Zocor
Zocor (Simvastatin)Pharmacological action
The Hypolipidemichesky preparation received synthetic by from a product of fermentation Aspergillus terreus.
In an organism Zocor, being an inactive lactone, is exposed to hydrolysis with formation corresponding the derivative. The last represents the basic metabolite having inhibiting influence on a 3-3-3-3-coenzyme And reductase, enzyme which initial and limiting rate a stage of biosynthesis of cholesterol (Xc). As a result, as it has been shown in clinical researches, Zocor reduces the maintenance of the general Xc in a blood plasma. Zocor causes maintenance dropping in plasma of triglycerides.
Researches of therapeutic Zocor influence on a primary hypercholesterinemia at which diet appointment has appeared insufficient were carried out. Zocor possesses high efficiency concerning depression of level of the general cholesterolin cases of heterozygotic family and single forms of a hypercholesterinemia, and also at the admixed lipidemia when the raised maintenance of cholesterol is a risk factor. The appreciable effect was reached within 2 weeks, the maximum therapeutic effect - within 4-6 weeks after the treatment beginning. The effect remained at treatment continuation. At the termination of therapy by Zocor preparation the general maintenance of cholesterol came back to initial level prior to the beginning of treatment.
By results of research it is established, that Zocor application reduced risk of development of an infarct, a stroke and reduced frequency of carrying out of operations on a revascularization on 1/3 (after the admission by regimen non-observance) with conservation of safety of use of a preparation. In research also it is established, that Zocor efficiency did not depend on initial level of cholesterol, age and a floor of patients and from simultaneous carrying out of other therapy.
Indications
Ischemic heart disease; the preparation is shown patients:
- For the purpose of depression of the general mortality;
- For the purpose of reduction of risk of a coronary mortality and myocardial infarction preventive maintenance;
- For the purpose of depression of risk of development of a stroke and transient disturbances of a cerebral circulation;
- For the purpose of probability depression to undergo operations on restoration of a coronary blood flow;
- For the purpose of retardation of advance of a coronary atherosclerosis.
Hypercholesterinemia:
Dosage regimen
Usually initial dose makes 10 mg of 1 times/sut in the evening.
At an easy or moderate hypercholesterinemia the initial dose makes 5 mg/days
In need of application of higher doses dose rising should be made, observing 4-week intervals. The maximum daily dose - 80 mg.
At ischemic heart disease Zocor prescribe in an initial dose of 1 times/24h of 20 mg in the evening. Correction of a regimen of dosage, in case of need, should be carried out the same as and at a hypercholesterinemia.
As Zocor is deduced by kidneys in a small amount, there is no necessity for change of a dose at patients with moderately expressed disturbances of function of kidneys. At patients with the expressed disturbances of function of kidneys (a clearance of a creatinine less than 30 ml/mines) should be estimated carefully expediency of appointment of a preparation in a dose exceeding 10 mg/days If such dose is considered necessary, it is necessary to prescribe it with care.
Side effect
During the researches spent on the average within 5.4 years, safety and shipping of a preparation in groups of the patients receiving Zocor (n=2221) on 20-40 mg/24h.
From the alimentary system: an abdominal pain, a constipation, a meteorism (1 % and more); it was in addition informed on cases of occurrence of a nausea, a diarrhoeia, a dyspepsia, a pancreatitis, vomiting, a hepatitis, an icterus; probably expressed and steady rising of activity of transaminases (more, than in 3 times exceeding the top limit of norm). Deviations in indicators of functional hepatic assays are usually weakly expressed and have transient character.
From party TSNS and peripheric nervous system: a headache (0 %), giddiness, muscular cramps, paresthesias, a peripheric neuropathy.
Allergic reactions: seldom - a Quincke's disease, a vasculitis, a thrombocytopenia, an eosinophilia, ESR augmentation, an arthritis, an urticaria, a photosensitization, a fever, a dermahemia, a dyspnea.
Dermatological reactions: a dermal eruption, an itch, an alopecia.
The other: an asthenia (0 %), an anaemia; in rare instances - a myopathy.
Zocor as a whole it is well transferred;
Contraindications
- Liver disease (in an active phase);
- Proof rising of activity of transaminases of an obscure aetiology;
- Pregnancy;
- A lactemia (thoracal feeding);
- A hypersensibility to a preparation.
Pregnancy and lactemia
Besides, cholesterol and other products of its biosynthesis play an essential role in a fetation, including synthesis of steroids and cellular membranes.
In need of Zocor appointment the woman in a lactemia should consider, that many medicinal preparations are allocated with thoracal milk, and there is a threat of development of serious adverse reactions, therefore feeding by a breast it is not recommended.
The women of genital age Zocor accepting, should avoid conception. If in the course of Zocor treatment there is a pregnancy, the preparation should be cancelled, and the woman should be warned about possible danger to a foetus.
Special indicatings
Prior to the beginning and during all course of Zocor therapy the patient should be on a hypocholesteric diet.
Zocor is necessary to prescribe with care to the patients abusing alcohol and-or having in the anamnesis of disease of a liver.
During Zocor therapy development transitional moderated (less, than in 3 times) risings of activity of the transaminases, a proceeding asymptomatically and not demanding preparation proceeding asymptomatically cancellation is possible.
The expressed observed in Zocor reception expressed and steady rising of activity of hepatic transaminases observed in Zocor reception (more than in 3 times) at the treatment termination usually came back to initial level. Rising of level of transaminases has not been bound to an icterus or other clinical semiology. Some of patients at whom rising of activity of transaminases was observed, before the beginning of Zocor treatment had deviations in results of functional hepatic assays and-or abused alcohol.
Before the treatment beginning all patients are recommended to carry out research of function of a liver, which follows periodically (for example, time in half a year) to repeat during 1 year of treatment or within 1 year after last rising of a dose. To patients at whom the daily dose makes 80 mg, it is necessary to carry out research of 1 times in 3 months Special attention it is necessary to give to patients with hyperactivity of transaminases. To these patients research is necessary for repeating in the near future and in the subsequent to spend him more often. When level of transaminases accrues, especially at excess in 3 times of the top border of norm, and has steady character, the preparation should be cancelled.
Use in pediatrics
Safety and efficiency of application of a preparation in pediatric practice are not established. Do not recommend to prescribe a preparation to children.
Overdosage
It was informed on several cases of an overdosage; at one of patients it is not taped any specific symptoms, consequences it was not observed. The maximum accepted dose - 450 mg.
Treatment: spend symptomatic therapy.
Medicinal interaction
At simultaneous Zocor application with cytostatics, high doses of nicotinic acid the risk of development of a myopathy raises.
Conditions and periods of storage
The preparation should be stored at temperature not above 30 C; to avoid time influence of temperatures above 50 C.
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