Simvastatin tabs 10mg #30

Simvastatin instruction for use

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Composition

The tablet contains the active ingredient Simvastatin. Dosage of the active substance: 10, 20, 40, 80 mg. Auxiliary components: titanium dioxide, citric acid, povidone, lactose, hypromellose, calcium stearate, corn starch, ascorbic acid, talc, macrogol, butylhydroxyanisole.

Form of issue

Simvastatin is available in tablet form. Tablets can be packed in polymer jars, blisters of 10, 15, 30 pieces.

pharmachologic effect

Lipid-lowering drug. The active component is produced synthetically by fermentation of Aspergillus terreus. The active substance is an inactive lactone, which, as a result of hydrolysis in the human body, passes into the hydroxy-acid derivative. The main metabolite inhibits a specific enzyme that catalyzes the formation of mevalonate from HMG-CoA. This reaction underlies the early synthesis of cholesterol, which allows Simvastatin to prevent the accumulation of toxic forms of sterols. HMG-CoA can be easily metabolized to acetyl-CoA, which takes an active part in many synthesis processes in the human body.
Against the background of taking simvastatin, the level of triglycerides, total cholesterol, "bad" and "very bad" cholesterol (LDL and VLDL) decreases. The effect of the medication is manifested after 15 days of treatment, and becomes noticeable by laboratory parameters after 1-1.5 months. Cholesterol reducing effect persists throughout the course of treatment. After discontinuation of therapy, the cholesterol level gradually returns to its original value.

Pharmacodynamics and pharmacokinetics

Simvastatin has a high absorption index. The maximum concentration is recorded after 1.5-2.5 hours, but after 12 hours it decreases by 90%. In plasma proteins, the active component is able to bind to 95%. For simvastatin, metabolism in the hepatic system is characterized by a peculiar "first passage" effect, when hydrolysis results in the formation of an active derivative, beta-hydroxy acid. The main way of excretion is through the intestine. In the inactive form, 10-15% of the active substance is output through the renal system.

Indications for use of simvastatin

From what tablets? Medication is prescribed to reduce cholesterol in hypercholesterolemia and ischemic heart disease. The main indications for the use of simvastatin:
    primary hypercholesterolemia (types: IIa and IIb) in the absence of the effect of diet therapy and other non-drug methods (weight loss, adequate physical activity) and individuals at high risk of developing coronary atherosclerosis;
    combined form of hypercholesterolemia and hypertriglyceridemia in case of diet inefficiency and adequate physical exertion;
    prevention of myocardial infarction;
    reduction of cardiovascular risk (stroke, transient ischemic attack);
    risk reduction after revascularization;
    preventing the progression of atherosclerosis of the heart vessels.

Contraindications

    Myopathy and other diseases of skeletal musculature;
    increase of ALT, AST;
    individual hypersensitivity;
    pronounced pathology of the hepatic system;
    age restriction - up to 18 years.
Relative contraindications, in which Simvastatin is administered with caution:
    therapy with immunosuppressors after organ transplantation;
    alcohol abuse;
    arterial hypotension;
    water-electrolyte imbalance;
    pronounced pathology of the endocrine system;
    metabolic changes;
    epilepsy;
    traumatic and surgical interventions.

Side effects

The digestive tract:

    pancreatitis;
    flatulence;
    epigastric pain;
    constipation;
    increased CK, ALT, AST;
    vomiting;
    diarrheal syndrome;
    nausea.

Nervous system:

    blurred vision;
    migraine headache;
    asthenic syndrome;
    paresthesia;
    dizziness;
    violation of taste perception;
    muscle cramps;
    insomnia;
    peripheral neuropathy.

Immunopathological reactions and allergic responses:

    tides;
    vasculitis;
    angioedema;
    thrombocytopenia;
    rheumatic polymyalgia;
    eosinophilia;
    lupus-like syndrome;
    photosensitization;
    hives;
    fever;
    increased ESR;
    hyperemia of the skin;
    arthritis, dyspnea.

Musculoskeletal system:

    muscle cramps;
    myopathy;
    severe weakness;
    rhabdomyolysis;
    myalgia.

Dermatological reactions:

    dermatomyositis;
    itching;
    alopecia.

Other reactions:

    decreased potency;
    acute renal failure with rhabdomyolysis;
    cardiopalmus;
    anemia.
When other negative reactions are shown against the background of treatment, it is recommended that a specialist be assisted and that the preparation Simvastatin be withdrawn independently.

Instructions for use (Method and dosage)

Before the appointment of statins, the cholesterol level is reduced by a special hypocholesteric diet. If inefficiency is additionally prescribed, Simvastatin. Instructions for use Simvastatin: 1 time per day for 1 tablet at night, washed down with water. Do not bind the medication with food. The daily dose depends on the level of cholesterol and lipid profile (from 10 to 80 mg). It is better to start cholesterol-lowering therapy with small doses, gradually increasing the amount of simvastatin every 4 weeks, monitoring laboratory parameters. In most cases, a good effect is recorded at a dose of 20 mg per day.
Patients with hereditary (homozygous) form of hyperlipidemia are prescribed 40 mg once a day or 80 mg for 3 doses (morning and afternoon 20 mg, in the evening - 40 mg). With IHD, the daily dose varies in the range of 20-40 mg. With simultaneous therapy with fibrates, gemfibrozil, Danazol, Ciclosporin, Naitsin, it is recommended to take no more than 10 mg of simvastatin every day. When taking Verapamil and Amiodarone, take no more than 20 mg of statin daily.

Overdose

Specific symptomatology is not described. Treatment: reception of enterosorbents, posindrome therapy. It is recommended to control the hepatic parameters, CK. With the development of renal failure, myopathies with rhabdomyolysis are prescribed intravenously sodium bicarbonate and a diuretic drug. Hemodialysis can be performed according to the indications. Against the background of rhabdomyolysis, hyperkalemia is registered, which requires an intravenous infusion of calcium gluconate, calcium chloride, insulin with glucose.

Interaction

Myopathy can be caused by the following medicines:
    Nefazodone;
    HIV protease inhibitors;
    Erythromycin;
    large doses of nicotinic acid;
    antimycotics (Itraconazole, ketoconazole);
    fibrates;
    immunosuppressants;
    Telithromycin;
    Clarithromycin.
High doses of simvastatin and the joint administration of Danazol and Cyclosporine may lead to rhabdomyolysis. The drug is able to potentiate the effect of oral forms of anticoagulants (Warfarin, Fenprokumone), increase the risk of bleeding. The drug increases the concentration of digoxin.

Terms of sale

You can buy Simvastatin without a prescription form.

Storage conditions

Dry place. It is recommended that the manufacturer comply with the temperature range of 15-25 degrees.
Shelf life - 2 years.

special instructions

The first days of therapy may be accompanied by an increase in ALT, AST, bilirubin. It is recommended a regular ultrasound-control (with the reception of 80 mg - every 3 months). The increase in enzymes of the hepatic system 3 times is an indication for the cessation of treatment. Compliance with the hypocholesterol diet allows you to achieve the best results. It is recommended to give up grapefruit juice during treatment. Medication is not used for hypertriglyceridemia of 1.4 and 5 types. The drug can provoke myopathy, which leads to kidney failure and rhabdomyolysis. The medication is effective both in monotherapy and in joint treatment with bile acid sequestrants.

During pregnancy (and lactation)

Simvastatin is contraindicated in carrying a pregnancy, tk. can cause various abnormalities in newborns. During treatment, contraception is mandatory. There are no data on the penetration of the active substance into breast milk. Nevertheless, it is important to remember there is a high risk of Simvastatin's influence on the health of the child.

Reviews about simvastatin (opinion of doctors, patients)

Reviews about simvastatin on the forums are different. The patients confirm that the medicine really lowers the cholesterol level, but at the same time they describe various negative reactions against the background of the entire course of hypocholesterolemic therapy. Patients suffering from chronic pancreatitis, note an increase in the frequency of exacerbations on the background of treatment. With prolonged therapy, the lipid profile changes for the better.
The doctors' opinions are divided. Some believe that the drug belongs to the "old guard" and outlived itself, given the severity of adverse reactions, and the appearance in the pharmaceutical market of Atorvastatin and Rosuvastatin, which are related to a new generation drug. Others note that the drug successfully reduces cholesterol and serves as an excellent means of preventing atherosclerosis.