Vytorin

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

Reduce risk of CV events (CV death, non-fatal MI & stroke, hospitalization for unstable angina or need for revascularization) in patients w/ CHD. Adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-C, Apo B, triglycerides (TG), & non-HDL-C, & to increase HDL-C in adult & adolescent (10-17 yr) w/ primary (heterozygous familial & non-familial) hypercholesterolemia or mixed hyperlipidemia. In combination w/ fenofibrate for further reduction in TG & non-HDL-C & increase HDL-C in adults w/ mixed hyperlipidemia. Reduction of elevated total-C & LDL-C levels in adult & adolescent (10-17 yr) w/ HoFH. Reduce risk of major CV events in patients w/ CKD.

Individualized dosage. Primary or mixed hyperlipidemia Dose range: 10/10 mg to 10/80 mg daily. Initially 10/20 mg daily. Patient requiring less aggressive LDL-C reductions Initially 10/10 mg daily. Patient requiring larger LDL-C reduction (>55%) Initially 10/40 mg daily. Patient at high risk for CV complications w/ unachieved treatment goals on lower doses 10/80 mg. CHD Initially 10/40 mg once daily in the evening. Combination w/ fenofibrate: 10/10 mg daily or 10/20 mg daily. HoFH 10/40 mg daily or 10/80 mg daily in the evening. Combination w/ lomitapide or amlodipine: Max: 10/40 mg daily. Combination w/ amiodarone, verapamil, diltiazem, or drugs containing elbasvir or grazoprevir: Max: 10/20 mg daily. CKD Patient w/ estimated GFR <60 mL/min/1.73 m² 10/20 mg once daily in the evening. Ped patient 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.

May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.

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

Discontinue treatment if myopathy is diagnosed or suspected; new onset or aggravate pre-existing myasthenia gravis or ocular myasthenia occur; transaminase levels rise to 3x ULN & are persistent; patients develop symptoms of myalgia at calf, back or whole body. Temporarily discontinue therapy 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. Risk of myopathy/rhabdomyolysis; unexplained muscle pain, tenderness or weakness. Uncontrolled hypothyroidism. Increased risk of higher blood sugar levels. Alcoholics &/or patients w/ past history of liver disease. Consider periodic creatine kinase (CK) determinations in patients starting the therapy or whose dose is being increased & when titrating dose to 10/80 mg dose. Closely monitor patients w/ complicated medical histories including renal insufficiency due to long-standing DM. Monitor INR in concomitant use w/ warfarin, another coumarin anticoagulant, or fluindione. Perform LFTs before treatment, & 6 & 12 wk thereafter; additional test prior to titration, 3 mth after titration to 10/80 mg dose, & periodically thereafter (eg, semi-annually) for 1st yr of treatment. Concomitant use w/ amiodarone; Ca channel blockers (eg, verapamil, diltiazem, amlodipine); lomitapide; moderate CYP3A4 inhibitors; BCRP inhibitors (eg, elbasvir & grazoprevir); fenofibrate; niacin (≥1 g/day); daptomycin; anticoagulants (eg, warfarin); digoxin; colchicine. Not recommended in concomitant use w/ fusidic acid; lipid modifying doses (≥1 g/day) of niacin in Asian patients. Avoid concomitant use w/ fibrates (except fenofibrate). May affect ability to drive or operate machinery. Not recommended in moderate (Child‑Pugh score 7-9) or severe (Child‑Pugh score >9) liver dysfunction. Renal impairment. Not to be used during pregnancy & lactation. Not recommended in childn <10 yr. Pre-menarchal girls. Elderly ≥65 yr. Female gender.

Increased ALT &/or AST & blood CK; myalgia. Abnormal LFT; thrombocytopenia, anemia; peripheral neuropathy, myasthenia gravis; ocular myasthenia; cough, ILD; constipation, pancreatitis, gastritis; alopecia, hypersensitivity reactions including rash, lichen planus, urticaria, anaphylaxis, angioedema, severe cutaneous adverse reactions including SJS, TEN, DRESS & erythema multiforme; muscle cramps, myopathy/rhabdomyolysis; decreased appetite; hot flush, HTN; pain; hepatitis/jaundice, fatal & non-fatal hepatic failure, cholelithiasis, cholecystitis, drug-induced liver injury; erectile dysfunction; depression.

Increased risk of myopathy/rhabdomyolysis w/ potent CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV PIs, boceprevir, telaprevir, nefazodone, drugs containing cobicistat); fusidic acid; amiodarone; Ca channel blockers (eg, verapamil, diltiazem, or amlodipine); lomitapide; moderate CYP3A4 inhibitors; lipid-modifying niacin doses (≥1 g/day); colchicine (in patients w/ renal insufficiency); daptomycin. Increased plasma conc of simvastatin & risk of myopathy w/ transport protein OATP1B1 & BCRP inhibitors eg, elbasvir & grazoprevir. Increased mean AUC of niacin & nicotinuric acid. Avoid concomitant use w/ grapefruit juice. Ezetimibe: Increased mean AUC w/ cyclosporine. Decreased mean AUC w/ cholestyramine. Increased INR of warfarin or fluindione.

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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