Co-Ezetimibe TEVA

Per 10/10 mg tab Ezetimibe 10 mg, simvastatin 10 mg. Per 10/20 mg tab Ezetimibe 10 mg, simvastatin 20 mg. Per 10/40 mg tab Ezetimibe 10 mg, simvastatin 40 mg

Risk reduction of CV events in patients w/ CHD & history of acute coronary syndrome (ACS) either treated previously w/ or w/o statin. Adjunct to diet for heterozygous familial & non-familial primary hypercholesterolaemia or mixed hyperlipidaemia in patients not appropriately controlled w/ statin alone or treated previously w/ statin & ezetimibe; HoFH w/ or w/o adjunctive treatments eg, LDL apheresis.

Individualized dosage. Hypercholesterolaemia Dose range: 10/10 mg-10/80 mg daily in the evening. Typical dose: 10/20 mg or 10/40 mg daily as single dose in the evening. Patient w/ severe hypercholesterolaemia & at high risk for CV complications 10/80 mg. CHD & ACS event history Initially 10/40 mg or 10/80 mg once daily in the evening. HoFH Initially 10/40 mg daily or 10/80 mg daily in the evening. Coadministration w/ lomitapide Not to exceed 10/40 mg daily, amiodarone, amlodipine, verapamil, diltiazem, or drugs containing elbasvir or grazoprevir & patient taking lipid-lowering doses of niacin (≥1 g daily) Not to exceed 10/20 mg daily. Paed & adolescent 10-17 yr Initially 10/10 mg once daily in the evening. Recommended dose range: 10/10 mg to max of 10/40 mg daily. CKD & estimated GFR <60 mL/min/1.73 m² 10/20 mg once daily in the evening.

May be taken with or without food: Do not split tab.

Hypersensitivity. Concomitant use w/ potent CYP3A4 inhibitors eg, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV PIs (eg, nelfinavir), boceprevir, telaprevir, nefazodone & drugs containing cobicistat; gemfibrozil, ciclosporin or danazol; lomitapide in patients w/ HoFH. Active liver disease or unexplained persistent serum transaminase elevations. Pregnancy & lactation.

Not to be started & discontinue treatment if creatine kinase (CK) levels are significantly elevated at baseline (>5x ULN). Discontinue treatment if myopathy is suspected; throughout duration of fusidic acid treatment in patients where use of this is essential; transaminase levels rise to 3x ULN & are persistent; patient develops ILD. Consider treatment discontinuation if muscular symptoms are severe & cause daily discomfort, even if CK levels are <5x ULN. Temporarily discontinue few days prior to elective major surgery & any major medical or surgical condition. Promptly interrupt therapy if serious liver injury &/or hyperbilirubinemia or jaundice occurs. Myopathy & rhabdomyolysis; immune-mediated necrotizing myopathy; hyperglycaemia; ILD; dizziness. Patients w/ history of MI; pre-disposing factors for rhabdomyolysis; previous muscle disorder on fibrate or statin; who consume substantial quantities of alcohol. Patients who are carriers of SLCO1B1 c.521T>C genotype. Measure CK level before starting treatment in patients w/ uncontrolled hypothyroidism, personal or familial history of hereditary muscular disorders, history of muscular toxicity w/ statin or fibrate, alcohol abuse, renal impairment, females & elderly ≥65 yr; if muscle pain, weakness or cramps occur while on treatment. Carefully monitor patients for signs & symptoms of muscle pain, tenderness or weakness during initial mth of therapy when combined w/ niacin (nicotinic acid); patients at risk of DM (fasting glucose 5.6-6.9 mmol/L, BMI >30 kg/m², raised triglycerides, HTN). Monitor INR if used concomitantly w/ warfarin, another coumarin anticoagulant, or fluindione. Perform LFTs before treatment & when clinically indicated thereafter. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ potent CYP3A4 inhibitors; ciclosporin, danazol, gemfibrozil; other fibrates, niacin (≥1 g/day), amiodarone, amlodipine, verapamil or diltiazem; fluconazole; grapefruit juice; fusidic acid; lomitapide; BCRP inhibitors eg, elbasvir & grazoprevir; daptomycin; warfarin. Not recommended in patients w/ moderate (Child-Pugh score 7-9) or severe (Child-Pugh score >9) hepatic impairment. Not recommended in childn <10 yr. Asian patients (Chinese).

Increased ALT &/or AST & blood CK; myalgia.

Increased risk of myopathy/rhabdomyolysis w/ potent CYP3A4 inhibitors eg, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV PIs (eg, nelfinavir), boceprevir, telaprevir, nefazodone, cobicistat, ciclosporin, danazol, gemfibrozil; fusidic acid; niacin (≥1 g/day); amiodarone; amlodipine, verapamil, diltiazem, elbasvir, grazoprevir; lomitapide; grapefruit juice; colchicine; daptomycin; moderate CYP3A4 inhibitors. Increased mean AUC of niacin & nicotinuric acid. Decreased absorption rate w/ antacids. Decreased mean AUC of total ezetimibe w/ cholestyramine. Increased mean AUC w/ ciclosporin. Increased ezetimibe total conc w/ fenofibrate or gemfibrozil. Increased simvastatin AUC w/ gemfibrozil. Increased plasma conc of simvastatin & risk of myopathy w/ transport protein OATP1B1 & BCRP inhibitors. Increased simvastatin exposure w/ grapefruit juice. Decreased simvastatin AUC w/ rifampicin. Increased INR w/ warfarin or fluindione. Potentiated effect of coumarin anticoagulants.

Dyslipidaemic Agents

C10BA02 - simvastatin 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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