Rosuzet

Adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), LDL-C, apo B, triglycerides, & non-HDL-C, & to increase HDL-C in patients w/ primary (heterozygous familial & non-familial) hypercholesterolemia or mixed hyperlipidemia. Reduction of elevated total-C & LDL-C levels in patients w/ HoFH.

Adult Primary hypercholesterolemia Initially 10/10 mg once daily, or 10/5 mg for special population if needed. Severe hypercholesterolemia (including heterozygous familial hypercholesterolemia) or those w/ aggressive lipid targets Initially 10/20 mg. HoFH Initially 10/20 mg once daily. Patient w/ severe renal impairment (CrCl <30 mL/min/1.73 m²) not on hemodialysis Initially 10/5 mg once daily. Max: 10/10 mg once daily. Asians Initially 10/5 mg. Patient w/ c.521 CC or c.421 AA genotype Max: 10/20 mg once daily.

May be taken with or without food.

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

Discontinue therapy if creatine kinase levels are markedly elevated (>10 x ULN) or if myopathy is diagnosed or suspected. Increased incidence of myositis & myopathy in patients receiving other HMG-CoA reductase inhibitors together w/ ciclosporin, fibric acid derivatives (including gemfibrozil), nicotinic acid, azole antifungals & macrolides. Caution in patients w/ pre-disposing factors for myopathy, eg, renal impairment, advanced age & hypothyroidism or situation where an increase in plasma levels may occur. Temporarily w/ hold in patient w/ acute serious condition 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). Reports of myopathy &/or rhabdomyolysis w/ coadministration of HMG-CoA reductase inhibitor & daptomycin. Reports of new onset or aggravated pre-existing myasthenia gravis or ocular myasthenia w/ statins. Caution in patients who consume excessive quantities of alcohol &/or history of liver disease. Not recommended in patients w/ moderate or severe hepatic impairment. Avoid combination therapy w/ gemfibrozil. Consider gallbladder studies & alternative lipid-lowering therapy if cholelithiasis is suspected in patient receiving Rosuzet & fenofibrate. Coadministration w/ fibrates (other than fenofibrate) is not recommended. Monitor INR when added to warfarin, another coumarin anticoagulant or fluindione. Increases in HbA1c & serum glucose levels w/ HMG-CoA reductase inhibitors. Increased rosuvastatin exposure in Asians compared w/ Caucasians. Not recommended in ped patients.

Pruritus.

Ezetimibe: Decreased mean AUC w/ cholestyramine. Increased mean AUC w/ cyclosporine. Risk of increased cholesterol excretion into the bile which may lead to cholelithiasis w/ fibrates. Rosuvastatin: Increased AUC w/ cyclosporin, atazanavir/ritonavir, simeprevir, lopinavir, clopidogrel, gemfibrozil, eltrombopag, darunavir/ritonavir, tipranavir/ritonavir, dronedarone, itraconazole. Decreased AUC w/ erythromycin or baicalin. Increased risk of myopathy/rhabdomyolysis w/ daptomycin. Decreased plasma conc w/ antacid susp containing Al & Mg hydroxide. Muscle related events including rhabdomyolysis may occur w/ fusidic acid. Rise in INR w/ warfarin. Increased risk of myopathy w/ gemfibrozil, fenofibrate, & other fibric acids including nicotinic acid.

Dyslipidaemic Agents

C10BA06 - rosuvastatin and ezetimibe ; Belongs to the class of HMG CoA reductase inhibitors in combination with other lipid modifying agents. Used in the treatment of hyperlipidemia.

Rx