Zevas

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

Individualized dosage. Primary hypercholesterolaemia Initially 10 mg/5 mg once daily. Max: 10 mg/20 mg once daily.

May be taken with or without food.

Hypersensitivity. Active liver disease, including unexplained persistent elevations of hepatic transaminase levels. Myopathy. Concomitant use w/ cyclosporine. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Pre-disposing factors for myopathy/rhabdomyolysis including moderate renal impairment (CrCl <60 mL/min), hypothyroidism, personal or family history of hereditary muscle disorders, previous history of muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, situations where increased in plasma levels occur, Asian patients, concomitant use w/ fibrates. Severe renal impairment (CrCl <30 mL/min). Pregnancy & lactation. Women of childbearing potential not using appropriate contraceptive measures.

Discontinue therapy if CK levels are markedly elevated (>5 x ULN) or if myopathy is diagnosed or suspected. Conduct LFT before initiation & repeat in patients w/ clinical signs & symptoms of liver disease. ILD. Patients w/ predisposing factors for myopathy/rhabdomyolysis eg, renal impairment or history of renal disorders, hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity w/ statins or fibrate, elderly >70 yr w/ factors of rhabdomyolysis, situations where an increase in plasma levels may occur. Patients w/ an acute serious condition suggestive of myopathy or renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders or uncontrolled seizures). Co-administration w/ anticoagulant, fibrates, bile acid binding resin, fusidic acid, OATP1B1 & BRCP inhibitors. Genetic polymorphism. DM. Alcoholics & patients who have a history of liver disease. Not recommended in patients w/ moderate or severe hepatic impairment. Dizziness may occur & affect ability to drive & use machines. Women of childbearing potential should use appropriate contraceptive measures. Childn. Elderly ≥65 yr. Asians.

Nasopharyngitis; arthralgia, myalgia; headache, dizziness; increased ALT; URTI. Abdominal pain. Rosuvastatin: DM; constipation, nausea; asthenia. Ezetimibe: Fatigue; diarrhea; pharyngitis; lower back pain.

Rosuvastatin: Increased risk of myopathy w/ OATP1B1 & BCRP inhibitors. Decreased plasma conc w/ antacid susp containing Al & Mg hydroxide. Myopathy including rhabdomyolysis w/ fusidic acid. Increased INR w/ warfarin. Increased risk of myopathy w/ gemfibrozil, fenofibrate, & other fibric acids including nicotinic acid. Increased plasma level of ethinyl oestradiol & norgestrel. Ezetimibe: Decreased mean AUC w/ cholestyramine. May increase cholesterol excretion into the bile which may lead to cholelithiasis w/ fibrates. Increased total conc w/ fenofibrates, gemfibrozil. Increased mean AUC w/ cyclosporine.

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