Simwagexal

Roman name

SimvaHEXAL

Characteristics

Gipolipidemicescoe vehicle produced by synthetic product of the fermentation Aspergillus terreus is lactonom inactive in the body is metabolizmu education gidroksikislotny derivative.

Pharmacokinetics

Absorption simwastatina high. Once inside C_max in plasma is about 1,3-2,4 h is reduced by 90% after 12 hours Linking blood plasma proteins is about 95%. Metabolised in the liver. There is a "first walk" through the liver (hydrolyses education active derivative-beta-gidrokshikislota, as well as other active and inactive metabolites). T_1/2 active metabolites 1.9 C.vwoditsa mainly from urine masses (60%) in the form of metabolites, about 10-15% in the kidneys inactive form.

Farmakodinamika

The effect is two weeks from the beginning of the reception, the maximum therapeutic effect was achieved through the 4-6 weeks. The remains for continuing treatment with a therapy cholesterol gradually returning to the original level.

Indications

Giperholesterinemia : primary giperholesterinemia (type IIa and IIb), with the poor diet low in cholesterol and other nemedikamentozhnykh activities (physical load and lower body mass index) in patients with increased risk of coronary atherosclerosis; Combined giperholesterinemia and gipertriglitzeridemia beyond the correction special diet and physical Nagruzka.ibs : prevention of myocardial infarction (secondary prevention of myocardial infarction) in patients with high cholesterol levels (> 5.5 mmol / l).

Pregnancy and lactation

We have to take Simwagexal during pregnancy. There are several reports on the development of abnormalities in the infants whose mothers took Simwastatin.jenshchina childbearing age taking simwastatin should avoid conception. If in the process of receiving drug pregnancy still occurred, it is necessary to cancel the reception Simwagexala, and the woman should be warned of the possible danger to Ploda.dannye allocating simwastatina with breastfed lacking. The appointment Simwagexala women in the period of breast-feeding, it should be borne in mind that many drugs are in breast milk, and there is a threat of severe reactions, and breast-feeding during a drug is not recommended.

Contraindications

Hypersensitivity to simwastatino or to other components of the drug, as well as other drugs statinovogo stimulants (inhibitors Hmg-coa-reduktaza) in history; Liver failure, acute liver disease, permanent increase in liver transaminaz unclear etiology; Violation of the red blood cells (porfirii); Of skeletal muscles (miopatia); Admission ketokonazola, itrakonazola (systemic antifungals) funds for the treatment of HIV infection; pregnancy, breast-feeding.

Specific guidance

At the beginning of therapy may simwastatinom transient increased liver enzymes (savorotocnaya transaminaza). Before therapy, and continue to be a study of the liver (monitor activity transaminaz liver every six weeks. For the first 3 months. , And then every 8 weeks. For the remainder of the first year, and then once a year) and with the increasing doses should be a test to determine the liver. When increasing doses up to 80 mg need to test every three months. The steady increase activity transaminaz (3 times compared to the reference level) reception Simwagexala Prekratiti.simwagexal should, like other inhibitors G-koa-reduktaza should not be applied to the increased risk of rabdomioliza and renal failure (in the face of severe acute infection, arterial hypotension, a planned surgery, injuries, heavy metabolic disturbance). The removal of lipid during pregnancy does not have a significant impact on the long-term treatment of primary �иперхолестеринемии.В �back to the fact that inhibitors G-koa-reduktaza down cholesterol synthesis and holestetrin and other products synthesis play a significant role in fetal development, including synthesis of steroids and cell membranes, simwastatin can have adverse effects on fruit in the appointment of his pregnant women (women of childbearing age should avoid conception). If the treatment was pregnancy, the drug must be lifted and the woman warned of the possible danger to Ploda.u patients with decreased function of the thyroid gland (hypothyroidism), or when a certain kidney disease (principally syndrome), with the increase cholesterol levels should be the therapy of the Zabolevania.patienta must inform the doctor of any kind on the part of the muscle system. For diagnosis of myo to regularly measure the KFK.S caution appoint persons who have history of Pecheni.do to and during the treatment of the patient should be gipoholesterinova Diete.odnowremenny reception grapefruit juice could increase the extent side effects associated with the admission Simwagexala, therefore avoid simultaneous Priema.u patients with mialgiei, myasthenia and / or expressed increased activity revolved drug treatment ceased. Simwagexal not shown when there is gipertriglitzeridemia I, IV and V Tipov.effectiven both in the form alone, or in combination with biliary sekwestrantami Kislot.v passes for the current dose medication to be taken as soon as possible. If it is time to receive the next dose, dose should not Udwaivati.patientam with severe renal failure treatment are under the control of the Pocek.dlitelnosti drug use by the attending physician individually.

Patient interaction

Cytostatics, antifungals (ketokonazol, Itraconazole) fibrata, high doses of nicotinic acid, immunosuppressants erythromycin, klaritromicin, protease inhibitors increase the risk of developing рабдомиолиза.Приводи�� a tightening of oral anticoagulants (eg, patients, warfarin), and increases the risk of bleeding, which requires that control blood coagulability prior to the start of treatment and regularly in the Lechenia.povshaet level of digoxin in plasma Krovi.holestiramin and colestipol reduce bioavailability (application simwastatina possibly through 6700 after taking the drugs, there was an additive effect).

Precautions

Be wary appoint people who misuse alcohol, patients after organ transplantation, which the therapy immunodepressantami (as a result of the heightened risk of rabdomioliza and kidney failure); For conditions that could lead to failure expressed by the kidney, such as arterial hypertension, acute infectious diseases heavy currents expressed metabolic and endocrine, Violations vodno-elektrolitnogo balance surgery (including dental), or injury; patients with reduced or increased tone skeletal muscles unclear etiology; with epilepsy; up to 18 years of age (the safety and effectiveness of the unknown).

Storage conditions

List B. The temperature is not above 30 ° C

Shelf life

3 years

The registration

015775/01

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