Симвакард®

General characteristics. Structure:

Active agent: 
each tablet, coated, contains 5 mg, on 10 mg, on 20 mg or on 40 mg of a simvastatin.
Excipients: 
kernel: lactose, starch corn prezhelatinizirovanny, cellulose microcrystallic, talc, magnesium stearate, butylhydroxyanisole;
film cover: a hypro rod, a gipromelloza, titanium dioxide, talc, dye ferrous oxide yellow (for tablets on 5 mg, coated).

DESCRIPTION
Tablets, coated, 5 mg. 
Oblong, biconvex tablets of yellow color, film coated, with risky for division from two parties and with an engraving of "SVT" and "5" on one party.
Tablets, coated, 10 mg. 
Oblong, biconvex tablets from white till almost white color, film coated, with risky for division from two parties and with an engraving of "SVT" and "10" on one party.
Tablets, coated, 20 mg. 
Oblong, biconvex tablets from white till almost white color, film coated, with risky for division from two parties and with an engraving of "SVT" and "20" on one party.
Tablets, coated, 40 mg. 
Oblong, biconvex tablets from white till almost white color, film coated, with risky for division from two parties and with an engraving of "SVT" and "40" on one party.

Pharmacological properties:

Pharmacodynamics. The hypolipidemic means received in the synthetic way from Aspergillus terreus fermentation product is an inactive lactone, in an organism is exposed to hydrolysis with formation of hydroxyacid derivative. The active metabolite inhibits 3-гидрокси-3-метил-глутарил-КоА-редуктазу (GMG-KOA-reduktazu), enzyme, katalaziruyu-shchy initial reaction of formation of a mevalonat from GMG-KOA. Causes decrease in contents in a blood plasma of triglycerides (TG), lipoproteids of the low density (LPNP), lipoproteids of very low density (LPONP) and the general cholesterol (in cases of heterozygous family and single forms of a hypercholesterolemia, at the mixed lipidemia when the increased content of cholesterol is risk factor).
Increases the maintenance of lipoproteids of the high density (LPVP) and reduces a ratio of LPNP/LPVP and the general cholesterol / LPVP.
The beginning of manifestation of effect - in 2 weeks from the beginning of reception, the maximum therapeutic effect is reached in 4-6 weeks. Action remains at treatment continuation, at the therapy termination the content of cholesterol gradually is returned to initial level.

Pharmacokinetics. Absorption of a simvastatin high. After intake the maximum concentration in a blood plasma is reached approximately in 1,3 - 2,4 hours and decreases by 90% in 12 hours. It is metabolized in a liver, has effect of "the first passing" through a liver (it is hydrolyzed with formation of active derivative: a beta - hydroxyacid, also other active, and also inactive metabolites are found). The elimination half-life of active metabolites makes 1,9 hours.
It is removed preferential with a fecal masses (60%) in the form of metabolites. About 10 - 15% are removed by kidneys in an inactive form.

Indications to use:

Hypercholesterolemia: 
• primary hypercholesterolemia (IIa and IIb type) at inefficiency of a dietotherapy with the low content of cholesterol and other non-drug actions (an exercise stress and decrease in body weight) at patients with the increased risk of developing of coronary atherosclerosis;
• the combined hypercholesterolemia and a gipertriglitseridemiya
 Coronary heart disease: 
for prevention of a myocardial infarction, for reduction of risk of death, reduction of risk of cardiovascular disturbances (a stroke or tranzitorny ischemic attacks), delay of progressing of atherosclerosis of coronary vessels, reduction of risk of procedures of revascularization.

Route of administration and doses:

Simvakard at lipidemias usually appoint in an initial dose 10 or 20 mg a day. Drug is accepted once in the evening before food or during food, including at the following states:

                                                                             Initial dose
Coronary heart disease                                   of 20 mg
Homozygous hypercholesterolemia                         of 40 mg
At the accompanying immunosuppressive therapy      of 5 mg

If necessary the dose is increased 1 time in 4 weeks. The maximum daily dose makes 80 mg.

Features of use:

With care use drug at patients with diseases of a liver, inclined to allergic reactions, abusing the alcohol lowered or raised by a tone of skeletal muscles of the not clear etiology expressed to a renal failure. Before the beginning and during treatment drug recommends to carry out control of indicators of function of a liver. Drug use Simvakard does not exert negative impact on the activity requiring special attention and high speed of mental and motor reactions, for example: at the persons managing transport, servicing cars during the work at height, etc.

Side effects:

Usually Simvakard is had well. The side effects connected with administration of drug usually are not expressed and are temporary. Side effects from digestive organs are most often noted: dyspepsia, abdominal pains, nausea, lock, diarrhea, meteorism. The feeling of weakness, dizziness, a headache, pancreatitis, signs of a peripheral neuropathy, a spasm, anemia are in rare instances possible. Side effects from a liver are extremely seldom noted: hepatitis, jaundice, perhaps temporary increase in level of hepatic transaminases. In extremely exceptional cases are possible a myopathy, рабдомиолиз. In case of pains or hypersensitivity of skeletal muscles, muscular weakness should stop administration of drug and to see urgently a doctor.

Interaction with other medicines:

At odnovrmenny use of a simvastatin with cytostatics, fibrata, niacin, erythromycin or klaritromitsiny, itrakonazoly. HIV protease inhibitors (индинавир, ритонавир, нелфинавир), antidepressant nefazodony the risk of development of a myopathy increases. Simvastatin strengthens effect of indirect anticoagulants, increases the level of concentration of digoxin in a blood plasma.

Contraindications:

Drug is contraindicated for use at hypersensitivity to active agent or other components of drug, at active pathological process in a liver, at children up to 18 years. Drug is contraindicated to pregnant women.

Overdose:

Treatment: to cause vomiting, to accept absorbent carbon. Symptomatic therapy.

Storage conditions:

At a temperature not above 25 °C. To store in the place, unavailable to children! PERIOD OF VALIDITY 2 years. Not to use after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Tablets coated on 5, 10, 20 and 40 mg. On 14 tablets in the blister from PVH/PE/PVDH/AL. On 2 or 6 blisters place in a cardboard pack together with the application instruction.