Corsim® 10, 20, 40
coated tablets
![CorsimRR 10, 20, 40](javascript:obrazek_big("http://promedcs.cz//en/../img/baleni/600_Corsim_10,20,40_web(1).jpg", "en"); "CorsimRR 10, 20, 40")
- Manufacturer:
- PRO.MED.CS Praha a.s.
- Marketing authorisation holder:
- PRO.MED.CS Praha a.s.
- Composition:
- Simvastatinum 10 mg, 20 mg or 40 mg in one coated tablet.
- Indication group:
- hypolipidemic agent
The following information is for health professionals only.
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Characteristics:
Simvastatin is biotransformed in the organism to produce the proper active principle β-hydroxyacid, which inhibits 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase, which markedly decreases cholesterol synthesis. Simvastatin is well absorbed after peroral administration and it is metabolized in the liver. Its biological half-life is 2-3 hours. It is excreted mainly in the bile, 10-15% is excreted in the urine.
Indications:
Hypercholesterolemia (primary hypercholesterolemia, mixed dyslipidemia, homozygotic familiar hypercholesterolemia); cardiovascular prevention in patients with manifest atherosclerotic diseases or with diabetes mellitus in normal or increased cholesterol concentrations.
Contraindications:
Hypersensitivity to simvastatin or the auxiliary substances, active liver disease or an unexplainable persistent increase in liver transaminases, gravidity and breast-feeding, concomitant administration of strong CYP3A4 inhibitors (e.g., itraconazol, ketoconazol, erythromycin, clarithromycin, inhibitors of HIV proteases, nefazodon); it is not recommended for children (because of lack of experience).
Undesirable effects:
Nausea, flatulence, constipation or diarrhoea, abdominal pains, headaches, allergic skin reactions, rarely myalgia, rhabdomyolysis, increased liver transaminases, and creatinekinases (CK).
Interactions:
Concomitant administration of itraconazol, ketoconazol, erythromycin, clarithromycin, telithromycin, inhibitors of HIV proteases, nefazodon, cyclosporine, fibrates, niacin, amiodarone, diltiazem, and verapamil results in increased risk of the development of myopathy up to rhabdomyolysis.
Caution:
Prior to the commencement of treatment, patients should be warned to immediately report any unexplainable muscular pains or muscular weakness. In patients with predisposition to rhabdomyolysis (e.g., aged over 70 years, decreased renal function, uncontrolled hypothyroidism, hereditary muscular disease), CK value is to be determined prior to the commencement of treatment. In the course of treatment, consumption of grapefruit juice should be avoided.
Dosage:
Treatment usually begins with a dose of 10-20 mg once a day at bedtime, in the case of insufficient effects the dose can be gradually increased up to 80 mg once a day; in homozygotic familiar hypercholesterolemia, the initial dose is 40 mg once a day at bedtime, in the case of insufficient effects it can be gradually increased up to 80 mg daily in 3 divided doses (20 mg in the morning and at noon, 40 mg at bedtime). The initial dose in cardiovascular prevention is 20-40 mg once a day at bedtime. In patients with serious renal insufficiency (creatinine clearance < 30 ml/min), doses over 10mg/day should be carefully considered. In elder patients it is not necessary to modify the dose. Tablets are washed down with a sufficient quantity of liquid, concomitant consumption of food does not influence absorption.
Package:
30, 50 or 100 coated tablets of 10 mg, 20 mg or 40 mg.
For greater details about the preparation see the product data summary.
Date of the latest revision of the text: June 28, 2006.
The preparation is available on medical prescription only.