Simvastatin tab p / 10 mg of the film 30 pcs vertex


Simvastatin tab p / 10 mg of the film 30 pcs vertex



Active substance:
1 tablet contains: simvastatin 10 mg or 20 mg.
Lactose (milk sugar), microcrystalline cellulose, polyvinylpyrrolidone (povidone), citric acid, ascorbic acid, butylhydroxyanisole, corn starch, calcium stearate, hypromellose (hydroxypropylmethylcellulose), macrogol 4000, talc, titanium dioxide.
Tablets, film-coated white or almost white, round, biconvex.
Product form:
Tablets, film-coated, 10 and 20 mg.
10 tablets, film-coated, in blisters or 30 tablets in a jar polymer. 3 blisters or each bank together with instructions for use in a stack of cardboard.
Hypersensitivity to simvastatin or to other components of the preparation (including hereditary lactose intolerance), as well as to other drugs Statins series (inhibitors MMC-CoA reductase) in history; liver disease in its active phase, a persistent increase in activity “liver” enzymes of unknown etiology; diseases of the skeletal muscles (myopathy); age 18 years (effectiveness and safety have been established)
Be wary appoint patients who abuse alcohol, transplant patients undergoing immunosuppressive therapy (due to an increased risk of rhabdomyolysis and renal failure); under conditions that can lead to severe renal insufficiency, such as hypotension, acute infectious diseases heavy currents expressed metabolic and endocrine disorders, water-electrolyte balance, surgery (including dental) or trauma; patients with low or high tone of the skeletal muscles of unknown etiology; epilepsy.
10 mg
Primary Hypercholesterolemia (IIa and IIb type) at a poor diet low in cholesterol and other non-drug interventions (exercise and weight reduction) in patients with an increased risk of coronary atherosclerosis; combined hypercholesterolemia and hypertriglyceridemia, not correctable special diet and exercise.
Coronary heart disease: for the prevention of myocardial infarction, to reduce the risk of death, reducing the risk of cardiovascular events (stroke and transient ischemic attacks), slowing the progression of atherosclerosis of the coronary vessels, reducing the risk of revascularization procedures.
None of the known several cases of overdose (maximum accepted dose 450 mg) of specific symptoms have been identified.
Treatment: Induce vomiting, take activated carbon, a symptomatic therapy. It should control the functions of liver and kidneys, creatine kinase levels in blood serum.
With the development of myopathy and rhabdomyolysis with acute renal failure (rare but severe side effects), stop taking the drug and the patient enter a diuretic and sodium bicarbonate (intravenous infusion). If necessary, hemodialysis is shown.
Rhabdomyolysis can cause hyperkalemia, which can eliminate the intravenous administration of calcium chloride or calcium gluconate, glucose infusion with insulin, using potassium ion exchangers or, in severe cases, by dialysis.
Interaction with other drugs:
Cytotoxic agents, antifungal agents (ketoconazole, itraconazole), fibrates, high doses of nicotinic acid, immunosuppressants, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone increase the risk of myopathy.
Cyclosporine or Danazol: the risk of myopathy / rhabdomyolysis is increased by concomitant use of cyclosporine or danazol with higher doses of simvastatin.
Other lipid-lowering drugs that can cause myopathy development: the risk of myopathy is increased by concomitant use of other lipid-lowering drugs that are not potent inhibitors of CYP3A4, but can cause myopathy monotherapy conditions. Such as gemfibrozil and other fibrates (except fenofibrate), and niacin (nicotinic acid) in a dose of – 1 g per day.
Amiodarone and verapamil: the risk of myopathy is increased by coadministration of amiodarone or verapamil with higher doses of simvastatin.
Diltiazem: the risk of myopathy is increased slightly in patients receiving diltiazem along with simvastatin 80 mg.
Simvastatin potentiates the action of oral anticoagulants (eg., Phenprocoumon, warfarin) and increases the risk of bleeding, which requires the need for monitoring indicators of bleeding prior to treatment, as well as quite often the initial treatment period. Once achieved a stable level indicator prothrombin time or the International Normalized Ratio (INR), a further control should be performed at intervals recommended for patients receiving anticoagulant therapy. When the dosage modification or termination of the reception of simvastatin should also carry out the control of prothrombin time or INR of the above scheme.
Therapy with simvastatin did not cause changes in prothrombin time and bleeding risk in patients not taking anticoagulants.
It increases the level of digoxin in the blood plasma.
Cholestyramine and colestipol reduce bioavailability (simvastatin possibly through 4 hours after administration of said drugs, the marked additive effect).
Grapefruit juice contains one or more components which inhibit CYP3A4 and can increase the concentration in the blood plasma agents metabolized by CYP3A4. Increased activity of HMG-CoA reductase inhibitor after consuming 250 ml juice per day is minimal and has no clinical significance. However, consumption of a large volume of juice (1 liter per day) while taking simvastatin significantly increases the level of inhibitory activity against HMG-CoA reductase inhibitor in blood plasma. In this connection it is necessary to avoid the intake of grapefruit juice in large quantities.
pharmachologic effect
Pharmacological group:
Lipid-lowering drugs – HMG-CoA reductase inhibitor.
Hypolipidemic agent derived synthetically from a fermentation product Aspergillus terreus, is an inactive lactone, is hydrolyzed in the body to form the hydroxy-acid derivative. The active metabolite inhibits 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase), an enzyme that catalyzes the initial reaction of mevalonate formation of HMG-CoA. Since the conversion of HMG-CoA to mevalonate is an early step in cholesterol synthesis, the use of simvastatin does not cause accumulation in the body is potentially toxic sterols. HMG-CoA is readily metabolized to acetyl-CoA, which is involved in the synthesis of many processes in the body.
Causes a decrease in plasma triglycerides (TG), low density lipoprotein (LDL), very low density lipoproteins (VLDL) and total cholesterol (in cases heterozygous familial and non-familial forms of hypercholesterolemia, in mixed hyperlipidemia where the high content of cholesterol is a risk factor) . Increases of high density lipoprotein (HDL) and reduces the ratio of LDL / HDL and total cholesterol / HDL.
Onset of effect – 2 weeks from the beginning of the reception, the maximum therapeutic effect is reached after 4-6 weeks. Action is maintained with continued treatment, at the termination of therapy cholesterol is gradually returning to its original level.
Absorption of simvastatin high. After oral administration the maximum plasma concentration is reached after approximately 1.3-2.4 hours, and reduced by 90% after 12 hours. Communication with the plasma proteins is approximately 95%.
It is metabolized in the liver, has the effect of “first pass” through the liver (hydrolyzed to form an active derivative: beta-hydroxyacids are found and other active and inactive metabolites). The half-life of the active metabolite is 1.9 hours.
Derived mainly from the feces (60%) in the form of metabolites. About 10-15% is excreted by the kidneys in an inactive form.
Pregnancy and breast-feeding
Simvastatin is contraindicated in pregnancy. There are several reports of malformations in newborns whose mothers took simvastatin.
Women of childbearing age who take simvastatin should avoid conception. If during treatment pregnancy yet occurred, simvastatin should be discontinued, and the woman should be advised of the potential hazard to the fetus.
Data on the allocation of simvastatin in breast milk are not available. If necessary, simvastatin during breast-feeding should be aware that many drugs are excreted in breast milk, and there is a threat of severe reactions, so breast-feeding during treatment is not recommended.
Conditions of supply of pharmacies
side effects
Digestive system: abdominal pain, constipation, flatulence, nausea, diarrhea, pancreatin, vomiting, hepatitis, increased activity of “liver” enzymes, alkaline phosphokinase, and creatine phosphokinase (CPK).
The nervous system and sensory organs: asthenic syndrome, headache, dizziness, insomnia, muscle cramps, paresthesia, peripheral neuropathy, blurred vision, taste disturbance.
Allergic and immunopathological reactions: angioedema, polymyalgia rheumatica, vasculitis, thrombocytopenia, increased ESR, fever, arthritis, rash, photosensitivity, skin flushing, flushing, dyspnea, lupus-like syndrome, eosinophilia.
Dermatological reactions: rare skin rash, pruritus, alopecia, dermatomyositis.
On the part of the musculoskeletal system: myopathy, myalgia, muscle cramps, weakness; rarely – rhabdomyolysis.
Other anemia, palpitations, acute renal failure (due to rhabdomyolysis) decreased potency.
special instructions
At the beginning of therapy with simvastatin possibly a transient increase in the level of “liver enzymes.”
Before therapy and more regular liver function tests (control activity “liver” enzymes every 6 weeks during the first 3 months., And then every 8 weeks for the remainder of the first year and then 1 time in months) and at higher doses It should be a test to determine liver function. By increasing the dose to 80 mg is necessary to carry out a test every 3 months. When persistent elevations of transaminase activity (in 3-fold compared with baseline) receiving simvastatin should be discontinued.
Simvastatin, like other inhibitors of HMG-CoA reductase inhibitors, should not be used at an increased risk of rhabdomyolysis and renal failure (on the background of severe acute infection, hypotension, planned major surgery, trauma, severe metabolic disorders).
Cancel hypolipidemic agents during pregnancy has no significant impact on the long-term treatment of primary hypercholesterolemia.
Due to the fact that inhibitors of HMG-CoA reductase inhibitors inhibit the synthesis of cholesterol and cholesterol and other products of its synthesis plays an important role in fetal development, including synthesis of steroids and cell membranes, simvastatin may have an adverse effect on the fetus in the appointment of his pregnant (women of childbearing age should avoid conception). If in the course of treatment became pregnant, the drug should be discontinued, and the woman warned of the possible danger to the fetus.
Simvastatin is not recommended in women of childbearing age, not using contraception.
Patients with decreased function of the thyroid (hypothyroidism) or in the presence of certain renal diseases (nephritic syndrome) with increasing cholesterol must first conduct therapy of the underlying disease.
Simvastatin prescribed with caution individuals who abuse alcohol and / or have a history of liver disease.
Before and during treatment the patient should be on hypolipidemic diet.
Simultaneous administration of grapefruit juice can enhance the degree of severity of side effects associated with taking simvastatin, so avoid their simultaneous administration.
Simvastatin is not shown in those cases where there is hypertriglyceridemia I, IV and V types.
Simvastatin treatment may cause myopathy, leading to rhabdomyolysis and renal failure. The risk of this disease increases in patients receiving concomitant simvastatin one or more of the following medicines: fibrates (gemfibrozil, fenofibrate), ciclosporin, nefazadon, macrolides (erythromycin, clarithromycin), antifungal medicines from the group “azoles” (ketoconazole, itraconazole) and HIV protease inhibitors (ritonavir). The risk of myopathy is also increased in patients with severe renal insufficiency.
All patients who start therapy with simvastatin and patients who need to increase the dose of the drug should be warned about the possibility of myopathy and the need for immediate treatment to the doctor in case of unexplained pain, pain in the muscles, weakness or muscle weakness, particularly if accompanied by malaise or fever. Drug therapy should be discontinued immediately if myopathy is diagnosed or suspected.
In order to diagnose myopathy should regularly carry out measurements of CPK.
In the treatment with simvastatin may increase the content of serum CK, which should be considered when diagnosing differintsialnoy pain behind the breastbone. The criterion for discontinuation of the drug is an increase in serum CPK more than 10 times the upper limit of normal. In patients with myalgia, myasthenia and / or markedly elevated CPK drug treatment is stopped.
The drug is effective as a monotherapy, or in combination with bile acid sequestrants.
In the case of the current dose skip the drug should be taken as soon as possible. If you come next dose, do not double the dose.
Patients with severe renal insufficiency treatment is carried out under the control of renal function.
Long-term use is determined by the physician individually.
Effect on ability to drive and use machines
On the adverse effects of the drug on the ability to drive and work with the mechanisms have not been reported.
Storage conditions
In a dry, the reach of children, protected from light at a temperature not higher than 25 C.
Dosing and Administration
Prior to treatment, patients should appoint simvastatin standard hypolipidemic diet, which must be maintained throughout the course of treatment.
Simvastatin should be taken orally once a day 1 night, drinking plenty of water.
Time of administration of the drug should not be associated with food intake.
The recommended dose of simvastatin for treating hypercholesterolemia varies from 10 to 80 mg 1 time per day in the evening. The recommended starting dose for patients with hypercholesterolemia is 10 mg. The maximum daily dose – 80 mg.
Changes (selection) the dose should be made at intervals of 4 weeks. In most patients, the optimal effect is obtained by taking the drug at doses up to 20 mg per day.
In patients with homozygous familial hypercholesterolemia recommended daily dose of simvastatin 40 mg 1 time per day in the evening or 80 mg in three divided doses (20 mg in the morning, afternoon 20 mg and 40 mg in the evening).
In the treatment of patients with coronary heart disease (CHD) or at high risk for CHD effective doses of simvastatin are 20-40 mg per day. Therefore, the recommended initial dose in these patients – 20 mg per day. Change (selection) dose should be performed at intervals of 4 weeks, if necessary, the dose can be increased to 40 mg per day. If the LDL content of less than 75 mg / dl (1.94 mmol / l), total cholesterol – less than 140 mg / dl (3.6 mmol / L), the dose should be reduced.
In elderly patients and in patients with mild or moderate renal impairment dosage changes of the drug is required.
In patients with chronic renal failure (creatinine clearance less than 30 mL / min) or receiving cyclosporin, danazol, gemfibrozil or other fibrates (except fenofibrate), niacin in lipid-lowering doses (1 g / day) in combination with simvastatin, the maximum recommended dose of simvastatin not must exceed 10 mg per day.
For patients taking amiodarone or verapamil simultaneously with simvastatin daily dose should not exceed 20 mg.
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg


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