Vasilip, 10 mg, film-coated tablets, 14 pcs.

Compound

Pharmacological properties of the drug Vasilip

Simvastatin is a drug that reduces cholesterol levels. It is an inhibitor of HMG-CoA reductase, an enzyme that takes part in the synthesis of cholesterol in the liver. Simvastatin reduces the concentration of total cholesterol in the blood serum, as well as the concentration of LDL cholesterol and TG in the blood plasma. The concentration of VLDL is also reduced with the use of simvastatin, and the concentration of HDL is moderately increased. In addition, simvastatin exhibits a number of positive effects: improves the function of the endothelium of blood vessels; has an antioxidant effect and slows down the proliferation and migration of cells during the atherosclerotic process. Simvastatin in the form of an inactive lactone is absorbed in the digestive tract from 61 to 85% and is converted into the active therapeutic form in the liver. During the initial passage through the liver, 79% of the absorbed drug is retained there and metabolized. The maximum concentration of active metabolites is achieved 1.1-3 hours after administration of the drug. After absorption, simvastatin is hydrolyzed in the liver to form the active β-hydroxy acid form. Plasma protein binding is 98%. The drug and its active metabolites are located mainly in the liver, which is the site of manifestation of their activity. The half-life of the main metabolite is 1.9 hours, and the total clearance from the body is 31.8 l/h. About 60% of the drug is excreted in the feces (unabsorbed drug, as well as its metabolites in bile) and 13% in the urine (inactive metabolites). The therapeutic effect is achieved within 4–6 weeks of therapy.

Directions for use and doses

Inside, once, in the evening.

The recommended dose of simvastatin ranges from 5 to 80 mg once a day in the evening. The most common initial dose of Vasilip® is 10 mg. Changes (selection) of the dose should be made at intervals of at least 4 weeks. The maximum daily dose is 80 mg. This dose is recommended only for patients with severe hypercholesterolemia or a high risk of cardiovascular complications. The duration of use of the drug is determined individually by the attending physician.

Hypercholesterolemia

The patient must follow a standard cholesterol-lowering diet throughout the entire period of treatment with Vasilip®. The recommended starting dose is 10 mg. In order to more significantly reduce LDL cholesterol levels (by 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 divided doses (20 mg in the morning, 20 mg in the afternoon and 40 mg in the evening); In these patients, Vasilip® is recommended to be used in combination with other lipid-lowering therapy (for example, LDL apheresis).

Cardiovascular prevention

In patients with a high risk of coronary artery disease, hyperlipidemia or without it, the effective dose of Vasilip® is 20–40 mg per day. Therefore, the recommended starting dose in such patients is 20 mg per day. Changes (selection) of the dose should be made at intervals of 4 weeks; if necessary, the 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.

Concomitant therapy

The drug Vazilip® is effective in monotherapy or in combination with bile acid sequestrants (for example, cholestyramine and colestipol). In patients receiving treatment with cyclosporine, gemfibrozil, other fibrates or nicotinic 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 amiodarone or verapamil, daily doses of Vasilip® should not exceed 20 mg.

In elderly patients and patients with moderately severe renal failure, no changes in the dosage of the drug are required. In patients with severe renal failure (creatinine clearance <30 ml/min), the recommended dose of Vasilip® should not exceed 10 mg per day. If it is necessary to increase the dose, careful monitoring of such patients is necessary.

Vasilip®

Myopathy/Rhabdomyolysis

Simvastatin, like other HMG-CoA reductase inhibitors, in rare cases causes myopathy, the symptoms of which are muscle pain, muscle soreness or weakness in combination with an increase in CPK activity more than 10 times the ULN. Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure due to myoglobinuria, in very rare cases with death. The risk of myopathy increases with increasing levels of HMG-CoA reductase inhibitory activity in the blood plasma (in particular, with increasing concentrations of simvastatin or simvastatin hydroxy acid in the blood plasma), which may be partly due to drugs that enter into drug interactions and, as a result, affect on the metabolism and/or transporters of simvastatin (see section “Interaction with other drugs”).

As with treatment with other HMG-CoA reductase inhibitors, the risk of developing myopathy/rhabdomyolysis is dose dependent. In a clinical trial database of 41,413 patients receiving simvastatin, the incidence of myopathy was approximately 0.03%, 0.08%, and 0.61% with daily doses of simvastatin 20 mg, 40 mg, and 80 mg, respectively.

In a clinical trial in which patients with a history of myocardial infarction received simvastatin 80 mg/day (mean follow-up 6.7 years), the incidence of myopathy was approximately 1.0% compared with 0.02% in patients receiving drug at a dose of 20 mg/day. In approximately half of these cases, myopathy developed during the first year of treatment. The incidence of myopathy during each subsequent year of treatment was approximately 0.1% (see sections “Pharmacological properties. Pharmacodynamics” and “Side effects”).

In patients taking simvastatin at a dose of 80 mg per day, the risk of developing myopathy is higher than when using other statins that cause a comparable decrease in LDL cholesterol concentrations. Therefore, Vasilip® at a dose of 80 mg per day should be prescribed only to patients with severe hypercholesterolemia and a high risk of cardiovascular complications, in whom therapy with the drug at lower doses did not achieve the desired therapeutic effect, and the expected benefit of treatment outweighs the potential risk. If a patient taking Vasilip® at a dose of 80 mg requires treatment with another drug that may interact with simvastatin, then it is necessary to reduce the dose of Vasilip® or prescribe another statin that has less potential for possible drug interaction (see sections “Contraindications”, "Method of administration and dosage").

All patients starting therapy with Vasilip®, as well as patients who need to increase the dose, should be warned about the possibility of myopathy and informed about the need to immediately contact a doctor if any unexplained muscle pain, muscle soreness or muscle weakness occurs. Therapy with Vasilip should be discontinued immediately if myopathy is suspected or diagnosed. The presence of the above symptoms and/or a more than 10-fold increase in CK activity in the blood plasma compared to ULN indicates the presence of myopathy. In most cases, after immediate cessation of simvastatin, the symptoms of myopathy resolve and CPK activity in the blood plasma decreases. In patients starting to take Vasilip® or switching to increased doses of the drug, it is advisable to periodically determine the activity of CPK in the blood plasma, but there is no guarantee that such monitoring can prevent the development of myopathy. Many patients who experienced rhabdomyolysis during simvastatin therapy had a complicated medical history, including impaired renal function, usually due to diabetes mellitus. Such patients require more careful monitoring.

Therapy with Vasilip® should be temporarily discontinued several days before major surgical interventions, as well as in the postoperative period.

In a clinical trial in which patients at high risk of cardiovascular disease received simvastatin 40 mg/day, the incidence of myopathy was approximately 0.05% in non-Chinese patients (n = 7367) compared with 0.24% in Chinese patients (n= 5468). Although the only Mongoloid population evaluated in this clinical study was the Chinese, caution should be exercised when prescribing simvastatin to Mongoloid patients and use the lowest dose necessary.

Decreased function of transport proteins

Decreased function of the liver OATP transport proteins may lead to increased systemic exposure of the hydroxy acid simvastatin and an increased risk of myopathy and rhabdomyolysis. A decrease in function may develop due to inhibition by drugs that interact with drugs (for example, cyclosporine), or in patients who are carriers of the C.521T > C polymorphism of the SLC01B1 gene.

Patients with the c.521T>C allelic variant of the SLC01B1 gene produce a less active OATP1B1 protein, and there is an increase in systemic exposure to the hydroxy acid simvastatin and an increased risk of developing myopathy. The risk of developing myopathy associated with high-dose simvastatin (80 mg) is generally 1% in the absence of genetic testing. Based on the results of a clinical study, in carriers of the homozygous allele C (CC) who received 80 mg of the drug, the risk of developing myopathy within a year was 15%, while in carriers of the heterozygous allele C (CT) this risk was 1.5%. The corresponding risk in patients with the most common genotype (TT) was 0.3% (see section “Pharmacological properties. Pharmacokinetics”). Whenever possible, genotyping for the presence of the C allele should be considered as part of the benefit-risk assessment before prescribing simvastatin 80 mg in individual patients, and high doses should be avoided in carriers of the CC genotype. At the same time, the absence of this gene during genotyping does not exclude the likelihood of developing myopathy.

Assessment of CPK activity in blood plasma

Plasma CPK activity should not be assessed after intense physical exercise or if there is any alternative cause for increased plasma CPK activity, as this makes the interpretation of the values ​​difficult. If plasma CPK activity was significantly elevated at baseline (> 5 x ULN), it should be assessed after 5-7 days to confirm the results.

Before treatment

When initiating or increasing the dose of simvastatin, all patients should be warned of the risk of developing myopathy and to promptly report any unexplained pain, tenderness, or muscle weakness.

Caution should be exercised when prescribing the drug to patients with predisposing factors to the development of rhabdomyolysis. In the following situations, CPK activity in blood plasma should be assessed before starting therapy in order to determine reference baseline values:

— old age (> 65 years);

- female;

- renal dysfunction;

- uncontrolled hypothyroidism;

— the patient’s or family history of hereditary muscle diseases;

- history of toxic effects of statins or fibrates on muscles;

- alcohol abuse.

In such situations, the benefit-risk ratio of treatment should be assessed, and clinical observation is recommended. If the patient has previously experienced muscle damage during fibrate or statin therapy, another drug in these classes can be prescribed only with caution. If there is a significant initial increase in CPK activity in the blood plasma (> 5 x ULN), treatment should not be started.

During treatment

If pain, muscle weakness or cramps occur during statin therapy, the activity of CPK in the blood plasma should be assessed. If a significant increase in CPK activity in the blood plasma (> 5 x ULN) is detected in the absence of intense physical activity, treatment should be discontinued. If muscle symptoms are severe and cause daily discomfort, discontinuation of treatment may be considered, even in the absence of an increase in plasma CPK activity <5 x ULN. If myopathy is suspected for any other reason, treatment should be discontinued.

There are very rare reports of IONM during or after treatment with some statins. Clinically, IONM is characterized by persistent proximal muscle weakness and increased serum CPK activity, which persists despite cessation of statin therapy (see section “Side Effects”). When symptoms resolve and plasma CPK activity returns to normal levels, resuming statin therapy or prescribing another statin at a minimal dose under close monitoring may be considered. A higher incidence of myopathy was observed in patients in whom the dose was increased to 80 mg (see section “Pharmacological properties. Pharmacodynamics”). It is recommended to periodically assess plasma CK activity as this may be useful in identifying subclinical cases of myopathy. At the same time, there is no certainty that such control will prevent the development of myopathy. Simvastatin therapy should be temporarily discontinued several days before major elective surgery and when severe conditions requiring medical or surgical intervention develop.

Measures to reduce the risk of myopathy caused by drug interactions (see section "Interaction with other drugs")

The risk of developing myopathy and rhabdomyolysis increases significantly when simvastatin is used concomitantly with strong inhibitors of the CYP3A4 isoenzyme, such as itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors (for example, nelfinavir), boceprevir, telaprevir, nefazodone, drugs containing cobicistat, as well as gemfibrozil, cyclosporine and danazol. The use of these drugs together with simvastatin is contraindicated (see section "Contraindications"). The risk of developing myopathy and rhabdomyolysis also increases with simultaneous use of amiodarone, amlodipine, verapamil or diltiazem with certain doses of simvastatin (see section "Method of administration and dosage", "Interaction with other drugs"). The risk of developing myopathy, including rhabdomyolysis, may increase with simultaneous use of fusidic acid and statins (see section "Interaction with other drugs"). In patients with homozygous familial hypercholesterolemia, this risk may be increased when lomitapide is used concomitantly with simvastatin.

Therefore, with regard to CYP3A4 inhibitors: the use of simvastatin concomitantly with itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors (eg, nelfinavir), boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone and medicinal products containing cobicistat is contraindicated (see Sections “Contraindications”, “Interaction with other drugs”). If the use of potent CYP3A4 inhibitors (drugs that increase AUC approximately 5-fold or greater) cannot be avoided, simvastatin therapy should be temporarily discontinued (and a different statin considered) for the duration of treatment. Moreover, caution must be exercised when combining simvastatin with other less potent inhibitors of the CYP3A4 isoenzyme: fluconazole, verapamil, diltiazem (see sections “Method of administration and dosage”, “Interaction with other drugs”). The concomitant use of simvastatin and grapefruit juice should be avoided.

The simultaneous use of simvastatin and gemfibrozil is contraindicated (see section "Contraindications"). Due to the increased risk of myopathy and rhabdomyolysis in patients receiving simvastatin along with other fibrates, with the exception of fenofibrate, the dose of simvastatin should not exceed 10 mg per day (see sections “Dosage and Administration”, “Interaction with other drugs” ). Caution should be exercised when prescribing fenofibrate and simvastatin, since each of these drugs itself can cause the development of myopathy. Simvastatin should not be co-administered with systemic fusidic acid or used within 7 days of finishing treatment with fusidic acid. If the use of fusidic acid is necessary, statin therapy should be suspended for the entire period of fusidic acid treatment. There are reports of cases of rhabdomyolysis (including fatal cases) in patients simultaneously receiving fusidic acid and statins (see section "Interactions with other drugs"). The patient should be advised to consult a doctor immediately if any symptoms such as pain, tenderness or muscle weakness develop. Statin therapy can be resumed 7 days after the last dose of fusidic acid. In exceptional situations where long-term systemic therapy with fusidic acid is necessary, for example in severe infections, the advisability of simultaneous use of simvastatin and fusidic acid should be assessed on a case-by-case basis and under close medical supervision.

The combined use of simvastatin in doses exceeding 20 mg/day should be avoided simultaneously with amiodarone, amlodipine, verapamil or diltiazem. In patients with homozygous familial hypercholesterolemia, the combined use of simvastatin in doses exceeding 40 mg / day should be avoided simultaneously with lomitapide (see sections “Contraindications”, “Dosage and Administration”, “Interaction with other drugs”).

In patients who take other drugs that have a moderate inhibitory effect on the CYP3A4 isoenzyme, together with simvastatin prescribed in high doses, the risk of developing myopathy may increase. When simvastatin is used concomitantly with moderate inhibitors of the CYP3A4 isoenzyme (drugs that increase AUC by approximately 2-5 times), dose adjustment of simvastatin may be required. For some moderate CYP3A4 inhibitors, such as diltiazem, the maximum recommended dose of simvastatin is 20 mg/day (see Dosage and Administration).

Simvastatin is a substrate of the BCRP efflux transporter. Concomitant use of drugs that are BCRP inhibitors (such as elbasvir and grazoprevir) may lead to increased plasma concentrations of simvastatin and an increased risk of myopathy. Therefore, consideration should be given to adjusting the dose of simvastatin depending on the prescribed dose. Concomitant use of elbasvir or grazoprevir with simvastatin has not been studied; in patients who simultaneously receive drugs containing elbasvir or grazoprevir and simvastatin, the dose of simvastatin should not exceed 20 mg / day (see section “Interaction with other drugs”).

Rare cases of myopathy/rhabdomyolysis have been associated with the concomitant use of HMG-CoA reductase inhibitors and lipid-lowering doses (> 1 g/day) of niacin (nicotinic acid), each of which alone can cause myopathy.

In a clinical study (median follow-up period - 3.9 years) involving patients at high risk of cardiovascular diseases with good control of plasma LDL-C concentrations during therapy with simvastatin 40 mg / day in combination with or without ezetimibe 10 mg Additional benefit on cardiovascular outcomes was found with the addition of niacin (niacin) at lipid-lowering doses (>1 g/day). Therefore, physicians considering combination therapy of simvastatin with lipid-lowering doses (> 1 g/day) of niacin (nicotinic acid) or niacin-containing products should carefully weigh the potential benefits and risks and closely monitor patients for any signs and symptoms symptoms in the form of pain, soreness or weakness in the muscles, especially in the first months of therapy and when the dose of any of the drugs is increased.

Additionally, in this study, the incidence of myopathy was approximately 0.24% in Chinese patients receiving simvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg, compared with 1.24% in Chinese patients receiving simvastatin 40 mg. or ezetimibe/simvastatin 10 mg/40 mg together with niacin/lamopiprant modified release 2000 mg/40 mg. Although the only Mongoloid population evaluated in this clinical study was Chinese, given the higher incidence of myopathy in Chinese patients compared to non-Chinese patients, concomitant use of simvastatin with niacin (niacin) at lipid-lowering doses (>1 g/day) It is not recommended for patients of the Mongoloid race (see section “Interaction with other drugs”).

Acipimox is structurally related to niacin. Although the effects of acipimox have not been studied, the risk of muscle toxicity may be similar to that of niacin.

Daptomycin

With the simultaneous use of HMG-CoA reductase inhibitors and daptomycin, reports of the development of myopathy and/or rhabdomyolysis have been received. Caution should be exercised when prescribing HMG-Co A reductase inhibitors concomitantly with daptomycin, as either agent may cause myopathy and/or rhabdomyolysis when used alone. You should consider temporarily suspending the use of Vasilip® in patients taking daptomycin (see section “Interaction with other drugs”).

Effect on the liver

In clinical studies, persistent increases in serum transaminase activity (up to > 3 x ULN) were observed in a small number of adult patients receiving simvastatin. When simvastatin therapy was discontinued or temporarily discontinued in these patients, transaminase activity usually decreased slowly to the level observed before treatment. It is recommended to assess liver function before starting treatment and then when clinically indicated. In patients whose dose was increased to 80 mg, liver function should be further assessed before the dose increase, 3 months thereafter, and periodically thereafter (eg, once every six months) during the first year of treatment. Particular attention should be paid to patients who experience increased transaminase activity in the blood serum. In such patients, liver function assessment should be repeated quickly and performed more frequently thereafter. If transaminase activity indicates progression of the condition, especially if it rises to 3 x ULN and persists, simvastatin should be discontinued. It should be noted that the activity of alanine aminotransferase (ALT) in the blood plasma may be due to damage to muscle tissue, therefore, an increase in ALT activity in combination with an increase in CPK activity in the blood plasma may indicate myopathy (see subsection “Myopathy/Rhabdomyolysis”/

There are limited post-marketing reports of fatal and non-fatal liver failure in patients treated with statins, including simvastatin. If serious liver damage develops during treatment with Vasilip®, accompanied by clinical symptoms and/or hyperbilirubinemia or jaundice, therapy should be discontinued immediately. Unless another cause of liver damage has been established, therapy with Vasilip ® should not be resumed.

In patients who consume significant amounts of alcohol, the drug should be used with caution. As with the use of other lipid-lowering drugs, cases of moderate (< 3 x ULN) increases in serum transaminase activity have been described during simvastatin therapy. These changes occurred shortly after initiation of simvastatin therapy, were often transient, were not accompanied by any symptoms, and did not require interruption of treatment.

Diabetes

Some evidence suggests that statins as a class increase blood glucose concentrations, and in some patients at high risk of developing diabetes mellitus, statins may lead to the development of a level of hyperglycemia at which hypoglycemic agents should formally be prescribed. At the same time, this risk is outweighed by the reduction in vascular risk with statins and, therefore, should not be a reason to discontinue therapy. Patients at risk of developing diabetes mellitus (fasting blood glucose concentration from 5.6 mmol/l to 6.9 mmol/l, BMI >30 kg/m2, elevated plasma triglyceride concentrations, arterial hypertension) should be monitored both clinically and and biochemically in accordance with national recommendations.

Interstitial lung diseases

Cases of the development of interstitial lung disease have been described with the use of some statins, including simvastatin, especially with long-term therapy (see section "Side effects"). Signs of interstitial lung disease include shortness of breath, nonproductive cough, and deterioration of the patient's general condition (weakness, weight loss, and fever). If the development of interstitial lung disease is suspected, statin therapy should be discontinued.

Use in children and adolescents aged 10-17 years

The safety and effectiveness of simvastatin in adolescents aged 10–17 years with heterozygous familial hypercholesterolemia was assessed in a controlled clinical trial in adolescent boys with Tanner stage II or higher and girls who were at least one year postmenarche. Patients receiving simvastatin had an overall adverse event profile similar to that of patients receiving placebo.

Doses above 40 mg have not been studied in this patient population. In this limited controlled study, there was no evidence of an effect of the drug on the growth or puberty of adolescent girls and boys, or no effect on the duration of the menstrual cycle in girls (see sections “Pharmacological properties. Pharmacodynamics”, “Dosage and Administration” , "Side effect"). Adolescent girls should be explained the need to use appropriate methods of contraception during therapy with simvastatin (see sections “Contraindications”, “Use during pregnancy and breastfeeding”). In patients aged <18 years, the effectiveness and safety of the drug for a duration of treatment > 48 weeks is unknown, long-term effects on physical, intellectual and pubertal development have not been studied. Studies on the use of simvastatin in patients under 10 years of age, as well as in prepubertal children and premenarchal girls, have not been conducted.

Special information on excipients

Vasilip® is contraindicated in patients with lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome, as it contains lactose.

Side effects of the drug Vasilip

Well tolerated by most patients, side effects are usually mild and transient. Constipation, nausea, dyspepsia, abdominal pain, diarrhea, vomiting, headache, sleep disturbance and increased activity of liver enzymes (AST and ALT) may occur; Dizziness, increased fatigue, muscle weakness, itching and alopecia are less common. Extremely rarely (in isolated cases), depression, peripheral neuropathy, impaired potency and renal function, proteinuria, pancreatitis, lens opacification, dermatomyositis, skin rash and eczema, myopathy, manifested by muscle pain, muscle weakness and an increase in the muscle fraction of CPK, are possible. In exceptional cases, rhabdomyolysis develops with further renal failure. The risk of developing myopathy with rhabdomyolysis is increased in patients using another lipid-lowering drug, cyclosporine, or certain drugs that increase the level of simvastatin in the blood. Hypersensitivity syndrome, also rare, can manifest as angioedema, vasculitis, dermatomyositis, thrombocytopenia, eosinophilia, increased ESR, symptoms and signs of arthritis, skin rashes, photosensitivity, fever and flushing.

Special instructions for the use of Vasilip

Simvastatin therapy may cause an increase in the level of hepatic transaminases in the blood serum. Before starting treatment, it is recommended to determine the level of transaminases in the blood serum and then regularly monitor these indicators throughout the entire period of treatment. In most cases, such a slight increase does not require discontinuation of the drug. If the level of transaminases in the blood serum is 3 times higher than the upper limit of normal, treatment with the drug must be discontinued. It is recommended to prescribe simvastatin with extreme caution to patients who abuse alcohol and/or have liver disease. When taking Vasilip, you must avoid drinking alcohol. Simvastatin may cause an increase in the activity of the muscle enzyme CPK, and in rare cases myopathy may develop. Myopathy is manifested by a significant (more than 10 times the normal value) increase in CPK levels, which is accompanied by pain, stiffness and muscle weakness. In the most severe cases, rhabdomyolysis (destruction of muscle tissue) may develop. This can lead to the development of acute renal failure. The risk of myopathy and rhabdomyolysis is increased when simvastatin is co-administered with strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone). If treatment with itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone is necessary, the use of simvastatin should be discontinued during such treatment. In addition, Vazilip should be used with caution when taken simultaneously with cyclosporine, other fibrates, and niacin. The increase in CK activity should also be taken into account when carrying out the differential diagnosis of chest pain. The safety and effectiveness of simvastatin in children and adolescents under 18 years of age have not been established. During pregnancy and breastfeeding. The drug is contraindicated during pregnancy and breastfeeding. Women of reproductive age can take Vasilip only if the possibility of pregnancy is completely excluded. Impact on the ability to drive vehicles and work with complex mechanisms . Simvastatin has no or almost no effect on the ability to drive vehicles or operate other machinery. However, dizziness has occasionally been reported in post-marketing studies.

Drug interactions Vasilip

Co-administration of simvastatin with cyclosporine, fibrates, nicotinic acid, niacin, erythromycin, clarithromycin, ketoconazole, itraconazole and nefazodone increases the risk of developing myopathy with rhabdomyolysis and acute renal failure. These drugs are inhibitors of the CYP 3A4 enzyme, which is involved in the metabolism of Vasilip in the liver. Similar complications can occur with the combined use of simvastatin in high doses (80 mg) with amiodarone and verapamil. When taken concomitantly with ritonavir, the concentration of simvastatin in the blood serum may increase. The simultaneous administration of simvastatin and warfarin may enhance the anticoagulant effect of the latter and thus increase the risk of hemorrhagic complications. In patients taking simvastatin and digoxin concomitantly, serum digoxin levels may be increased and such patients should be under medical supervision.

Indications for use of the drug Vasilip

IHD IHD and a high risk of developing cardiovascular complications (heart attack or transient ischemic disorders). The drug reduces the level of total cholesterol and LDL cholesterol in patients with coronary artery disease and thus slows the progression of coronary atherosclerosis, reduces the risk of myocardial infarction and mortality as a result. Reduces the risk of complications after coronary revascularization (coronary artery bypass grafting and percutaneous transluminal coronary angioplasty). Hyperlipidemia Vasilip regulates the serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol and TG in patients with primary hyperlipidemia (type IIa and IIb), including polygenic hypercholesterolemia, heterozygous hereditary hypercholesterolemia and mixed hyperlipidemia. Vasilip is also used to reduce high levels of total cholesterol and LDL cholesterol in patients with homozygous hereditary hypercholesterolemia.

Overdose of the drug Vasilip, symptoms and treatment

Several cases of simvastatin overdose have been described, which were not accompanied by the development of any specific disorders or negative consequences. In case of overdose, standard measures are carried out (gastric lavage and administration of activated carbon, monitoring the vital functions of the body). It is also necessary to monitor liver and kidney function and serum CPK levels. If myopathy occurs with the development of rhabdomyolysis and acute renal failure, the use of the drug should be stopped immediately and, if necessary, hemodialysis should be performed.