Agencia Lei Va Hong


Concise Prescribing Info
Per 10/10 mg FC tab Ezetimibe 10 mg, atorvastatin 10 mg. Per 10/20 mg FC tab Ezetimibe 10 mg, atorvastatin 20 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; adults w/ homozygous familial hypercholesterolaemia (HoFH).
Dosage/Direction for Use
Hypercholesterolaemia &/or CHD (w/ ACS history) 10/10 mg once daily. Dose range: 10/10 to 10/80 mg/day. Dose adjustment should be made at ≥4 wk intervals. HoFH 10/10 to 10/80 mg daily. May be used as an adjunct to other lipid-lowering treatments (eg, LDL apheresis). Patients taking hepatitis C antivirals elbasvir/grazoprevir Max: 10/20 mg/day.
May be taken with or without food.
Hypersensitivity. Active liver disease or unexplained persistent elevations in serum transaminases >3x upper limit of normal (ULN). Patients treated w/ hepatitis C antivirals glecaprevir/pibrentasvir. Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.
Special Precautions
Reports of myopathy & rhabdomyolysis; interstitial lung disease, especially w/ long-term therapy; consecutive transaminase elevations. Do not start treatment if creatine phosphokinase (CPK) levels are significantly elevated (>5x ULN) at baseline. Discontinue treatment if clinically significant CPK level elevation (>10x ULN) occur, or if rhabdomyolysis is diagnosed or suspected. Discontinue if interstitial lung disease is suspected. Perform liver function tests before treatment initiation & periodically thereafter. Potential risk of haemorrhagic stroke should be carefully considered before initiating treatment. Patients at risk of DM. Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. 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. Concomitant use w/ fibrates is not recommended. Appropriately monitor INR if Atozet is added to warfarin, another coumarin anticoagulant, or fluindione. Not recommended in patients w/ moderate or severe hepatic insufficiency. Women of childbearing potential should use appropriate contraceptive measures during treatment. Safety & efficacy in childn have not been established.
Adverse Reactions
Drug Interactions
Ezetimibe: Decreased mean AUC w/ cholestyramine. Increased mean AUC w/ ciclosporin. Increased total conc w/ fibrates (eg, fenofibrate & gemfibrozil). Reports of increased INR when added to anticoagulants (eg, warfarin or fluindione). Atorvastatin: Increased conc w/ CYP3A4 inhibitors (eg, ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole, some antivirals for HCV [eg, elbasvir/grazoprevir], HIV PIs [eg, ritonavir, lopinavir, atazanavir, indinavir, darunavir], erythromycin, diltiazem, verapamil, fluconazole, amiodarone); BCRP inhibitors (eg, elbasvir & grazoprevir). Variable reductions of 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 rhabdomyolysis, w/ fibric acid derivatives (eg, gemfibrozil); ezetimibe; fusidic acid; colchicine; daptomycin. Lower plasma conc w/ colestipol. Slightly increased steady-state digoxin conc. Increased plasma conc of OCs (eg, norethisterone & ethinyl estradiol). Small decrease in prothrombin time w/ warfarin.
MIMS Class
Dyslipidaemic Agents
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.
Atozet film-coated tab 10 mg/10 mg
Atozet film-coated tab 10 mg/20 mg
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