Rosuzet

Rosuzet

Manufacturer:

Hanmi Pharmaceutical

Distributor:

Organon
Concise Prescribing Info
Contents
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
Indications/Uses
Adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), LDL-C, Apo B, triglycerides (TG), & 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.
Dosage/Direction for Use
Adult Primary hypercholesterolemia Initially 10/10 mg once daily. 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.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ active liver disease. Pregnancy & lactation. Women of child-bearing potential not using appropriate contraceptive measures.
Special Precautions
Discontinue therapy if CK levels are markedly elevated (>10 x ULN) or if myopathy is diagnosed or suspected. Patients w/ predisposing factors for myopathy eg, renal impairment, advanced age & hypothyroidism or situations where an increase in plasma levels may occur. Temporarily w/held therapy in patients w/ an 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; uncontrolled seizures). Concomitant use w/ ciclosporin, fibric acid derivatives (including gemfibrozil), nicotinic acid, azole antifungals, & macrolides; daptomycin; gemfibrozil; fenofibrate & other fibrates; anticoagulant. DM. Patients who consume excessive quantities of alcohol &/or have a history of liver disease. Not recommended in patients w/ moderate or severe hepatic impairment. Asians.
Adverse Reactions
Drug Interactions
Ezetimibe: Decreased rate of absorption w/ antacids. Decreased mean AUC w/ cholestyramine. Increased mean AUC w/ cyclosporine. May increase cholesterol excretion into the bile which may lead to cholelithiasis w/ fibrates. Increased total conc w/ fenofibrates, gemfibrozil. Rosuvastatin: Increased risk of myopathy/rhabdomyolysis w/ drug or herbal products & 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.
MIMS Class
Dyslipidaemic Agents
ATC Classification
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.
Presentation/Packing
Form
Rosuzet 10 mg/10 mg FC tab
Packing/Price
30's
Form
Rosuzet 10 mg/20 mg FC tab
Packing/Price
30's
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