Suvardio pills 10 mg 28 pcs
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Active ingredients
Rosuvastatin
Release form
Pills
Composition
1 tab. Rosuvastatin calcium (in terms of rosuvastatin) 10 mg. Excipients: anhydrous lactose - 53.
Pharmacological effect
Rosuvastatin is a selective, competitive inhibitor of HMG-CoA reductase - an enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A into mevalonate, the precursor of cholesterol. Rosuvastatin acts on the liver, where cholesterol (Xc) is synthesized and the catabolism of low density lipoproteins (LDL) is performed. Rosuvastatin increases the number of LDL receptors on the surface of hepatocytes, which enhance the uptake and catabolism of LDL, and inhibits the synthesis of very low density lipoproteins (VLDLP) by the liver, thereby reducing the amount of LDL and VLDL. Rosuvastatin reduces the concentration of low-density cholesterol-lipoproteins (Xc-LDL), total cholesterol, triglycerides (TG), increases the concentration of high-density cholesterol-lipoprotein (Xc-HDL), and also reduces the concentration of apolipoprotein B (ApoV), Xc-neLPVP, - VLDL, TG-VLDL and increases the concentration of apolipoprotein A-1 (ApoA-1) (see Table 1), reduces the ratio of Xc-LDL / Xc-HDL, total Xc / Xc-HDL and Xc-non-LPVP / Xs-LPLP and ApoB / ApoA-1 ratio. After initiation of rosuvastatin therapy, the therapeutic effect appears within one week, after 2 weeks of treatment it reaches 90% of the maximum possible effect. The maximum therapeutic effect is usually achieved by week 4 and is maintained with regular use of the drug. Clinical efficacy: Rosuvastatin is effective in adult patients with hypercholesterolemia, with or without hypertriglyceridemia, regardless of their race, gender, or age, including in patients with diabetes and familial hypercholesterolemia. In 80% of patients with hypercholesterolemia IIa and IIb type according to Fredrickson's classification (the average initial concentration of Xc-LDL is about 4.8 mmol / l) when using rosuvastatin at a dose of 10 mg, the concentration of Xc-LDL reaches less than 3 mmol / l. Patients with heterozygous familial hypercholesterolemia who took rosuvastatin in doses of 20 to 80 mg according to the forced dose titration scheme showed a positive trend in lipid profile parameters.After the titration of the daily dose to 40 mg / day (12 weeks of therapy), the concentration of Xc-LDL decreased by 53%. In 33% of patients, a decrease in the concentration of LDL-LDL of less than 3 mmol / l was achieved. In patients with homozygous familial hypercholesterolemia who took rosuvastatin in doses of 20 and 40 mg, the average decrease in the concentration of LDL-C LDL was 22%. The additive effect is observed in combination with fenofibrate in relation to the concentration of TG and with nicotinic acid (more than 1 g / day) in relation to the concentration of Xc-HDL. In patients with a low risk of developing IHD (the Framingham risk is less than 10% over a period of more than 10 years), with an average concentration of Xc-LDL 4.0 mmol / l (154.5 mg / dl) and subclinical atherosclerosis, assessed by the thickness of the intima media "carotid arteries (TCIM), rosuvastatin at a dose of 40 mg / day significantly slowed the rate of progression of the maximum TCIM for 12 segments of the carotid artery compared to placebo with a speed of 0.0145 mm / year (95% confidence interval (CI)): from - 0.0196 to - 0.0093, with p less than 0.0001). The dose of 40 mg should be prescribed only to patients with severe hypercholesterolemia and a high risk of developing cardiovascular diseases.
Pharmacokinetics
Absorption: Cum rosuvastatin in the blood plasma is reached approximately 5 hours after ingestion. Absolute bioavailability is about 20%. Distribution: Vd of rosuvastatin is approximately 134 l. About 90% of rosuvastatin binds to plasma proteins, mainly albumin. Metabolism: A limited amount of rosuvastatin (approximately 10%) is subject to biotransformation. Rosuvastatin is metabolized primarily by the liver, which is the main site of cholesterol synthesis and Xc-LDL metabolism. Rosuvastatin metabolism is slightly associated with cytochrome P450 isoenzymes. CYP2C9 isoenzyme is the main isoenzyme involved in rosuvastatin metabolism, while CYP2C19, CYP3A4 and CYP2D6 isoenzymes are less involved in metabolism. The main identified metabolites of rosuvastatin are N-dismethylrozuvastatin and lactone metabolites. N-desmethylrosuvastatin is approximately 50% less active than rosuvastatin, lactone metabolites are pharmacologically inactive. More than 90% of the pharmacological activity on inhibition of circulating HMG-CoA reductase is provided by rosuvastatin, the rest is provided by its metabolites.Withdrawal: Approximately 90% of the dose of rosuvastatin is excreted unchanged through the intestines (including absorbed and unabsorbed rosuvastatin), the rest is excreted by the kidneys. Unchanged by the kidneys excreted about 5% of the administered dose of the drug. T1 / 2 is 19 hours, does not change with increasing dose of the drug. The geometric mean plasma clearance is approximately 50 l / h (coefficient of variation 21.7%). As in the case of other inhibitors of HMG-CoA reductase, membrane cholesterol transporter is involved in the hepatic capture process of rosuvastatin. This carrier plays a major role in the removal of rosuvastatin by the liver. Linearity: The systemic exposure of rosuvastatin increases in proportion to the dose. After repeated daily administration of the drug, no change in pharmacokinetic parameters occurs. Genetic polymorphism: Inhibitors of MMC-CoA reductase, incl. Rosuvastatin, binds to the OATP1B1 transport proteins (a polypeptide of organic anion transport that participates in the capture of statins by hepatocytes) and BCRP (an efflux transporter). In carriers of the SLCO1B1 (OATP1B1) C.521CC and ABCG2 (BCRP) C.421AA genotypes, there was an increase in exposure (AUC) of rosuvastatin 1.6 and 2.4 times, respectively, compared to the carriers of the SLC01B1c.521TT and ABCG2c.421AA genotypes. Pharmacokinetics in special patient groups: Age and gender do not have a clinically significant effect on the pharmacokinetic parameters of rosuvastatin. Pharmacological studies have shown an approximately two-fold increase in the median AUC and Cm of rosuvastatin in patients of the Mongoloid race (Japanese, Chinese, Filipinos, Vietnamese, and Koreans) compared with those of the Caucasians; Hindu patients showed an increase in the median AUC and C max by about 1.3 times. At the same time, the analysis of pharmacokinetics indicators for the entire studied population did not reveal clinically significant differences in the pharmacokinetics of the drug among representatives of the Caucasian and Negroid races. In patients with mild to moderate renal insufficiency, the plasma concentration of rosuvastatin or N-desmethylrozuvastatin does not change significantly. In patients with severe renal insufficiency (CK less than 30 ml / min), plasma concentration of rosuvastatin is 3 times higher, and the concentration of N-desmethylrosuvastatin is 9 times higher than in healthy volunteers. The concentration of rosuvastatin in blood plasma in patients on hemodialysis is approximately 50% higher than in healthy volunteers.Patients with varying degrees of liver failure with a score of 7 or less on the Child-Pugh scale did not show an increase in T1 / 2 of rosuvastatin. However, in 2 patients with a score of 8 and 9 on the Child-Pugh scale, a T1 / 2 lengthening was observed, approximately 2 times higher than the same indicator for patients with lower values on the Child-Pugh scale. Experience with rosuvastatin in patients with a score above 9 on the Child-Pugh scale is absent.
Indications
- family homozygous hypercholesterolemia as an adjunct to diet and other lipid-lowering therapy - as an adjunct to diet when diet and other non-drug treatments are inadequate primary hypercholesterolemia classification Fredrickson (type IIa including family heterozygous hypercholesterolemia) or mixed hypercholesterolaemia (type IIb) (for example, LDL-apheresis), or in cases where such therapy is not effective enough - hypertriglyceridemia (type IV according to Fredrickson classification) as supplement to diet - to slow the progression of atherosclerosis as a supplement to the diet in patients who have been shown therapy to reduce the concentration of total Xc and Xc-LDL - primary prevention of major cardiovascular complications (stroke, heart attack, unstable angina, arterial revascularization) in adults patients without clinical signs of coronary artery disease, but with an increased risk of its development (age over 50 years in men, over 60 years in women, increased concentration of C-reactive protein (2 mg / l) in the presence of as min Imum of one additional risk factor, such as hypertension, low concentration of HD-C HDL, smoking, family history of early onset of CHD).
Contraindications
For a daily dose of 5 mg, 10 mg and 20 mg: - hypersensitivity to rosuvastatin or any of the components of the drug - liver disease in the active phase, including a persistent increase in liver transaminase activity, as well as any increase in serum hepatic transaminase activity in more than 3 times compared with VGN - severe renal dysfunction (CC less than 30 ml / min) - myopathy - concurrent use of cyclosporine - pregnancy - breastfeeding period - use in patients predisposed to develop myotok ble complications - lactase deficiency, lactose intolerance, a syndrome of glucose-galactose malabsorption (drug contains lactose) - up to age 18 years (effectiveness and safety have been established).for a daily dose of 40 mg: - hypersensitivity to rosuvastatin or any of the components of the drug - liver disease in the active phase, including a persistent increase in liver transaminase activity, as well as any increase in serum hepatic transaminase activity by more than 3 times compared with VGN - the presence of risk factors for the development of myopathy / rhabdomyolysis-renal failure of moderate severity (CC less than 60 ml / min) - a hypothyroid myopathy in history, including hereditary miotoksichnost against the reception of other x history of HMG-CoA reductase inhibitors or fibrates — excessive drinking — conditions that can lead to an increase in plasma concentration of rosuvastatin — simultaneous use of fibrates — use of patients of the Mongoloid race — simultaneous use of cyclosporine — pregnancy — period of breastfeeding — use of patients predisposed to the development of myotoxic complications - lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome (the product contains lactose) - age ie up to 18 years (effectiveness and safety have been established). With a caution For a daily dose of 5 mg, 10 mg and 20 mg: the risk of myopathy / rhabdomyolysis is renal failure, hypothyroid or family history of hereditary muscular diseases and a previous history of muscular toxicity with the use of other HMG-CoA reductase inhibitors (statins) or fibrate-medication alcohol use, in which there is an increase in the plasma concentration of rosuvastatin over the age of 65 years, a high risk of developing diabetes mellitus and liver disease in the history of nonsecretory arterial disease Hypotension is a wide range of surgical interventions, traumatic, severe metabolic, endocrine, or water-electrolyte disturbances and uncontrolled epilepsy-racial affiliation (Mongoloid race), simultaneous intake of fibrates. For a daily dose of 40 mg: there is a risk of myopathy / rhabdomyolysis - mild renal failure (QC more than 60 ml / min), over 65 years of age a high risk of developing diabetes mellitus in history of nonseparasitic hypotension, extensive surgical intervention, trauma, severe metabolic, endocrine or water, metabolic, endocrine or aquatic, hypotension, extensive surgical interventions, trauma, severe metabolic, endocrine or water, heavy metabolic, endocrine or aquatic hypotension, extensive surgical interventions, trauma, severe metabolic, endocrine or water, heavy metabolic, endocrine or aquatic hypotension; uncontrolled epilepsy.
Use during pregnancy and lactation
Suvardio drug is contraindicated for use during pregnancy and during breastfeeding. Women of reproductive age should use reliable and adequate contraception. Since cholesterol and cholesterol biosynthesis products are important for the development of the fetus, the potential risk of inhibition of HMG-CoA reductase exceeds the benefits of its use during pregnancy. If pregnancy is diagnosed, taking Suvardio should be stopped immediately. Data on the allocation of rosuvastatin with breast milk are not available. If necessary, the appointment of the drug Suvardio during lactation is necessary to decide on the termination of breastfeeding.
Dosage and administration
The drug is taken orally, at any time of the day, regardless of the meal. The tablet should be swallowed whole (do not chew, do not grind) with a glass of water. Before starting therapy with Suvardio, the patient should begin to follow the standard cholesterol-lowering diet and continue to follow it throughout the entire period of therapy. The dose of Suvardio is selected individually, taking into account the cholesterol concentration targets and the individual therapeutic response to the therapy being administered. The recommended initial dose of Suvardio is 5 mg or 10 mg 1 time / day for patients who have not previously taken statins, and for patients who have been transferred to this drug after therapy with other HMG-CoA reductase inhibitors. Choosing the initial dose should be guided by the concentration of cholesterol and the possible risk of cardiovascular complications in this patient, and the potential risk of side effects should also be evaluated. If necessary, after 4 weeks, you can adjust the dose of the drug. Due to the possible development of side effects when taking a dose of 40 mg compared with lower doses of the drug, the final titration to the maximum dose of 40 mg should be carried out only in patients with severe hypercholesterolemia and a high risk of cardiovascular complications (especially in patients with hereditary hypercholesterolemia), in which the target concentration of cholesterol was not achieved when taking a dose of 20 mg, and which will be under medical supervision.At purpose of a dose of 40 mg careful observation of the doctor is recommended. It is not recommended to prescribe a dose of 40 mg to patients who have not previously visited a doctor. For elderly patients (over 65 years), the recommended initial dose of Suvardio is 5 mg. In other cases, dose adjustment due to age is not required. In patients with mild or moderate renal insufficiency, dose adjustment of Suvardio is not required. The recommended initial dose of the drug is 5 mg for patients with moderately severe renal failure (CC less than 60 ml / min). Patients with renal insufficiency of moderate degree should not be prescribed the drug in a dose of 40 mg. The use of the drug Suvardio in any doses is contraindicated in patients with severe renal insufficiency (CC less than 30 ml / min). An increase in the systemic concentration of rosuvastatin in patients with hepatic insufficiency with a Child-Pugh score of 7 or lower was not detected. However, an increase in the systemic concentration of rosuvastatin was observed in patients with hepatic insufficiency with Child-Pugh scores of 8 and 9. In such patients, liver function should be monitored during therapy with rosuvastatin. Data on the use of rosuvastatin in patients with hepatic insufficiency with a Child-Pugh score above 9 are not available. Rosuvastatin is contraindicated in patients with liver disease in the active phase. Ethnic groups In patients of the Mongoloid race, an increase in the systemic concentration of rosuvastatin in the blood plasma is possible. The recommended initial dose of Suvardio in Mongoloid patients is 5 mg. The use of the drug in a dose of 40 mg is contraindicated in such patients. Patients predisposed to the development of myopathy The recommended initial dose of Suvardio for patients with a predisposition to the development of myopathy is 5 mg. The use of the drug in a dose of 40 mg is contraindicated in such patients. Genetic polymorphism In carriers of the SLCO1B1 (OATP1B1) C.521CC and ABCG2 (BCRP) S.421AA genotypes, there was an increase in exposure (AUC) of rosuvastatin by 1.6 and 2.4 times, respectively, compared with the SLCO1B1c.521TT and ABCG2c.421AA genotypes carriers. For carriers of genotypes p.521CC or p.421AA, the recommended maximum dose of Suvardio is 20 mg 1 time / day.Concomitant therapy Rosuvastatin binds to various transport proteins (in particular, OATR1B1 and BCRP). With simultaneous use of the drug Suvardio with drugs (such as cyclosporine, some HIV protease inhibitors, including a combination of ritonavir with atazanavir, lopinavir and / or tipranavir), increasing the concentration of rosuvastatin in the blood plasma due to interaction with transport proteins, may increase the risk of myopathy ( including rhabdomyolysis); You must read the instructions for use of these drugs before prescribing the drug Suvardio). In such cases, you should evaluate the possibility of using alternative therapy or the temporary cessation of taking the drug Suvardio. If necessary, the use of the above drugs should evaluate the ratio of the benefits and the risk of concomitant therapy with Suvardio and consider reducing its dose.
Side effects
According to the WHO, adverse reactions are classified according to their development frequency as follows: very often (1/10), often (1/100, less than 1/10), infrequently (1/1000, less than 1/100), rarely (1/10 000, less than 1/1000) and very rarely (less than 1/10 000); frequency is unknown - according to the available data it was not possible to establish the frequency of occurrence. From the hemopoietic system: the frequency is unknown - thrombocytopenia. On the part of the immune system: rarely - hypersensitivity reactions, including angioedema. On the part of the endocrine system: often - type 2 diabetes. From the side of the central nervous system: often - headache, dizziness; very rarely - polyneuropathy, loss of memory. On the part of the respiratory system: the frequency is unknown - cough, shortness of breath. On the part of the digestive system: often - constipation, nausea, pain in the abdomen; rarely - pancreatitis; frequency is unknown - diarrhea. On the part of the liver and biliary tract: rarely - increased activity of hepatic transaminases; very rarely - jaundice, hepatitis. From the urinary system: very rarely - hematuria. When receiving rosuvastatin, proteinuria can be observed. Changes in the protein content in the urine (from absence to the presence of trace amounts to level ++ and above) are observed in less than 1% of patients taking rosuvastatin at a dose of 10 mg and 20 mg, and about 3% of people taking the drug at a dose of 40 mg.A slight change in the amount of protein in the urine, expressed in a change from the zero level or the presence of traces to the level of +, was observed when taking the drug in a dose of 20 mg. In most cases, proteinuria decreased and independently passed on during the treatment. When analyzing data from clinical studies, no causal relationship was found between proteinuria and acute or progressive kidney disease. From the musculoskeletal system: often - myalgia; rarely - myopathy (including myositis), rhabdomyolysis; very rarely - arthralgia; frequency unknown - immune necrotizing myopathy. On the part of the skin: infrequently - itchy skin, rash, urticaria; frequency is unknown - Stevens-Johnson syndrome. Laboratory indicators: increased activity of CPK, the concentration of glucose, glycosylated hemoglobin, bilirubin in the blood plasma, the activity of gamma-glutamyltranspeptidase, ALP, thyroid gland dysfunction. Other: often - asthenic syndrome, gynecomastia, peripheral edema. With the use of some statins, side effects were reported such as: depression, sleep disturbance (including insomnia and nightmares), sexual dysfunction.
Overdose
Treatment: There is no specific treatment for an overdose of rosuvastatin. It is recommended to carry out symptomatic treatment and measures aimed at maintaining the function of vital organs and systems. It is necessary to control liver function and CPK activity. It is unlikely that hemodialysis will be effective.
Interaction with other drugs
With simultaneous use of rosuvastatin and cyclosporine, the AUC of rosuvastatin was on average 7 times higher than that observed in healthy volunteers. The combined use of these drugs leads to an increase in the concentration of rosuvastatin in the blood plasma by 11 times, while the plasma concentration of cyclosporine does not change. With the use of other statins, there were reports of cases of rhabdomyolysis with the simultaneous use of rosuvastatin and fusidic acid, monitoring of the patient’s condition is necessary, and if necessary, it is possible to temporarily stop taking rosuvastatin. As with other HMG-CoA reductase inhibitors, the initiation of rosuvastatin therapy or an increase in the dose of the drug in patients receiving vitamin K antagonists (for example,warfarin or other coumarin anticoagulants) may cause an increase in INR. Canceling or lowering the dose of rosuvastatin can cause a decrease in INR. In such cases, INR should be monitored. The simultaneous use of rosuvastatin and gemfibrozil and other agents that reduce the concentration of lipids, leads to an increase in Cmax and AUC of rosuvastatin by 2 times. Table 2. Effect of concomitant therapy on the exposure of rosuvastatin (AUC, data are given in descending order) Concomitant therapy regimen 7.1 times Atazanavir 300 mg / ritonavir 100 mg 1 time / day, 8 days 10 mg once Increased 3.1 times Lopinavir 400 mg / ritonavir 100 mg 2 times / day, 17 days 20 mg 1 time / day, 7 days Increased 2.1 times Hemifibrozil 600 mg 2 times / day, 7 days 80 mg once Increase by 1.9 times Eltrombopag 75 mg 1 time / day, 10 days 10 m d one-time increase 1.6 times Darunavir 600 mg / ritonavir 100 mg 2 times / day, 7 days 10 mg 1 time / day, 7 days Increase 1.5 times Tipranavir 500 mg / ritonavir 200 mg 2 times / day, 11 days 10 mg once 1.4-fold increase Dronedarone 400 mg 2 times / day. No data. 1.4-fold increase. Itraconazole 200 mg 1 time / day, 5 days 10 mg or 80 mg. Once 1.4-fold increase. Ezetimibe 10 mg 1 time / day, 14 days 10 mg. 1 times / day, 14 days Increase by 1.2 times Fosamprenavir 700 mg / ritonavir 100 mg 2 times / day, 8 days 10 mg once No change Aleglitazar 0.3 mg, 7 days 40 mg, 7 days No change Silim Rin 140 mg 3 times / day, 5 days 10 mg once No change Fenofibrate 67 mg 3 times / day, 7 days 10 mg, 7 days No change Rifampicin 450 mg 1 time / day, 7 days 20 mg once No change Ketoconazole 200 mg 2 times / day, 7 days 80 mg once. No change Fluconazole 200 mg 1 time / day, 11 days 80 mg once. No change Erythromycin 500 mg 4 times / day, 7 days 80 mg one time. 28% decrease Baikalin 50 mg 3 times / day, 14 days 20 mg once. Decrease by 17%. Based on data on specific interactions, no pharmacokinetically significant interaction with fe is expected. ofibratom may pharmacodynamic interaction. Gemfibrozil, fenofibrate, other fibrates and nicotinic acid in lipid-lowering doses (1 g or more per day) while being used with HMG-CoA reductase inhibitors increased the risk of myopathy, possibly due to the fact that they can cause myopathy and in monotherapy. Simultaneous use of 40 mg of rozuvastatin and fibrates is contraindicated.With simultaneous use of the drug with gemfibrozil and other lipid-lowering agents, the initial dose of rosuvastatin is 5 mg. With the simultaneous use of rosuvastatin and ezetimiba, there is no change in the AUC or Cmax of both drugs. However, the pharmacodynamic interaction of rosuvastatin and ezetimibe, which can cause undesirable effects, cannot be ruled out. Despite the fact that the exact mechanism of interaction is unknown, the simultaneous use of rosuvastatin with protease inhibitors can lead to the elongation of T1 / 2 of rosuvastatin. In a pharmacokinetic study, while taking 20 mg of rozuvastatin and a combined preparation containing two protease inhibitors (400 mg of lopinavir / 100 mg of ritonavir), healthy volunteers showed an increase of 2 times AUC (0-24) and 5 times C max of rosuvastatin, respectively. Therefore, it is not recommended to simultaneously administer rosuvastatin and protease inhibitors when treating patients with HIV. The simultaneous use of rosuvastatin and antacids in suspensions containing aluminum or magnesium hydroxide, reduces the plasma concentration of rosuvastatin by approximately 50%. This effect is less pronounced if antacids are applied 2 hours after taking rosuvastatin. The clinical significance of this interaction has not been established. The simultaneous use of rosuvastatin and erythromycin leads to a decrease in AUC (0-t) of rosuvastatin by 20% and Cmax of rosuvastatin by 30%. Such an interaction may be caused by increased intestinal motility, caused by taking erythromycin. The simultaneous use of rosuvastatin and oral contraceptives increases the AUC of ethinyl estradiol and AUC of norgestrel by 26% and 34%, respectively. Such an increase in plasma concentrations should be considered when selecting the dose of oral contraceptives. Pharmacokinetic data on the simultaneous use of rosuvastatin and hormone replacement therapy are not available, therefore, a similar effect cannot be excluded when using this combination. However, this combination was widely used by women during clinical trials and was well tolerated. No clinically significant interaction is expected with simultaneous use of rosuvastatin and digoxin.The results of in vivo and in vitro studies have shown that rosuvastatin is neither an inhibitor nor an inducer of cytochrome P450 isoenzymes. In addition, rosuvastatin is a weak substrate for these isoenzymes. There was no clinically significant interaction between rosuvastatin and fluconazole (an inhibitor of CYP2C9 and CYP3A4 isoenzymes) or ketoconazole (an inhibitor of CYP2A6 and CYP3A4 isoenzymes). The combined use of rosuvastatin and itraconazole (an inhibitor of the isoenzyme CYP3A4) increases the AUC of rosuvastatin by 28% (clinically insignificant). Therefore, any interaction of drugs associated with the metabolism of cytochrome P450 is not expected.
special instructions
Proteinuria (determined using test strips), mainly of tubular origin, was observed in patients taking high doses of rosuvastatin, especially 40 mg, but in most cases it was intermittent or short-term. It is shown that such proteinuria does not mean the occurrence of acute or progression of existing kidney disease. The frequency of severe renal impairment is increased when receiving 40 mg of rosuvastatin. It is recommended to monitor indicators of renal function during therapy with rosuvastatin. When using the drug Suvardio in all doses, and especially when taking the drug in a dose exceeding 20 mg, myalgia, myopathy and, in rare cases, rhabdomyolysis were detected. Very rarely did rhabdomyolysis occur while taking ezetimibe and HMG-CoA reductase inhibitors. In this case, pharmacological interaction of drugs cannot be ruled out, therefore, the drug Suvardio and ezetimibe should be used with caution together. The incidence of rhabdomyolysis when taking 40 mg of the drug Suvardio increases. Determination of CPK activity should not be carried out after intense physical exertion or in the presence of other possible reasons for an increase in CPK activity, which may lead to a misinterpretation of the results obtained. If the activity of CPK before the start of therapy is significantly increased (5 times higher than VGN), after 5-7 days it is necessary to re-measure. You should not start therapy with Suvardio, if the repeated test confirms the initial activity of CPK (more than 5 times higher compared to VGN).Rosuvastatin, like other HMG-CoA reductase inhibitors, should be used with extreme caution in patients with myopathy / rhabdomyolysis risk factors. These factors include: - renal failure; - hypothyroidism (for a dose of 40 mg); - myopathy in history (including hereditary) (for a dose of 40 mg); - the presence of a history of myotoxicity while taking other HMG-CoA reductase inhibitors or fibrates (for a dose of 40 mg); - alcohol abuse (for a dose of 40 mg); - age over 65 years; - conditions involving an increase in the plasma concentration of rosuvastatin (for a dose of 40 mg); - simultaneous reception of fibrates (for a dose of 40 mg). In such patients, the ratio of risk to potential benefit of therapy should be assessed and clinical observation should be carried out throughout the course of therapy. It is recommended to inform patients about the need to immediately report to the doctor about cases of sudden onset of muscle pain, muscle weakness or spasms, especially in combination with indisposition or fever. In such patients, the activity of CPK should be monitored. Treatment should be discontinued if CPK activity is more than 5 times greater than VGN or if muscle symptoms are pronounced and cause daily discomfort throughout the day (even if CPK activity is 5 times less than VGN). If the symptoms disappear and the activity of CPK returns to normal, consideration should be given to reappointment of the drug or prescription of an alternative inhibitor of HMG-CoA reductase in smaller doses with careful monitoring of the patient. Regular monitoring of CPK activity in patients with no symptoms of rhabdomyolysis is impractical. There are no signs of an increase in adverse events on the part of the skeletal muscles when taking the drug Suvardio and concomitant therapy. However, an increase in the incidence of myositis and myopathy was found in patients taking other HMG-CoA reductase inhibitors together with fibrin acid derivatives, including gemfibrozil, cyclosporine, nicotinic acid in lipid-lowering doses (more than 1 g / day), antifungal preparations of the azole group, inhibitors proteases and macrolide antibiotics. Gemfibrozil increases the risk of myopathy in combination with some inhibitors of HMG-CoA reductase.Therefore, concomitant use of rosuvastatin and gemfibrozil is not recommended. It is necessary to carefully evaluate the ratio of risk and possible benefit when rosuvastatin is combined with fibrates or nicotinic acid in lipid-lowering doses (more than 1 g / day). The concomitant use of rozuvastatin in a dose of 40 mg and fibrates is contraindicated. Suvardio should not be prescribed to patients with acute, serious diseases, suspected myopathy or with the possible development of secondary renal failure (for example, sepsis, arterial hypertension, surgery,