Expiration date: 08/2026

The composition and form of issue:

1 tablet contains simvastatin 10, 20, or 40 mg, 1 tablet, coated — 80 mg, in a contour acheikova packing 14 PCs., in box 1 or 2 packaging.

Pharmacological action:

Restricts the synthesis of cholesterol in the initial stages, inhibiting 3-hydroxy?3-methylglutaryl-coenzyme A reductase.

Pharmacokinetics:

Quickly extracted from the blood at the first passage through the liver with high selectivity is accumulated in it, is excreted in the bile. The content of active forms in the systemic circulation is less than 5% of the dose is associated with a protein 95%.

Clinical pharmacology:

Reduces the plasma total cholesterol, LDL, VLDL, triglycerides and increases the HDL content. The effect develops within 2 weeks and reaches a maximum at 4-6 weeks. Upon discontinuation of therapy, the cholesterol returns to the original level.

Indications:

Hypercholesterolemia, coronary artery disease, atherosclerosis of brain vessels. Reducing the risk of total and coronary mortality in CHD patients.

Contraindications:

Hypersensitivity (to any component of the drug), liver disease in active form, a persistent increase in transaminaz in plasma unclear etiology.

Application of pregnancy and breast-feeding:

During pregnancy is contraindicated. Breast-feeding during treatment is not recommended.

Side effects:

Headache, dizziness, asthenia, dyspepsia, hepatitis/jaundice, pancreatitis, muscle cramps, myalgia, myopathy, rhabdomyolysis, paresthesia, peripheral neuropathy, anemia, alopecia, skin rash, itching, hypersensitivity reaction (urticaria, photosensitivity, fever, flushing of the skin, shortness of breath, malaise, angioedema, volchanochnopodobny syndrome, rheumatic polimialgia, vasculitis, arthritis, arthralgia, increased ESR, thrombocytopenia, eosinophilia) deviations in laboratory parameters (increase in transaminases, alkaline phosphatase, gamma-glutamyltranspeptidase, of creatine skeletal muscle, changes in the functional liver samples).

Drug interactions:

Moderately potentiates the effect of coumarin anticoagulants. When combined with cyclosporine, Itraconazole, ketoconazole, fibrin acid derivatives, Niacin, erythromycin, clarithromycin, protease inhibitors, nefazodone increases the risk of rhabdomyolysis. Treatment should be discontinued if confirmed or assumed the presence of myopathy.

Method of application and dose:

Before and during the course of therapy is necessary to observe gipoholesterinovu diet. Inside, initial dose 10 mg once in the evening for mild or moderate NCEP initial dose of 5 mg, if necessary dose gradually increased at intervals of 4 weeks. With familial homozygous hypercholesterolemia daily dose of 40 mg once in the evening or 80 mg/day (divided into 3 doses — 20 mg morning, 20 mg day, 40 mg in the evening). In IBS initial dose of 20 mg once daily, in the evening if necessary, it gradually increased at intervals of 4 weeks to 80 mg.

Overdose:

In several known cases of overdose (maximum dose of 450 mg) have not identified any specific symptoms or consequences. Apply symptomatic treatment.

Precautions:

Before treatment is recommended (and then repeated periodically) study of liver function. When the transaminase level exceeds the upper normochromic 3 times, the drug overturned. Be wary designate patients who misuse alcohol and/or with a history of liver disease.