Atozet

Atozet

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
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
Indications/Uses
Reduced risk of CV death, nonfatal MI & stroke, hospitalization for unstable angina or need for revascularization in patients w/ CHD & history of acute coronary syndrome (ACS). Adjunctive therapy to diet in adult w/ primary hypercholesterolaemia (heterozygous familial & non-familial), mixed hyperlipidaemia or homozygous familial hypercholesterolaemia (HoFH).
Dosage/Direction for Use
Hypercholesterolaemia &/or CHD w/ ACS history Initially 10/10 mg once daily. Dose range: 10/10-10/80 mg daily. HoFH 10/10-10/80 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent serum transaminases elevation. Pregnancy & lactation. 
Special Precautions
Discontinue use if myopathy is diagnosed & serious liver injury w/ clinical symptoms &/or hyperbilirubinemia or jaundice occurs. Recent stroke or transient ischemic attack. Substantial alcohol consumption &/or history of liver disease. Co-administration w/ ketoconazole, spironolactone, cimetidine, gemfibrozil, fenofibrate & other fibrates, fusidic acid, warfarin, fluindione, cyclosporine, HIV & hepatitis C PI, erythromycin, clarithromycin, itraconazole, bocepravir, elbasvir, grazoprevir, niacin. May affect ability to drive & use machines. Not recommended in moderate to severe hepatic impairment. Not to be used during pregnancy & lactation.
Adverse Reactions
Drug Interactions
Increased risk of myopathy w/ clarithromycin, HIV & hepatitis C PIs, itraconazole, grapefruit juice (>1.2 L daily), cyclosporine, gemfibrozil, fenofibrate, fusidic acid, niacin, colchicine. Decreased ezetimibe mean AUC w/ cholestyramine. Increased cholesterol bile excretion w/ other fibrates. Increased atorvastatin plasma conc w/ breast cancer resistant protein (BCRP) inhibitors (eg, elbasvir, grazoprevir). Reduced atorvastatin plasma conc w/ efavirenz, rifampin. Decreased plasma conc w/ colestipol. Increased steady-state plasma conc of digoxin. Increased AUC w/ OC (eg, norethindrone & ethinyl estradiol).
ATC Classification
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.
Presentation/Packing
Form
Atozet 10 mg/20 mg FC tab
Packing/Price
30's
Form
Atozet 10 mg/40 mg FC tab
Packing/Price
30's
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