Rhea Rosuvastatin

Adjunct to diet in response of inadequate diet & exercise. Reduction of total mortality & risk of major CV events (eg, CV death, stroke, MI, unstable angina, or arterial revascularization). In adult w/ hypercholesterolaemia, to reduce elevated LDL-C, total cholesterol, triglycerides, & to increase HDL-cholesterol in patients w/ primary hypercholesterolaemia (heterozygous & non familial) & mixed dyslipidaemia (Fredrickson Types IIa & IIb); lowers Apo B, non-HDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C, non-HDL-C/HDL-C, Apo B/Apo A-I ratios & increases Apo A-I in these populations. Primary dysbetalipoproteinaemia (Fredrickson type III hyper lipoproteinaemia); isolated hypertriglyceridaemia (Fredrickson type IV hyperlipidaemia). Reduction of total cholesterol & LDL-C in adult w/ homozygous familial hypercholesterolaemia as adjunct to diet & other lipid lowering treatments (eg, LDL apheresis) or monotherapy. Slow or delay progression of atherosclerosis. Reduction of total cholesterol, LDL-C & Apo B in childn & adolescents 6-17 yr w/ heterozygous familial hypercholesterolaemia (HeFH).

Individualized dosage. 10-40 mg orally once daily. May be adjusted at 2-4 wk intervals. Adult Primary hypercholesterolaemia (including heterozygous familial hypercholesterolaemia), mixed dyslipidaemia, dysbetalipoproteinaemia, isolated hypertriglyceridaemia, treatment of atherosclerosis & prevention of CV events Initially 10 mg once daily, may start at 5 mg for special populations if needed. May consider starting at 20 mg in patients w/ severe hypercholesterolaemia (including heterozygous familial hypercholesterolaemia) or those w/ aggressive lipid targets. Homozygous familial hypercholesterolaemia Initially 20 mg once daily. Heterozygous familial hypercholesterolaemia Childn & adolescent 10-17 yr 5-20 mg orally once daily, 6-9 yr 5-10 mg orally once daily. Severe renal impairment Max: 10 mg once daily. Asian patients Consider starting at 5 mg. Patient w/ c.521CC or c.421AA genotype Max: 20 mg once daily.

May be taken with or without food.

Hypersensitivity. Patients w/ active liver disease. Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.

Excessive consumption of alcohol & history of liver disease. Measure CK levels in patients who develop any signs or symptoms suggestive of myopathy. Discontinue therapy when CK levels are markedly elevated (>10 x ULN) or if myopathy is diagnosed or suspected. Patients w/ predisposing factors for myopathy eg, hypothyroidism, or situations where increase in plasma levels may occur. Temporary withheld in 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. Severe renal & hepatic impairment. Asian patients. Childn & adolescent 6-17 yr. Elderly.

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

Increased plasma conc & risk of myopathy w/ OATP1B1 & BCRP inhibitors. Decrease in plasma conc w/ antacid susp containing Al & Mg hydroxide. Muscle related events including rhabdomyolysis w/ fusidic acid. May increase INR w/ warfarin. May increase risk of myopathy w/ fenofibrates/fibric acid derivatives (gemfibrozil, fenofibrate & other fibric acid, including nicotinic acid).

Dyslipidaemic Agents

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

Rx