Atozet

Per 10 mg/20 mg FC tab Ezetimibe 10 mg, atorvastatin 20 mg. Per 10 mg/40 mg FC tab Ezetimibe 10 mg, atorvastatin 40 mg

Reduce risk of CV events (CV death, nonfatal MI & stroke, hospitalization for unstable angina or need for revascularization) in patients w/ CHD & history of acute coronary syndrome (ACS) either previously treated w/ statin or not. Adjunctive therapy to diet in adults w/ primary (heterozygous familial & non-familial) hypercholesterolaemia, mixed hyperlipidaemia or HoFH.

Hypercholesterolaemia &/or CHD w/ ACS history Initially 10/10 mg once daily. Dose range: 10/10-10/80 mg daily. Dose adjustments should be made at ≥4 wk intervals. HoFH 10/10-10/80 mg daily.

May be taken with or without food.

Hypersensitivity. Active liver disease or unexplained persistent serum transaminases elevation. Pregnancy & lactation.

Discontinue use if markedly elevated CPK levels occur or myopathy is diagnosed or suspected; serious liver injury w/ clinical symptoms &/or hyperbilirubinemia or jaundice occurs. Temporarily withheld or discontinue use in patients w/ acute, serious condition suggestive of myopathy or risk factor predisposing to renal failure secondary to rhabdomyolysis eg, severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders, uncontrolled seizures; myasthenia gravis/ocular myasthenia. Recent stroke or transient ischemic attack; immune-mediated necrotizing myopathy. Substantial alcohol consumption &/or history of liver disease. Perform liver enzyme tests prior to therapy & repeated as clinically indicated. Avoid concomitant use w/ gemfibrozil, cyclosporine, HIV & hepatitis C PIs. Not recommended w/ other fibrates, fusidic acid. Concomitant use w/ fenofibrate; anticoagulants, ketoconazole, spironolactone, cimetidine, colchicine, daptomycin, erythromycin, clarithromycin, azole antifungals, niacin (≥ 1 g/day), lopinavir/ritonavir. May affect ability to drive & use machines. Not recommended in moderate or severe hepatic impairment. Women of childbearing potential should use effective contraception. Not to be used during pregnancy & lactation. Childn.

Diarrhea; myalgia.

Increased risk of myopathy w/ CYP3A4 inhibitors eg, clarithromycin, HIV or hepatitis C PIs, itraconazole, grapefruit juice >1.2 L daily, cyclosporine, gemfibrozil, fenofibrates, fusidic acid, colchicine, daptomycin. Decreased plasma conc w/ oral Mg- & Al hydroxide-containing antacid. Decreased ezetimibe mean AUC w/ cholestyramine. Increased cholesterol bile excretion w/ other fibrates. Increased atorvastatin plasma conc w/ BCRP inhibitors eg, elbasvir, grazoprevir. Decreased atorvastatin plasma conc w/ efavirenz, rifampin, colestipol. Increased steady-state plasma conc of digoxin. Increased AUC of norethindrone & ethinyl estradiol. Enhanced risk of skeletal muscle effects w/ niacin.

Dyslipidaemic Agents

C10BA05 - atorvastatin 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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