Zocor/Zocor HP

Patients at high risk of CHD (w/ or w/o hyperlipidemia) ie, patients w/ diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or w/ existing CHD to reduce the risk of total mortality, risk of major vascular events (non-fatal MI, CHD death, stroke or revascularization procedures), risk of major coronary events (non-fatal MI or CHD deaths), risk of stroke, the need for coronary revascularization procedures (including CABG & percutaneous transluminal coronary angioplasty), the need for peripheral & other non-coronary revascularization procedures, risk of hospitalization for angina pectoris; reduces the risk of developing peripheral macrovascular complications (peripheral revascularization procedures, lowers limb amputation or, leg ulcers) in DM patients; slows progression of coronary atherosclerosis, including reducing the development of new lesions & total occlusions, in hypercholesterolemic patients w/ CHD. Adjunct to diet to reduce elevated total-C, LDL-C, triglycerides, & apo B, & to increase HDL-C in patients w/ primary hypercholesterolemia including heterozygous familial hypercholesterolemia (Fredrickson type IIa), or combined (mixed) hyperlipidemia (Fredrickson type IIb), when response to diet & other nonpharmacological measures is inadequate; patients w/ hypertriglyceridemia (Fredrickson type IV hyperlipidemia); primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia); adjunct to diet & other non-dietary measures for the treatment of patients w/ HoFH to reduce elevated total-C, LDL-C & apo B. Adjunct to diet to reduce total-C, LDL-C, triglycerides, & apo B levels in adolescent boys & girls who are at least 1 yr post-menarche, 10-17 yr, w/ heterozygous familial hypercholesterolemia.

Dose range: 5-80 mg/day as a single dose in the evening. If required, adjust dose at intervals of not <4 wk to a max of 80 mg/day as a single dose in the evening. 80 mg is only recommended in patients at high risk of CV complications who have not achieved treatment goals on lower doses & when the benefits are expected to outweigh the potential risk. Patient at high risk of CHD or w/ existing CHD Initially 40 mg/day as a single dose in the evening. Patient w/ hyperlipidemia (not high-risk patient) Initially 20 mg/day as a single dose in the evening. Patient who requires a large reduction in LDL-C (>45%) Initially 40 mg/day as a single dose in the evening. Patient w/ mild to moderate hypercholesterolemia Initially 10 mg. Patient w/ HoFH 40 mg/day in the evening; 80 mg is only recommended when the benefits are expected to outweigh the potential risks. If concomitantly taking lomitapide, max of 40 mg/day. Severe renal insufficiency (CrCl <30 mL/min) Doses >10 mg/day should be carefully considered. Ped (10-17 yr) w/ heterozygous familial hypercholesterolemia Initially 10 mg once daily in the evening, max: 40 mg/day. Patient taking fibrates other than gemfibrozil or fenofibrate Max: 10 mg/day. Patient taking amiodarone, verapamil, diltiazem, or products containing elbasvir or grazoprevir Max: 20 mg/day. Patient taking amlodipine Max: 40 mg/day.

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

Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases. Concomitant administration of 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.

Risk of myopathy/rhabdomyolysis; discontinue immediately if myopathy is diagnosed or suspected. Consider periodic creatine kinase determinations in patients starting therapy w/ simvastatin or whose dose is being increased. Temporarily stop therapy a few days prior to elective major surgery & when any major medical or surgical condition supervenes. Reports of new onset or aggravated pre-existing myasthenia gravis or ocular myasthenia w/ statins. Perform LFTs before treatment begins & thereafter when clinically indicated; patients titrated to 80 mg dose should receive an additional test prior to titration, 3 mth after titration to the 80 mg dose, & periodically thereafter (eg, semi-annually) for the 1st yr of treatment. Discontinue therapy in case of progressive & persistent rise in serum transaminase levels. Caution in patients who consume substantial quantities of alcohol &/or have a past history of liver disease. Not recommended w/ fusidic acid. Co-administration w/ lipid-modifying doses (≥1 g/day) of niacin is not recommended in Asian patients. Concomitant use w/ other fibrates (except fenofibrate), amiodarone, verapamil, diltiazem, amlodipine, lomitapide, moderate CYP3A4 inhibitor, BCRP inhibitor (eg, elbasvir & grazoprevir), daptomycin. Adolescent females should be counseled on appropriate contraceptive methods while on therapy. Has not been studied in childn <10 yr or in pre-menarchal girls. Elderly ≥65 yr. Asian patients.

Abdominal pain, constipation & flatulence; asthenia & headache. Nausea, diarrhea, rash, lichen planus, dyspepsia, pruritus, alopecia, dizziness, muscle cramps, myalgia, pancreatitis, paresthesia, peripheral neuropathy, insomnia, depression, vomiting, anemia, erectile dysfunction, ILD.

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); gemfibrozil, cyclosporine, danazol; other fibrates (except fenofibrate); fusidic acid; amiodarone; verapamil, diltiazem; amlodipine; lomitapide; moderate CYP3A4 inhibitors; niacin (≥1 g/day); colchicine; daptomycin. Increased plasma levels w/ grapefruit juice. Potentiated effect of coumarin anticoagulants.

Dyslipidaemic Agents

C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

Rx