Abbreviated Prescribing Information
Crestor

Presentation: Rosuvastatin calcium film-coated tablet. Indications: Primary Hyperlipidemia and Mixed Dyslipidemia – as an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and TG levels and to increase HDL-C; Pediatric Patients 10 to 17 years of age with Heterozygous Familial Hypercholesterolemia (HeFH) – as an adjunct to diet to reduce Total-C, LDL-C and ApoB levels in adolescents, who are at least one year postmenarche, 10-17 years of age with heterozygous familial hypercholesterolemia 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; Hypertriglyceridemia – as an adjunct to diet; Primary Dysbetalipoproteinemia – as an adjunct to diet; Homozygous familial hypercholesterolemia – to reduce LDL-C, total-C and ApoB; Slowing of the Progression of Atherosclerosis – as part of a treatment strategy to lower total-C and LDL-C to target levels as an adjunct to diet; Primary Prevention of Cardiovascular Disease – to reduce risk of stroke, myocardial infarction and arterial revascularization procedures in patients without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age ≥ 50 years old in men and ≥ 60 years old in women, hsCRP ≥ 2 mg/L, and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease. Dosage: The usual starting dose is 10-20mg. 40 mg only for patients not reaching LDL-C goal with 20 mg. Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10-17 years of age) The usual dose range is 5-20mg/day; the maximum recommended dose is 20mg/day. Homozygous familial hypercholesterolemia Starting dose 20 mg. For patients taking cyclosporine, maximum 5 mg once daily; For patients taking fenofibrate, initiate with 5 mg daily dose, maximum 10 mg once daily; For patients taking lopinavir & ritonavir or atazanavir and ritonavir, maximum 10 mg once daily; Asian should be considered to start at 5 mg once daily; For patients with severe renal impairment, start at 5 mg daily, maximum 10 mg once daily. Contraindications: Hypersensitivity to rosuvastatin; active liver disease or unexplained persistent elevations of serum transaminases; pregnancy & lactation; The 40 mg dose is contraindicated in patients with pre-disposing factors for myopathy/rhabdomyolysis. Such factors include moderate renal impairment (creatinine clearance < 60 ml/min), hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, situations where an increase in plasma levels may occur, Asian patients, concomitant use of fibrates. Precautions: Skeletal muscle effects; Liver enzyme abnormalities; Hepatic failure; Concomitant coumarin anticoagulants; Proteinuria and hematuria; Endocrine effects and Concomitant use of fenofibrate. Interactions: Cyclosporine; Gemfibrozil; Atazanavir/ritonavir; Lopinavir/ritonavir; Simeprevir; Coumarin anticoagulants; Niacin and Antacid. Undesirable effects: Headache; Myalgia; Abdominal pain; Asthenia and Nausea. Full local prescribing information is available upon request. API.HK.CRE.0323

HK-10000 19/02/2024