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ETC / RX - Anti-diabetics - Simvatin 20

COMPOSITION:

Simvastatin: 10 mg; 20 mg.
Per each film coated tablet.


INDICATIONS:

Coronary Heart disease: in patients with Coronary Heart disease and hypercholeslerolemia, Simvastatin is indicated to reduce the risk of death; reduce the risk of coronary death and non fatal myocardial infarction: reduce the risk for undergoing myocardial revascularisation procedures (coronary artery bypass grafting and percutaneous transluminal coronary angioplasty) and slow the progression of coronary artherosclerosis,  including reducing the development of new lesions and new total occlusions.

Hypercholesterolemia: Simvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B and triglycerides in patients with primary hypercholesterolemia, heterozygous familial hypercholesterolemia or combined (mixed) hypercholesterolemia when the response to diet and other net pharmacological measures alone has been inadequate. Simvastatin also raises HDL-cholesterol and therefore lowers the LDL/HDL and total cholesterol/ HDL ratios.

Simvastatin is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol, LDL-cholesterol, apolipoprotein B in patients with homozygous familial hypercholesterolemia when response to these measures in inadequate.


ADMINISTRATION AND DOSAGE:

Recommend to start from the lowest dosage which is still effective. After that, if needed, it can be adjusted the dosage that is based on individual response by increasing dosage periodically (interval time for each wave is at least 4 weeks).

The patient should be placed on a standard cholesterol lowering diet before receiving Simvastatin and should continue on this diet during treatment with Simvastatin.

Hypercholesterolemia: the usual starting dose is 10 mg/day given as a single dose in the evening. Patients with mild to moderate hypercholesterolemia can be treated with a starting dose of 5 mg of Simvastatin. Adjustment of dosage, 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. In patients with severe hypercholesterolemia not corrected by the 40mg daily dose and at high cardiovascular risk, the dosage can be exceptionally increased up to 80mg daily.

In patients taking Amiodarone concomitantly with Simvastatin, the maximum recommended dose is 20mg/day.

If LDL-cholesterol levels fall below 75 mg/dL (1.94 mmol/L) or total plasma cholesterol levels fall below 140 mg/dL (3.6 mmol/L), consideration should be given to reducing the dose of Simvastatin.

Homozygous familial hypercholesterolemia: based on a result of a controlled clinical study, the recommended dosage for patients with homozygous familial hypercholesterolemia is Simvastatin 40mg/day in the evening or 80 mg/day in 3 of divided doses of 20 mg, 20 mg and an evening dose of 40 mg. Simvastatin should be used as an adjunct to other lipid lowering treatments (eg, LDL apheresis) in these patients of if such treatments are unavailable.

Coronary heart disease: patients with Coronary heart disease can be treated with a starting dose of 20 mg/day given as a single dose in the evening. Adjustment of dosage if required should be made as specified previously.

Concomitant therapy: Simvastatin is effective alone or in combination with bile acid sequestrants.

In patients taking cyclosporine, fibrates or niacin concomitantly with Simvastatin, the maximum recommended dose is 10mg/day.

Dosage in renal insufficiency: because Simvastatin dose not undergo significant renal excretion, modification of dosage should not be necessary in patients with moderate renal insufficiency. In patients with severe renal insufficiency (creatinine clearance below 30 ml/min), dosages above 10mg/day should be carefully considered and, if deemed necessary, implemented cautiously.


CONTRAINDICATIONS:

Hypersensitivity to any component of this drug.

Active liver disease of unexplained persistent elevations of serum transaminases.

Pregnancy and lactation.


WARNINGS AND PRECAUTIONS:

Physicians must consider when use this drug for patients at high risk of muscle injuries. Statin-containing product    can cause adverse events related to muscle, especially to patients over 65 years. It is recommended to monitor closely patients.

Simvastatin may elevate serum creatine phosphokinase and transaminase levels. This should be considered in the differential diagnosis of chest pain in patients on therapy with Simvastatin.

Simvastatin should be temporarily discontinued in any patient with an acute, serious condition suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis, severe acute infections, hypotension, major surgery, trauma and severe metabolic, endocrine and electrolyte disorders and uncontrolled seizure.

Liver function test should be performed during therapy with Simvastatin. Serum transaminases should be monitored before treatment starts, every 6 weeks during the first 3 months, every 8 weeks during the remainder of the first year and periodically thereafter.

Simvastatin should be used with caution in patient who consume substantial quantities of alcohol and/or have a past history of liver disease.

Patients should be advised to report promptly any unexplained muscle pain, tenderness or weakness, if accompanied by malaise or fever.

Take care when driving or operating machinery until you know how simvastatin affects you.

Close monitoring for adverse events is required in elderly, patients with hypothyroidism and renal impairment

Pregnancy: Simvastatin is contraindicated in pregnancy. Simvastatin should only be administered to women of child bearing age if they are not likely to become pregnant. If the patient becomes pregnant while taking simvastatin, the treatment should be immediately discontinued and the patient informed of the potential adverse reactions of the medicinal product to the foetus. As the safety of simvastatin in pregnant women has not been established and there is no apparent benefit to therapy with simvastatin during pregnancy, treatment should be immediately discontinued as soon as pregnancy is recognized.

Nursing Mothers: It is not known whether simvastatin or its metabolites are excreted in human milk. Because of the potential risk of adverse reactions in nursing infants, women taking simvastatin should not nurse their infants.

Geriatric use: In controlled clinical studies in patients aged over 65 years receiving simvastatin, there is no clear increase about frequency of adverse reactions in clinical and in paraclinical data.

Pediatric use: Safety and effectiveness of simvastatin in patients under 18 years of age have not been established.


SIDE EFFECTS:

Simvastatin is generally well tolerated; for the most part, side effects have been mild and transient in nature. Less than 2% of patients were discontinued from controlled clinical studies due to side effects attributable to Simvastatin. In the pre-marketing controlled clinical studies, adverse effects occurring with a frequency of 1% or more and considered by the investigator as possibly, probably or definitely drug related were: abdominal pain, constipation, and flatulence. Other side effects occurring in 0.5-0.9% of patients were asthenia and headache.

Myopathy has been reported rarely.

The following additional side effects were reported either in uncontrolled clinical trials or in marketed use: nausea, diarrhea, rash, dyspepsia, pruritus, alopecia, dizziness, muscle cramps, myalgia, pancreatitis, paresthesia, peripheral neuropathy, vomiting and anemia. Rarely, rhabdomyolysis and hepatitis/ jaundice occurred.

An apparent hypersensitivity syndrome has been reported rarely which has included some of the following feature: angioedema, lupus-like syndrome, polymyalgia rheumatics, vasculitis, thrombocytopenia. eosinophilia, arthritis, arthralgia, urticaria, photosensitivity, lever, flushing, dyspnea and malaise.

Marked and persistent increases of serum transaminases have been reported infrequently. Elevated alkaline phosphatase and gamma-glutamyl transpeptidase have been reported.

Liver function test abnormalities generally have been mild and transient. Increases in serum creatine kinase (CK) levels, derived from skeletal muscle, have been reported.

In case of an unexpected reaction, consult your physician.


INTERACTIONS:

It is not recommended to combine this drug with dosage exceed 20mg daily with Amiodarone. For patients who have use dosage over 20mg/24h, doctors should choose alternative statin drug (such as Pravastatin).

The risk of rhabdomyolysis is increased by the concomitant use of Simvastatin with drugs that have a significant inhibitory effect on cytochrome P-450 3A4 at therapeutic doses (eg, cyclosporine, mibefradil, itraconazole, ketoconazole. erythromycin, clarithromycin and nefazodone) or with fibric acid derivatives or niacin.

Digoxin: Concomitant administration of simvastatin and digoxin in healthy volunteers resulted in a slight elevation (less than 0.3ng/mL) in plasma drug concentrations (as measured by a digoxin radioimmunoassay) compared to concomitant administration of placebo and digoxin. Patients taking digoxin should be monitored appropriately when simvastatin is initiated.

Coumarine derivatives: Simvastatin produced a modest potentiation of the effect of Coumarine anticoagulants. Simvastatin therapy has not been associated with bleeding or with changes in prothrombine time in patients not taking anticoagulants.


PRESENTATION:

Box of 3 blisters x 10 film-coated tablets

Box of 3 blisters x 7 film-coated tablets

Box of 1 blisters x 7 film-coated tablets