Zuellig Pharma
Concise Prescribing Info
Rosuvastatin Ca
Reduction of elevated total cholesterol (total-C), LDL-C, apolipoprotein B (ApoB), total-C: HDL-C ratio & triglycerides & increasing HDL-C in hyperlipidemic & dyslipidemic conditions. Reduction of total mortality & risk of major CV events in adults w/ increased risk of atherosclerotic CV disease based on presence of CV disease risk markers. Primary dysbetalipoproteinemia (type III hyperlipoproteinemia); primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia & severe non-familial hypercholesterolaemia); combined (mixed) dyslipidaemia (type IIb); homozygous familial hypercholesterolaemia. Adjunctive therapy to diet to slow progression of atherosclerosis in adults as part of treatment strategy to lower total-C & LDL-C to target levels. Adjunct to diet to reduce total-C, LDL-C & ApoB levels in adolescents at least 1 yr post-menarche, 10-17 yr w/ heterozygous familial hypercholesterolaemia.
Dosage/Direction for Use
Individualized dosage. Usual initial dose: 10 mg once daily. Patient requiring less aggressive LDL-C reductions Initially 5 mg once daily. Dose adjustments can be made after 4-wk interval. Max response is usually achieved w/in 2-4 wk & maintained during chronic therapy. Severe hypercholesterolemia at high CV risk Increase dose to 40 mg. Ped patient 10-17 yr Heterozygous familial hypercholesterolemia 5-20 mg daily. Dose adjustments should be made at ≥4-wk interval. Max dose: 20 mg daily. Asian patient Initially 5 mg once daily. Predisposing factors to myopathy Recommended starting dose: 5 mg. Severe renal impairment Initially 5 mg once daily. Not to exceed 10 mg once daily.
May be taken with or without food.
Hypersensitivity. Active liver disease including unexplained, persistent elevations of serum transaminases >3 x upper limit of normal (ULN). Patients w/ myopathy. Women of childbearing potential. Pregnancy & lactation.
Special Precautions
Discontinue use if markedly elevated creatinine kinase (>5 x ULN) occurs or interstitial lung disease is suspected. Not to be used in patients w/ acute, serious condition suggestive of myopathy or predisposing to development of renal failure secondary to rhabdomyolysis. Predisposing factors for myopathy/rhabdomyolysis eg, hypothyroidism, history of hereditary muscular disorders or muscular toxicity; situations where increased plasma levels occur. Immune-mediated necrotising myopathy; DM. Asian patients. Assess renal function during routine follow-up. Perform liver function test prior to & 3 mth after initiation of treatment. Not recommended in concomitant use w/ fibric derivatives eg, gemfibrozil, cyclosporin, nicotinic acid, azole antifungals, PIs, macrolides. Concomitant use w/ fibrates, niacin. Avoid excessive alcohol consumption. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. History of liver disease. Severe renal impairment. Women of childbearing potential should use effective contraception. Pregnancy & lactation. Childn <10 yr. Elderly >70 yr.
Adverse Reactions
DM; headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia.
Drug Interactions
Increased plasma conc w/ transporter protein inhibitors. Increased risk of myopathy w/ ciclosporin, gemfibrozil, fenofibrates, other fibrates, niacin ≥1 g daily. Increased exposure w/ PIs. Increased Cmax & AUC w/ gemfibrozil. Increased AUC w/ ezetimibe. Decreased plasma conc w/ Al- & Mg hydroxide-containing antacids. Muscle-related events w/ fusidic acid. Decreased AUC & Cmax w/ erythromycin. Severe myositis & myoglobinuria w/ fibrates. Increased INR w/ vit K antagonists. Increased ethinylestradiol & norgestrel AUC.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Crestor FC tab 10 mg
Crestor FC tab 20 mg
Crestor FC tab 5 mg
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