially, 10 mg daily. Higher doses may be required to attain LDL-C levels according to current guidelines.

Administration*

May be taken with or without food. Avoid excessive consumption (>1 L/day) of grapefruit juice.

*written indications, directions, and administration are updated as of March 24, 2024 and may not be accurate with the actual product purchased. Please read the details in the packaging.

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