Atozet

Atozet

Manufacturer:

Organon

Distributor:

Zuellig Pharma
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. Per 10/80 mg FC tab Ezetimibe 10 mg, atorvastatin 80 mg
Indications/Uses
Adjunctive therapy to diet for use in adults w/ primary (heterozygous familial & non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate. Reduction of elevated total-cholesterol & LDL-cholesterol levels in patients w/ homozygous familial hypercholesterolemia (HoFH).
Dosage/Direction for Use
Adult Primary hypercholesterolemia Initially 10/10 or 10/20 mg once daily. Dose range: 10/10-10/80 mg once daily. Patient who require larger LDL-cholesterol reduction (>55%) Initially 10/40 mg once daily. HoFH 10/40 or 10/80 mg daily, as an adjunct to other lipid-lowering treatments (eg, LDL apheresis). Patient taking clarithromycin, itraconazole, boceprevir, elbasvir, grazoprevir, saquinavir + ritonavir, darunavir + ritonavir, fosamprenavir, fosamprenavir + ritonavir Limit to 10/20 mg. Patient taking nelfinavir Limit to 10/40 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal (ULN). Patients concomitantly treated w/ glecaprevir/pibrentasvir. Pregnancy & lactation.
Special Precautions
Possible rhabdomyolysis w/ acute renal failure secondary to myoglobinuria; closely monitor for skeletal muscle effects. Discontinue if markedly elevated creatine phosphokinase levels occur or myopathy is diagnosed or suspected. Increased risk of myopathy w/ concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, clarithromycin, telaprevir, elbasvir, grazoprevir, HIV PI combinations 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 & any periods of upward dosage titration. 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). Obtain liver enzyme tests prior to initiating therapy. Substantial alcohol consumption &/or history of liver disease. Increased HbA1c & fasting serum glucose levels. Periodic monitoring in patients at high risk of DM. Concomitant administration w/ gemfibrozil, fenofibrate, other fibrates; fusidic acid; anticoagulants. Carefully consider potential risk of hemorrhagic stroke before initiating treatment in patients w/ recent (1-6 mth) stroke or transient ischemic attack. Not recommended in patients w/ moderate or severe hepatic impairment. Certain side effects may affect ability to drive or operate machinery. Not recommended for ped patients.
Adverse Reactions
Diarrhea, myalgia. Nasopharyngitis; thrombocytopenia; hypersensitivity reactions including anaphylaxis, angioedema, rash & urticaria; decreased appetite, anorexia, hyperglycemia, hypoglycemia; nightmares; hypesthesia; peripheral neuropathy; blurred vision, visual disturbance; tinnitus, hearing loss; HTN; cough, pharyngolaryngeal pain, epistaxis; dry mouth, pancreatitis, GERD, eructation, vomiting; hepatitis, cholelithiasis, cholecystitis, cholestasis, fatal & non-fatal hepatic failure; alopecia, pruritus, skin rash, erythema multiforme, angioneurotic oedema, bullous dermatitis including erythema multiforme, Stevens-Johnson syndrome & toxic epidermal necrolysis; myopathy/rhabdomyolysis, neck pain, joint swelling, myositis, tendinopathy, sometimes complicated by rupture; gynecomastia; chest pain, pain, peripheral edema, pyrexia; WBC urine positive.
Drug Interactions
Increased risk of myopathy/rhabdomyolysis w/ gemfibrozil, fenofibrate, fusidic acid. May increase cholesterol bile excretion w/ other fibrates. May enhance risk of skeletal muscle effects w/ niacin. Cases of myopathy including rhabdomyolysis w/ colchicine. Atorvastatin: Increased plasma conc w/ CYP450 3A4 inhibitors. Significantly increased AUC w/ clarithromycin, HIV/hepatitis C PIs, itraconazole, grapefruit juice (>1.2 L/day), cyclosporine. Decreased plasma conc when co-administered w/ oral antacid susp containing Mg & Al hydroxide. Increased plasma conc & risk of myopathy w/ breast cancer resistant protein inhibitors (eg, elbasvir & grazoprevir). Reduced plasma conc when co-administered w/ CYP450 3A4 inducers (eg, efavirenz, rifampin). Decreased plasma conc when co-administered w/ colestipol. Increased steady-state plasma conc of digoxin. Increased AUC of OCs (eg, norethindrone & ethinyl estradiol). May increase risk of myopathy &/or rhabdomyolysis w/ daptomycin. Increased exposure when used concomitantly w/ glecaprevir & pibrentasvir. Ezetimibe: Increased mean AUC w/ cyclosporine. Decreased mean AUC w/ cholestyramine.
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.
Presentation/Packing
Form
Atozet 10/10 mg FC tab
Packing/Price
30's
Form
Atozet 10/20 mg FC tab
Packing/Price
30's
Form
Atozet 10/40 mg FC tab
Packing/Price
30's
Form
Atozet 10/80 mg FC tab
Packing/Price
30's
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