Atozet

Atozet

Manufacturer:

Merck Sharp & Dohme
Concise Prescribing Info
Contents
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
Indications/Uses
Adjunctive therapy to diet for reduction of elevated total cholesterol (total-C), LDL-C, apolipoprotein B (Apo B), triglycerides, non-HDL-C in patients w/ primary (heterozygous familial & non-familial) hypercholesterolaemia or mixed hyperlipidemia. Reduction of elevated total-C & LDL-C levels in patients w/ homozygous familial hypercholesterolemia.
Dosage/Direction for Use
Individualized dose. Primary hypercholesterolemia Initially 10/10 or 10/20 mg once daily. Dose range: 10/10-10/40 mg once daily. Patients who require a larger reduction in LDL-C (>55%) May be started at 10/40 mg once daily. Homozygous familial hypercholesterolemia 10/40 or 10/80 mg once daily, may be used as an adjunct to other lipid-lowering treatments (eg, LDL apheresis).
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent serum transaminases elevation. Myopathy secondary to other lipid lowering agents. Concomitant use w/ fenofibrate in patients w/ gallbladder disease; fusidic acid. Pregnancy & lactation.
Special Precautions
Closely monitor patients w/ a history of renal impairment for skeletal muscle effects. Discontinue if markedly elevated creatine phosphokinase levels occur or myopathy is diagnosed or suspected; patient developed interstitial lung disease. Increased risk of myopathy w/ concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, clarithromycin, telaprevir, elbasvir, grazoprevir, combination of HIV protease inhibitors including saquinavir/ritonavir, lopinavir/ritonavir, tipranavir/ritonavir, darunavir/ritonavir, fosamprenavir & fosamprenavir/ritonavir, niacin or azole antifungals. Carefully monitor patients for signs or symptoms of muscle pain, tenderness or weakness particularly during initial mth of therapy & during any periods of upward dosage titration. Concomitant use w/ colchicine; drugs that may decrease levels of activity of endogenous steroid hormones eg, ketoconazole, spironolactone & cimetidine; fenofibrate, other fibrates; gemfibrozil; fusidic acid. Temporarily w/hold or discontinue use in patient w/ an acute, serious condition suggestive of myopathy or having a 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). Perform liver function tests prior to initiation of therapy & periodically thereafter. Promptly interrupt therapy if serious liver injury w/ clinical symptoms &/or hyperbilirubinemia or jaundice occurs during therapy. Substantial alcohol consumption &/or history of liver disease. Increase in HbA1c & fasting serum glucose levels. Consider potential risk of hemorrhagic stroke before initiating treatment in patients w/ recent (1-6 mth) stroke or transient ischemic attack. Can cause elevations in ALT/AST, alkaline phosphatase, GGT, bilirubin & creatine kinase. Monitor INR in concomitant use w/ warfarin, another coumarin anticoagulant or fluindione. Some adverse effects may affect ability to drive or operate machinery. Not recommended in patients w/ moderate or severe hepatic impairment. Ped patient.
Adverse Reactions
Drug Interactions
Increased risk of myopathy/rhabdomyolysis w/ gemfibrozil, fenofibrate, fusidic acid, colchicine. Increased cholesterol bile excretion w/ other fibrates. May enhance risk of skeletal muscle effects w/ niacin. Atorvastatin: Increased plasma conc w/ CYP450 3A4 inhibitors. Reduced atorvastatin plasma conc w/ efavirenz, rifampin, colestipol. Increased AUC w/ clarithromycin, HIV & hepatitis C PIs, itraconazole, diltiazem, grapefruit juice (>1.2 L/day), cyclosporine. Decreased plasma conc w/ oral antacid susp containing Mg & Al hydroxide. Increased atorvastatin plasma conc w/ breast cancer resistant protein (BCRP) inhibitors (eg, elbasvir, grazoprevir). Increased steady-state plasma conc of digoxin. Increased AUC w/ OCs (eg, norethindrone & ethinyl estradiol). Ezetimibe: Decreased mean AUC w/ cholestyramine.
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 10/40 mg FC tab
Packing/Price
3 × 10's (Rp643,940/boks)
Form
Atozet 10/20 mg FC tab
Packing/Price
3 × 10's (Rp643,940/boks)
Form
Atozet 10/10 mg FC tab
Packing/Price
3 × 10's (Rp643,940/boks)
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