Buy Vasilip tablets 40 mg 28 pcs
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Vasilip pills 40 mg 28 pcs

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Description

Tablets, film coated Vasilip - lipid-lowering agent. The active ingredient of Vasilip is simvastatin, the main effect of which is the reduction of total cholesterol and low density lipoprotein cholesterol (LDL) in plasma. It is an inhibitor of Z-hydroxy-3-methyl glutaryl coenzyme A (HMG-CoA) - reductase, an enzyme that catalyzes the conversion of HMG-CoA to mevalonic acid (an early stage of cholesterol synthesis). Simvastatin lowers total cholesterol, low density lipoprotein cholesterol (LDL) and triglycerides. The very low density lipoprotein cholesterol (VLDL) is also reduced, while the high density lipoprotein cholesterol (HDL) is moderately increased. Reduces total cholesterol and LDL in cases of heterozygous familial and non-familial forms of cholesterolemia, with mixed hyperlipidemia, when elevated cholesterol is a risk factor. The drug reduces total cholesterol and LDL cholesterol in patients with coronary heart disease, reducing the risk of myocardial infarction and death for these patients. Simvastatin also significantly reduces the content of apolipoprotein B, moderately increases the concentration of HDL cholesterol and reduces plasma concentrations of triglycerides (TG). As a result of these effects of simvastatin, the ratio of total cholesterol (OH) to HDL cholesterol (OH / HDL) and LDL cholesterol to HDL cholesterol (LDL / HDL) cholesterol decreases. The anti-atherosclerotic effect of simvastatin is a consequence of the effect of the drug on the walls of blood vessels and blood components. Simvastatin alters the metabolism of macrophages, inhibiting the activation of macrophages and the destruction of atherosclerotic plaques. The drug inhibits the synthesis of isoprenoids, which are growth factors in the proliferation of smooth muscle cells of the inner lining of blood vessels. Simvastatin improves endothelium-dependent dilation of blood vessels. The therapeutic effect occurs after 2 weeks, the maximum effect is observed after 4-6 weeks of treatment.

Active ingredients

Simvastatin

Release form

Pills

Composition

Active ingredient: simvastatin.Excipients: lactose monohydrate, pregelatinized starch, butyl hydroxyanisol, citric acid, anhydrous, ascorbic acid, corn starch, microcrystalline cellulose, magnesium stearate. Film coating: hypromellose, talc, propylene glycol, titanium dioxide.

Indications

Hypercholesterolemia: primary hypercholesterolemia or mixed dyslipidemia (in addition to the diet and with the ineffectiveness of other non-drug measures (exercise and weight loss)), homozygous hereditary hypercholesterolemia (in addition to a special diet and hypothyroid therapy (for example, apresis). . Cardiovascular prophylaxis: a reduction in cardiovascular mortality and morbidity in patients with clinical manifestations of atherosclerotic cardiovascular diseases or diabetes mellitus, with normal or elevated cholesterol and as an additional measure to correct other risk factors and cardioprotective therapy.

Precautionary measures

Before use, consult with your doctor. The drug is available on prescription.

Use during pregnancy and lactation

The drug is contraindicated in pregnancy. An increase in the incidence of congenital malformations in children of women who took simvastatin or another HMG-CoA reductase inhibitor has not been proven. When pregnant women take simvastatin, they may decrease levels of mevalonate in the fetus, which is a precursor of cholesterol biosynthesis. Cancellation of hypolipidemic drugs during pregnancy does not have a significant effect on the results of short-term risk associated with primary hypercholesterinemia. Simvastatin should not be used in pregnant women, women planning a pregnancy, or if a pregnancy is suspected. If a pregnancy occurs during the treatment, the drug should be canceled and the woman warned of the possible danger to the fetus. It is not known whether the drug is excreted into breast milk, therefore therapy with Vasilip during breastfeeding is contraindicated.

Dosage and administration

Inside, once in the evening. The recommended dose of simvastatin varies from 5 to 80 mg once a day in the evening. The most common initial dose of Vasilip is 10 mg.Changes (selection) dose should be carried out at intervals of not less than 4 weeks. The maximum daily dose is 80 mg. The maximum daily dose is recommended only for patients with severe hypercholesterolemia or high risk of cardiovascular complications. The duration of the drug is determined by the attending physician individually. Hypercholesterolemia. The patient must follow a standard hypocholesterol diet throughout the entire period of treatment with Vasilip. The recommended initial dose for patients with hypercholesterolemia is 10 mg. In order to more pronounced reduction in LDL cholesterol (more than 45%), treatment can be started with 20 mg - 40 mg / day (once in the evening). In patients with homozygous hereditary hypercholesterolemia, the recommended daily dose of Vasilip is 40 mg in the evening or 80 mg in 3 doses (20 mg in the morning, 20 mg in the afternoon and 40 mg in the evening), these patients should be used in combination with another hypolshdemic therapy (for example, apheresis LDL). Cardiovascular prophylaxis. In patients with a high risk of coronary heart disease (CHD), with or without hyperillipidemia, effective doses of Vasilip are 20–40 mg per day. Therefore, the recommended initial dose in such patients is 20 mg per day. Changes (selection) dose should be carried out at intervals of 4 weeks, if necessary, the dose can be increased to 40 mg per day. If the content of LDL is less than 75 mg / dl (1.94 mmol / l), the total cholesterol content is less than 140 mg / dl (3.6 mmol / l), the dose of the drug should be reduced. Concomitant therapy. Vasilip is effective in monotherapy or in combination with bile acid sequestrants (for example, colestyramine and colestipol). In patients receiving treatment with cyclosporine, gemfibrozil, other fibrates or nicotinic acid (more than 1 g / day), the recommended initial dose of 5 mg, the maximum daily dose of Vasilip is 10 mg. A further dose increase in such situations is not recommended. In patients receiving amiodarone or verapamil at the same time, daily doses of Vasilip should not exceed 20 mg. In elderly patients and in patients with moderately severe renal insufficiency, changes in the dosage of the drug are not required.In patients with severe renal insufficiency (CC less than 30 ml / min), the recommended dose of Vasilip should not exceed 10 mg per day. If you need to increase the dose, it is necessary to carefully monitor such patients.

Side effects

The classification of the incidence of side effects (WHO): very often> 1/10, often from> 1/100 to <1/10, rarely from> 1/1000 to <1/100, rarely from> 1/10000 to <1 / 1000, very rarely from <1/10000, including individual messages. From the gastrointestinal tract, liver: rarely - constipation, abdominal pain, flatulence, dyspepsia, nausea, vomiting, diarrhea, pancreatitis, hepatitis, jaundice, increased activity of "hepatic "Transaminases, alkaline phosphatase, creatine phosphokinase (CPK). From the central and peripheral nervous system and sensory organs: rarely - headache, paresthesias, dizziness, peripheral neuropathy, asthenia, insomnia, convulsions, blurred vision, impaired taste. syndrome, rheumatic polymyalgia, dermatomyositis, vasculitis, thrombocytopenia, eosinophilia, increased erythrocyte sedimentation rate (ESR), arthritis, arthralgia, urticaria, photo sibilizatsiya, fever, "tides" of blood to the skin of the face, shortness of breath and severe fatigue) .Dermatologicheskie reactions: seldom - skin rash, itching, alopetsiya.Prochie: rarely - anemia, palpitations, acute renal failure (due to rhabdomyolysis), reduced potency.

Overdose

There are data on several cases of simvastatin overdose. The maximum accepted dose is 3.6 g. Treatment: in case of overdose, symptomatic treatment is carried out, general measures are necessary: ​​monitoring and maintaining vital functions, preventing further absorption of the drug (washing the stomach ). Monitoring liver function and CK is recommended. There is no specific antidote. With the development of myopathy with rhabdomyolysis (a rare but severe side effect), you should immediately stop taking the drug, give the patient a diuretic and sodium bicarbonate (intravenous infusion).Rhabdomyolysis can cause hyperkalemia, which can be eliminated by intravenous administration of calcium chloride and calcium gluconate, by infusion of glucose with insulin, using potassium ion exchangers or, in severe cases, by hemodialysis.

Interaction with other drugs

Pharmacodynamic interactions. Simultaneous use of simvastatin with fibrates, nicotinic acid (more than 1 g / day) increases the risk of myopathy, including rhabdomyolysis (when used simultaneously with fenofibrate, there is no proven increase in the risk of myopathy compared to monotherapy with each drug separately). Simultaneous use with gemfibrozil can lead to an increase in the concentration of simvastatin in the serum. Pharmacokinetic interactions. CYP3 A4 cytochrome inhibitors (itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors and nefazodone), which are involved in the metabolic conversion of simvastatin in the liver, increase the risk of myopathy and rhabdomyolysis during simvastatin therapy. Simultaneous use with these drugs is contraindicated. With caution, you must simultaneously prescribe with less potent inhibitors of CYP3A4: cyclosporine, verapamil and diltiazem. The daily dose of simvastatin while taking it with cyclosporine should not exceed 10 mg. The daily dose of simvastatin on the background of simultaneous administration of amiodarone or verapamil should not exceed 20 mg, and 40 mg - on the background of simultaneous administration of diltiazem, unless the expected benefit clearly exceeds the potential risk of developing myopathy and rhabdomyolysis. Simvastatin at a dose of 20–40 mg / day in volunteers and patients with hypercholesterolemia potentiates the effects of coumarin anticoagulants (for example, warfarin), in particular, an increase in prothrombin time, International Normalized Relationship (MHO). Therefore, in patients taking coumarin anticoagulants, prothrombin time and MHO must be determined before starting therapy with simvastatin, in the initial period of treatment, when changing the dose of simvastatin or discontinuation of the drug. When a stable indicator of prothrombin time and MHO is reached, further monitoring should be carried out at intervals recommended for patients receiving anticoagulant therapy.Simvastatin therapy does not cause changes in prothrombin time and risk of bleeding in patients not taking anticoagulants. Grapefruit juice inhibits CYP3A4 activity. The simultaneous intake of large quantities of grapefruit juice (more than 1 liter per day) and simvastatin leads to a significant increase in the concentration in the blood plasma of simvastatinic acid. Therefore, during therapy with simvastatin, grapefruit juice should be avoided.

special instructions

Contraindications: hypersensitivity to simvastatin and other components of the drug, liver disease in the active phase or a persistent increase in the activity of “liver” transaminases of unknown etiology, simultaneous administration of cytochrome P450 ZA4 (CYP3A4) inhibitors (for example, itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, inhibitors of HIV, erythromycin, inhibitors of HIV, erythromycin, inhibitors of HIV, erythromycin, inhibitors of HIV, erythromycin, inhibitors of HIV, erythromycin, inhibitors of HIV, erythromycin; , telithromycin and nefazodon), pregnancy and lactation, age up to 18 years (efficacy and safety have not been studied). With caution: alcohol abuse before the start of therapy, history of liver disease, severe electrolyte imbalance, marked endocrine and metabolic disorders, arterial hypotension, severe acute infections (sepsis), myopathy, uncontrolled epilepsy, extensive surgery, trauma, lactase deficiency, galactosemia, or glucose-galactose malabsorption syndrome; k. the preparation contains lactose), simultaneous administration with gemfibrosin, cyclosporin, nicotinic acid (more than 1 g / day), amiodarone, verapamil, diltiazem, fenofibrate, grapefruit juice. In patients with reduced thyroid function (hypothyroidism) or in the presence of certain kidney diseases (nephrotic syndrome), with an increase in cholesterol level, the therapy underlying the disease should first be carried out. Patients with severe renal insufficiency are treated under the control of renal function. During the period of treatment with Vasilip, women of reproductive age should use reliable contraception. Treatment with simvastatin, like other inhibitors of HMC-CoA reductase, can cause myopathy, sometimes resulting in rhabdomyolysis with or without renal failure, as a consequence of myoglobinuria.The risk of myopathy increases with increasing doses of simvastatin and in patients with severe renal failure. When treating with simvastatin, an increase in serum creatine phosphokinase (CPK) is possible, which should be taken into account in the differential diagnosis of chest pain and after intense physical exertion. Before starting treatment with Vasilip or increasing its dose, patients should be informed about the risk of myopathy and the need to immediately consult a doctor in the case of unexplained pain, tension or weakness in the muscles, especially if this is accompanied by indisposition or fever. The initial level of CPK before treatment should be determined in the following situations: in elderly patients, with kidney damage, with decompensated hypothyroidism, with a burdened family history of hereditary muscle diseases, with a history of toxic effects on the statins or fibrates, with alcohol abuse. to evaluate the possible risk and expected benefits and during therapy, clinical monitoring during therapy is recommended. If the initial CPK level is significantly increased (more than 5 times relative to the upper limit of the norm), the measurement should be repeated after 5-7 days to confirm the results. With a significant initial increase in the level of CPK (more than 5 times relative to the upper limit of the norm), it is not recommended to prescribe the drug. Before and during the course of treatment, the patient should be on a cholesterol-free diet. During Vasilip treatment with muscle pain, weakness, or cramps, it is necessary to determine the level of CPK. The criterion for the abolition of the drug is an increase in the content of CK in the serum of more than 5 times relative to the upper limit of normal. If the muscle symptoms are severe and cause discomfort, even with a CPK level of less than 5 times relative to the upper limit of the norm, you may need to stop treatment. If myopathy is suspected, the therapy should be discontinued, regardless of the cause of myopathy. If the symptoms disappear, and the content of CPK returned to normal levels, it is possible to reappoint a statin or an alternative drug of the same class in the minimum clinically effective dose and under careful medical supervision.Vasilip should be temporarily stopped several days before major surgical interventions. Patients with severe renal insufficiency are treated under the control of renal function. Measures to reduce the risk of myopathy caused by drug interactions. The risk of myopathy and rhabdomyolysis increases significantly with the simultaneous use of simvastatin and potent inhibitors of CYP3A4 (for example, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitor, nefazodone), gemfibrozil, or cyclosporine (see the section “Interaction of c) and the cyclosporine (see the section, for example,). The risk of myopathy and rhabdomyolysis also increases with the combined use of fibrates and high doses of nicotinic acid (more than 1 g / day) or with simultaneous therapy with amiodarone or verapamil with high doses of simvastatin. The risk also increases slightly with simultaneous administration of diltiazem and high doses of simvastatin (80 mg). Therefore, the use of simvastatin simultaneously with itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors and nefazodone is contraindicated. If it is impossible to refuse therapy with the listed CYP3A4 inhibitors, one should refrain from prescribing simvastatin. Simvastatin also needs to be carefully combined with some other, less potent inhibitors of CYP3A4: cyclosporine, verapamil and diltiazem (see section “Interaction with Other Drugs”). Simultaneous administration of simvastatin and grapefruit juice should be avoided. In patients taking cyclosporin, gemfibrozil or high doses of nicotinic acid (more than 1 g / day), the daily dose of simvastatin should not exceed 10 mg. Simultaneous administration of simvastatin and gemfibrozil is possible only in cases where the expected benefit significantly exceeds the potential risk of such a drug combination. The advantages of the combined use of simvastatin 10 mg per day and other fibrates (except fenofibrate), nicotinic acid (more than 1 g / day) or cyclosporine should be carefully weighed, taking into account the potential risk of such combinations. There is a risk of myopathy when prescribing fenofibrate and simvastatin separately, therefore caution is necessary when taking this combination at the same time.When taking simvastatin in doses greater than 20 days, it is necessary to avoid the simultaneous appointment of amiodarone or verapamil, except in cases where the expected benefit exceeds the potential risk of myopathy. Effect on the liver. Treatment with simvastatin may cause an increase in the activity of liver enzymes in the blood serum. This increase is usually insignificant and clinically insignificant. After discontinuation of the drug, transaminase levels usually decrease slowly to baseline. However, before starting treatment and in the future, it is necessary to conduct a study of liver function (monitor the activity of “liver” transaminases every 6 weeks for the first 3 months, then every 8 weeks for the remaining first year, and then once every six months). If it is necessary to increase the dose to 80 mg, it is necessary to monitor liver function before increasing the dose, 3 months after the increase and then periodically (for example, 1 time in 6 months) during the first year of treatment. With a persistent increase in the activity of ACT and / or ALT in the serum by 3 times relative to the upper limits of the norm, treatment with simvastatin should be discontinued. With caution, prescribe to people who abuse alcohol and / or have a history of liver disease.

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