Rosuzet

Per 10/10 mg FC tab Ezetimibe 10 mg, rosuvastatin Ca 10 mg. Per 10/20 mg FC tab Ezetimibe 10 mg, rosuvastatin Ca 20 mg

Reduction of elevated total-C & LDL-C levels in patients w/ HoFH. Adjunctive therapy to diet for reduction of elevated 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.

Adult Primary hypercholesterolemia Initially 10/10 mg once daily. Severe hypercholesterolemia (including heterozygous familial hypercholesterolaemia) or w/ aggressive lipid targets; HoFH Initially 10/20 mg once daily. 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. Patient w/ predisposing factor to myopathy Initially rosuvastatin 5 mg. Asian patient Initially 10/5 mg once daily. Max: 10/20 mg once daily. Patient w/ c.521 CC or c.421 AA genotype Max: 10/20 mg once daily.

May be taken with or without food.

Hypersensitivity. Active liver disease. Concomitant use w/ cyclosporine. Women of childbearing potential not using appropriate contraception. Pregnancy & lactation.

Discontinue use if CK levels are markedly elevated (>10 x ULN) or if myopathy is diagnosed or suspected. Patients w/ predisposing factors for myopathy eg, advanced age, hypothyroidism or situations where increased plasma levels occur. Temporarily withhold or discontinue use in patients w/ acute serious condition suggestive of myopathy or risk factor predisposing to renal failure secondary to rhabdomyolysis eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders, uncontrolled seizures; DM. Excessive alcohol consumption &/or history of liver disease. Asian patients. Avoid concomitant use w/ gemfibrozil. Not recommended w/ other fibrates. Concomitant use w/ ciclosporin, fibric acid derivatives (including gemfibrozil), nicotinic acid, azole antifungals, macrolides; daptomycin; fenofibrate; anticoagulant. Monitor INR w/ concomitant use of warfarin, another coumarin anticoagulants or fluindione. Not recommended in moderate or severe hepatic impairment. Renal impairment. Not recommended in childn.

Pruritus.

Increased INR w/ vit K antagonists eg, warfarin or fluindione. Ezetimibe: Decreased absorption rate w/ antacids. Decreased mean AUC w/ cholestyramine. Increased mean AUC w/ cyclosporine. Severe myositis & myoglobinuria w/ fibrates. Increased total conc w/ fenofibrate, gemfibrozil. Rosuvastatin: Increased AUC w/ cyclosporine, atazanavir/ritonavir, simeprevir, lopinavir/ritonavir, clopidogrel, gemfibrozil, eltrombopag, darunavir/ritonavir, tipranavir/ritonavir, dronedarone, itraconazole, ezetimibe. Decreased AUC w/ erythromycin, baicalin. Decreased plasma conc w/ Al- & Mg hydroxide-containing antacid susp. Muscle-related events eg, rhabdomyolysis w/ fusidic acid. Increased risk of myopathy w/ gemfibrozil, fenofibrate & other fibrates eg, nicotinic acid; daptomycin.

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.

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