Rosukon-20

Rosuvastatin Ca

Prevention of CV events to reduce total mortality & risk of major CV events (eg, CV death, stroke, MI, unstable angina or arterial revascularization) in adults w/ increased risk of atherosclerotic CV disease. To reduce elevated LDL-C, total cholesterol, triglycerides & to increase HDL-C in patients w/ primary hypercholesterolaemia (heterozygous familial & nonfamilial) & mixed dyslipidaemia (Fredrickson types IIa & IIb); also lowers Apo B, nonHDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C, nonHDL-C/HDL-C, Apo B/Apo A-I ratios & increases Apo A-I in adults w/ hypercholesterolaemia. Primary dysbetalipoproteinaemia (Fredrickson type III hyperlipoproteinaemia); isolated hypertriglyceridaemia (Fredrickson type IV hyperlipidaemia). To reduce total cholesterol & LDL-C in patients w/ HoFH as adjunct to diet & other lipid-lowering treatments (eg, LDL apheresis) or alone. To slow or delay progression of atherosclerosis. To reduce total cholesterol, LDL-C & Apo B on childn & adolescents 6-17 yr w/ heterozygous familial hypercholesterolaemia (HeFH).

10-40 mg once daily. Adult Primary hypercholesterolaemia (including HeFH), mixed dyslipidaemia, dysbetalipoproteinaemia, isolated hypertriglyceridaemia, atherosclerosis & prevention of CV event Initially 10 mg once daily. 5 mg start dose in special patient population if needed. Severe hypercholesterolaemia (including HeFH) or w/ aggressive lipid target Initially 20 mg. HoFH Initially 20 mg once daily. HeFH Childn 10-17 yr 5-20 mg once daily, 6-9 yr 5-10 mg once daily. Elderly & mild to moderate renal & hepatic impairment Usual dose range. Severe renal impairment Max: Not to exceed 10 mg once daily. Asian Initially 5 mg. Patient known to have c.521CC or c.421AA genotype Max: 20 mg once daily.

May be taken with or without food.

Hypersensitivity. Active liver disease. Women of childbearing potential not using appropriate contraception. Pregnancy & lactation.

Discontinue use if creatine kinase (CK) levels are markedly elevated (>10 x ULN) or if myopathy is diagnosed or suspected. Skeletal muscle effects eg, myalgia, myopathy & rarely rhabdomyolysis. Patients w/ predisposing factors for myopathy eg, renal impairment, advanced age & hypothyroidism or situations where increased plasma levels may occur. Temporarily w/hold treatment in any patient 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). DM. Asians. Concomitant use w/ ciclosporin, fibric acid derivatives (including gemfibrozil), nicotinic acid, azole antifungals & macrolides. Patients consuming excessive quantities of alcohol &/or have history of liver disease. Women of childbearing potential should use appropriate contraception.

Headache, myalgia, asthenia, constipation, dizziness, nausea, abdominal pain, DM.

Increased AUC w/ ciclosporin, atazanavir/ritonavir, simeprevir, lopinavir/ritonavir, clopidogrel, gemfibrozil, eltrombopag, darunavir/ritonavir, tipranavir, dronedarone, itraconazole, ezetimibe. Decreased AUC w/ erythromycin, baicalin. Decreased plasma conc w/ antacid susp containing Al & Mg hydroxide. Possible muscle-related events including rhabdomyolysis w/ fusidic acid. May result in rise in INR w/ warfarin. May increase risk of myopathy w/ gemfibrozil, fenofibrate & other fibric acids including nicotinic acid.

Dyslipidaemic Agents

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

Rx