Simvastatin 20 Tablet
Simvastatin dengan Simvastatin sebagai zat aktif tersedia dalam bentuk kaplet salut selaput 20 mg.
Treatment with lipid-altering agents can be considered for use in patients which have increased atherosclerosis vascular risk that caused by hypercholesterolemia.
Treatment with lipid-altering agents is indicated as an adjunct to diet, when response to diet and other non-pharmacological measures alone has been inadequate.
Coronary Heart Disease (CHD) : In patients with coronary heart disease and hypercholesterolemia, Simvastatin is indicated to :
Reduce the risk of total mortality by reducing CHD deaths.
Reduce the risk of non-fatal myocardial infarction.
Reduce the risk in patients taking myocardial revascularization procedures.
Reduction of elevated total and LDL-cholesterol levels in patients with primary hypercholesterolemia (Type IIa and IIb).
General recommendation :
Prior to initiating therapy with Simvastatin, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be exclude and a lipid profile performed to measure Total-C, HDL-C and triglycerides (TG). In patients with triglycerides (TG) less than 400 mg/dl (4.5 mmol/L), LDL-cholesterol = total cholesterol – (0.20 x (triglycerides) + HDL-cholesterol). In patients with triglycerides (TG) 400 mg/dl (4.5 mmol/L), this equality is not accurate and it is recommended that LDL-cholesterol concentrations can be decided with ultracentrifugation. In several hypercholesterolemia patients, although LDL-cholesterol is low or normal, total cholesterol can be high. In this cases, Simvastatin is not indicated.
The patients should be placed on a standard cholesterol-lowering diet before receiving and should continue on this diet during treatment with Simvastatin.
The usual starting dose is 5-10 mg/day given as a single dose in the evening. Patient with mild to moderate hypercholesterolemia can be started with a starting dose of 5 mg/day. Dosage adjustment should be made at intervals of not less than 4 weeks, to a maximum of 40 mg daily given as a single dose in the evening. Lipid measurement should be performed at intervals of not less than 4 weeks and dosage adjusted according to the patients response to therapy.
In patients taking immunosuppressive drugs concomitantly with HMG-CoA reductase inhibitor should be given the lowest recommended dose of Simvastatin.
If LDL-cholesterol concentration decreased below 75 mg/dl (1.94 mmol/L) or plasma total cholesterol concentration decreased below 140 mg/dl (3.6 mmol/L), it should be considered to reduce Simvastatin dose.
Patients in renal insufficiency : dosage adjustment is not neccesary, because Simvastatin does not undergo significant renal excretion. However, caution should be exercised when Simvastatin is administered to patient with severe renal insufficiency, such patients should be started at 5 mg/day and be closely monitored.
Concomitant therapy : Simvastatin is effective alone or in combination with bile acid sequestrants.