Simvastatin Alkaloid, 10 mg 28 pcs

Pharmacotherapeutic group:

Hypolipidemic drug – HMG-CoA reductase inhibitor
ATC:
C.10.A.A HMG-CoA reductase inhibitors
C.10.A.A.01 Simvastatin

Pharmacodynamics:

Hypolipidemic agent produced synthetically from Aspergillus terreus fermentation product, is an inactive lactone, it undergoes hydrolysis in the body with formation of hydroxy acid derivative. The active metabolite inhibits Z-hydroxy-Z-methyl-glutaryl-CoA reductase (HMG-CoA reductase), the enzyme that catalyzes the initial reaction of mevalonate formation from HMG-CoA. Since the conversion of HMG-CoA to mevalonate represents an early step in cholesterol synthesis, the use of Simvastatin Alkaloid does not cause accumulation of potentially toxic sterols in the body. HMG-CoA is easily metabolized to acetyl-CoA, which is involved in many synthesis processes in the body.

Causes reduction of plasma levels of triglycerides (TG), low-density lipoproteins (LDL), very low-density lipoproteins (VLDL) and total cholesterol (in cases of heterozygous familial and non-family forms of hypercholesterolemia, in mixed hyperlipidemia, when high cholesterol is a risk factor).

Increases the content of high density lipoproteins (HDL) and reduces the ratio of HDL / HDL and total cholesterol / HDL.
Effect starts after 2 weeks after the start of treatment, the maximum therapeutic effect is achieved after 4-6 weeks. The effect is maintained during the continuation of therapy, after discontinuation of therapy cholesterol gradually returns to baseline. L

Pharmacokinetics:

Absorption
After oral administration simvastatin is absorbed from the gastrointestinal tract (GIT) – about 61-85%_ and enters the systemic bloodstream. Maximum therapeutic concentration in plasma is reached after 1.3-2.4 hours and decreases by 90% after 12 hours. Simultaneous intake of food does not affect absorption of simvastatin.

Distribution
Binding to plasma proteins is approximately 98 %.

Metabolism
Simvastatin undergoes “first pass” effect through liver (mainly hydrolyzed to its active form beta-hydro acid).
Concentration of active metabolite simvastatin in systemic blood flow is 5% of the ingested dose.

Excretion
Simvastatin is excreted with bile. The elimination half-life of active metabolites is 1.9 h. It is excreted mainly through the intestine (about 60%) as metabolites. About 10-15% is excreted by the kidneys in the inactive form.

Indications

Active ingredient

Composition

Active ingredient:

Simvastatin 10,000 mg.

Associates:

ascorbic acid 2.500 mg;

citric acid monohydrate 1,250 mg;

butyl hydroxytoluene 0,020 mg;

microcrystalline cellulose 15,000 mg;

lactose monohydrate 64,630 mg;

Pregelatinized starch 15,000 mg;

Povidone 1,100 mg;

Magnesium stearate 0.500 mg.

Cover: opadray II pink 5,000 mg (for 10 mg and 20 mg tablets), or 10,000 mg (for 40 mg tablets) [polyvinyl alcohol, partially hydrolyzed; titanium dioxide; talc; macrogol-3000; iron oxide red dye [pigment 30] [E 172]; iron oxide yellow dye [pigment 10] [E 172]].

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How to take, the dosage

Interaction

Special Instructions

Contraindications

Side effects

Overdose

Pregnancy use

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