Apo-Rosuvastatin

Rosuvastatin Ca

Primary hypercholesterolaemia & mixed dyslipidaemia (including Fredrickson type IIa, IIb) as an adjunct to diet when response to diet & exercise is inadequate. Primary dysbetalipoproteinaemia (Fredrickson type III hyperlipoproteinaemia) as an adjunct to diet when response to diet & exercise is inadequate. Homozygous familial hypercholesterolaemia, either alone or as an adjunct to diet & other lipid-lowering treatments (eg, LDL apheresis). Primary prevention of CV disease (reduce the risk of stroke, MI & arterial revascularization procedures). Reduction of total-C, LDL-C & apo B levels in childn & adolescents 10-17 yr as an adjunct to diet.

Initially 5 or 10 mg once daily in both statin-naive patients or patients switched from another HMG-CoA reductase inhibitor, may be increased to the next dose level after 4-6 wk, if necessary. Patient w/ severe hypercholesterolaemia at high CV risk May be increased to 40 mg. Asian patient Initially 5 mg once daily. Childn Initially 5 mg once daily. Max: 10 mg daily. Adjustments should be made at ≥4-wk intervals

May be taken with or without food.

Hypersensitivity. Active liver disease or unexplained, persistent elevations of serum transaminases. Severe renal impairment (CrCl <30 mL/min). Concomitant cyclosporin therapy. Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.

Asian patients. Unexplained, persistent proteinuria during routine urinalysis testing. Skeletal muscle effects (eg, myalgia, myopathy, & rhabdomyolysis, & potential immune-mediated necrotising myopathy); DM. Do not start treatment if creatinine kinase levels are significantly elevated at baseline (>10 x ULN). Predisposing factors for myopathy/rhabdomyolysis [eg, renal impairment, hypothyroidism, hereditary muscular disorders (personal or family history), history of muscular toxicity w/ other HMG-CoA reductase inhibitors, fibrate or niacin, alcohol abuse, elderly ≥65 yr, situations where increased plasma levels occur & concomitant use of fibrate or niacin]. Temporarily w/held in acute serious conditions suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders or uncontrolled seizures). Increase incidence of myositis & myopathy in patients receiving other MHG-CoA reductase inhibitors together w/ gemfibrozil, cyclosporin, nicotinic acid, azole antifungals, PIs & macrolide antibiotics. Excessive alcohol consumption &/or history of liver disease. Moderate hepatic impairment. Dizziness may affect ability to drive or operate machinery. Use is limited to 1-yr period in childn & adolescents 10-17 yr.

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

Increased C_max & AUC_(0-t) w/ cyclosporin, gemfibrozil & other lipid-lowering drugs. Increase exposure w/ PIs. Decreased plasma conc w/ antacid containing Al & Mg hydroxide. Decreased AUC_(0-t) & C_max w/ erythromycin. Increased INR w/ warfarin. Increased AUC of OC (ethinyl oestradiol & norgestrel). Not recommended in combination w/ fusidic acid.

Dyslipidaemic Agents

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

POM