Crestor

Rosuvastatin Ca

Reduction of total mortality & risk of major CV events (CV death, stroke, MI, unstable angina, or arterial revascularization) in adults w/ increased risk of atherosclerotic CV disease based on the presence of CV disease risk markers eg, elevated high sensitivity C-reactive protein (hsCRP) level, age, HTN, low HDL-C, smoking or family history of premature CHD. Adults w/ primary hypercholesterolaemia [type IIa including heterozygous familial hypercholesterolaemia (HeFH)] or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet & other non-pharmacological treatments (eg, exercise, wt reduction) is inadequate. Homozygous familial hypercholesterolaemia as an adjunct to diet & other lipid lowering treatments eg, LDL apheresis or if such treatments are inappropriate. Slow or delay the progression of atherosclerosis. Reduction of total cholesterol, LDL-C & Apo B in childn & adolescents 6-17 yr w/ HeFH.

Individualized dosage. Statin-naïve patients or patients switched from another HMG-CoA reductase inhibitor Initially 5 or 10 mg once daily, may adjust dose to 20 mg after 2-4 wk. Severe hypercholesterolaemia at high CV risk (in particular those w/ familial hypercholesterolaemia) Consider doubling dose to 40 mg if treatment goal on 20 mg is not achieved. Asian patients Initially 5 mg once daily. Patients known to have c.521CC or c.421AA genotype Max dose: 20 mg once daily. HeFH Childn & adolescent 10-17 yr 5-20 mg once daily, 6-9 yr 5-10 mg once daily.

May be taken with or without food: May be given at any time of day.

Hypersensitivity. Patients w/ active liver disease including unexplained, persistent elevations of serum transaminases & any serum transaminase elevation exceeding 3x ULN; myopathy. Concomitant use w/ cyclosporin. Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.

Discontinue if markedly elevated creatinine kinase level >5x ULN; serum transaminase >3x ULN occurs. Not to be used in patients w/ acute, serious condition suggestive of myopathy or predisposing to development of renal failure secondary to rhabdomyolysis eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders; or uncontrolled seizures. Dipstick-positive proteinuria & microscopic hematuria in patients w/ dose above the recommended range ie, 80 mg. Predisposing factors for myopathy/rhabdomyolysis eg, hypothyroidism, history of hereditary muscular disorders or muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, >70 yr, situations where increased plasma levels occur, concomitant use w/ fibrates. Immune-mediated necrotising myopathy; DM. Secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome. Asian patients. HIV patients receiving PIs. Assess renal function during routine follow-up. Perform LFT prior to & 3 mth following initiation of treatment & on any dose elevation, & periodically thereafter. Not recommended in concomitant use w/ fibric derivatives eg, gemfibrozil, cyclosporin, nicotinic acid, azole antifungals, PIs, macrolides. Combination w/ fibrates, niacin. May affect ability to drive & use machines. Excessive alcohol consumption or w/ history of liver disease. Women of childbearing potential should use effective contraception. Pregnancy & lactation. Childn & adolescents 6-17 yr; ≥8 yr w/ homozygous familial hypercholesterolaemia.

Headache, myalgia, asthenia, constipation, dizziness, nausea abdominal pain, DM. Thrombocytopenia; immune-mediated necrotizing myopathy; peripheral neuropathy; depression, sleep disorders (including insomnia & nightmares); gynaecomastia; DRESS.

Increased plasma conc & risk of myopathy w/ transporter protein inhibitors. Increased AUC w/ cyclosporin &, itraconazole. Increased exposure w/ PIs. Increased INR w/ vit K antagonists. Increased C_max & AUC w/ gemfibrozil. Increased risk of myopathy w/ gemfibrozil, fenofibrate, other fibrates & lipid lowering doses of niacin. Decreased plasma conc w/ Al- & Mg-hydroxide containing antacids. Decreased AUC_(0-t) & C_max w/ erythromycin. Increased AUC of ethinyl oestradiol & norgestrel. Concomitant use w/ fusidic acid. Decreased AUC w/ baicalin.

Dyslipidaemic Agents

C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

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