Hypercholesterolemia. Treatment of primary hypercholesterolemia or mixed dyslipidemia, as a supplement to the diet, when the response to the diet and other non-drug treatments (such as exercise, weight loss) is inadequate. Treatment of homozygous familial hypercholesterolemia as a supplement to diet and other lipid-lowering treatments (eg, low-density lipid apheresis) or if such treatments are not appropriate. Cardiovascular prevention. Reduction of cardiovascular mortality and morbidity in patients with overt atherosclerotic cardiovascular disease or diabetes mellitus, with normal or elevated cholesterol levels, as adjunctive therapy for the correction of other risk factors and for other cardioprotective therapy.
Composition and form of release
Main active ingredient: simvastatin.
Excipients included in the preparation: lactose, cellulose, starch, citric and ascorbic acid, magnesium stearate, butylhydroxyanisole, hypromellose, etc.
It is produced in the form of tablets, in a dosage of 20 mg of simvastatin.
This pharmaceutical product belongs to the group of monocomponent lipid-lowering drugs, inhibitors of one of the types of reductase.
The main active ingredient is simvastatin. It is an inactive lactone, a hydroxy acid ester that can be hydrolyzed in the liver. In this case, a derivative is formed that has an inhibitory activity against the enzyme HMG-CoA reductase, which has the property of catalyzing the formation of mevalonate crystals from it, which are involved in the initial and most significant stage of cholesterol formation.
Simvastatin, therefore, has the ability to reduce not only elevated, but also normal cholesterol levels, which have a low density.
These types of cholesterol can also be formed from cholesterol, which has a low density, and then catabolized mainly with receptors that have significant similarity to low density lipoproteins.
The use of simvastatin leads to a decrease in the content of apolipoproteins, cholesterol with high density lipoproteins and reduces the production and catabolism of low density lipoprotein cholesterol, also affecting the content of these substances in the blood, shifting the ratio of lipoproteins of different density.
This drug is used to treat:
- hypercholesterolemia, dyslipidemia, as an adjunct to non-drug types;
- homozygous familial hypercholesterolemia.
Also used for the prevention of cardiovascular diseases. Its use leads to a decrease in the risks of death in patients with cardiovascular diseases, atherosclerosis, diabetes mellitus.
The drug in question is contraindicated for use in cases where the patient has severe hypersensitivity (allergy) to the main or to one of the auxiliary components.
Also contraindicated for:
- liver diseases;
- concomitant use of potent CYP3A4 inhibitors (itraconazole, ketoconazole, posaconazole, HIV protease inhibitors, etc.)
Do not take simultaneously with gemfibrozil, cyclosporine or danazol.
Application during pregnancy and lactation
This drug should not be used when treating pregnant women.
If it is necessary to take the drug during breastfeeding, it is advisable to interrupt lactation.
Method of administration and dosage
The drug is administered orally, once a day, before going to bed.
The dosage is set by the attending physician on an individual basis, in the range from 5 to 80 mg of simvastatin.
The dosage can be revised once every 4 weeks.
The maximum dosage of 80 mg is recommended only in cases of severe high blood cholesterol levels or when there is a risk of serious complications and concomitant cardiovascular diseases.
Taking this drug is not a reason for dieting or exercise.
When treating patients with renal or hepatic impairment, there is no need to adjust the dosage. In severe renal failure, a dosage of 10-20 mg of simvastatin is recommended.
Overdose cases are extremely rare. An overdose of 3.6 mg had no side effects.
Theoretically, with a more significant overdose for a long time, an increase in side effects is possible.
In this case, you should rinse the stomach, take enterosorbents.
The drug is usually well tolerated.
In some cases, hypersensitivity reactions are possible, such as:
- anemia, insomnia, depression, paresthesia, neuropathy;
- memory impairment, flatulence, dyspepsia, nausea, vomiting, pancreatitis;
- jaundice, liver failure, rash, pruritus, alopecia;
- myalgia, erectile dysfunction, asthenia;
- allergic reactions in the form of angioedema, arthritis, arthralgia, urticaria, vasculitis, eosinophilia, hot flashes;
- when taken on an empty stomach, blood glucose levels may increase;
- cognitive impairment is possible.
Storage conditions and periods
Expiration date – up to 3 years from the production date indicated on the package.
Storage temperature should not exceed 30 ° C.