Rosucres-10/Rosucres-20

Adjunctive therapy to diet to reduce elevated total-C, LDL-C, Apo B, non HDL-C & triglycerides & to increase HDL-C in adults w/ primary hyperlipidemia or mixed dyslipidemia. Adjunct to diet to reduce total-C, LDL-C & Apo B levels in adolescent boys & girls, who are at least 1 yr post-menarche, 10-17 yr of age w/ heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: LDL-C >190 mg/dL or >160 mg/dL & +ve family history of premature CV disease or ≥2 other CV disease risk factors. Adjunctive therapy to diet in adults w/ hypertriglyceridemia; primary dysbetalipoproteinemia (type III hyperlipoproteinemia); to slow the progression of atherosclerosis in adults, as part of a treatment strategy to lower total-C & LDL-C to target levels. Adjunctive therapy to other lipid-lowering treatments (eg, LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, total-C & Apo B in adult patients w/ HoFH. Reduce risk of stroke, MI & arterial revascularization procedures.

Dose range: 5-40 mg once daily. Usual starting dose: 10-20 mg. Can be administered as single dose at any time of day. Use 40-mg dose only for patients who have not achieved LDL-C goal utilizing the 20-mg dose. Adult HoFH Initially 20 mg once daily. Childn & adolescent 10-17 yr Heterozygous familial hypercholesterolemia Usual dose range: 5-20 mg once daily. Max: 20 mg/day. Asian patient Initially 5 mg once daily. Patient w/ severe renal impairment (CrCl <30 mL/min/1.73 m²) not on hemodialysis Initially 5 mg once daily. Max: 10 mg once daily. Patient taking cyclosporine Max: 5 mg once daily. Patient taking gemfibrozil, lopinavir & ritonavir or atazanavir & ritonavir Initially 5 mg once daily. Max: 10 mg once daily.

May be taken with or without food.

Hypersensitivity. Patients w/ active liver disease including unexplained persistent elevations of hepatic transaminase levels. Pregnancy & lactation.

Discontinue treatment if markedly elevated creatine kinase levels occur or myopathy is diagnosed or suspected. 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, dehydration, major surgery, trauma, severe metabolic, endocrine, & electrolyte disorders, or uncontrolled seizures). Interrupt therapy if serious liver injury w/ clinical symptoms &/or hyperbilirubinemia or jaundice occurs during treatment; do not restart if alternate etiology is not found. Consider dose reduction for patients w/ unexplained persistent proteinuria &/or hematuria during routine urinalysis testing. Reports of myopathy & rhabdomyolysis w/ acute renal failure secondary to myoglobinuria; immune-mediated necrotizing myopathy; increases in serum transaminases (AST or ALT); proteinuria & hematuria; increases in HbA1c & fasting serum glucose levels. Post-marketing reports of fatal & non-fatal hepatic failure. Perform liver enzyme tests before initiation of treatment & if signs or symptoms of liver injury occur. Patients w/ predisposing factors for myopathy (eg, age >65 yr, inadequately treated hypothyroidism, renal impairment); patients who consume substantial quantities of alcohol &/or have history of chronic liver disease. Concomitant use w/ other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, lopinavir/ritonavir, or atazanavir/ritonavir; colchicine; anticoagulants; drugs that may decrease levels or activity of endogenous steroid hormones eg, ketoconazole, spironolactone & cimetidine. Increased exposure in Asian patients & in patients w/ severe renal impairment who are not receiving hemodialysis. Counsel adolescent females on appropriate contraceptive methods while on therapy. Has not been studied in controlled clinical trials involving prepubertal or patients <10 yr. Higher risk of myopathy in elderly.

Headache, myalgia, abdominal pain, asthenia, nausea.

Increased exposure w/ cyclosporine; gemfibrozil; lopinavir/ritonavir & atazanavir/ritonavir. Increased INR w/ coumarin anticoagulants. Enhanced risk of skeletal muscle effects w/ lipid modifying doses of niacin (>1 g daily). Increased risk of myopathy w/ fenofibrates. Myopathy including rhabdomyolysis w/ colchicine.

Dyslipidaemic Agents

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

Rx