Tablets Vazilip and their application. Vasilip Instructions for use, contraindications, side effects, reviews

Vazilip is a hypolypidemic drug.

Composition and form of release

Tablets Vazilip covered with film shell in a package of 14 or 28 pieces.

One tablet contains an active substance - simvastatin - in a dosage of 10, 20 or 40 mg. Auxiliary substances are: anhydrous citric acid, lactose monohydrate, titanium dioxide, hypimosellos, ascorbic acid, microcrystalline cellulose, talc, starch, magnesium stearate, butylhydroxyanisole, propylene glycol.

Analogue of the Vazilip is the simvastatin drug.

pharmachologic effect

According to the instructions, the Vazilip is a means designed to reduce cholesterol. The active component of the drug - Simvastatin - is an enzyme inhibitor of the 3Hidroxy-3Methylglutaryl-co-reductase enzyme, which is actively involved in the production of cholesterol hepatic cells.

The drug significantly reduces the content of total cholesterol, as well as triglycerides and low-density lipoproteins in serum. In addition, the Vazilip has a number of positive actions to which the antioxidant effect of the drug can be attributed, the normalization of the functional state of the endothelocytes of vessels. In the atherosclerotic process, the migration and proliferation of cells occurs.

Indications for use

According to the instructions, the Vazilip is prescribed at:

Hyperlipidemia. At the same time, the drug can be used both in the primary hyperlipidemia and under hereditary (polygenic hereditary hypercholesterolemia, heterozygous hereditary hypercholesterolemia, monosigital and mixed hyperlipidemia);
Ischemic disease is accompanied by a serum increase in total cholesterol and atherogenic fractions of lipoprotein. In this case, the medicine is advisable to apply in order to prevent transient ischemic violations, heart attacks, the development of cardiovascular failure.

Also, the drug is used in the postoperative period after angioplasty of coronary vessels, the aortocortonary shunting.

METHOD OF USE OF VASILIP AND DOSING MODE

Tablets should be taken inside.

With hypercholesterolemia, patients are prescribed 10-80 mg of medication once, mainly before bedtime. The starting dosage is 10 mg per day. After a month of reception of the drug in this dosage, the patient gradually increase the dose of up to 80 mg. Reception does not depend on food meals.

In hereditary hypercholesterolemia, the patient is prescribed a vasilip in a dosage of 40-80 mg in the evening, depending on the severity of the disease.

With ischemic heart disease, the patient takes a drug in the initial dosage of 20 mg. The maximum daily dose of medication is 40 mg. Rules for increasing the dosage and taking medication are the same as in the treatment of hypercholesterolemia.

If necessary, taking the vasilip or its analogue to patients after transplantation (especially in combination with cyclosporine) should not be prescribed a drug in a dose in excess of 10 mg.

Sideflines

According to reviews, Vazilip can cause the following side effects from various organism of the body:

Central nervous system: sleep disorders, depression, feeling of fatigue, peripheral neuropathy, headache, dizziness;
Gastrointestinal tract: pancreatitis, vomiting and nausea, diarrhea or constipation, increasing activity of hepatic enzymes, abdominal pain, dyspepsia;
Muscle system: muscle weakness, myopathy, accompanied by an increase in the level of muscular fraction of creatine phosphocainase, dermatomyositis, pain in the muscles. In very rare cases, rabbamyolysis and renal failure is possible (especially in patients who combine the vazilip or its analogue with cyclosporin or other drugs that increase the level of simvastatin in the blood plasma);
Visual organs: clouding lens;
Greeting system: a violation of potency, impaired renal function;
Allergies: Rash on the skin, angioedema edema, itching, eczema, leather redness, vasculitis, fever;
Laboratory indicators: thrombocytopenia, ESP, Eosinophilia;
Others: photosensitization, alopecia.

In general, according to reviews, Vazilip is predominantly transferred to patients positively, and the above-described side effects are rarely developed and are unprofitable.

Contraindications

Persistent increase in the level of transaminase in the blood of unexplained etiology;
Acute liver diseases;
Pregnancy and lactation period;
Increased sensitivity to simvastatin or the auxiliary components of the drug.

Medicinal interaction

The combination of vasilip with cyclosporine, nicotine acid, fibrators, niacin, itraconazole, clarithromycin, erythromycin, nefazodone increases the risk of robbomyolysis. Care should also be taken when using simvastatin at a dose of 80 mg per day in combination with verapamil or amiodarone.

The combination of simvastatin with ritonavir can raise the level of simvastatin in the blood.

With a combination of simvastatin with warfarin, the likelihood of hemorrhagic complications has increased dramatically.

Simvastatin is able to increase the blood level of digoxin, so combining simvastatin with Digitalis preparations should only be under strict medical control.

Additional Information

During the treatment period, the vasilip should regularly donate blood on transaminase. If the results of the study show that during treatment, the transaminase level increased, further therapy simvastatin should be discontinued.

The drug is not prescribed to patients under the age of 18, since its safety and effectiveness for individuals in this age category has not been investigated.

Release form and composition

The drug is released in the form of tablets coated with film shell: round, slightly double-screwed with beveled edges, white or almost white (7 pieces in blisters, in a cardboard pack 2 or 4 blisters and an instruction for the use of vasilipa).

The composition of 1 tablets includes 10 mg, 20 mg or 40 mg of active substance - simvastatin.

Auxiliary components: butylhydroxyanisole, lactose monohydrate, microcrystalline cellulose, premarital starch, anhydrous citric acid, ascorbic acid, corn starch, magnesium stearate.

The composition of the film shell: hypimosellose, propylene glycol, talc, titanium dioxide.

Pharmacological properties

Pharmacodynamics

Simvastatin is an active substance of the vasilip, is a hypolypidemic agent obtained by a synthetic pathway from the ASPERGILLUS Terreus fermentation product.

After oral administration, the simvastatin, which relates to inactive lactones, is subjected to hydrolysis in the liver, while the formation of the corresponding form of β-hydroxy cells of the substance occurs. It is the main metabolite and has a high inhibitory activity with respect to the GMG-CoA (3-hydroxy-3-methylglutaryl-coenzyme a) -RUCTAZ - an enzyme that catalyzing biological synthesis (initial and most significant stage) cholesterol.

The effectiveness of simvastatin is confirmed with respect to the reduction of the OSE (total cholesterol) concentration in the blood plasma, XC LDL (low-density lipoprotein cholesterol), TG (triglycerides) and HS LPONP (cholesterol Lipoprotein lipoproteins), as well as increasing the concentration of HF HPP (lipoprotein cholesterol high density) in the blood plasma in patients with heterozygous family / unseasonal hypercholesterolemium or mixed hyperlipidemia in cases where the increased plasma concentration of XC in the blood refers to the number of risk factors and the purpose of one diet is not sufficient. A noticeable therapeutic effect is observed within 14 days of admission of simvastatin, the maximum - within 4-6 weeks from the start of use. When continuing therapy, the effect is preserved. The plasma concentration of the XC after stopping the reception of simvastatin in the blood returns to the initial value, which was observed before the start of treatment.

Active metabolite of simvastatin is a specific inhibitor of the GMG-Coa-reductase (an enzyme catalyzing the reaction of the formation of the MEVALONATE from the GMG-KOA). However, the reception of the therapeutic doses of the substance to the complete inhibition of the GMG-Coa-reductase does not lead, due to which the development of the biologically necessary amount of the mevalonate is preserved. It is believed that the use of the vasilip cause the accumulation in the body of potentially toxic sterols should not, since the early stage of the biological synthesis of HC is the conversion of the GMG-CoA into the Mevalonate. In addition, there is a fast reverse metabolism of the GMG-CoA to Acetyl-CoA, which participates in many biosynthesis processes in the body.

Xc is the predecessor of all steroid hormones, while the clinical influence of simvastatin on steroidogenesis is not observed. Since the vasilip to an increase in bile lithogenicity does not lead, its influence on increasing the incidence of gallstone disease is unlikely.

Simvastatin helps to reduce both the increased and normal concentration of HC LDL in the blood plasma. The formation of LDL comes from LPONP (very low density lipoproteins). The Catabolism of the LDL is carried out mainly with the help of a high-philic LDL receptor. The mechanism for reducing the concentration of HS LDL in the blood plasma after taking simvastatin can be due to a decrease in the plasma concentration of HS LPONP in the blood and the activation of LDL receptors. Due to this, there is a decrease in the formation and strengthening of catabolism XC LDL. With therapy, the simvastatin also significantly decreases the plasma concentration of apolipoprotein in (APO B) in the blood. Since in each particle of the LDL contains one molecule of the APO B, and small amounts of APO were found in other lipoproteins, it can be assumed that simvastatin, in addition, which causes the loss of HC in LDL particles, helps to reduce the plasma concentration of circulating LDL particles in the blood.

Also, Simvastatin also increases the concentration of HS HPP and reduces the concentration of TG in the blood plasma. As a result, the attitude of the HC LDL / HS HDL and OE / CX HDL decreases.

With IHD (ischemic heart disease) and the original concentration of OS 212-309 mg / dl (from 5.5 to 8 mmol / l), simvastatin helps to reduce the risk of total mortality, mortality from IHD, the frequency of non-phantal confirmed myocardial infarction. The substance also reduces the likelihood of the need to carry out surgical interventions for the restoration of coronary blood flow (for example, an aortocortonary shunting or percutaneous translucent coronary angioplasty). Against the background of diabetes, the likelihood of the emergence of basic coronary complications is reduced. Moreover, during therapy, the simvastatin significantly reduces the risk of developing fatal / non-phantal violations of cerebral circulation (including strokes and transient brain circulation disorders).

There is evidence of the effectiveness of the use of simvastatin in patients with / without hyperlipidemia, which are in the group of high risk of developing IBS on the accompanying diabetes mellitus, exhausted anamnesis on stroke and other vascular diseases.

When using a vasilip in a daily dose of 40 mg, the total mortality rate is reduced, the risk of death associated with the IBS, the risk of the main coronary complications (including a nefatal myocardial infarction or death associated with IBS), the need for surgical interventions to restore coronary blood flow (incl. Aorticoronary artery shunting and peripheral transluminal angioplasty), as well as peripheral blood flow and other types of non-coronary revascularization, risk of stroke, hospitalization frequency over heart failure.

The probability of the occurrence of basic vascular / coronary complications is reduced in patients with / without IHD, including patients with diseases of peripheral vessels, diabetes or cerebrovascular pathologies. In diabetes mellitus, the Vazilip helps to reduce the risk of serious vascular complications, including the need for surgical interventions over the amputation of the lower limbs, the restoration of peripheral blood flow, as well as the occurrence of trophic ulcers.

According to coronary angiography, the treatment with simvastatin leads to a slowdown in the progression of the coronary atherosclerosis and the appearance of both new sections of atherosclerosis and new total occlusions, while the patients received the standard therapy of patients noted the steady progression of atherosclerotic damage to the coronary arteries.

Pharmacokinetics

Simvastatin refers to inactive lactones. The substance is quickly hydrolyzed, with its conversion to the β-hydroxy acid of simvastatin (L-654.969), which is a powerful inhibitor of the GMG-Coa-reductase. The main metabolites of simvastatin in the blood plasma - β-hydroxy acid of Simvastatin (L-654.969) and its 6 "-Exometretina, 6" -Hidroxy and 6 "-Hidroximethel derivatives.

The criterion for the quantitative assessment of all pharmacokinetic studies of β-hydroxy acid metabolites (active inhibitors) and active / latent inhibitors (all inhibitors), which are formed as a result of hydrolysis, is inhibiting the GMG-Coa-reductase. When taking simvastatin inside in plasma, both types of metabolites are determined.

The hydrolysis of simvastatin takes place mainly in the primary passage through the liver, therefore there is a low plasma concentration of unchanged simvastatin in human blood (< 5% от принятой дозы). С mах (максимальная концентрация вещества) метаболитов симвастатина в плазме крови достигается за 1,3–2,4 часа после перорального приема однократной дозы. Максимальная плазменная концентрация общей радиоактивности (14 С меченый симвастатин + 14 С меченые метаболиты симвастатина) достигается за 4 часа. Затем в течение 12 часов происходит ее быстрое снижение до примерно 10% от максимального значения. Несмотря на то, что диапазон рекомендованных терапевтических доз симвастатина составляет от 5 до 80 мг в день, отмечается сохранение линейного характера профиля AUC (площади под кривой «концентрация – время») активных метаболитов в общем кровотоке при увеличении дозы до 120 мг.

Approximately 85% of the adopted dose of Simvastatin is subjected to suction. Meal (as part of the compliance with the standard hypocholesterist diet) immediately after receiving the simvastatin on the pharmacokinetic profile of the drug influence does not.

Higher concentrations of simvastatin are determined in the liver (in comparison with other tissues).

The concentration in the systemic bloodstream of the active metabolite of Simvastatin L-654.969 is< 5% от принятой внутрь дозы, 95% от этого объема находится в состоянии, связанном с белками плазмы крови.

Low concentration of simvastatin in general blood flow is the result of active metabolism in the liver (\u003e 60% in men).

The possibility of penetration of the substance through the hematorecephalic and hematoplazent barriers has not been studied.

Simvastatin with primary passage through the liver is metabolized, the subsequent excretion of the substance and its metabolites occurs with bile.

When taking 100 mg of simvastatin 14, the labeled substance accumulates in the blood plasma, as well as the carte masses (about 60%) and the urine (about 13%). In the wheel masses, labeled simvastatin is represented by the products of the metabolism of Simvastatin, which were styled with biliary, and non-absorbing labeled simvastatin. Less than 0.5% of the adopted dose of the labeled substance is found in the urine in the form of active metabolites of the substance. In the blood plasma, 14% and 28% AUC are due to active inhibitors and all the inhibitors of the GMG-Coa-reductase, respectively. This indicates that predominantly products of the metabolism of simvastatin are among the inactive or weak gmg-co-reductase inhibitors.

An essential deviation of the AUC linearity in general blood flow with an increase in the dose in the range of 5-120 mg is not noted. With a single and multiple reception inside Simvastatin, pharmacokinetic indicators demonstrated the lack of accumulation of a substance in tissues in the case of repeated use.

< 30 мл/мин) общая плазменная концентрация ингибиторов ГМГ-КоА-редуктазы в крови после приема однократной дозы внутрь соответствующего ингибитора ГМГ-КоА-редуктазы (статина) превышает таковую у здоровых добровольцев приблизительно в два раза.

Symastatin therapy at a dose of 80 mg (maximum dose) in healthy volunteers on the Midazolam and erythromycin metabolism, which are the substrates of the CYP3A4 isoenzyme, did not affect the influence. This means that the substance inhibitor of the CYP3A4 isoenzyme is not, and suggests that the oral use of the simvastatin effect on the plasma concentration in the blood of drugs metabolizing under the action of CYP3A4 isoenzyme does not.

It has been established that cyclosporine increases AUC inhibitors of the GMG-Coa-reductase, and the mechanism of drug interaction is not fully studied. Presumably an increase in the AUC simvastatin is associated with the inhibition of the CYP3A4 and / or transport protein of the OAST1B1.

With a combined therapy with a diltiazem, an increase in the AUC of β-hydroxy cells of simvastatin is estimated by about 2.7 times, which is estimated due to the inhibition of CYP3A4 isoenzyme. With the combined application with amlodipine AUC β-hydroxy cells, simvastatin increases 1.6 times.

In the case of simultaneous use of 2000 mg (single dose) of nicotinic acid of slow release and 20 mg of simvastatin, there is a slight increase in C MAX β-hydroxy cells of simvastatin in the plasma of blood and AUC simvastatin β-hydroxy acid.

Specific methods of metabolism in the liver of fusidic acid are unknown, there is an assumption about the presence of interaction between fusidic acid and statins, metabolizing with the help of the CYP3A4 isoenzyme.

The probability of the occurrence of myopathy with increasing the concentration of the inhibitors of the GMG-Coa-reductase in the blood plasma increases. The powerful inhibitors of the CYP3A4 isoenzyme can lead to an increase in the concentration of GMG-Coa-reductase inhibitors and the risk of myopathy appearance.

Indications for use

IHS or high risk of its development

With a high risk of developing IBS with / without hyperlipidemia (for example, in patients with diabetes mellitus, stroke or other cerebrovascular diseases, anamnesis, IBS or predisposition to its development, peripheral vessel diseases) Vazilip is shown in order to achieve the following results:

reducing the risk of total mortality due to a decrease in mortality as a result of the CHD;
reducing the likelihood of serious coronary and vascular complications: coronary death, non-infamary myocardial infarction, revascularization procedure, stroke;
reducing the risk of the need to conduct surgical interventions about the restoration of coronary blood flow (aortocortonary shunting and percutaneous transluminal coronary angioplasty);
reduction of the risk of need to carry out surgical interventions to restore peripheral blood flow and other types of non-coronary revascularization;
reducing the likelihood of hospitalization due to angina attacks.

Hyperlipidemia

Vazilip is appointed as a supplement to a diet in cases where applications only diets and other non-drug treatment methods in patients with primary or mixed hypercholesterolemia (according to Fredrickson classification - with hyperlipidemia IIA and IIB type) to achieve the following goals is not enough:

reducing the increased plasma concentration of OSH, HS LDL, TG, Apolipoprotein in (APO B) in the blood;
reducing the ratio of HS LDL / HS HDLP and OHS / HC HDL in blood plasma;
increasing the plasma concentration of HS HDL in the blood.

Also, the use of vasilip is shown in the following cases:

hypertriglyceridemia (according to Fredrickson classification - type IV hyperlipidemia);
primary dovelyipoproteinemia (according to the classification of Fredrinkson - type III hyperlipidemia);
homozygous family hypercholesterolemia: to reduce the increased concentration of OS, XC LDL and APO in (as a supplement to the diet and other methods of therapy).

Heterozygous family hypercholesterolemia in children and adolescents

The use of the vazilip is shown to reduce the increased concentration of OSH, HC LDL, TG, APO in the blood plasma in the boys of 10-17 years and the girls of the same age [But not earlier than one year after Menarh (first menstrual bleeding)] with heterozygous family hypercholesterolemia (combined with a diet).

Contraindications

Absolute:

liver disease in the active phase, or a persistent increase in the activity of hepatic transaminase in the blood plasma of unclear etiology;
lactase deficiency, lactose intolerance or glucose-galactose malabsorption syndrome;
combined therapy with hemfibrosyl, danasol or cyclosporine;
combined use with powerful inhibitors of CYP3A4 isoenzyme (preparations such as isratenazole, ketoconazole, boosame, voriconazole, HIV protease inhibitors, boolavir, teleprevir, erythromycin, clarithromycin, telitromycin, nefazodon and cobicistat-containing means);
pregnancy, as well as application in women planning pregnancy, and women with preserved reproductive potential, which do not apply reliable methods of contraception;
lactation period;
age up to 18 years old (except for children of 10-17 years with heterozygous family hypercholesterolemia);
individual intolerance to the components of the vasilip, as well as other preparations of the statin range in history.

Relative (Vazilip is appointed under medical control):

the condition after the suffered chandomyolysis during therapy with the Vazilip with the presence of complicated anamnesis (a violation of the renal function is usually associated with diabetes mellitus) - more thorough medical observation is required; before performing large surgical interventions, as well as in the postoperative period, the use of the drug must be temporarily terminated;
sustainable increase in the activity of serum transaminases - when the upper limit is exceeded by three times the Vazilip need to be canceled;
heavy renal failure (in patients with creatinine clearance< 30 мл/мин) – нужно тщательно взвесить целесообразность назначения симвастатина в дозе > 10 mg per day; If necessary, therapy is assigned to caution;
alcohol abuse before therapy;
combined use with fibrators (with the exception of fenofibrate or hemfibrosyl), amiodaron, lomitapid, blockers of slow calcium channels (verapamil, amlodipine or diltiazem), moderate inhibitors of the CYP3A4 isoenzyme (drone), fusidic acid, nicotinic acid (in a lipid-lining daily dose at least 1000 mg), colchicine, inhibitors of the OAST1V1 transport protein - is associated with an increase in the likelihood of rudomyolysis and myopathy;
age from 65 years.

Vasilip, Application Instructions: Method and Dosage

Vasilip tablets take inside, 1 time per day, in the evening. The recommended daily dosage varies from 5 mg to 80 mg.

Most often, the drug is prescribed in the initial dose of 10 mg. Dosage changes must be carried out with an interval of at least 4 weeks. The maximum daily dose (80 mg) is recommended only for patients with severe hypercholesterolemium or high risk of developing cardiovascular complications. The duration of receiving the vasilip is determined by an individually attending physician.

With hypercholesterolemia:

Throughout the period of therapy, the patient must comply with the standard hypocholesterin diet. Recommended initial dosage - 10 mg. With the aim of a more pronounced decrease in the level of the HC-LPNP (more than 45%), the reception of the Vazilip can be started from 20-40 mg 1 time per day, in the evening.

Patients with homozygous hereditary hypercholesterolemia are recommended to take 40 mg 1 time per day, in the evening. It is possible to use in 3 reception - in the morning and in the afternoon of 20 mg and 40 mg in the evening. To such patients, the Vazilip is recommended to be taken in combination with another hypolypidemic therapy (for example, the APheresome LDL).

With the prevention of cardiovascular diseases:

With a high risk of developing coronary heart disease (with hyperlipidemia or without it), 20-40 mg of vasilip per day is prescribed. The initial dose is 20 mg, the increase in the dose should occur with an interval of at least 4 weeks. Maximum daily dose - 40 mg. When the LDL content is less than 75 mg / dl (1.94 mmol / l), the total XC content is less than 140 mg / dL (3.6 mmol / l), the dosage of the drug should be reduced.

Concomitant therapy:

Vazilip is effective in monotherapy or simultaneously with sequestrances of bile acids (for example, a bearsipol and skewer). In patients receiving treatment with hemphibrosyl, cyclosporin, other fibrators or nicotine acid (more than 1 g per day), therapy is recommended to start with 5 mg per day, the maximum daily dose is 10 mg. In such situations, a further increase in the dose is not recommended.

In patients receiving simultaneously verapamil or amiodarone, the daily dose of the vasilip should not exceed 20 mg.

In patients with severe renal failure (KK less than 30 ml / min), the recommended daily dose of the vasilip should not exceed 10 mg. If you need to increase the dose, careful medical observation is required.

Patients with moderately pronounced renal failure and elderly, dose correction is not required.

Side effects

When using the Vazilip, side effects are rarely developed:

From the digestive system: meteorism, constipation, dyspepsia, nausea, vomiting, abdominal pain, diarrhea, jaundice, pancreatitis, hepatitis, increasing activity of SFF, hepatic transaminases, creatine phosphocainase;
On the part of the musculoskeletal system: Mopathic, Rabbomioliz, Malgia, muscle cramps;
From the side of the senses, CNS and the peripheral nervous system: dizziness, headache, paresthesia, vision, peripheral neuropathy, insomnia, convulsions, asthenia, disruption of taste sensations;
From the side of the skin: alopecia, skin rash, itching;
Immune system and allergic reactions: expanded high sensitivity syndrome - rheumatic polymalgia, angioedema swelling, dermatomyositis, vasculitis, thrombocytopenia, clothing syndrome, eosinophilia, arthritis, increase in ESR, arthritium, photosensitization, fever, urticaria, shortness of breath, pronounced weakness and tides blood to leather persons;
Other: anemia, acute renal failure (due to robberyolysis), heartbeat, reduced potency.

Overdose

There is information about several cases of overdose, it has been reported receiving the maximum dose of simvastatin, which is 3600 mg. The consequences of an overdose in no patient were detected.

Therapy: Supporting and symptomatic treatment.

special instructions

Women of reproductive age with the use of the Vazilip need to use reliable means of contraception.

With an increase in the level of Xc in patients with a reduced function of the thyroid gland (hypothyroidism) or in the presence of certain diseases of the kidneys (nephrotic syndrome), the main disease should be carried out initially.

Patients with renal insufficiency of severe therapy should be carried out under the control of the kidney function.

Before starting treatment or with an increase in the dose of the Vazilip, the patient must be informed about the risk of myopathy and the need to immediately appeal to the doctor when an inexplicable pain, stress or weakness in the muscles appears, especially simultaneously with fever or general weakness. Before starting therapy, the initial level of KFK should be determined in alcohol abuse, elderly people, as well as sick with:

Defeat kidney;
Hereditary muscle diseases;
Decompensated hypothyroidism;
The presence in the history of toxic effects on the muscles of fibrators or statins.

Before the beginning and during therapy, the patient must comply with the hypocholesterol diet.

When the preparation of muscle pain during therapy, seizures or weakness should determine the level of KFK. The cancellation criterion is the increase in the content of KFK in serum more than 5 times relative to the VGN. If you suspect the development of myopathy (regardless of the cause), treatment should be discontinued.

The simultaneous use of simvastatin and hemfibrosyl is possible only in cases where the intended benefit from treatment significantly exceeds the potential risk of such a combination.

The drug can cause a minor and clinically insignificant increase in the activity of hepatic serum enzymes. Usually, after canceling the vasilip, transaminase levels slowly decrease to the source value. However, before starting treatment and in the future, it is necessary to study the liver function (during the first 3 months every 6 weeks to control the activity of hepatic transaminases, then every 2 months for the remaining first year, then 1 time in 6 months). Before increasing the dose to 80 mg, it is necessary to control the liver functions, then the surveys are carried out periodically. Therapy is stopped with a resistant increase by 3 times the activity of ACT and / or alt in blood serum relative to the VGN.

Vasilip is prescribed with caution with abuse of alcohol, as well as during diseases of the liver in an anamnesis.

Impact on the ability to control vehicles and complex mechanisms

A single cases of dizziness are noted when using the vasilip, which should be considered when driving a car.

Application during pregnancy and lactation

Vasilip during pregnancy / lactation is not appointed.

At the occurrence of pregnancy, the reception of simvastatin needs to stop immediately. Women of childbearing age Vazilip can be appointed only in cases if the probability of pregnancy is very small. Therapy by the drug during pregnancy can lead to a decrease in the concentration of the mevalonate (predecessor in cholesterol biosynthesis) in the fetus. Atherosclerosis is considered chronic disease, and usually cancellation of hypolypidemic drugs during pregnancy slightly affects long-term risks that are associated with primary hypercholesterolemia. In this regard, Simvastatin cannot be prescribed to women who are pregnant, want to get pregnant or suspected that pregnant. Therapy Wazilip should be suspended for the entire period of pregnancy or until pregnancy is diagnosed, and the woman itself must be warned about the existing danger to the fetus.

Information confirming or refuting the allocation of simvastatin and its metabolites with breast milk is not.

Childcare

Patients under 18 years old Vazilip is not appointed, in addition to applying with heterozygous family hypercholesterolemia in children of 10-17 years.

With violations of the kidney function

With severe renal failure (in patients with creatinine clearance< 30 мл/мин) перед применением Вазилипа нужно тщательно взвесить целесообразность назначения препарата в дозах > 10 mg per day, if necessary, therapy is assigned to caution.

When violations of the liver function

Vazilip is contraindicated in the liver disease in the active phase or with a resistant increase in the activity of hepatic transaminase in the blood plasma of unclear etiology.

Application in old age

Elderly patients Vazilip must be appointed under medical control.

Medicinal interaction

Contraindicated combinations:

powerful inhibitors of CYP3A4 isoenzyme (itraconazole, telitromycin, ketoconazole, posacuance, clarithromycin, voriconazole, erythromycin, inhibitors of HIV protease, boilerrevir, nefazodon, teleprevir, containing cobicistat drugs): associated with an increase in the risk of myopathy due to a decrease in the impact rate of simvastatin;
hemfibrosyl, Danazol or Cyclosporine.

Other drug interactions:

hemfibrosyl and other fibrates (with the exception of fenofibrate), fusidic acid: an increase in the likelihood of the development of myopathy;
amiodaron, Lomitapid, Blockers of slow calcium channels (verapamil, diltiazem or amlodipine), nicotinic acid in lipid-lining doses (at least 1000 mg per day): an increase in the probability of the development of myopathy / rubondiolesis;
moderate inhibitors of CYP3A4 isoenzyme (for example, droneard, ranolazine): an increase in the likelihood of the development of myopathy, the dose of vasilip can be reduced;
inhibitors of the transport protein OAST1V1: an increase in the plasma concentration of the hydroxy acidity of the simvastatin and the probability of the development of myopathy;
colchicine (in patients with renal failure): an increase in the risk of development of myopathy and rhabdomyolysis; Combined use requires careful monitoring of patients;
indirect anticoagulants (Cumarine derivatives): an increase in prothrombin time defined as MHO (international normalized relationship); The value of the indicator is controlled before the start of therapy simvastatin, then in the initial period of treatment it is determined quite often, which makes it possible to eliminate significant changes in MHO. After achieving a stable protrusion rate of prothrombin time, its further definition should be carried out with interruptions recommended for the control of patients receiving anticoagulant therapy. In cases of changing the dose of simvastatin or after its cancellation, the regular dimension of this indicator is also recommended. In patients who did not take anticoagulants, the treatment with simvastatin with the advent of bleeding or changes in prothrombin time was not connected;
grapefruit juice (in large volumes): improving the activity of the inhibitors of the GMG-CoA-reductase in plasma.

Analogs

Analogs of the Vazilip are: Zokor, Zocor Forte, Symal, Simvakard, Simvastol, Simlo, Simvastatin Zentiv, Simvagexal, Zovatin, Levomir, Simvatimits, Actalipide, Sinkard, Atherostat, Zorstat, Symbar, Simmostat, Simvastatin, Holvashim, Simvastatin-Fereyn, Simvastatin Chaykafarma, Simvastatin-SZ, Simvastatin Alkaloid, Ovenscore, Simvastatin Pfiser.

Terms and conditions of storage

Store in an inaccessible place at temperatures up to 30 ° C.

Shelf life - 3 years.

This article allows you to familiarize yourself with the instructions for the use of the drug. Vazilip.. Reviews of site visitors - consumers of this medicine, as well as the opinions of doctors of specialists in the use of statina Vazilip in their practice. A big request to more actively add your reviews about the preparation: helped or did not help the medicine to get rid of the disease, which complications were observed and side effects, possibly not stated by the manufacturer in annotations. Analogs of the Vazilip in the presence of available structural analogues. Use for the treatment of hypercholesterolemia and reducing the increased level of cholesterol in adults, children, as well as during pregnancy and breastfeeding.

Vazilip. - Limiticidemic drug (Statin).

The active substance of the drug Vazilip is Simvastatin, the main effect of which is to reduce the content of total cholesterol (total XC) and low-density lipoprotein cholesterol (HC-LDL) in the blood plasma. It is an inhibitor of the GMG-Coa-reductase, the enzyme catalyzing the conversion of the GMG-CoA into the mevalonic acid (early stage of Xc synthesis). Simvastatin reduces the concentration of common hs, HC-LDL and triglycerides (TG). The content of XC lipoproteins of very low density (HC-LPONP) is also reduced, while the XC content of high density lipoproteins (HC-HPLP) is moderately rising. Reduces the content of the total XC and LDL in cases of heterozygous family and incoming forms of cholesterolemia, with mixed hyperlipidemia, when the high content of the hC is a risk factor. The drug reduces the level of total HC and HC-LDL in patients with IBS, reducing the risk of myocardial infarction and death for these patients.

Simvastatin also significantly reduces the content of the apolipoprotein B, moderately increases the concentrations of HC-HPLP and reduces plasma concentrations of TG. As a result of these effects of simvastatin, the ratio of the total xc to the total HC-HPVP and the HC-LPNP to the HC-LPLN is reduced.

The anti-theterosclerotic effect of simvastatin is a consequence of the effect of the drug on the walls of blood vessels and blood components. Simvastatin changes the metabolism of macrophages, the coal activation of macrophages and the destruction of atherosclerotic plaques. The drug suppresses the synthesis of isoprenoids, which are factors of growth in the proliferation of smooth muscle cells of the inner shell of vessels. Under the action of simvastatin, endothelium-dependent expansion of blood vessels is improved.

The therapeutic effect occurs after 2 weeks, the maximum effect is observed after 4-6 weeks of treatment.

Structure

Simvastatin + excipients.

Pharmacokinetics

Simvastatin is presented in an inactive lactone form, which is relatively well absorbed (from 61% to 85%) from the gastrointestinal tract. Bioavailability - less than 5%. Simultaneous meal does not affect the absorption of the drug. With long-term reception of the cumulation of the drug in the body does not occur. Bonding with blood plasma proteins - 98%. Metabolized in the liver, subjected to the effect of the "first passage" through the liver (mainly hydrolyzed into its active form of beta hydroxy acid). Basically excreted through the intestines (60%) in the form of metabolites. About 13% is deducted by the kidneys in inactive form.

Indications

Hyperholesterolemia:

primary hypercholesterolemia or mixed dyslipidemia (additionally to the diet and in the ineffectiveness of other non-drug activities (physical activity and loss of body weight));
homozygous hereditary hypercholesterolemia (in addition to a special diet and hypolipidemic therapy (for example, the APheresse of LDL) or with the ineffectiveness of these measures).

Prevention of cardiovascular diseases:

reducing cardiovascular mortality and morbidity in patients with clinical manifestations of atherosclerotic cardiovascular diseases or diabetes, at a normal or elevated level of cholesterol and as an additional measure to the correction of other risk factors and cardioprotective therapy.

Forms of release

Tablets coated with a shell of 10 mg, 20 mg and 40 mg.

Instructions for use and dosing mode

Inside, once in the evening. The recommended dose of Simvastatin varies from 5 mg to 80 mg 1 time per day in the evening. The most commonly initial dose of the drug is 10 mg. Changes (selection) doses should be carried out at intervals of at least 4 weeks. Maximum daily dose - 80 mg. The maximum daily dose is recommended only to patients with severe hypercholesterolemium or high risk of cardiovascular complications. The duration of the use of the drug is determined by the attending physician individually.

Hyperholesterolemia

The patient must comply with the standard hypocholesterin diet throughout the entire period of treatment with the preparation of Vazilip. The recommended initial dose of the drug for patients with hypercholesterolemia is 10 mg. For the purpose of a more pronounced reduction in the level of HC-LDL (more than 45%), treatment can be started from 20-40 mg per day (once in the evening).

In patients with homozygous hereditary hypercholesterolemia, the recommended daily dose of the Vazilip preparation is 40 mg in the evening or 80 mg in 3 receptions (20 mg in the morning, 20 mg during the day and 40 mg in the evening); Wasilip is recommended to be used in combination with another hypolypidemic therapy (for example, the PNL's apferase).

Prevention of cardiovascular diseases

In patients with a high risk of IBS, with hyperlipidemia or without it, effective doses of the preparation Vazilip are 20-40 mg per day. Therefore, the recommended initial dose in such patients is 20 mg per day. Changes (selection) doses should be carried out at intervals of 4 weeks, if necessary, a dose can be increased to 40 mg per day. If the LDL content is less than 75 mg / dL (1.94 mmol / l), the total XC content is less than 140 mg / dL (3.6 mmol / l), the dose of the drug must be reduced.

Recognizing therapy

The preparation of Vasilip is effective in monotherapy or in combination with sequestrances of bile acids (for example, kolistramine and bears). In patients receiving treatment with cyclosporine, hemfibrosyl, other fibrators or nicotine acid (more than 1 g per day), the recommended initial dose of 5 mg, the maximum daily dose of the Vasilip preparation is 10 mg. A further increase in dose in such situations is not recommended.

In patients simultaneously receiving amiodar or verapamil, daily doses of the Vazilip drug should not exceed 20 mg.

In patients with elderly and in patients with a moderately pronounced renal failure of changes in the dosage of the drug is not required.

Side effect

constipation, diarrhea;
abdominal pains;
flatulence;
dyspepsia;
nausea, vomiting;
pancreatitis;
hepatitis;
jaundice;
headache;
paresthesia;
dizziness;
peripheral neuropathy;
asthenia;
insomnia;
convulsions;
blurry;
violation of taste sensations;
myopathy;
malgy;
muscle cramps;
deployed high sensitivity syndrome (angioedema edema, lupus-like syndrome, rheumatic polymalgia, dermatomyositis, vasculitis, thrombocytopenia, eosinophilia, increase in ESR, arthritis, arthralgia, urticaria, photosensibilization, fever, tides blood to face, shortness of breath and pronounced weakness);
skin rash;
skin itch;
alopecia;
anemia;
heartbeat;
acute renal failure (due to rabbdomyolysis);
reduced potency.

Contraindications

liver disease in the active phase or persistent increase in the activity of liver transaminases of unclear etiology;
simultaneous reception of CYP3A4 inhibitors (for example, itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telitromycin and nefazodon);
pregnancy;
lactation period (breastfeeding);
age up to 18 years (efficiency and safety of application are not studied);
increased sensitivity to simvastatin and other components of the drug.

Application in pregnancy and breastfeeding

The drug is contraindicated in pregnancy. It has not been proven to increase the frequency of congenital defects in children of women who took the Vazilip or another inhibitor of the GMG-CoA-reductase. When taking a pregnant woman of Simvastatin, it is possible to reduce the fetus of the levels of the Mevalonate, which is the predecessor of the biosynthesis of HC. The abolition of hypolipidemic drugs during pregnancy does not have a significant impact on the results of short-term risk associated with primary hypercholesterolemia.

Simvastatin should not be used in pregnant women, in women planning pregnancy, or with pregnancy suspected. If pregnancy has come during the treatment, the drug must be canceled, and the woman is warned of possible danger to the fetus.

During the treatment with the drug Vazilip, the women of reproductive age should use reliable means of contraception.

It is not known whether the drug is excreted in breast milk, therefore the treatment with the preparation of Vazilip during breastfeeding is contraindicated.

Application in elderly patients

Patients of the elderly changes in the dosage of the drug is not required.

Application in children

Contraindicated to children and adolescents under the age of 18 (effectiveness and safety of application are not studied).

special instructions

In patients with a reduced thyroid function (hypothyroidism) or in the presence of some kidney diseases (nephrotic syndrome), with an increase in the level of hC, it is necessary to first carry out the therapy of the disease underlying the disease.

Treatment with Vazilip, as well as other inhibitors of MMC-coa-reductase, can cause myopathy, sometimes leading to rhadomiosis with or without renal failure, due to myoglobinuria. The risk of developing myopathy increases with an increase in the dose of simvastatin and in patients with renal failure of severe. In the treatment of simvastatin, an increase in the content of serum KFK is possible, which should be taken into account with the differential diagnosis of chest pains and after intensive physical exertion.

Before starting therapy with the preparation of Vazilip or an increase in its dose, patients should be informed about the risk of developing myopathy and the need to immediately appeal to the doctor in the event of an inexplicable pain, voltage or weakness in muscles, especially if it is accompanied by a lichtaking or fever. The initial level of KFK before starting therapy must be determined in the following situations:

in older patients;
with kidney damage;
with decompensulated hypothyroidism;
with a family history of hereditary diseases of the muscles;
if there is a toxic effect on the muscles of statins or fibrats;
with alcohol abuse.

It is necessary to estimate the possible risk and expected benefits and during therapy is recommended to clinical monitoring against the background of therapy. If the initial level of KFK is significantly increased (more than 5 times relative to the VGN), the measurement must be repeated after 5-7 days to confirm the results. With a significant initial increase in the level of KFK (more than 5 times relative to the VGN), the drug is not recommended.

Before the beginning and during the course of treatment, the patient should be on a hypocholesterist diet.

During treatment with the preparation of Vazilip when pain in muscles, weakness or convulsion, it is necessary to determine the level of KFK. The criterion for cancellation of the drug is an increase in the content of KFK in the blood serum more than 5 times relative to the VGN. If muscle symptoms are strongly pronounced and cause discomfort, even at the level of KFK less than 5 times relative to the VGN, it is possible to discontinue treatment. If myopathy suspected, therapy must be discontinued, regardless of the cause of myopathy.

If the symptoms disappear, and the KFK content returned to a normal level, it is possible to reappoint the statina or an alternative drug of the same class in a minimum clinically effective dose and under thorough medical supervision. Therapy with the preparation of Vazilip must be temporarily stopped a few days to large surgical interventions.

Patients with renal failure of severe treatment are carried out under the control of the kidney function.

Measures to reduce the risk of myopathy caused by drug interactions

The risk of myopathy and robbomyolysis significantly increases with the simultaneous use of simvastatin and powerful CYP3A4 inhibitors (for example, itraconazole, ketoconazole, erythromycin, clarithromycin, telitromycin, HIV protease inhibitors, nefazodone), hemfibrosyl or cyclosporine. The risk of myopathy and robbomyolysis also increases with the joint use of fibrators and high doses of nicotinic acid (more than 1 g per day) or with simultaneous therapy with amiodarone or verapamil with high doses of Simvastatin. The risk is also somewhat increased by simultaneously appointing diltiazem and high doses of simvastatin (80 mg). Consequently, the use of simvastatin simultaneously with itraconazole, ketoconazole, erythromycin, clarithromycin, telitromycin, HIV protease inhibitors and nefazodone contraindicated. If you can not refuse therapy with the CYP3A4 inhibitors listed inhibitors, you should refrain from the appointment of simvastatin. Simvastatin is also necessary to combine with some other, less strong CYP3A4 inhibitors: cyclosporin, verapamil and diltiazem.

Simultaneous intake of the vasilip and grapefruit juice should be avoided.

In patients taking cyclosporine, hemfibrosyl or high doses of nicotinic acid (more than 1 g per day), the daily dose of simvastatin should not exceed 10 mg.

The simultaneous purpose of simvastatin and hemfibrosyl is possible only in cases where the expected benefits significantly exceeds the potential risk of such a drug combination. The advantages of the combined application of simvastatinate 10 mg per day and other fibrators (except for fenofibrate), nicotine acid (more than 1 g per day) or cyclosporine should be carefully weighed taking into account the potential risk of such combinations.

There is a risk of developing myopathy when prescribed separately of the fenofibrate and simvastatin, therefore caution is needed while taking this combination.

When taking simvastatin in doses exceeding 20 mg per day, it is necessary to avoid simultaneous administration of amiodarone or verapamila, except when the expected benefit exceeds the potential risk of myopathy.

Impact on the liver

Vazilip treatment can cause an increase in the activity of hepatic serum enzymes. This increase is usually insignificant and clinically insignificant. After canceling the drug, transaminase levels are usually slowly reduced to the initial level. However, before starting treatment, it is necessary to study the liver function (control the activity of hepatic transaminases every 6 weeks during the first 3 months, then every 8 weeks during the remaining first year, and then 1 time in six months). If you need to increase the dose of up to 80 mg, the control of the liver function is required before an increase in the dose, after 3 months after the increase and then periodically (for example, 1 time in 6 months) during the first year of treatment. With an increase in the activity of ACT and / or alt in the blood serum 3 times relative to the VGN, the treatment of simvastatin must be discontinued.

With caution to appoint persons, abuse of alcohol, and / or having a history of liver disease.

Impact on the ability to driving vehicles and control mechanisms

On the adverse effect of the drug Vazilip on the ability to control the car and work with the mechanisms was not reported. Nevertheless, it should be borne in mind that in the post-marketing application of Simvastatin, single cases of dizziness are noted.

Medicinal interaction

Pharmacodynamic interactions

The simultaneous use of simvastatin with fibraty, nicotine acid (more than 1 g per day) increases the risk of developing myopathy, including rhabdomyolysis (while using fenofibrate simultaneously - not proven to increase the risk of developing myopathy in comparison with the monotherapy by each drug separately).

Simultaneous use with hemfibrosyl can lead to an increase in symbastatin concentration in serum.

Pharmacokinetic interactions

Cyp3a4 cytochrome inhibitors (itraconazole, ketoconazole, erythromycin, clarithromycin, telitromycin, HIV and nefazodon protease inhibitors), which participates in the metabolic transformation of simvastatin in the liver, increase the risk of developing myopathy and robbomyolysis against the background of the treatment with simvastatin. Simultaneous use with these drugs is contraindicated.

With caution, it is necessary to simultaneously assign with less strong CYP3A4 inhibitors: cyclosporin, verapamil and diltiazem. The daily dose of simvastatin with simultaneous reception with the cyclosporine should not exceed 10 mg. The daily dose of simvastatin against the background of the simultaneous intake of amiodarone or verapamil should not exceed 20 mg, and 40 mg - against the background of the simultaneous reception of the diltiazem, unless the expected benefits clearly do not exceed the potential risk of developing myopathy and rhabdomyolysis.

Vasilip at a dose of 20-40 mg per day in volunteers and patients with hypercholesterolemium potentials the effects of kumarine anticoagulants (for example, warfarin), in particular an increase in prothrombin time, MHO. Therefore, patients taking kumarine anticoagulants, prothrombin time and MHO must be determined before the start of the treatment with simvastatin, in the initial period of treatment, with a change in the dose of simvastatin or cancellation of the drug. Upon reaching a stable prothrombin time and MHO indicator, further control should be carried out at intervals recommended for patients receiving anticoagulant therapy. The therapy simvastatin does not cause changes in prothrombin time and risk of bleeding in patients who do not accept anticoagulants.

Grapefruit juice suppresses CYP3A4 activity. The simultaneous reception of a large amount of grapefruit juice (more than 1 l per day) and simvastatin leads to a significant increase in the concentration in the blood plasma of Simvastanic acid. Therefore, during therapy, the simvastatin should avoid the use of grapefruit juice.

Analogs of the Medicinal Vasilip

Structural analogues for the acting substance:

Actalipide;
Atherostat;
Zokor;
Zokor Forte;
ZORSTAT;
OVENKOR;
Simvagexal;
Simvakard;
Symmolk;
Similarism;
Simvastatin;
Simvastol;
Symbol;
Simgal;
Symot;
Sinkard;
Holvashim.

Analogs in the pharmacological group (statins):

Akort;
Anvistat;
Apptatin;
Athord;
Atomax;
Atorvastatin;
Atorvox;
Atoris;
Vasator;
Vasilip;
Cardiostatin;
Scroll;
Lesk;
Lesk Forte;
Lipobay;
Lipon;
Lipostat;
Lipopord;
Liprimar;
Liptonorm;
Lovor;
Lovastatin;
Lovaster;
Mevor;
Medostatin;
Mertenyl;
OVENKOR;
RTustatin;
Rovakor;
Rosart;
Rosistark;
Rosavastatin;
Rosecard;
Rosulip;
Roxker;
Simvastatin;
Simvastol;
Tevastor;
Torvasin;
Torvakard;
Tulip;
Holvashim;
Choletar.

In the absence of analogues of drugs on the active substance, you can follow the links below on the disease, which helps the appropriate drug, and see the analogues on therapeutic effects.

Vasilip is a drug used to reduce the content of total cholesterol and low-density lipoprotein cholesterol (LDL) in blood plasma.

The active ingredient of the drug reduces the concentration of total XC, HC-LPNP and triglycerides (TG). The content of XC lipoproteins of very low density (HC-LPONP) is also reduced, while the XC content of high density lipoproteins (HC-HPLP) is moderately rising.

On this page you will find all the information about Vazilip: Complete instructions for use in this medicinal medium, average prices in pharmacies, full and incomplete analogues of the drug, as well as the reviews of people who have already used Vazilip. Want to leave your opinion? Please write in the comments.

Clinical and Pharmacological Group

Limiticidemic drug.

Conditions of vacation from pharmacies

Recommended by a doctor's prescription.

Prices

How much is the Vazilip? The average price in pharmacies is at the level of 250 rubles.

Release form and composition

They are produced in the form of tablets coated with film shell (round, slightly double-screwed with beveled edges, white or almost white), 7 pieces in blisters, 2 or 4 blisters in cardboard packs.

The composition of 1 tablets includes 10 mg, 20 mg or 40 mg of active substance - simvastatin.
Auxiliary components included in the preparation: butylhydroxyanisole, lactose monohydrate, microcrystalline cellulose, premarital starch, anhydrous citric acid, ascorbic acid, corn starch, magnesium stearate.

Pharmacological effect

The active ingredient of the vasilip has a hypolypidemic effect and reduces the cholesterol content in the blood plasma. The drug is effective in coronary heart disease, because it reduces the risk of myocardial infarction. The therapeutic effect of the use of the Vazilip is developing over two weeks, and the maximum occurs in a month of daily reception.

In addition, the vasilip according to the reviews has an anti-seaterosclerotic effect, affecting the blood components and the walls of the vessels.

Indications for use

What helps? Vazilip is prescribed to patients for the treatment and prevention of the following states:

Large arteries, with the result that the blood supply to vital organs and systems deteriorates.
Prevention of repeated heart attacks and in patients with severe atherosclerosis or.
Prevention of development and in people from a risk group - overweight patients, people with a predominance in the diet of carbohydrates and excessively oily food, patients with genetic predisposition to hypercholesterolemia.

Contraindications

There are contraindications to the use of Vazilip, which should be adhered to. So, with acute liver diseases, in no case cannot be used by medicine. It may affect this organ and aggravate the situation.

Resistant increase in transaminase content, with an unexplained gene, also refers to the number of contraindications. This can lead to the development of anomalous reactions from the body.

A special danger is people who have increased sensitivity to the components of the drug. In this case, you need to consult a doctor. After all, when used, severe allergic reactions may occur. It is desirable to choose a similar means or a medication with a more gentle composition.

There are such cases when you need to take medicine, and a person has hypersensitivity. This suggests that we need to look for alternative ways to solve the problem. But the use of Vazilip is strictly prohibited.

Application during pregnancy and lactation

The components of the Vazilip adversely affect the development of the fetus, so the medicine is excluded for the treatment of pregnant women. If in the process of therapy with vasilip, pregnancy arose, the reception of the drug is stopped.

Instructions for use

The instructions for use indicate that the Vazilip is taken inward, once in the evening.

The recommended Dose Simvastatin varies from 5 mg to 80 mg 1 time / day in the evening. The most commonly initial dose of the drug is 10 mg. Changes (selection) doses should be carried out at intervals of at least 4 weeks. Maximum daily dose - 80 mg. The maximum daily dose is recommended only to patients with severe hypercholesterolemium or high risk of cardiovascular complications. The duration of the use of the drug is determined by the attending physician individually.

Prevention of cardiovascular diseases:

With a high risk of developing coronary heart disease (with hyperlipidemia or without it), 20-40 mg of vasilip per day is prescribed. The initial dose is 20 mg, the increase in the dose should occur with an interval of at least 4 weeks. Maximum daily dose - 40 mg. When the LDL content is less than 75 mg / dl (1.94 mmol / l), the total XC content is less than 140 mg / dL (3.6 mmol / l), the dosage of the drug should be reduced.

Hyperholesterolemia:

The patient must comply with the standard hypocholesterin diet throughout the entire period of treatment with the preparation of Vazilip. The recommended initial dose of the drug for patients with hypercholesterolemia is 10 mg. In order to a more pronounced reduction in the level of HC-LDL (more than 45%), treatment can be started with 20-40 mg / day (once in the evening). In patients with homozygous hereditary hypercholesterolemia, the recommended daily dose of the Vazilip preparation is 40 mg in the evening or 80 mg in 3 receptions (20 mg in the morning, 20 mg during the day and 40 mg in the evening); Wasilip is recommended to be used in combination with another hypolypidemic therapy (for example, the PNL's apferase).

Concomitant therapy:

The drug is effective in monotherapy or simultaneously with sequestrances of bile acids (for example, a bearsipol and skewer). In patients receiving treatment with hemphibrosyl, cyclosporin, other fibrators or nicotine acid (more than 1 g per day), therapy is recommended to start with 5 mg per day, the maximum daily dose is 10 mg. In such situations, a further increase in the dose is not recommended.

In patients simultaneously receiving amiodar or verapamil, daily doses of the Vazilip drug should not exceed 20 mg.

In patients with severe renal failure (QC less than 30 ml / min), the recommended dose of the drug should not exceed 10 mg / day. If you need to increase the dose, it is necessary to carefully monitor such patients.

Side effects

In general, the medication is well tolerated by patients. Side effects and allergic reactions are not manifested so often, in a low-rise form, and quickly pass.

Nevertheless, such manifestations are possible:

From vision: clouding lens.
From the urogenital system: Violation of potency, violation of the kidney function.
From the gastrointestinal tract: Increase the activity of hepatic transaminases, dyspepsia, pancreatitis, nausea and vomiting, constipation.
From the central nervous system: Increased fatigue, peripheral neuropathy, depression, sleep disorders, headache.
From the muscles: dermatimiositis, muscle weakness, rudomylosis, followed by renal failure. This side effect is extremely rare, mainly in those patients who parallelly take cyclosporine or other drugs from the Statin Group.
Other Possible Side Effects: photosensitization, alopecia.

In some cases, the reception of this drug is characterized by such manifestations of allergies as the urticaria, an increase in body temperature, eczema and redness of the skin. In these cases, it is necessary to inform the doctor about such a reaction of the body to receive medication. Blood analysis can also show such changes as an enlarged content of eosinophils and ESO.

Overdose

There are cases of exceeding the dose of Vazilip, however, they did not cause severe consequences and serious disorders. Despite this, in the event of an overdose of the drug, it is necessary to take enterosorbents and rinse the stomach, and also recommended observation of the system systems, especially the kidneys and liver.

special instructions

It is recommended to avoid joint admission of simvastatin and grapefruit juice.
Before the start and during the course of therapy, the patient should be on the hypocholesterist diet.
With inexplicable pain in the muscles, the patient is recommended to urgently consult a doctor.
The drug can cause a minor and clinically insignificant increase in the activity of hepatic serum enzymes. Usually, after canceling the vasilip, transaminase levels slowly decrease to the source value. However, before the start of treatment, it is necessary to study the liver function.
It is not recommended to take in the presence of risk of rabbomyolysis or renal failure (due to arterial hypotension, severe acute infection, severe metabolic disorders, injuries).

On the adverse effect of the drug on the ability to control the car and work with the mechanisms was not reported. However, it should be borne in mind that in the post-marketing application of simvastatin, cases of dizziness are noted.

Medicinal interaction

Vasilip (and the analogues of this drug) cannot be taken in a complex with amiodarone, diltiazem, hemphibrosine, verapamil, cyclosporin, fenofibrate, nicotinic acid.

Last update of description by the manufacturer 27.09.2017

Filtered list

Active substance:

ATX

Pharmacological group

Nonological Classification (ICD-10)

3D images

Structure

pharmachologic effect

pharmachologic effect - hypolypidemic, inhibitory GMG-CoA-Reduktaz.

Method of application and dose

Inside Once, in the evening.

The recommended Dose Simvastatin varies from 5 to 80 mg 1 time per day in the evening. The most commonly initial dose of Vazilip ® is 10 mg. The changes (selection) of the dose should be carried out at intervals at least 4 weeks. Maximum daily dose - 80 mg. This dose is recommended only to patients with severe hypercholesterolemium or high risk of cardiovascular complications. The duration of the use of the drug is determined by the attending physician individually.

Hyperholesterolemia

The patient must comply with a standard hypocholecystrium diet throughout the entire period of treatment with Vazilip ® preparation. Recommended initial dose - 10 mg. In order to a more pronounced reduction in the level of cholesterol, LDL (more than 45%) treatment can be started with 20-40 mg / day (once in the evening).

In patients with homozygous hereditary hypercholesterolemia, the recommended daily dose is 40 mg in the evening or 80 mg in 3 reception (20 mg in the morning, 20 mg during the day and 40 mg in the evening); To these patients, Vazilip ® is recommended to be used in conjunction with another hypolypidemic therapy (for example, the NPNL apferase).

Cardiovascular Prevention

In patients with high risk of IBS, hyperlipidemia or without it, effective doses of the preparation of Vazilip ® - 20-40 mg per day. Therefore, the recommended initial dose in such patients is 20 mg per day. Changes (selection) Doses should be carried out at intervals of 4 weeks, if necessary, a dose can be increased to 40 mg per day. If the LDL content is less than 75 mg / dl (1.94 mmol / l), total cholesterol is less than 140 mg / dl (3.6 mmol / l), the dose of the drug must be reduced.

Recognizing therapy

Vazilip ® preparation is effective in monotherapy or in combination with sequestrances of bile acids (for example, a skewer and a bearsipol). In patients receiving treatment with cyclosporine, hemfibrosyl, other fibrators or nicotine acid (more than 1 g / day), the recommended initial dose is 5 mg, the maximum daily dose is 10 mg. Further increase in dose in such situations is not recommended. In patients simultaneously receiving amiodar or verapamil, daily doses of the Vazilip ® drug should not exceed 20 mg.