Content: Rosuvastatin Ca
Description:
Each tablet contains 5 mg, 10 mg or 20 mg of rosuvastatin as rosuvastatin calcium.
Excipients/Inactive Ingredients: Tablet core: Crospovidone, Lactose monohydrate, Microcrystalline cellulose, Calcium phosphate, Magnesium stearate.
Tablet coat: Lactose monohydrate, Hypromellose, Triacetin, Titanium dioxide (E171), Yellow Ferric oxide (E172) (5 mg tablet), Red Ferric oxide (E172) (10 mg and 20 mg tablets).
Indication:
Crestor (rosuvastatin calcium) is indicated as an adjunct to diet, at least equivalent to the Adult Treatment Panel III (ATP III TLC diet), for the reduction of elevated total cholesterol, LDL-cholesterol, ApoB, the total cholesterol: HDL-cholesterol ratio and triglycerides and for increasing HDL-C, in hyperlipidemic and dyslipidemic conditions, when response to diet and exercise alone has been inadequate including: Prevention of Cardiovascular Events. In adult patients with an increased risk of atherosclerotic cardiovascular disease based on the presence of cardiovascular disease risk markers such as an elevated hsCRP level, age, hypertension, low HDL-C, smoking or a family history of premature coronary heart disease, Crestor is indicated to reduce total mortality and the risk of major cardiovascular events (cardiovascular death, stroke, MI, unstable angina, or arterial revascularization).
Crestor is indicated as an adjunct to diet for the treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
Primary hypercholesterolaemia (Type IIa including heterozygous familial hypercholesterolaemia and severe non-familial hypercholesterolaemia).
Combined (mixed) dyslipidemia (Type IIb).
Homozygous familial hypercholesterolaemia where Crestor is used either alone or as an adjunct to diet and other lipid lowering treatment such as apheresis.
Crestor is indicated as adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels.
Pediatric Patients 10 to 17 years of age with Heterozygous Familial Hypercholesterolemia (HeFH): Adjunct to diet to reduce Total-C, LDL-C and ApoB levels in adolescent boys and girls, who are at least one year post-menarche, 10-17 years of age with heterozygous familial hypercholesterolaemia if after an adequate trial of diet therapy the following findings are present: LDL-C > 190 mg/dL or > 160 mg/dL and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors.
Dosage: atients should be placed on a standard cholesterol-lowering diet (at least equivalent to the Adult Treatment Panel III (ATP III TLC diet)) before receiving Crestor (rosuvastatin calcium), and should continue on this diet during treatment with Crestor. If appropriate, a program of weight control and physical exercise should be implemented.
Prior to initiating therapy with Crestor, secondary causes for elevations in plasma lipid levels should be excluded. A lipid profile should also be performed. After initiation or upon titration of Crestor, lipid levels should be analyzed within 2-4 weeks and the dosage adjusted accordingly.
The usual recommended starting dose of Crestor is 10 mg once daily. However, initiation of therapy with 5 mg once daily should be considered for special patient populations or patients requiring less aggressive LDL-C reductions. The choice of starting dose should take into account the individual patients' cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions. Crestor may be taken in the morning or evening, with or without food. The majority of patients are controlled at the 10 mg dose. However, if necessary, dose adjustments to the next dose level can be made after 4-week intervals. The maximum response is usually achieved within 2-4 weeks and is maintained during chronic therapy. Increasing the dose to 40 mg should be reserved for patients with severe hypercholesterolaemia at high cardiovascular risk (in particular those with familial hypercholesterolaemia), who do not achieve their treatment goal on 20 mg and should only be initiated under specialist supervision (see Precautions). The physician who elects to use Crestor at a dose higher than 20 mg should periodically re-evaluate the long term risk/benefit of Crestor for the individual patient. Crestor should be prescribed with caution in patients with pre-disposing factors for myopathy/rhabdomyolysis (see Precautions).
The dosage of Crestor should be individualised according to baseline LDL-C, total-C/HDL-C ratio and/or TG levels, the recommended target lipid values (see Recommendations for the Management and Treatment of Dyslipidemia [Canada] summarised as follows in Table 5) and/or the Third Report of the U.S. National Cholesterol Education Program [NCEP Adult Treatment Panel III]) and the patient response.
The majority (80%) of patients treated with rosuvastatin 10 mg achieved their NCEP ATP III treatment target for LDL-C levels; fewer subjects (68%) achieved target on the 5 mg dose. The difference between rosuvastatin 5 mg and 10 mg was greatest for high risk subjects (40% versus 61%, respectively), i.e. for subjects who have a lower LDL-C target.
