Atozet

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

Risk reduction of CV events in patients w/ CHD & history of acute coronary syndrome (ACS), either previously treated w/ statin or not. Adjunctive therapy to diet for use in adults w/ primary (heterozygous familial & non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of combination product is appropriate in patients not appropriately controlled w/ statin alone or in patients already treated w/ statin & ezetimibe. Adjunctive therapy to diet for use in adults w/ HoFH.

Hypercholesterolaemia &/or CHD (w/ ACS history) 10/10 mg once daily. Dose range: 10/10 to 10/80 mg daily. Adjust dose at ≥4 wk intervals. HoFH 10/10 to 10/80 mg daily. May be used as adjunct to other lipid-lowering treatments (eg, LDL apheresis). Patient concomitantly taking elbasvir/grazoprevir Max: 10/20 mg daily.

May be taken with or without food.

Hypersensitivity. Patients w/ active liver disease or unexplained persistent elevations in serum transaminases >3x ULN. Patients treated w/ glecaprevir/pibrentasvir. Women of childbearing potential not using appropriate contraception. Pregnancy & lactation.

Risk of myopathy & rhabdomyolysis; myasthenia gravis & ocular myasthenia; transaminase elevations; ILD (especially w/ long-term therapy); raised blood glucose. Caution in patients w/ pre-disposing factors for rhabdomyolysis. Do not start treatment if creatine phosphokinase (CPK) levels are significantly elevated (>5x ULN) at baseline. Discontinue treatment in case of clinically significant elevation of CPK levels (>10x ULN), or diagnosed or suspected rhabdomyolysis. Perform LFTs before treatment initiation & periodically thereafter. Caution in patients who consume substantial quantities of alcohol &/or have history of liver disease. Carefully consider potential risk of haemorrhagic stroke before initiating treatment. Discontinue therapy if ILD is suspected. Monitor patients at risk of DM. Dosing should occur either ≥2 hr before or ≥4 hr after administration of bile acid sequestrant. Increased risk of rhabdomyolysis when concomitantly administered w/ medicinal products that may increase plasma conc of atorvastatin. Avoid concomitant use w/ telaprevir. Must not be co-administered w/ systemic fusidic acid or w/in 7 days of stopping fusidic acid treatment. Caution when co-administered w/ daptomycin or ciclosporin. Co-administration w/ fibrates is not recommended. Appropriately monitor INR if Atozet is added to warfarin, another coumarin anticoagulant, or fluindione. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. Not recommended in patients w/ moderate or severe hepatic insufficiency. Women of childbearing potential should use appropriate contraception during treatment. Safety & efficacy in childn have not been established.

Diarrhoea; myalgia.

Ezetimibe: Decreased AUC w/ cholestyramine. Increased AUC w/ ciclosporin. Increased conc w/ fibrates eg, fenofibrate or gemfibrozil. Reports of increased INR when added to anticoagulants eg, warfarin or fluindione. Atorvastatin: Increased plasma conc w/ potent CYP3A4 inhibitors eg, ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole, some HCV antivirals (eg, elbasvir/grazoprevir), HIV PIs (eg, ritonavir, lopinavir, atazanavir, indinavir, darunavir); moderate CYP3A4 inhibitors eg, erythromycin, diltiazem, verapamil, fluconazole, amiodarone; BCRP inhibitors eg, elbasvir & grazoprevir. Reduced plasma conc w/ CYP3A4 inducers eg, efavirenz, rifampicin, St. John's wort. Increased systemic exposure w/ transport protein inhibitors eg, ciclosporin; boceprevir. Increased risk of muscle-related events, including myopathy &/or rhabdomyolysis, w/ fibric acid derivatives eg, gemfibrozil; ezetimibe; systemic fusidic acid; colchicine; daptomycin. Lower plasma conc w/ colestipol. Slightly increased conc of digoxin. Increased plasma conc of OCs eg, norethisterone & ethinyl estradiol. Co-administration w/ warfarin caused a small decrease in prothrombin time.

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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