Zocor

Zocor

simvastatin

Manufacturer:

MSD

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Simvastatin
Indications/Uses
High risk of CHD or w/ existing CHD: Reduce the risk of total mortality by reducing CHD deaths; nonfatal MI & stroke; the need for coronary & noncoronary revascularization procedures. Hyperlipidemia: Adjunct to diet to reduce elevated total-cholesterol, LDL-cholesterol, apolipoprotein B (apo B) & triglycerides & to increase HDL-cholesterol 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. Adjunct to diet & other nondietary measures for the treatment of patients w/ homozygous familial hypercholesterolemia to reduce elevated total-cholesterol, LDL-cholesterol & apo B.
Dosage/Direction for Use
5-80 mg/day as a single dose in the evening. Adjustments should be made at intervals of not <4 wk. Max: 80 mg/day. Patient who have not achieved their LDL-cholesterol goal in 40-mg dose Use 80 mg. High risk of CHD or w/ existing CHD Initially 20 mg/day as a single dose in the evening. Hyperlipidemia Initially 10 mg/day as a single dose in the evening. Homozygous familial hypercholesterolemia 40 mg/day in the evening or 80 mg/day in 3 divided doses of 20 mg, 20 mg & an evening dose of 40 mg. Concomitant therapy Patient taking fibrates other than gemfibrozil or fenofibrate Max: 10 mg/day. Patient taking amiodarone, verapamil or diltiazem Max: 20 mg/day. Patient taking amlodipine Max: 40 mg/day. Severe renal insufficiency (CrCl <30 mL/min) Caution on dosages >10 mg/day.
Administration
May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases. Pregnancy & lactation.
Special Precautions
Risk of myopathy/rhabdomyolysis. Perform liver function tests before initiating treatment & periodically thereafter. Discontinue use if transaminase levels increase to 3x upper limit of normal. Substantial alcohol consumption &/or previous history of liver disease. Childn. Elderly.
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, interstitial lung disease.
Drug Interactions
Increased risk of myopathy/rhabdomyolysis concomitant w/ other fibrates except fenofibrate, amiodarone, verapamil, diltiazem, amlodipine, niacin, fusidic acid, colchicine, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inihibitors, nefazodone, moderate CYP3A4 inhibitors. Gemfibrozil, cyclosporine, danazol. Avoid grapefruit juice. Potentiation of coumarin anticoagulants.
ATC Classification
C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Zocor tab 10 mg
Packing/Price
120's;30's
Form
Zocor tab 40 mg
Packing/Price
30's
Form
Zocor tab 80 mg
Packing/Price
30's
Form
Zocor tab 20 mg
Packing/Price
30's
Form
Zocor tab 5 mg
Packing/Price
30's
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