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Zocor

Zocor

simvastatin

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig Pharma

Marketer:

A. Menarini
Concise Prescribing Info
Contents
Simvastatin
Indications/Uses
Reduction in risk of CHD deaths, non-fatal MI & stroke & the need for coronary & non-coronary revascularization procedures. Adjunct to diet to reduce elevated total-C, LDL-C, Apo B & TG & increase HDL-C in patients w/ primary & heterozygous familial hypercholesterolemia or combined (mixed) hyperlipidemia when response to diet & other nonpharmacological measures is inadequate. Adjunct to diet to reduce total-C, LDL-C, TG & Apo B levels in adolescent boys 10-17 yr & girls at least 1 yr post-menarche 10-17 yr w/ heterozygous familial hypercholesterolemia.
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Dosage/Direction for Use
Initially 20-40 mg daily in the evening. Dose range: 5-80 mg daily in the evening. High risk of CHD or existing CHD Initially 40 mg daily in the evening. Hyperlipidemia Initially 20 mg daily in the evening. Patient requiring large reduction in LDL-C 40 mg single daily dose in the evening. Mild to moderate hypercholesterolemia Initially 10 mg daily. HoFH 40 mg daily in the evening. Patient on lomitamide, amlodipine Not to exceeed 40 mg daily. Patient on fibrates other than gemfibrozil or fenofibrate Not to exceed 10 mg daily. Patient on amiodarone, verapamil, diltiazem or products containing elbasvir or grazoprevir Not to exceed 20 mg daily. Heterozygous familial hypercholesterolemia in paed patient 10-17 yr Initially 10 mg daily in the evening. Recommended dose range: 10-40 mg daily. Max: 40 mg daily.
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Overdosage
View Zocor overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food: Avoid excessive consumption (>1 L daily) of grapefruit juice.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevations in serum transaminases. Concomitant use w/ CYP3A4 inhibitors, gemfibrozil, cyclosporine, danazol. Pregnancy & lactation.
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Special Precautions
Discontinue use if myopathy is diagnosed or suspected & serious liver injury w/ clinical symptoms &/or hyperbilirubinemia or jaundice occurs. Immune-mediated necrotizing myopathy. Perform LFT prior to & 3 mth after titration & periodically thereafter. Temporarily w/draw therapy few days prior to elective major surgery. Asian patients. Not recommended w/ fusidic acid. Concomitant use w/ potent & moderate CYP3A4 inhibitors, other fibrates (except fenofibrate), amiodarone, Ca-channel blockers, lomitamide, elbasvir, grazoprevir, niacin (≥1 g daily), daptomycin. Alcohol consumption &/or history of liver disease. Severe renal insufficiency. Not to be used in women of childbearing potential. Not to be used during pregnancy & lactation. Ped <10 yr & pre-menarchal girls. Elderly ≥65 yr.
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Adverse Reactions
Abdominal pain, constipation, flatulence. Asthenia, headache; nausea, diarrhea, rash, dyspepsia, pruritus, alopecia, dizziness, muscle cramps, myalgia, pancreatitis, paresthesia, peripheral neuropathy, insomnia, depression, vomiting, anemia, erectile dysfunction, ILD.
Drug Interactions
Increased risk of myopathy w/ 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 daily), colchicine, daptomycin. Increased plasma conc & risk of myopathy w/ BCRP (eg, elbasvir, grazoprevir) & transport protein OATP1B1 inhibitors. Increased plasma levels of HMG-CoA reductase inhibitory activity w/ grapefruit juice. Potentiated effect of coumarin anticoagulants.
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Storage
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Action
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MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Zocor FC tab 10 mg
Packing/Price
120's
Form
Zocor FC tab 20 mg
Packing/Price
120's
Form
Zocor FC tab 40 mg
Packing/Price
60's
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