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Rosuvastatin

Fadztat

20 mg Film-Coated Tablet

Anti-hypercholesterolemia/ Anti-dyslipidemia

Formulation

Each film-coated tablet contains:

  • Rosuvastatin Calcium

  • Equivalent to Rosuvastatin - 20 mg

Mechanism of Action

Rosuvastatin is a selective, potent and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. Triglycerides (TG) and cholesterol in the liver are incorporated, with apolipoprotein B (Apse), into very low-density lipoprotein (VLDL) and released into the plasma for delivery to peripheral tissues. VLDL particles are TG-rich. Cholesterol-rich low-density lipoprotein (LDL) is formed from VLDL and is cleared primarily through the high affinity LDL receptor in the liver.

Rosuvastatin produces its lipid-modifying effects in two ways; it increases the number of hepatic LDL receptors on the cell-surface, enhancing uptake and catabolism of LDL and it inhibits the hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles.

High density lipoprotein (HDL), which contains Apo A-I is involved, amongst other things, in transport of cholesterol from tissues back to the liver (reverse cholesterol transport). The involvement of LDL-C in atherogenesis has been well documented. Epidemiological studies have established that high LDL-C, TG, low HDL-C and Apo A-I have been linked to a higher risk of cardiovascular disease. Intervention studies have shown the benefits on mortality and CV event rates of lowering LDL-C and TG or raising HDL-C. More recent data has linked the beneficial effects of HMG-CoA reductase inhibitors to lowering of non-HDL (i.e., all circulating cholesterol not in HDL) and ApoB or reducing the ApoB/ApoA-I ratio.

Indication

Rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate.

Dosaging

The usual dose is 10-40 mg orally once a day.

The dosage of Rosuvastatin should be individualized according to the goal of therapy and patient response. The majority of patients are controlled at the start dose. However, if necessary, dose adjustment can be made at 2-to-4-week intervals.

Rosuvastatin may be given at any time of day, with or without food.

Adults:

Primary Hypercholesterolemia (including Heterozygous Familial Hypercholesterolemia), Mixed Dyslipidemia, Dysbetalipoproteinemia, Isolated Hypertriglyceridemia and Treatment of Atherosclerosis and Prevention of Cardiovascular Events

The usual start dose is 10 mg once a day. A 5 mg start dose is available for special patient populations if needed. For patients with severe hypercholesterolemia (including heterozygous familial hypercholesterolemia) or those with aggressive lipid targets, a start dose of 20 mg may be considered.

Homozygous Familial Hypercholesterolaemia

For patients with homozygous familial hypercholesterolemia a start dose of 20 mg once a day is recommended.

Children and Adolescents 6 to 17Years of Age:

In children 6 to 9 years of age with heterozygous familial hypercholesterolemia, the usual dose range is 5­10 mg orally once daily. Safety and efficacy of doses greater than 10 mg have not been studied in this population. In children 10 to 17 years of age with heterozygous familial hypercholesterolemia, the usual dose range is 5-20 mg orally once daily. Safety and efficacy of doses greater than 20 mg have not been studied in this population.

The dose should be appropriately titrated to achieve treatment goal.

In children and adolescents with homozygous familial hypercholesterolemia experience is limited to a small number of patients (aged 8 years and above).

Availability

  • Alu/Alu Blister Pack x 10's

  • Box of 30's

Contraindication

  • In patients with hypersensitivity to any component of this product.

  • In patients with active liver disease.

  • During pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures.

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