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Crestor

Crestor
Crestor is indicated for adults, adolescents and children over 10 years of age for the treatment of primary hypercholesterolemia or mixed dyslipidemia. The drug is prescribed as a supplement to the diet. The medicine is effective when diet, exercise is not enough.

Brand: Rosuvastatin

Availability: In Stock
Average Delivery Time: 9 Days
Exp. Date: September 2023
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Crestor 20 mg
270 pills - 20 mg
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$499.49 $1.85 $334.27 Add to cart
180 pills - 20 mg
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$337.93 $1.88 $217.91 Add to cart
120 pills - 20 mg
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$240.95 $2.01 $129.61 Add to cart
90 pills - 20 mg
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$191.75 $2.13 $86.17 Add to cart
60 pills - 20 mg
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$140.99 $2.35 $44.29 Add to cart
30 pills - 20 mg $92.64 $3.09 No Add to cart
Crestor 10 mg
270 pills - 10 mg
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$369.91 $1.37 $185.84 Add to cart
180 pills - 10 mg
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$253.99 $1.41 $116.51 Add to cart
120 pills - 10 mg
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$177.95 $1.48 $69.05 Add to cart
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$139.99 $1.56 $45.26 Add to cart
60 pills - 10 mg $99.53 $1.66 $23.97 Add to cart
30 pills - 10 mg $61.75 $2.06 No Add to cart
Crestor 5 mg
270 pills - 5 mg
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$194.99 $0.72 $95.62 Add to cart
180 pills - 5 mg
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$134.99 $0.75 $58.75 Add to cart
120 pills - 5 mg $93.99 $0.78 $35.17 Add to cart
90 pills - 5 mg $73.99 $0.82 $22.88 Add to cart
60 pills - 5 mg $52.95 $0.88 $11.63 Add to cart
30 pills - 5 mg $32.29 $1.08 No Add to cart

Product description

Pharmacokinetics of Crestor

Buy Crestor in Canada

Absorption and distribution of Cmax of rosuvastatin in blood plasma is achieved approximately 5 hours after oral administration. The absolute bioavailability is approximately 20%.

Rosuvastatin is metabolized predominantly by the liver, which is the main site of Xc synthesis and LDL-C metabolism. The Vd of rosuvastatin is approximately 134 liters. Approximately 90% of rosuvastatin binds to blood plasma proteins, mainly albumin.

Metabolism

Undergoes limited metabolism (about 10%). Rosuvastatin is a non-core substrate for metabolism by cytochrome P450 enzymes. The main isoenzyme involved in the metabolism of rosuvastatin is the CYP2C9 isoenzyme. Isoenzymes CYP2C19, CYP3A4 and CYP2D6 are involved in metabolism to a lesser extent.

The main metabolites of rosuvastatin identified are N-desmethyl rosuvastatin and lactone metabolites. N-desmethyl rosuvastatin is approximately 50% less active than rosuvastatin, lactone metabolites are pharmacologically inactive. More than 90% of the pharmacological activity in inhibiting circulating HMG-CoA reductase is provided by rosuvastatin, the rest is provided by its metabolites.

Withdrawal

About 90% of a dose of rosuvastatin is excreted unchanged through the intestines (including absorbed and unabsorbed rosuvastatin). The remainder is excreted by the kidneys. The plasma half-life (T1/2) is approximately 19 hours. T1/2 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 HMG-CoA reductase inhibitors, the membrane transporter Xc is involved in the process of hepatic uptake of rosuvastatin, which plays an important role in the hepatic elimination of rosuvastatin.

Linearity

The systemic exposure of rosuvastatin increases in proportion to the dose. Pharmacokinetic parameters do not change with daily intake.

Special populations of patients

Age and sex. Gender and age do not have a clinically significant effect on the pharmacokinetics of rosuvastatin.

Ethnic groups. Pharmacokinetic studies have shown an approximately twofold increase in the median area under the concentration-time curve (AUC) and Cmax of rosuvastatin in patients of the Asian group (Japanese, Chinese, Filipinos, Vietnamese and Koreans) compared with Europeans; Indian patients showed aincrease in the median AUC and Cmax 1.3-fold. Pharmacokinetic analysis did not reveal clinically significant differences in pharmacokinetics among Europeans and representatives of the Negroid race.

Renal failure In patients with mild to moderate renal failure, the plasma concentration of rosuvastatin or N-desmethyl ozuvastatin does not change significantly. In patients with severe renal failure (Cl creatinine less than 30 ml / min), the concentration of rosuvastatin in the blood plasma is 3 times higher, and the concentration of N-desmethyl rosuvastatin is 9 times higher than in healthy volunteers. The plasma concentration of rosuvastatin in hemodialysis patients was approximately 50% higher than in healthy volunteers.

Liver failure. In patients with various stages of hepatic failure, there was no increase in T1/2 of rosuvastatin in patients with a score of 7 and below on the Child-Pugh scale. Two patients with scores 8 and 9 on the Child-Pugh scale showed an increase in T1/2, at least 2 times. There is no experience with rosuvastatin in patients with a score above 9 on the Child-Pugh scale.

Genetic polymorphism. HMG-CoA reductase inhibitors, incl. Crestor®,bind to transport proteins OATP1B1 (organic anion transport polypeptide involved in the capture of statins hepatocytes) and BCRP (efflux transporter). In carriers of the SLCO1B1 (OATP1B1) C.521CC and ABCG2 (BCRP) C.421AA genotypes, an increase in the exposure (AUC) of rosuvastatin was noted by 1.6 and 2.4 times, respectively, compared with carriers of the SLCO1B1 C.521TT and ABCG2 C.421CC genotypes.

Indications of the drug Crestor®

Prescription of the drug Crestor by a doctor

primary hypercholesterolemia according to Fredrickson (type IIa, including familial heterozygous hypercholesterolemia) or mixed hypercholesterolemia (type IIb) as an adjunct to the diet when diet and other non-drug treatments (eg exercise, weight loss) are insufficient;

familial homozygous hypercholesterolemia as an adjunct to diet and other lipid-lowering therapy (eg, LDL apheresis) or in cases where such therapy is not effective enough;

hypertriglyceridemia (Fredrickson type IV) as an adjunct to diet;

slowing down the progression of atherosclerosis, as an addition to the diet in patients who are indicated for therapy to reduce the concentration of total cholesterol and LDL-C;

primary prevention of major cardiovascular complications (stroke, heart attack, arterial revascularization) in adult patients without clinical signs of ischemic heart disease, but with an increased risk of its development (age over 50 for men and over 60 for women, increased concentration of C-reactive protein (≥2 mg / L) in the presence of at least one of the additional risk factors, such as arterial hypertension, low concentration of HDL-C, smoking, family history of early onset of coronary heart disease).

Method of administration and dosage

Packaging of the drug Crestor

Inside, without chewing or crushing the tablet, swallowing it whole, drinking water. The drug can be prescribed at any time of the day, regardless of food intake.

Before starting therapy with Crestor®, the patient should begin to follow a standard cholesterol-lowering diet and continue to follow it during treatment. The dose of the drug should be selected individually, depending on the goals of therapy and the therapeutic response to treatment, taking into account the current recommendations for the target lipid concentration.

The recommended starting dose for patients starting to take the drug, or for patients transferred from taking other HMG-CoA reductase inhibitors, should be 5 or 10 mg of Crestor® once a day. When choosing an initial dose, one should be guided by the individual concentration of Xc and take into account the possible risk of developing cardiovascular complications, and it is also necessary to assess the potential risk of side effects. If necessary, the dose can be increased to a larger one after 4 weeks (see "Pharmacodynamics").

In connection with the possible development of side effects when taking a dose of 40 mg compared with lower doses of the drug (see "Side Effects"), an increase in the dose to 40 mg, after taking an additional dose higher than the recommended initial dose for 4 weeks of therapy, can be performed only in patients with severe hypercholesterolemia and with a high risk of cardiovascular complications (especially in patients with familial hypercholesterolemia) who did not achieve the desired treatment result when taking a dose of 20 mg, and who will be under the supervision of a specialist (see " Special instructions"). Particularly careful monitoring of patients receiving the drug at a dose of 40 mg is recommended.

It is not recommended to prescribe a dose of 40 mg to patients who have not previously consulted a doctor. After 2–4 weeks of therapy and / or with an increase in the dose of Crestor®, it is necessary to monitor the parameters of lipid metabolism (if necessary, dose adjustment is required).

Elderly patients. No dose adjustment required.

Patients with renal impairment. No dose adjustment is required in patients with mild to moderate renal impairment. In patients with severe renal insufficiency (Cl creatinine less than 30 ml / min), the use of Crestor® is contraindicated. The use of the drug at a dose of 40 mg is contraindicated in patients with moderate renal impairment (Cl creatinine 30-60 ml / min) (see "Special instructions", "Pharmacodynamics"). An initial dose of 5 mg is recommended for patients with moderate renal impairment.

Patients with hepatic impairment. Crestor® is contraindicated in patients with active liver disease (see "Contraindications").

Special populations

Ethnic groups. When studying the pharmacokinetic parameters of rosuvastatin in patients belonging to different ethnic groups, an increase in the systemic concentration of rosuvastatin in the Japanese and Chinese was noted (see "Special instructions"). This fact should be taken into account when prescribing Crestor® to these patient groups. When prescribing doses of 10 and 20 mg, the recommended starting dose for patients of the Mongoloid race is 5 mg. It is contraindicated to prescribe the drug in a dose of 40 mg to patients of the Mongoloid race (see "Contraindications").

Genetic polymorphism. In carriers of the SLCO1B1 (OATP1B1) C.521CC and ABCG2 (BCRP) C.421AA genotypes, an increase in the AUC of rosuvastatin was noted compared to carriers of the SLCO1B1 C.521TT and ABCG2 C.421CC genotypes. For patients with genotypes a521CC or C.421AA, the recommended maximum dose of Crestor® is 20 mg once a day (see Pharmacokinetics, Special Instructions and Interaction).

Patients predisposed to myopathy. The appointment of the drug at a dose of 40 mg is contraindicated in patients with factors that may indicate a predisposition to the development of myopathy (see "Contraindications"). When doses of 10 and 20 mg are prescribed, the recommended starting dose for this group of patients is 5 mg (see "Contraindications").

Concomitant therapy

Rosuvastatin binds to various transport proteins (in particular, OATP1B1 and BCRP). When the joint application of the drug Crestor® with drugs (such as cyclosporin, some HIV protease inhibitors, including a combination of ritonavir with atazanavir, lopinavir and / or tipranavir), increase the concentration of rosuvastatin in the plasma due to the interaction with the transport proteins, may increase the risk of myopathy (including rhabdomyolysis) (see "Special instructions" and "Interaction"). You should read the instructions for use of these drugs before prescribing them in conjunction with Crestor®. In such cases, you should evaluate the possibility of alternative therapies destination or temporary discontinuation of drug Crestor®.If the use of the above drugs is necessary, the balance of benefits and risks of concomitant therapy with Crestorshould be evaluated® and the possibility of reducing its dose should be considered (see "Interaction").


Contraindications

Tablets, 10 mg:

  • hypersensitivity to rosuvastatin or any of the components of the drug;
  • liver disease in the active phase, including a persistent increase in serum transaminase activity and any increase in serum transaminase activity (more than 3 times compared with VGN);
  • severe renal dysfunction (Cl creatinine less than 30 ml / min);
  • myopathy;
  • simultaneous administration of cyclosporine;
  • in women: pregnancy, lactation, lack of adequate methods of contraception;
  • patients prone to the development of myotoxic complications;
  • lactose intolerance, lactase deficiency or glucose-galactose malabsorption (the drug contains lactose).

Tablets, 40 mg:

  • hypersensitivity to rosuvastatin or any of the components of the drug;
  • simultaneous administration of cyclosporine;
  • in women: pregnancy, lactation, lack of adequate methods of contraception;
  • liver disease in the active phase, including a persistent increase in serum transaminase activity and any increase in serum transaminase activity (more than 3 times compared with VGN);
  • patients with risk factors for the development of myopathy / rhabdomyolysis, namely:
  • - moderate renal failure (Cl creatinine less than 60 ml / min);
  • - hypothyroidism;
  • - personal or family history of muscle disease;
  • - myotoxicity while taking other inhibitors of HMG-CoA reductase or fibrates in anamnesis;
  • excessive alcohol consumption;
  • conditions that can lead to an increase in the plasma concentration of rosuvastatin;
  • simultaneous reception of fibrates;
  • patients of the Asian race;
  • lactose intolerance, lactase deficiency or glucose-galactose malabsorption (the drug contains lactose).

With caution

Tablets, 10 and 20 mg: risk of myopathy / rhabdomyolysis - renal failure, hypothyroidism, personal or family history of hereditary muscle diseases and a previous history of muscle toxicity when using other HMG-CoA reductase inhibitors or fibrates; excessive alcohol consumption; age over 65; conditions in which an increase in the plasma concentration of rosuvastatin is noted; race (Asian race); simultaneous appointment with fibrates (see "Pharmacokinetics"); a history of liver disease; sepsis; arterial hypotension; major surgery, trauma, severe metabolic, endocrine, or electrolyte disturbances, or uncontrolled seizures.

Tablets, 40 mg: renal failure of mild severity (Cl creatinine more than 60 ml / min); age over 65; a history of liver disease; sepsis; arterial hypotension; major surgery, trauma, severe metabolic, endocrine, or electrolyte disturbances, or uncontrolled seizures.

Application in pediatric practice

The effectiveness and safety of the drug in children under 18 years of age has not been established. The experience of using the drug in pediatric practice is limited to a small number of children (8 years and older) with familial homozygous hypercholesterolemia. Currently, it is not recommended to use Crestor® in children under 18 years of age.

Patients with hepatic impairment There are no

data or experience with the drug in patients with a score above 9 on the Child-Pugh scale (see Pharmacodynamics, Special instructions).

Application during pregnancy and lactation

Crestor® is contraindicated during pregnancy and lactation.

Women of reproductive age must use adequate contraceptive methods.

Since Xc and other products of Xc biosynthesis are important for fetal development, the potential risk of inhibition of HMG-CoA reductase outweighs the benefits of using the drug in pregnant women.

If pregnancy occurs during therapy, the drug should be discontinued immediately.

There are no data on the excretion of rosuvastatin in breast milk, therefore, during breastfeeding, the drug should be discontinued (see "Contraindications").

Interaction

Effect of other drugs on rosuvastatin

Transport protein inhibitors: pOsuvastatin binds to some transport proteins, in particular OATP1B1 and BCRP. The concomitant use of drugs that are inhibitors of these transport proteins may be accompanied by an increase in the plasma concentration of rosuvastatin and an increased risk of myopathy (see table 3, "Method of administration and dosage", "Special instructions").

Cyclosporine: with the simultaneous use of rosuvastatin and cyclosporin, the AUC of rosuvastatin was, on average, 7 times higher than that observed in healthy volunteers (see table 3). Does not affect the plasma concentration of cyclosporine. Crestor® is contraindicated in patients taking cyclosporine (see "Contraindications").

HIV protease inhibitors: although the exact mechanism of interaction is unknown, co-administration of HIV protease inhibitors can lead to a significant increase in the exposure of rosuvastatin (see table 3). A pharmacokinetic study on the simultaneous use of 20 mg rosuvastatin with a combined preparation containing two HIV protease inhibitors (400 mg lopinavir / 100 mg ritonavir) in healthy volunteers showed an approximately two-fold and five-fold increase in AUC0-24 and Cmax of rosuvastatin, respectively. Therefore, the simultaneous administration of rosuvastatin and HIV protease inhibitors in the treatment of patients with HIV is not recommended (see "Dosage and Administration", "Special instructions", table 3).

Gemfibrozil and other hypolipidemic agents: the combined use of rosuvastatin and gemfibrozil leads to a 2-fold increase in the Cmax of rosuvastatin in blood plasma and the AUC of rosuvastatin (see "Special instructions"). Based on data on specific interactions, pharmacokinetically significant interactions with fenofibrates are not expected, pharmacodynamic interactions are possible.

Gemfibrozil, fenofibrate, other fibrates and lipid-lowering doses of nicotinic acid increased the risk of myopathy when used with HMG-CoA reductase inhibitors, possibly due to the fact that they can cause myopathy when used in monotherapy (see "Special instructions"). With the simultaneous administration of the drug with gemfibrozil, fibrates, nicotinic acid in lipid-lowering doses (more than 1 g / day), patients are recommended an initial dose of 5 mg, a dose of 40 mg is contraindicated when administered jointly with fibrates (see "Contraindications", "Method of administration and doses "," Special instructions ").

Ezetimibe: simultaneous application Crestorformulation® at a dose of 10 mg of ezetimibe and 10 mg was accompanied by an increase in AUC of rosuvastatin in patients with hypercholesterolemia (see Table 3.). We can not exclude an increased risk of side effects due to the pharmacodynamic interaction of the drug Crestor® and ezetimibe.

Antacids: the simultaneous use of rosuvastatin and antacid suspensions containing aluminum and magnesium hydroxide leads to a decrease in the plasma concentration of rosuvastatin by about 50%. This effect is less pronounced if antacids are used 2 hours after taking rosuvastatin. The clinical significance of this interaction has not been studied.

Erythromycin: the simultaneous use of rosuvastatin and erythromycin leads to a decrease in the AUC of rosuvastatin by 20% and the Cmax of rosuvastatin by 30%. This interaction can occur as a result of increased intestinal motility caused by the intake of erythromycin.

Cytochrome P450 isoenzymes: 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 enzymes. Therefore, the interaction of rosuvastatin with other drugs at the metabolic level with the participation of cytochrome P450 isoenzymes is not expected. There was no clinically significant interaction of rosuvastatin with fluconazole (an inhibitor of CYP2C9 and CYP3A4 isoenzymes) and ketoconazole (an inhibitor of CYP2A6 and CYP3A4 isoenzymes).

Fusidic acid: studies on the interaction of rosuvastatin and fusidic acid have not been conducted. As with other statins, there have been post-marketing reports of cases of rhabdomyolysis when rosuvastatin and fusidic acid are taken together. Patients must be closely monitored. If necessary, it is possible to temporarily stop taking rosuvastatin.

Overdose

Symptoms: while taking several daily doses, the pharmacokinetic parameters of rosuvastatin do not change.

Treatment: there is no specific treatment for an overdose of rosuvastatin. In case of an overdose, it is recommended to carry out symptomatic treatment and measures aimed at maintaining the functions of vital organs and systems. It is necessary to monitor liver function and CPK levels. Hemodialysis is unlikely to be effective.

Special instructions

Renal effects

In patients who received high doses of the drug Crestor® (mainly 40 mg), tubular proteinuria was observed, which in most cases was transient. This proteinuria was not indicative of acute kidney disease or progression of kidney disease. In patients taking the drug at a dose of 40 mg, it is recommended to monitor renal function indicators during treatment.

The musculoskeletal system

When using the drug Crestor® in all dosages, and especially when taking doses of the drug exceeding 20 mg, the following effects on the musculoskeletal system were reported: myalgia, myopathy, in rare cases, rhabdomyolysis.

Determination of CPK activity

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, which may lead to an incorrect interpretation of the results obtained. If the initial CPK activity is significantly increased (5 times higher than VGN), a second measurement should be performed after 5-7 days. You should not start therapy if a repeated test confirms the initial CPK activity more than 5 times higher than that of VGN.

Before starting therapy

When prescribing the drug Crestor®, as well as when prescribing other inhibitors of HMG-CoA reductase, caution should be exercised in patients with existing risk factors for the development of myopathy / rhabdomyolysis (see With caution), it is necessary to consider the ratio of risk and possible benefits of therapy and conduct clinical observation.

During therapy

The patient should be informed about the need to immediately inform the doctor about cases of sudden onset of muscle pain, muscle weakness or spasms, especially in combination with malaise and fever. In such patients, the CPK level should be determined. Therapy should be discontinued if the CPK activity is significantly increased (more than 5 times compared to the VLN) or the muscle symptoms are pronounced and cause daily discomfort (even if the CPK activity is less than 5 times higher than the VLN). If the symptoms disappear and the activity of CK returns to normal, you should consider re-appointment of the drug Crestor® or other inhibitors of HMG-CoA reductase in smaller doses with careful observation of the patient.

Routine control of CPK activity in the absence of symptoms is inappropriate.

There have been very rare cases of immune-mediated necrotizing myopathy with clinical manifestations in the form of persistent weakness of the proximal muscles and increased serum CPK activity during treatment or upon discontinuation of statins, incl. rosuvastatin. Additional studies of the muscular and nervous system, serological studies, and therapy with immunosuppressive drugs may be required.

There was no evidence of increased impact on skeletal muscles while taking the drug Crestor® and concomitant therapy. However, an increase in the number of cases of myositis and myopathy has been reported in patients taking other HMG-CoA reductase inhibitors in combination with fibric acid derivatives, including gemfibrozil, cyclosporine, nicotinic acid in lipid-lowering doses (more than 1 g / day), azole antifungals, inhibitors HIV proteases and macrolide antibiotics. Gemfibrozil increases the risk of myopathy when used together with some HMG-CoA reductase inhibitors. Thus, the simultaneous use of Crestornot recommended® and gemfibrozil is. The balance of risk and possible benefit should be carefully weighed when using Crestor® and fibrates or lipid-lowering doses of nicotinic acid together. Medication contraindicated reception Crestor® 40 mg in conjunction with fibrates (cm. "Contra", "Interaction").

2–4 weeks after the start of treatment and / or with an increase in the dose of Crestor®, it is necessary to monitor lipid metabolism parameters (if necessary, dose adjustment is required).

Liver

It is recommended to determine the parameters of liver function before starting therapy and 3 months after starting therapy. Youtaking Crestor® should stopor reduce the dose of the drug if the activity of "hepatic" transaminases in the blood serum is 3 times higher than VGN.

In patients with hypercholesterolemia due to hypothyroidism or nephrotic syndrome underlying disease therapy should be conducted prior to drug treatment Crestor®.

Special populations

Ethnic groups. In the course of pharmacokinetic studies among Chinese and Japanese patients, an increase in the systemic concentration of rosuvastatin was noted in comparison with the values ​​obtained in European patients (see "Dosage and Administration", "Pharmacokinetics").

protease inhibitors Combined HIV

use of the drug with HIV protease inhibitors is not recommended (see "Interaction").

Lactose

The drug should not be used in patients with lactase deficiency, galactose intolerance and glucose-galactose malabsorption.

Interstitial lung disease

With the use of some statins, especially for a long time, isolated cases of interstitial lung disease have been reported. Symptoms include shortness of breath, unproductive cough, and deterioration in general well-being (weakness, weight loss, and fever). If interstitial lung disease is suspected, statin therapy should be discontinued.

Type 2 diabetes mellitus

In patients with a glucose concentration of 5.6 to 6.9 mmol / L, therapy with Crestor® was associated with an increased risk of type 2 diabetes mellitus.

Impact on the ability to drive a car or perform work that requires an increased speed of physical and mental reactions. No studies have been conducted to study the effect of Crestor® on the ability to drive and use mechanisms. However, based on the pharmacodynamic properties, Crestor® should not have such an effect. Caution should be exercised when driving vehicles or work associated with increased concentration and psychomotor reaction (dizziness may occur during therapy).


Side effects

Side effects observed when taking Crestor are usually mild and gotheir own. As with other HMG-CoA reductase inhibitors, the incidence of side effects is mainly dose-dependent.

The incidence of undesirable effects is presented as follows: often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10000, <1/1000); very rare (<1/10000), including isolated messages.

Immune system: rarely - hypersensitivity reactions, including angioedema.

Endocrine system: often - type 2 diabetes mellitus.

From the side of the central nervous system: often - headache, dizziness.

From the digestive tract: often - constipation, nausea, abdominal pain; rarely - pancreatitis.

From the side of the skin: infrequently - itchy skin, rash, urticaria.

From the musculoskeletal system: often - myalgia; rarely - myopathy (including myositis), rhabdomyolysis.

Others: often - asthenic syndrome.

From the urinary system: in patients who received Crestor®, proteinuria may be detected. Changes in the amount of protein in the urine (from no or trace amounts to ++ or more) are observed in less than 1% of patients receiving 10–20 mg of the drug, and about 3% of patients receiving 40 mg of the drug. A slight change in the amount of protein in the urine was noted with a dose of 20 mg. In most cases, proteinuria diminishes or disappears with therapy and does not mean acute or progression of existing kidney disease.

From the side of the musculoskeletal system: when using the drug Crestor® in all dosages and especially when taking doses of the drug exceeding 20 mg - myalgia, myopathy (including myositis); in rare cases, rhabdomyolysis with or without acute renal failure. A dose-dependent increase in CPK activity is observed in a small number of patients taking rosuvastatin. In most cases, it was minor, asymptomatic, and temporary. In case of an increase in the level of CPK (more than 5 times compared with VGN), therapy should be suspended (see "Special instructions").

From the liver: when using rosuvastatin, there is a dose-dependent increase in the activity of "hepatic" transaminases in a small number of patients. In most cases, it is minor, asymptomatic, and temporary.

Laboratory indicators: when using the drug Crestor® , the following changes in laboratory indicators were observed: an increase in the concentration of glucose, bilirubin, the activity of GGTP, alkaline phosphatase, signs of thyroid dysfunction.

Post

-marketing use

The following side effects have been reported in the post-marketing use of Crestor®.

From the digestive tract: very rarely - jaundice, hepatitis; rarely - increased activity of "hepatic" transaminases; unspecified frequency - diarrhea.

From the side of the musculoskeletal system: very rarely - arthralgia; unspecified frequency - Immune-mediated necrotizing myopathy.

From the side of the central nervous system: very rarely - loss or decrease in memory; unspecified frequency - peripheral neuropathy.

From the respiratory system: unspecified frequency - cough, shortness of breath.

From the urinary system: very rarely - hematuria.

On the part of the skin and subcutaneous fat: unspecified frequency - Stevens-Johnson syndrome.

From the reproductive system and mammary glands: unspecified frequency - gynecomastia.

Other: unspecified frequency - peripheral edema.

With the use of some statins, the following side effects have been reported: depression, sleep disturbances, including insomnia and "nightmares", sexual dysfunction. Reported isolated cases of interstitial lung disease, especially with prolonged use of drugs (see "Special instructions").