COMPOSITIONS :
| Simvastatin Film coated caplet 10 mg, each film coated caplet contains : Simvastatin 10 mg. |
DESCRIPTIONS :
Simvastatin containing Simvastatin is available in 10 mg and 20 mg film coated caplet.
INDICATIONS :
- Treatment with lipid-altering agents can be considered for use in patients which have increased atherosclerosis vascular risk due to 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 heart coronary disease and hypercholesterolemia, Simvastatin is indicated for :
- 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.
- Hypercholesterolemia
Reduction of elevated total and LDL-cholesterol levels in patients with primary hypercholesterolemia (Types 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 cholesterol, HDL cholesterol 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 acurate 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.
DOSAGE AND ADMINISTRATIONS :
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, if required, 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 determination should be performed at intervals of not less than 4 weeks and dosage is adjusted according to the patient response to therapy.
- Patients taking immunosuppressive drugs concomitantly with HMG-CoA reductase inhibitor, should be given the recommended lowest dose of Simvastatin.
- If LDL-cholesterol concentration decreases under 75 mg/dl (1.94 mmol/l) or plasma cholesterol total concentration decreases under 140 mg/dl (3.6 mmol/l), it should be considered to reduce Simvastatin dose.
- Patients in renal insufficiency : Dosage adjustment is not necessary, 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 with other drug : Simvastatin is effective alone or in combination with bile acid sequestrants.
CONTRAINDICATIONS :
- Hypersensitivity to Simvastatin and any component of the drug.
- Active liver disease or unexplained persistent elevations of serum transaminase.
- Pregnant and nursing women.
WARNINGS AND PRECAUTIONS :
- Cholesterol examination should be done periodically during therapy with Simvastatin. Patients who develop elevated serum transaminase levels, special attention should be paid by measuring transaminase level. If there is persistent elevation (up to 3 times from normal upper limit), the drug should be discontinued.
- It is recommended that liver function tests be performed before initiating treatment, 6 and 12 weeks after the first treatment and periodically thereafter.
- Caution in patients who consume alcohol and/or have a history of liver disease.
- If long term therapy is required, it is recommended to conduct periodic laboratory test every 3 months, to decide subsequent treatment.
- Therapy with Simvastatin should be stopped temporarily or discontinued in patients with an acute and severe myopathy or having a risk secondary renal failure due to rhabdomyolysis or elevation of creatinine phosphokinase (CPK).
- Patients should inform to the doctor promptly if unexplained muscle pain, tenderness and weakness occur.
- Simvastatin is not effective in patients with homozygous form of familial hypercholesterolemia.
- Simvastatin is not indicated where hypertriglyceridemia is the main abnormality (i.e., hyperlipidemia types I, IV and V).
- Safety and effectiveness in children or adolescents have not been established.
DRUG INTERACTIONS :
- Concomitant administration with immunosuppressant, Itraconazole, Gemfibrozil, Niacin and Erythromycin may cause increasing skeletal muscle disorder (rhabdomyolysis and myopathy).
- Concomitant administration with Coumarin anticoagulant may increase prothrombin time.
- Antipyrine, Propanolol, Digoxin.
ADVERSE REACTIONS :
- Abdominal pain, constipation, flatulence, asthenia, headache, myopathy, rhabdomyolysis. Isolated cases of angioneurotic oedema also have been reported.
- The following effects have been reported with drugs in this class :
- Neurological : Dysfunction of certain cranial nerves, tremor, vertigo, memory loss, paresthesia, peripheral neuropathy, peripheral nerve palsy.
- Hypersensitivity reactions : Anaphylaxis, angioedema, thrombocytopenia, leucopenia, haemolytic anemia.
- Gastrointestinal : Anorexia, vomiting.
- Skin : Alopecia, pruritus.
- Reproduction : Gynecomastia, loss of libido, erectile dysfunction.
- Eye : Progression of cataracts, ophthalmoplegia.
PRESENTATIONS :
Simvastatin Film coated caplet 10 mg Box, 10 strips @ 10 film coated caplets
Reg. No. GKL0602339309A1
STORAGE :
STORE BELOW 30ºC
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
