Aurobindo Pharma


Apotheca Marketing
Concise Prescribing Info
Patients at high risk of CHD or w/ existing CHD; reduction in risk of total mortality; non-fatal MI & stroke; need for coronary & non-coronary revascularization procedures. Slows progression of coronary atherosclerosis in hypercholesterolemic patients w/ CHD. Patients w/ hyperlipidemia; adjunct to diet to reduce elevated total-C & LDL-C, triglycerides & apolipoprotein B, & to increase HDL-C in patients w/ hypercholesterolemia including heterozygous familial hypercholesterolemia (Fredrickson type IIa), or combined (mixed) hyperlipidemia (Fredrickson type IIb) when inadequately responsive to diet or other non-pharmacological measures. Lowers LDL-C/HDL-C & total-C/HDL-C ratios. Adjunct to diet & other non-dietary measures for patients w/ homozygous familial hypercholesterolemia.
Dosage/Direction for Use
5 to 80 mg/day as a single evening dose. May adjust dosage if required at intervals not <4 wk. Max: 80 mg/day. Hypercholesterolaemia Initially 10-20 mg/day as a single evening dose. Patient who require a large reduction in LDL-C (more than 45%) Initially 20-40 mg/day as a single evening dose. Homozygous familial hypercholesterolaemia 40 mg/day in the evening or 80 mg/day in 3 divided doses of 20 mg & an evening dose of 40 mg. Patient w/ CHD Initially 20 mg/day as a single evening dose. Patient at high risk for a CHD event Initially 40 mg/day. Patient concomitantly taking fibrates other than gemfibrozil or fenofibrate Max: 10 mg/day. Patient concomitantly taking amiodarone, verapamil, diltiazem, or elbasvir- or grazoprevir-containing products Max: 20 mg/day. Patient concomitantly 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 serum transaminase elevations. Porphyria. Myopathy. Concomitant administration of potent CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, & cobicistat-containing drugs), gemfibrozil, cyclosporine, danazol, delaviridine & amiodarone. Women of child-bearing potential (unless w/ adequate contraception). Pregnancy & lactation.
Special Precautions
Do not measure creatine kinase (CK) following strenuous exercise or in presence of plausible alternative cause of CK increase. Re-measure w/in 5 to 7 days if CK levels are significantly elevated at baseline >5x Upper Limit of Normal (ULN); do not initiate treatment if CK levels are significantly elevated (>5x ULN). Patients w/ pre-disposing factors for rhabdomyolysis. Measure CK levels prior to initiating treatment in renal impairment, hypothyroidism, personal or familial history of hereditary muscular disorders, previous history of muscular toxicity w/ a statin or fibrate, alcohol abuse, elderly (>70 yr). Risk of myopathy, rhabdomyolysis w/ or w/o acute renal failure secondary to myoglobinuria. Avoid concomitant use w/ gemfibrozil. Concomitant use w/ verapamil is not recommended. Perform liver function tests prior to treatment & periodically thereafter for the 1st yr of treatment or until 1 yr after the last dose elevation. Promptly repeat & frequently perform measurements on patients who develop elevated serum transaminase levels. Substantial quantities of alcohol &/or history of liver disease. Risk for increased effect of vit K antagonists. Secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome must be treated prior to initiation of therapy. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Severe renal impairment (CrCl <30 mL/min). Childn. Elderly ≥65 yr.
Adverse Reactions
Constipation, abdominal pain, flatulence, nausea.
Drug Interactions
May increase risk of myopathy/rhabdomyolysis w/ fusidic acid; verapamil, diltiazem, or amlodipine; lomitapide; amiodarone. May increase plasma conc & risk of myopathy w/ transporter protein inhibitors; BCRP inhibitors (eg, elbasvir & grazoprevir). Concomitant use w/ gemfibrozil & other fibrates, niacin. May increase risk of myopathy w/ potent CYP450 3A4 inhibitors (eg, cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV-protease inhibitors, delaviridine & nefazodone). May increase plasma conc w/ grapefruit juice. Coumarin derivatives.
ATC Classification
C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
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