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Vazilip

Application instruction:

Form of release and structure

Indications to use

Contraindications

Route of administration and dosage

Side effects

Special instructions

Analogs

Terms and storage conditions

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In more detail

Вазилип Vazilip – the drug used for decrease in content of the general cholesterol and cholesterol of lipoproteins of the low density (LPNP) in a blood plasma.

Form of release and structure

Vazilip produce in the form of tablets, film coated (round, slightly biconvex with slanted edges, white or almost white color), 7 pieces in blisters, on 2 or 4 blisters in cardboard packs.

10 mg, 20 mg or 40 mg of active agent – a simvastatin are a part of 1 tablet.

The auxiliary components which are a part of drug: butylhydroxyanisole, monohydrate of lactose, microcrystallic cellulose, prezhelatinizirovanny starch, anhydrous citric acid, ascorbic acid, corn starch, magnesium stearate.

Structure of a film cover: gipromelloza, propylene glycol, talc, titanium dioxide.

Indications to use

Vazilip apply to treatment of a hypercholesterolemia:

Primary hypercholesterolemia or the mixed dislipidemiya (along with a diet and at inefficiency of holding other non-drug actions – an exercise stress and decrease in body weight);
Homozygous hereditary hypercholesterolemia (at the same time with a special diet and hypolipidemic therapy, for example, from aferezy LPNP, or at inefficiency of these measures).

Also drug is used for prevention of cardiovascular diseases:

For reduction of cardiovascular mortality and incidence at patients with a diabetes mellitus or clinical displays of atherosclerotic cardiovascular diseases at the normal or increased cholesterol level;
As additional measure of cardiotyre-tread therapy and correction of other risk factors.

Contraindications

Vazilip's use is contraindicated:

In an active phase of diseases of a liver or at permanent increase in activity of hepatic transaminases of not clear etiology;
Along with CYP3A4 isoenzyme inhibitors (for example, ketokonazoly, itrakonazoly, HIV protease inhibitors, erythromycin, nefazodony, klaritromitsiny and telitromitsiny);
At hypersensitivity to drug components;
To children up to 18 years (safety and efficiency of use of drug for treatment of children are not studied);
To the feeding and pregnant women.

Vazilip it is necessary to appoint with care at an alcohol abuse before an initiation of treatment, extensive surgical interventions, injuries, and also the patient with:

Heavy acute infections (sepsis);
Liver diseases in the anamnesis;
The expressed metabolic and endocrine disturbances;
Heavy disturbances of electrolytic balance;
Arterial hypotension;
Myopathy;
Uncontrollable epilepsy;
Deficit of lactase, galactosemia or sprue of glucose galactose (because of the lactose which is contained in drug).

Also drug should be taken with caution along with cyclosporine, gemfibroziny, niacin (more than 1 g a day), verapamil, fenofibraty, Amiodaronum, diltiazem and grapefruit juice.

Route of administration and dosage

Vazilip accept inside, 1 time a day, in the evening. The recommended daily dosage varies from 5 mg to 80 mg.

Most often drug appoint 10 mg in an initial dose. Changes of a dosage it is necessary to spend not less than 4 weeks with an interval. The maximum daily dose (80 mg) is recommended only to patients with a heavy hypercholesterolemia or high risk of development of cardiovascular complications. Duration of administration of drug is defined by individually attending physician.

At a hypercholesterolemia:

Throughout the entire period of therapy of the patient has to keep to a standard hypocholesteric diet. The recommended initial dosage – 10 mg. For the purpose of more expressed lowering of the level of Hs-LPNP (it is more than for 45%) administration of drug can be begun with 20-40 mg of 1 times a day, in the evening.

To patients with a homozygous hereditary hypercholesterolemia about 40 mg of 1 times a day, are recommended to accept in the evening. Use in 3 receptions - in the morning and in the afternoon on 20 mg and 40 mg is possible in the evening. To such patients Vazilip is recommended to accept in combination with other hypolipidemic therapy (for example, aferezy LPNP).

At prevention of cardiovascular diseases:

At high risk of development of coronary heart disease (with a lipidemia or without it) about 20-40 mg of Vazilip a day are appointed. An initial dose – 20 mg, increase in a dose has to happen to an interval not less than 4 weeks. The maximum daily dose – 40 mg. At the maintenance of LPNP less than 75 mg/dl (1,94 mmol/l), the maintenance of general Hs less than 140 mg/dl (3,6 mmol/l), it is necessary to reduce a dosage of drug.

The accompanying therapy:

Drug is effective in monotherapy or along with sekvestrant of bile acids (for example, kolestipoly and Colestyraminum). At the patients receiving treatment gemfibrozily, cyclosporine, other fibrata or niacin (more than 1 g a day), the maximum daily dose – 10 mg is recommended to begin therapy with 5 mg a day. In such situations further increase in a dose is not recommended.

At the patients receiving at the same time verapamil or Amiodaronum, the daily dose of Vazilip should not exceed 20 mg.

At patients with the expressed renal failure (KK is less than 30 ml/min.) the recommended daily dose of Vazilip should not exceed 10 mg. In need of increase in a dose, careful medical observation is required.

And to elderly people dose adjustment is not required to patients with moderately expressed renal failure.

Side effects

At Vazilip's use side effects develop seldom:

From the alimentary system: meteorism, lock, dyspepsia, nausea, vomiting, abdominal pains, diarrhea, jaundice, pancreatitis, hepatitis, increase in activity of ShchF, hepatic transaminases, kreatinfosfokinaza;
From a musculoskeletal system: myopathy, рабдомиолиз, mialgiya, muscular spasms;
From sense bodys, TsNS and peripheral nervous system: dizziness, headache, paresthesias, sight vagueness, peripheral neuropathy, sleeplessness, spasms, adynamy, disturbance of flavoring feelings;
From integuments: alopecia, skin rash, itch;
Immune system and allergic reactions: the developed hypersensitivity syndrome - a rheumatic polimialgiya, a Quincke's disease, a dermatomyositis, a vasculitis, thrombocytopenia, a volchanochnopodobny syndrome, an eosinophilia, arthritis, increase SOE, an arthralgia, a photosensitization, fever, urticaria, an asthma, the expressed weakness and rushes of blood to face skin;
Other: anemia, an acute renal failure (owing to a rabdomioliz), heartbeat, decrease in a potentiality.

Special instructions

Women of reproductive age at Vazilip's use need to use well-tried remedies of contraception.

At increase in level of Hs at patients with reduced function of a thyroid gland (hypothyroidism) or in the presence of some diseases of kidneys (a nephrotic syndrome) originally it is necessary to carry out treatment of a basic disease.

Patients from a renal failure of heavy degree need to carry out therapy under control of function of kidneys.

Before an initiation of treatment or at increase in a dose of drug, the patient has to be informed on risk of emergence of a myopathy and need of the immediate address to the doctor at emergence of inexplicable pain, tension or weakness in muscles, especially along with fever or the general weakness. Before therapy the KFK initial level should be determined at an alcohol abuse, to elderly people, and also patients with:

Damage of kidneys;
Hereditary diseases of muscles;
Dekompensirovanny hypothyroidism;
Existence in the anamnesis of toxic impact on muscles of fibrat or statines.

Prior to the beginning of and during therapy the patient has to keep to a hypocholesteric diet.

At emergence during therapy or weakness it is necessary to determine by drug of muscular pains, spasms the KFK level. Criterion of drug withdrawal is increase in maintenance of KFK in blood serum more, than by 5 times VGN is relative. At suspicion on development of a myopathy (regardless of the reason) treatment should be stopped.

Simultaneous use of a simvastatin and gemfibrozil is possible only in cases when the estimated advantage of treatment considerably exceeds potential risk of such combination.

Drug can cause insignificant and clinically insignificant increase in activity of liver enzymes in blood serum. Usually after Vazilip's cancellation levels of transaminases slowly decrease to a reference value. Nevertheless, before an initiation of treatment and further it is necessary to conduct a research of function of a liver (within the first 3 months each 6 weeks to control activity of hepatic transaminases, then each 2 months within the remained first year, then 1 time in 6 months). Before increase in a dose to 80 mg it is necessary to control functions of a liver, then examinations are conducted periodically. Therapy by drug is stopped at permanent increase by 3 times of activity of ACT and/or ALT in blood serum concerning VGN.

Vazilip appoint with care the sick abusing alcohol, and also at liver diseases in the anamnesis.

Isolated cases of dizziness at Vazilip's use are celebrated that should be considered when driving the car.

Analogs

Vazilip's analogs are: Zokor, Zokor Forte, Simvor, Simvakard, Simvastol, Simlo, Simvastatin Zentiva, SIMVAGEKSAL, Zovatin, Levomir, Simvalimit, Aktalipid, Sinkard, Aterostat, Zorstat, Simvakol, Simplakor, Simvastatin, Holvasim, Simvastatin-Fereyn, Simvastatin-Chaykafarma, Simvastatin-SZ, Simvastatin Alkaloid, Ovenkor, Simvastatin Pfayzer.