Rozuvastin сандоз

General characteristics. Structure:

Active ingredient: rosuvastatin;

1 tablet, coated, contains 5 mg, 10 mg, 20 mg or 40 mg of a rozuvastatin (in the form of a rozuvastatin of calcium);

excipients: lactose, silicon dioxide colloid anhydrous, cellulose microcrystallic, starch corn, talc, the sodium stearylfumarating;

cover: gipromelloza, mannitol (Е 421), macrogoal 6000, titanium dioxide (E171), ferrous oxide yellow (E172), ferrous oxide red (Е 172), talc.

Pharmacological properties:

Pharmacodynamics. Rozuvastatin is the selection and competitive inhibitor of GMG-KOA-reduktazy — the enzyme turning 3-hydroxy-3-metilglutarilkoenzim A in мевалонат, the predecessor of XC. A target organ of action of a rozuvastatin is the liver where regulation of level XC is carried out.

Rozuvastatin increases the number of hepatic receptors of LPNP by surfaces of cells, and also capture and a catabolism of LPNP that, in turn, leads to oppression of synthesis of LPONP, reducing total quantity of LPNP and LPONP. Rozuvastatin reduces excess quantity of the XC LPNP, the general XC and TG and increases quantity of the XC LPVP. It also reduces amount of apolipoprotein B (Apov), the XC NELPVP, the XC LPONP, TG LPONP also increases the level of A-1 apolipoprotein (Apoa 1). Rozuvastatin also reduces a ratio of the XC LPNP/HS LPVP, the general XC/XC LPVP and XC NELPNP/HS LPVP and a ratio of Apov/Apoa-1.

The therapeutic effect is reached during 1 week after the beginning of therapy, and in 2 weeks of treatment — 90% from greatest possible. The maximum effect is reached on 4 weeks and supported at further reception.

Pharmacokinetics. After oral administration of Cmax of a rozuvastatin in a blood plasma it is reached in 5 h. Absolute bioavailability makes ≅20%. Rozuvastatin collects in a liver which is the place of primary synthesis of XC and clearance of the XC LPNP. The volume of distribution of a rozuvastatin makes about 134 l. About 90% of a rozuvastatin contact proteins of a blood plasma, are preferential with albumine. Is exposed to limited metabolism (≅10%). Researches of metabolic transformation in vitro using hepatocytes of the person demonstrate to what розувастатин is non-core substrate for isoenzymes of system of P450 cytochrome. The main isoenzyme participating in metabolic transformation of a rozuvastatin is CYP 2C9 enzyme whereas isoenzymes 2C19, 3A4 and 2D6 are involved in this process to a lesser extent. The main revealed metabolites of a rozuvastatin are N-desmetil and lactone metabolites. N-desmetil metabolite for about 50% is less active, than розувастатин, and lactone metabolites are considered as clinically inactive. More than 90% of pharmacological activity on inhibition of the circulating GMG-KOA-reduktazy are provided rozuvastatiny.

About 90% of a dose of a rozuvastatin are removed in not changed view with a stake (including absorbed and not adsorbed розувастатин), the rest — with urine. About 5% are removed in not changed view with urine. T½ makes about 19 h of plasma. Duration of T½ does not change at increase in a dose. Geometrical average value of clearance makes ≅50 l/h of a blood plasma (coefficient of variation — 21,7%). As well as in case of other inhibitors of GMG-KOA-reduktazy, the membrane carrier of OATP-C which is carrying out an important role in hepatic elimination of a rozuvastatin is involved in process of hepatic capture of a rozuvastatin.

Indicators of system influence of a rozuvastatin raise in proportion to a dose. At repeated daily administration of drug of change of pharmacokinetic indicators does not occur.

Pharmacokinetics in populations 

Age and floor. Clinically significant influence of age and a sex of patients on pharmacokinetic indicators of a rozuvastatin was not revealed.

Ethnic groups. Results of pharmacokinetic researches showed approximately double increase in median AUC and Cmax value at reception by patients of Mongoloid race (Japanese, Chinese, Filipinos, Vietnamese and Koreans) in comparison with the Caucasian; at natives of India median AUC and Cmax value increased approximately by 1,3 times. The population pharmacokinetic analysis did not show clinically significant distinctions in pharmacokinetic characteristics at administration of drug by patients of Caucasian and negroid races.

Renal failure. Results of a research of patients with a renal failure of various degree demonstrate that the disease of kidneys from low to moderate degree does not influence indicators of concentration of a rozuvastatin and its metabolite of N-desmetila in a blood plasma. At patients with the expressed renal failure (clearance of creatinine <30 ml/min.) concentration of a rozuvastatin in a blood plasma is 3 times higher, and concentration of N-desmetila is 9 times higher, than at healthy volunteers. Concentration of a rozuvastatin in a condition of a dynamic equilibrium in a blood plasma of the patients who are on a hemodialysis is about 50% higher, than at healthy volunteers.

Liver failure. According to results of clinical trials, at patients with a liver failure with point 7 on a scale of Chayld-Pyyu increase in T½ of a rozuvastatin is not revealed. At 2 patients with points 8 and 9 on a scale of Chayld-Pyyu increase in T½ is noted at least twice. Experience of use of a rozuvastatin for patients with point higher than 9 on a scale of Chayld-Pyyu is absent. 

Children. Pharmacokinetic parameters at reception by patients aged from 10 up to 17 years with a heterozygous family hypercholesterolemia are completely not described. Results of a limited pharmacokinetic research at reception of a rozuvastatin (in the form of tablets) 18 children demonstrate that indicators of its influence correspond to that at reception at adults. Besides, the obtained data showed that there is no essential deviation from a proportion at reception of various doses.

Indications to use:

Treatment of a hypercholesterolemia 

Primary hypercholesterolemia or dislipidemiya of the mixed type (IIB type) at adults and children is aged more senior than 10 years as addition to a diet when the answer to a diet or other non-drug methods of treatment (such as physical exercises, a body degrowth) is insufficiently effective.

Homozygous family hypercholesterolemia as addition to a diet and other methods of decrease in maintenance of lipids (for example an afereza of LPNP) or in cases when performing such therapy is impossible.

Prevention of cardiovascular diseases 

It is shown for decrease in risk of emergence of serious cardiovascular violations at adult patients with the increased risk of development of atherosclerotic cardiovascular diseases what existence of risk factors testifies to: age, AG, the LPVP low level XC, the increased protein SRB-reaktivnogo level, smoking or existence in the family anamnesis of a prematurity of an ischemic heart disease.

Route of administration and doses:

Prior to therapy of the patient it is necessary to transfer to a standard diet with the reduced content of XC which he should observe further at therapy. Doses select individually, taking into account the purpose of therapy and the answer to it, following recommendations.

Rozuvastatin it is possible to accept at any time during the day, irrespective of meal.

Treatment of a hypercholesterolemia 

The recommended initial dose — 5/10 mg in 1 times a day for the patients who were not receiving drugs of group of statines earlier or the patients receiving earlier other drugs — GMG-KOA-reduktazy inhibitors. At the choice of an initial dose it is necessary to consider individual indicators: level is XC and risk from cardiovascular system, and also risk of by-effects. Dose adjustment with its increase if necessary is carried out in 4 weeks. Because of increase in frequency of cases of side reactions at administration of drug in a dose of 40 mg in comparison with lower doses increase in a dose to 40 mg is recommended only at treatment of patients with a hypercholesterolemia of heavy degree, at high risk of development of the phenomena from cardiovascular system when administration of drug in a dose of 20 mg does not provide desirable result, on condition of regular carrying out medical control. Administration of drug in a dose of 40 mg is recommended to be carried out only under observation of the doctor.

Prevention of disturbances from cardiovascular system 

During the research of influence of drug on decrease in risk of development of complications from cardiovascular system drug applied 20 mg/days in a dose.

Children aged from 10 up to 17 years (boys — on reaching pubertal development of the II stage on Tannera or the highest, the girl — not earlier than in 1 year after menarche). In pediatric practice the specialist has to appoint drug only. To children, as a rule, appoint 5 mg/days in an initial dose. Usual range of doses — 5–20 mg orally 1 time a day. Increase in a dose is carried out taking into account individual reaction and portability according to recommendations to use in pediatric practice. Before therapy using a rozuvastatin the child should appoint a standard diet with the low content of XC; it is necessary to adhere to a diet also during performing therapy. Safety and efficiency of use of drug in a dose> did not investigate 20 mg for treatment of children aged from 10 up to 17 years.

Tablets on 40 mg are not intended for use in pediatric practice.

Children aged up to 10 years 

Experience of use of drug for treatment of children aged up to 10 years is limited by a small amount of patients (aged from 8 up to 10 years) with a homozygous family hypercholesterolemia. Rozuvastatin is not recommended to apply at children aged up to 10 years.

Elderly people 

At use of drug at the age of ≥70 years the recommended initial dose has to make 5 mg. The subsequent dose adjustment is not required.

Renal failure 

Dose adjustment at a renal failure of easy and moderate degree is not required.

At use of drug for patients with a renal failure of average degree (clearance of creatinine <60 ml/min.) the recommended initial dose — 5 mg. Use of drug in a dose of 40 mg is contraindicated. Use of a rozuvastatin for patients with a heavy renal failure is contraindicated in any doses.

Liver failure 

Increase in indicators of system influence of a rozuvastatin at reception by patients with a liver failure with point 7 on a scale of Chayld-Pyyu or below is not noted. At reception by patients with a liver failure points 8 and 9 on a scale of Chayld-Pyyu noted increase in indicators of system influence of a rozuvastatin. At treatment of patients of such category it is necessary to check function of kidneys also regularly. There is no experience of use of drug for patients with a liver failure higher than 9 points on a scale of Chayld-Pyyu. Use of a rozuvastatin for patients with an aggravation of a zabolevaniy liver is contraindicated.

Ethnic groups 

Increase in indicators of system influence at use of drug for patients of Mongoloid race is noted. The recommended initial dose for patients of Mongoloid race makes 5 mg. Use of drug in a dose of 40 mg at such patients is contraindicated.

The dosing mode for the patients inclined to a myopathy 

The recommended initial dose — 5 mg. Use of drug in a dose of 40 mg at such patients is contraindicated. The maximum daily dose makes 20 mg.

Features of use:

From kidneys 

The proteinuria of a canalicular origin confirmed laboratory was noted at use of a rozuvastatin in high doses, especially 40 mg, in most cases disturbances had temporality. It is proved that the proteinuria is not the evidence of development acute or progressing of the existing disease of kidneys. Frequency of heavy disturbances from kidneys increases at administration of drug in a dose of 40 mg. At purpose of drug in a dose of 40 mg it is necessary to include a research of function of kidneys in the program of standard monitoring surely.

From skeletal muscles 

Disturbances in the form of a mialgiya (infrequently — a rabdomioliza) were noted against the background of reception of a rozuvastatin in any doses, most often at reception in doses> 20 mg. It was very seldom reported about cases of a rabdomioliz at the combined use of an ezetimib and inhibitors of GMG-KOA-reduktazy. Pharmakodinamichesky interaction is not excluded. Therefore, at the combined use of drugs extra care is necessary.

As well as in case of use of other inhibitors of GMG-KOA-reduktazy, the frequency of cases of a rabdomioliz against the background of reception of a rozuvastatin increases at use in a dose of 40 mg.

Determination of the KFK level 

Determination of the KFK level should not be carried out after an active exercise stress or in the presence of other probable causes of increase in concentration of KFK because of probability of obtaining false positive results. In case of increase in concentration of KFK prior to therapy (> 5 VGN) it is necessary to carry out repeated determination of the KFK level for inspections of the received result in 5–7 days. If results of retest confirm preliminary result — increase in concentration of KFK (> 5 VGN), treatment it is not necessary to begin.

Prior to therapy 

Rozuvastatin, as well as other inhibitors of GMG-KOA-reduktazy, with care it is necessary to apply at the patients inclined to a myopathy / рабдомиолизу. Risk factors of development of a myopathy / рабдомиолиза are: a renal failure, a hypothyroidism, existence in the personal or family anamnesis of hereditary diseases of muscles, existence in the anamnesis of cases of muscular toxicity at use of other drugs — inhibitors of GMG-KOA-reduktazy or fibrat, an alcoholism, age> 70 years, situations in which increase in concentration of drug in a blood plasma, simultaneous use of fibrat is possible. At purpose of drug such patients should weigh carefully a ratio advantage/risk; continuous clinical monitoring is recommended. In case of increase in concentration of KFK prior to therapy (> 5 VGN) treatment should not be begun.

During therapy 

In cases of emergence of unclear pain in muscles, weakness or spasms, especially if such phenomena are followed by an indisposition or fever, it is necessary to see a doctor immediately. In such cases definition of concentration of KFK is necessary. Therapy should be cancelled at substantial increase of concentration of KFK (> 5 VGN) or at heavy symptoms from muscles which are the reason of discomfort (even at the KFK level of ≤5 VGN). After elimination of symptoms and normalization of a creatine kinase therapy resuming rozuvastatiny or alternative drugs — GMG-KOA-reduktazy inhibitors in the lowest dose and on condition of appropriate monitoring of a condition of the patient is possible. Continuous monitoring of the KFK level in the absence of symptoms is not necessary.

Increase in frequency of cases of a miositis and myopathy at the patients receiving other drugs — GMG-KOA-reduktazy inhibitors together with derivatives of fibroyevy acid, including gemfibrozily, cyclosporine, niacin drugs, azolny antifungal drugs, inhibitors of protease and makrolidny antibiotics is noted. Gemfibrozil increases risk of development of a myopathy at simultaneous use with some inhibitors of GMG-KOA-reduktazy. Simultaneous use of a rozuvastatin and gemfibrozil is not recommended. It is necessary to weigh comprehensively influence on decrease in level of lipids at a concomitant use of a rozuvastatin and fibrat or Niacinum, considering potential risk of the similar combined use. Purpose of drug in a dose of 40 mg at a concomitant use of fibrat is contraindicated.

Rozuvastatin it is not necessary to apply in case of a heavy acute myopathy, or provocative development of the renal failure caused rabdomiolizy (for example at sepsis, arterial hypotension, carrying out extensive surgical intervention, injuries, disbolism, endocrine disturbances or disturbances of electrolytic balance of high degree, or at uncontrollable epilepsy).

From a liver 

As well as other drugs — GMG-KOA-reduktazy inhibitors, Rozuvastatin Sandoz it is necessary to apply with care at the patients abusing alcohol and/or in the anamnesis of which there are liver diseases.

It is recommended to carry out monitoring of function of a liver before, and also in 3 months after the beginning of therapy. Further reception of a rozuvastatin it is necessary to cancel or lower a drug dose in cases when the level of serumal transaminases more than by 3 times exceeds VGN. Frequency of cases of heavy disturbances from a liver (which manifestations increase in level of hepatic transaminases preferential is) during the post-registration period higher against the background of administration of drug in a dose of 40 mg.

In existence cases at the patient of a secondary hypercholesterolemia owing to a hypothyroidism or a nephrotic syndrome the basic disease should be cured prior to therapy rozuvastatiny.

Protease inhibitors 

Simultaneous use of drug with drugs — inhibitors of protease is not recommended.

Drug Rozuvastatin Sandoz contains lactose. To patients with rare hereditary diseases (intolerance of a galactose, deficit of lactase or disturbance of digestion of glucose galactose) розувастатин it is contraindicated.

Intersticial disease of lungs 

It was reported about separate cases of development of an intersticial disease of lungs against the background of reception of some drugs from group of statines, especially at long therapy. Short wind, unproductive cough and deterioration in the general state of health (fatigue, a degrowth of a body and fever) can be symptoms of a disease. At suspicion on development of an intersticial disease of lungs therapy using statines should be cancelled.

Diabetes mellitus 

At use of a rozuvastatin for patients with uroveny concentration of glucose on an empty stomach of 5,6-6,9 mmol/l the risk of development of a diabetes mellitus increases.

Ability to influence speed of response at control of vehicles or work with mechanisms. There are not enough data. It is necessary to consider a possibility of dizziness which is sometimes noted against the background of treatment.

Use during pregnancy and feeding by a breast. Use of a rozuvastatin is contraindicated. Women of reproductive age should apply well-tried remedies of contraception. As XC and other products of biosynthesis of XC are important for fetation, the potential risk of inhibition of GMG-KOA-reduktazy during pregnancy exceeds advantage of therapy. Results of researches on animals demonstrate the limited delayed toxic influence. In case of approach of pregnancy during drug use further therapy should be cancelled immediately. There are no data on release of drug in breast milk.

Children. Use of drug for children aged up to 10 years is not recommended.

Definition of growth rates, body weights, the body weight index (BWI) and formation of secondary signs of sexual development on Tanner's scale at teenagers aged from 10 up to 17 years against the background of reception of a rozuvastatin is limited to the period in 1 year. After completion of 52 weeks therapy of a deviation of indicators of growth, body weight, IMT and sexual development were not noted. Experience of use of a rozuvastatin during clinical trials with participation of children and teenagers is limited, influence of drug on sexual development at prolonged use (> 1 years) it is unknown.

During clinical trial with participation of the children and teenagers receiving розувастатин during 52 weeks, cases of increase in concentration of KFK to level by 10 times exceeded VGN, and also symptoms from skeletal muscles after sports or an exercise stress were noted more often than during clinical trials with participation of adults.

Side effects:

The side effects noted at treatment are temporary and pass in easy degree. Frequency of side effects is determined by the following parameters: very often (≥1/10), it is frequent (≥1/100 to <1/10), infrequently (≥1/1000 to <1/100), is rare (≥1/10 000 to <1/1000), is very rare (<1/10 000), frequency is unknown (it cannot be established according to the available data).

From immune system: seldom — hypersensitivity reactions, including a Quincke's disease.

From endocrine system: often — a diabetes mellitus.

From a nervous system: often — a headache, dizziness.

From a GIT: often — a lock, nausea, an abdominal pain; seldom — pancreatitis.

From skin and appendages: infrequently — an itch, rash, urticaria.

From a musculoskeletal system and connecting fabric: often — a mialgiya; seldom — a myopathy (including a miositis) and рабдомиолиз.

System disturbances: often — an adynamy.

As well as at use of other inhibitors of GMG-KOA-reduktazy, the frequency of side reactions depends on a drug dose.

From an urinary system: at reception of a rozuvastatin the proteinuria of a canalicular origin confirmed laboratory was noted. Increase in protein content in urine from total absence or insignificant quantity to ++ more at various stages of therapy was noted at <1% of patients at use of drug in a dose of 10 and 20 mg and at ≅3% of patients at use of drug in a dose of 40 mg. Increase in protein content in urine from total absence or insignificant quantity to + was noted at use of drug in a dose 20 mg. In most cases manifestations of a proteinuria decreased or disappeared independently against the background of therapy continuation. 

From skeletal muscles: a mialgiya, a myopathy (including a miositis) and it is rare рабдомиолиз, the accompanied or not accompanied OPN, were noted at the patients receiving розувастатин in any doses, in particular in doses> 20 mg.

At the patients receiving розувастатин dozozavisimy increase in concentration of KFK was noted. In most cases easy degree, with an asymptomatic current, temporality. At increase in concentration of KFK to level> the 5th upper U UU (UUU) therapy should be cancelled.

From gepatobiliarny system: as well as at reception of other inhibitors of GMG-KOA-reduktazy, the increase in activity of transaminases depending on a dose was noted at some patients receiving розувастатин. In most cases — easy degree, with an asymptomatic current also had reversible character.

Period of post-marketing use of a rozuvastin 

From a nervous system: very seldom — polyneuropathy, memory loss.

From respiratory system: frequency is unknown — cough, suffocation.

From a GIT: frequency is unknown — diarrhea.

From gepatobiliarny system: very seldom — jaundice, hepatitis, it is rare — increase in activity of hepatic transaminases.

From skin and hypodermic fatty tissue: frequency is unknown — Stephens's syndrome — Johnson.

From a musculoskeletal system: very seldom — an arthralgia.

From an urinary system: seldom — a hamaturia.

System and local disturbances: frequency is unknown — hypostases.

At use of some statines the following side effects were noted: depression, sleep disorder, including sleeplessness and alarming dreams, disturbance of reproductive functions; very seldom — an intersticial disease of lungs, especially when performing long therapy.

Frequency of cases of a rabdomioliz, heavy disturbances from kidneys and/or a liver (preferential growth of activity of hepatic transaminases) increases at administration of drug in a dose of 40 mg.

Interaction with other medicines:

At simultaneous use of a rozuvastatin and cyclosporine AUC value of a rozuvastatin was on average 7 times higher than value at healthy volunteers. Concentration of cyclosporine in a blood plasma at the same time did not change.

As well as in case of use of other drugs-inhibitors of GMG-KOA-reduktazy, at the beginning of therapy or at increase in a dose of a rozuvastatin at patients who at the same time receive drugs — antagonists of vitamin K (warfarin or other indirect anticoagulants) growth of a prothrombin time is possible. Cancellation of therapy using a rozuvastatin or a dose decline can provide decrease in an indicator of the international normalized relation (INR). In such cases appropriate monitoring of indicators of MNO is recommended.

Simultaneous use of a rozuvastatin and gemfibrozil leads to increase in indicators of Cmax and AUC of a rozuvastatin twice.

According to data of researches of specific interaction with medicines, there is no significant pharmacokinetic interaction with fenofibraty, however it is not excluded. Gemfibrozil, fenofibrata, other fibrata and Niacinum (niacin) in a dose which is applied to decrease in maintenance of lipids (≥1 g/days) increase risk of development of a myopathy at simultaneous use with GMG-KOA-reduktazy inhibitors probably because these drugs can cause development of a myopathy and at separate use. Administration of drug in a dose of 40 mg is contraindicated at a concomitant use of fibrat. Administration of drug at such patients is recommended to begin 5 mg/days with a dose.

At a concomitant use of a rozuvastatin and an ezetimib indicators of AUC and Cmax of one of drugs do not change. However the possibility of pharmakodinamichesky interaction between rozuvastatiny and ezetimiby that leads to development of side effects, is not excluded.

Though the exact mechanism of interaction is unknown, at a concomitant use of inhibitors of protease significant growth in indicators of influence of a rozuvastatin is possible. According to a pharmacokinetic research, at a concomitant use of a rozuvastatin in a dose of 20 mg and the combined drug containing two inhibitors of protease (400 mg lopinavira/100 the mg of a ritonavir), at healthy volunteers noted growth of an indicator of AUC (0–24) rozuvastatin in a condition of a dynamic equilibrium twice, and Cmax indicator — by 5 times. Thus, simultaneous use of a rozuvastatin in therapy of the HIV-positive patients receiving protease inhibitors is not recommended.

The concomitant use of a rozuvastatin and suspension of the antacids containing aluminum and magnesium hydroxide leads to decrease in concentration of a rozuvastatin in a blood plasma for 50%. This effect is expressed more weakly if antacids accept in 2 h after a rozuvastatin. Clinical value of this interaction was not investigated.

Simultaneous use of a rozuvastatin and erythromycin leads to decrease in AUC value (0-t) for 20%, and Cmax values of a rozuvastatin — for 30%. Such interaction is probably result of strengthening of motility of the intestines caused by erythromycin reception.

The concomitant use of a rozuvastatin and peroral contraceptives leads to increase in AUC value of ethinylestradiol and Norgestrelum for 26 and 34% respectively. Such increase in concentration in a blood plasma should be considered at the choice of the corresponding dose of contraceptives for oral administration. Pharmacokinetic data on reception of a rozuvastatin against the background of gormonozamestitelny therapy are absent, therefore, similar influence is not excluded. However the similar combination was widely applied at the women included in clinical trials and well transferred.

According to researches of specific interaction with medicines, there is no clinically significant interaction with digoxin.

Enzymes of system of P450 cytochrome. Results of the researches in vitro and in vivo demonstrate to what розувастатин does not show neither the inhibiting, nor stimulating influence on isoenzymes of system of P450 cytochrome. Besides розувастатин is bad substrate for these isoenzymes. Clinically significant interaction between rozuvastatiny and flukonazoly (inhibitor of CYP 2C9 and CYP 3A4 enzymes) or ketokonazoly is noted (inhibitor of CYP 2A6 and CYP 3A4 enzymes). At simultaneous use of a rozuvastatin and itrakonazol (inhibitor of CYP 3A4 enzymes) AUC value of a rozuvastatin increases by 28% that is not considered clinically significant. Thus, the medicinal interactions caused by change of activity of enzymes of system of P450 cytochrome no.

Contraindications:

Hypersensitivity to a rozuvastatin or to any of drug components.

Liver diseases in an aggravation stage, including at continuous increase in concentration of serumal transaminases of not clear etiology, and also increase in concentration of serumal transaminases more than by 3 times. Renal failure of heavy degree (clearance of creatinine <30 ml/min.). Myopathy. Simultaneous use of cyclosporine.

The dose of 40 mg is contraindicated to the patients inclined to a myopathy / рабдомиолизу. Treat factors of predisposition: renal failure of average degree (clearance of creatinine <60 ml/min.); hypothyroidism; existence in the individual or family anamnesis of hereditary diseases of muscles; existence in the anamnesis of cases of muscular toxicity at use of other drugs-inhibitors of GMG-KOA-reduktazy or fibrat; honichesky alcoholism; states at which increase in concentration of drug in a blood plasma is possible; Mongoloid race; simultaneous use of fibrat.

Overdose:

Treatment — symptomatic, if necessary to carry out a maintenance therapy. Monitoring of functions of a liver and the KFK level is necessary. Carrying out a hemodialysis is inexpedient.

Storage conditions:

In original packaging at a temperature up to 25 °C.

Issue conditions:

According to the recipe

Packaging:

Tablets п / captivity. cover of 5 mg blister, No. 28

Tablets п / captivity. cover of 10 mg blister, No. 28

Tablets п / captivity. cover of 20 mg blister, No. 28

Tablets п / captivity. cover of 40 mg blister, No. 28