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

Reduction of risk of CV events (CV death, non-fatal MI & stroke, hospitalization for unstable angina, or need for revascularization) in patients w/ CHD. Reduction of elevated total cholesterol (total-C) & LDL-C levels in patients w/ HoFH. Adjunctive therapy to diet for reduction of elevated total-C, LDL-C, Apo B, triglycerides (TG) & non-HDL-C & to increase HDL-C in patients w/ primary (heterozygous familial & non-familial) hypercholesterolemia or mixed hyperlipidemia.

Individualized dosage. Adult Primary hypercholesterolemia &/or CHD Initially 10/10 mg or 10/20 mg once daily. May start at 10/40 mg once daily in patients who require larger reduction in LDL-C (>55%). HoFH 10/40 mg or 10/80 mg daily. May be used as adjunct to other lipid-lowering treatments (eg, LDL apheresis). Patient taking clarithromycin, itraconazole, or hepatitis C antiviral agents boceprevir, elbasvir, grazoprevir or w/ HIV taking combination of saquinavir + ritonavir, darunavir + ritonavir, fosamprenavir, or fosamprenavir + ritonavir Limit to 10/20 mg; taking HIV PI nelfinavir Limit to 10/40 mg.

May be taken with or without food.

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

Discontinue therapy if markedly elevated creatine phosphokinase levels occur or myopathy is diagnosed or suspected; in new onset or aggravated pre-existing myasthenia gravis or ocular myasthenia; throughout duration of fusidic acid treatment in patients where use of systemic fusidic acid is essential; patients develop symptoms of myalgia at calf, back or body; transaminase levels rise to >3x ULN. Temporarily withhold or discontinue therapy in patient w/ acute, serious condition suggestive of myopathy or having risk factor predisposing to development of renal failure secondary to rhabdomyolysis (eg, severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders & uncontrolled seizures). Promptly interrupt therapy if serious liver injury w/ clinical symptoms &/or hyperbilirubinemia or jaundice occurs during treatment. Temporarily suspend use in patients taking daptomycin. Rhabdomyolysis w/ acute renal failure secondary to myoglobinuria. Increased risk of higher blood sugar levels. Patients who consume substantial quantities of alcohol &/or have history of liver disease; w/ recent stroke or transient ischemic attack; w/ alcoholism, or hypothyroidism. Closely monitor patients w/ history of renal impairment for skeletal muscle effects. Carefully monitor patients for signs or symptoms of muscle pain, tenderness or weakness particularly during initial mth of therapy & any periods of upward dosage titration. Obtain liver enzyme tests prior to initiating therapy. Monitor INR if added to warfarin, another coumarin anticoagulant or fluindione. Perform LFTs before treatment, & 6 & 12 wk thereafter; every 6 mth in patients regularly taking this drug. Concomitant use w/ cyclosporine, fibric acid derivatives, erythromycin, clarithromycin, hepatitis C antiviral agents telaprevir, elbasvir, grazoprevir, combinations of HIV PIs including saquinavir + ritonavir, lopinavir + ritonavir, tipranavir + ritonavir, darunavir + ritonavir, fosamprenavir, & fosamprenavir + ritonavir, indinavir, nelfinavir, niacin or azole antifungals; colchicine; drugs that may decrease levels or activity of endogenous steroid hormones eg, ketoconazole, spironolactone & cimetidine; fenofibrate; digoxin; verapamil, diltiazem, nicotinic acid, amiodarone. Avoid concomitant administration w/ gemfibrozil. Not recommended in coadministration of ezetimibe w/ other fibrates. Not recommended in coadministration w/ fusidic acid. May affect ability to drive or operate machinery. Not recommended in patients w/ moderate (Child-Pugh score 7-9) or severe (Child-Pugh score >9) liver dysfunction. Females of reproductive potential should use effective contraception during treatment. Discontinue use during pregnancy. Not recommended in ped patients. Elderly.

Diarrhea; myalgia. Nasopharyngitis; thrombocytopenia; hypersensitivity reactions including anaphylaxis, angioedema, rash & urticaria; decreased appetite, anorexia, hyper-/hypoglycemia; nightmares; hypesthesia, peripheral neuropathy, myasthenia gravis. SJS, TEN, DRESS.

Increased atorvastatin plasma conc w/ CYP450 3A4 inhibitors &/or transporter (eg, OATP1B) pathways; grapefruit juice; elbasvir or grazoprevir. Increased total ezetimibe conc w/ gemfibrozil; fenofibrate. Increased risk of myopathy/rhabdomyolysis w/ fusidic acid; colchicine; daptomycin. Increased atorvastatin AUC w/ clarithromycin; combinations of HIV PIs, hepatitis C PIs telaprevir; itraconazole; cyclosporine 5.2 mg/kg daily. Decreased plasma conc of atorvastatin w/ oral antacid susp containing Mg-/Al-hydroxides; efavirenz, rifampin; colestipol. Decreased mean AUC of total ezetimibe w/ cholestyramine. Increased steady-state plasma digoxin. Increased AUC of norethindrone & ethinylestradiol. Increase in exposure to atorvastatin w/ amlodipine. 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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