Manufacturer:

          AstraZeneca

Contents:

          Rosuvastatin Ca

Indications:

          Primary hypercholesterolaemia & mixed dyslipidaemia (including Fredrickson type IIa, IIb; & heterozygous familial hypercholesterolaemia) as an adjunct to diet when response to diet & exercise is inadequate. Primary dysbetalipoproteinaemia (Fredrickson type III hyperlipoproteinaemia) as an adjunct to diet when response to diet & exercise is inadequate. Homozygous familial hypercholesterolaemia, either alone or as an adjunct to diet & other lipid-lowering measures. Primary prevention of CV disease (reduce the risk of stroke, MI & arterial revascularization procedures). Reduction of total-C, LDL-C & ApoB levels in childn & adolescents 10-17 yr as an adjunct to diet.

Contraindications:

          Active liver disease or unexplained, persistent elevations of serum transaminases. Severe renal impairment (CrCl <30 mL/min). Concomitant cyclosporin therapy. Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.

Special Precautions:

          Asian patients. Unexplained, persistent proteinuria during routine urinalysis testing. Excessive alcohol consumption &/or history of liver disease. Moderate & severe hepatic impairment. Predisposing factors for myopathy/rhabdomyolysis [eg renal impairment, hypothyroidism, hereditary muscular disorders (personal or family history), history of muscular toxicity w/ other HMG-CoA reductase inhibitors, fibrates or niacins, alcohol abuse, elderly ≥65 yr, situations where increased plasma levels occur & concomitant use of fibrates or niacin]. Check serum transaminases (eg creatine kinase levels) before starting therapy & periodically thereafter. Discontinue therapy if signs &/or symptoms suggestive of myopathy occur. Crestor 40 mg will only be required for patients w/ severe hypercholesterolaemia at high CV risk who do not achieve their treatment goal on 20 mg & should only be initiated under close specialist supervision. May impair ability to drive or operate machinery. Use is limited to 1-yr period in childn & adolescents 10-17 yr.

Dosage:

          Initially 5 or 10 mg once daily in both statin-naive patients or patients switched from another HMG-CoA reductase inhibitor, may be increased to the next dose level after 4-6 wk, if necessary. Severe hypercholesterolemia at high CV risk May be increased to 40 mg. Asian patient Initially 5 mg. Childn w/ heterozygous familial hypercholesterolemia Initially 5 mg once daily. Max: 10 mg daily. Adjustments should be made at ≥4-wk intervals. Concomitant use w/ gemfibrozil, fenofibrate, other fibrates or lipid-lowering doses (0