Roswin

Rosuvastatin Ca

Decrease elevated total cholesterol (total-C), LDL-cholesterol (LDL-C) & triglycerides (TG); increase high density lipoprotein cholesterol (HDL-C) in adult patients w/ primary hypercholesterolemia (heterozygous familial & nonfamilial) or mixed dyslipidemia (Fredrickson types IIa & IIb). Decrease Apo B, non-HDL-C, VLDL-C, VLDL-TG, LDL-C/HDL-C, total-C/HDL-C, non-HDL-C/HDL-C & Apo B/Apo A-I ratios & increase Apo A-I. Decrease total-C, LDL-C & Apo B levels in adolescent boys & girls (who are at least 1 yr post-menarche), 10-17 yr w/ heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy, the following are present: LDL-C >190 mg/dL or LDL-C >160 mg/dL & +ve family history of premature CV disease or ≥2 other CV risk factors are present. Treatment of isolated hypertriglyceridemia (Fredrickson type IV hyperlipidemia) & primary dysbetalipoproteinemia (Fredrickson type III hyperlipoproteinemia). Decrease total-C & LDL-C in patients w/ homozygous familial hypercholesterolemia as adjunct to other lipid-lowering treatments (eg, LDL apheresis) or alone if such treatments are unavailable. Slow progression of CV disease. Primary prevention of CV disease.

5-40 mg/day as single dose. Hyperlipidemia (including heterozygous familial hypercholesterolemia), mixed dyslipidemia, isolated hypertriglyceridemia, slowing of atherosclerosis progression Initially 10 mg once daily. Patient w/ severe hypercholesterolemia (including heterozygous familial hypercholesterolemia) 20 mg once daily. Childn (10-17 yr) w/ heterozygous familial hypercholesterolemia Initially 5 mg once daily. Max: 20 mg once daily. Adjustments should be made at intervals of ≥4 wk. Homozygous familial hypercholesterolemia Initially 20 mg once daily. Response to therapy should be estimated from pre-apheresis LDL-C levels. Primary prevention of CV disease 20 mg once daily. Patient w/ predisposing factors to myopathy, moderate renal impairment & elderly >70 yr 5 mg once daily. Severe hepatic impairment 10 mg once daily.

May be taken with or without food.

Hypersensitivity. Active liver disease including unexplained, persistent elevations in serum transaminases & any serum transaminase elevation >3 times the upper limit of normal. Moderate & severe renal impairment, myopathy, hypothyroidism. History of hereditary muscular disorders; muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrate. Alcohol abuse. Situations where an increase in plasma rosuvastatin levels may occur. Asian patients. Concomitant use of fibrates. Pregnancy & lactation.

Monitor skeletal muscle (eg, myopathy, rhabdomyolysis), renal (eg, proteinuria, hematuria) & endocrine (eg, increased HbA1c & fasting serum glucose levels) effects. Perform liver function tests before initiation of therapy & if signs & symptoms of liver injury occur. Increased risk of interstitial lung disease (particularly w/ long-term therapy), DM (in patients w/ fasting glucose 5.6-6.9 mmol/L). Childn <10 yr. Elderly.

Asthenia, edema, flu syndrome; GI, hepatic, metabolic, nutritional, lab, musculoskeletal, nervous, resp, skin & urogenital effects.

Increased exposure w/ ciclosporin, gemfibrozil; AUC w/ PIs & itraconazole. Increased INR w/ coumarin anticoagulants; risk of skeletal muscle effects w/ niacin (≥1 g/day), myopathy w/ fenofibrates. Decreased plasma conc w/ antacid containing Al & Mg hydroxide; AUC & C_max w/ erythromycin. Increased plasma conc of OCs/hormone replacement therapy.

Dyslipidaemic Agents

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

Rx