Rosuvastatin-SZ - Instructions For Use, Price, Reviews, Analogs Of Tablets

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Rosuvastatin-SZ - Instructions For Use, Price, Reviews, Analogs Of Tablets
Rosuvastatin-SZ - Instructions For Use, Price, Reviews, Analogs Of Tablets

Video: Rosuvastatin-SZ - Instructions For Use, Price, Reviews, Analogs Of Tablets

Video: Rosuvastatin-SZ - Instructions For Use, Price, Reviews, Analogs Of Tablets
Video: Rosuvastatin tablet - Rosuvastatin tablet ip 10 mg, 20 mg, 40, tablet - uses, side effects, Dosage 2024, April
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Rosuvastatin-SZ

Rosuvastatin-SZ: instructions for use and reviews

  1. 1. Release form and composition
  2. 2. Pharmacological properties
  3. 3. Indications for use
  4. 4. Contraindications
  5. 5. Method of application and dosage
  6. 6. Side effects
  7. 7. Overdose
  8. 8. Special instructions
  9. 9. Application during pregnancy and lactation
  10. 10. Use in childhood
  11. 11. In case of impaired renal function
  12. 12. For violations of liver function
  13. 13. Use in the elderly
  14. 14. Drug interactions
  15. 15. Analogs
  16. 16. Terms and conditions of storage
  17. 17. Terms of dispensing from pharmacies
  18. 18. Reviews
  19. 19. Price in pharmacies

Latin name: Rosuvastatin-SZ

ATX code: C10AA07

Active ingredient: rosuvastatin (Rosuvastatin)

Manufacturer: SEVERNAYA ZVEZDA, JSC (Russia)

Description and photo updated: 30.11.2018

Prices in pharmacies: from 166 rubles.

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Film-coated tablets, Rosuvastatin-SZ
Film-coated tablets, Rosuvastatin-SZ

Rosuvastatin-SZ is a lipid-lowering drug.

Release form and composition

The drug is produced in the form of film-coated tablets: biconvex, round, pink-colored shell, the core is almost white or white in cross-section (10 pcs. In a blister strip, in a cardboard box 3 or 6 packages; 14 pcs. In blister strip packaging, in a cardboard bundle 2 or 4 packages; 30 pcs. in a blister strip packaging, in a cardboard bundle 2, 3 or 4 packages; 20 or 90 pcs. in a polymer bottle / polymer can, in a cardboard box 1 bottle / bank; each pack also contains instructions for the use of Rosuvastatin-SZ).

1 tablet contains:

  • active substance: rosuvastatin (in the form of rosuvastatin calcium) - 5, 10, 20 or 40 mg;
  • additional components: calcium hydrogen phosphate dihydrate, lactose monohydrate (milk sugar), povidone (low molecular weight polyvinylpyrrolidone), sodium stearyl fumarate, croscarmellose sodium (primellose), microcrystalline cellulose, colloidal silicon dioxide (aerosil);
  • film casing: Opadray II [macrogol (polyethylene glycol) 3350, polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E171), talc, soy lecithin (E322), aluminum varnish based on azorubin dye, aluminum varnish based on indigo carmine dye, aluminum based varnish dye crimson (Ponso 4R)].

Pharmacological properties

Pharmacodynamics

Rosuvastatin belongs to selective competitive inhibitors of HMG-CoA (3-hydroxy-3-methylglutaryl coenzyme A) reductase, an enzyme that converts 3-hydroxy-3-methylglutaryl CoA into mevalonic acid, which is a precursor of cholesterol (CS). The action of the active substance is primarily directed to the liver, in which the production of cholesterol and the catabolism of low density lipoproteins (LDL) is carried out. The drug helps to increase the number of LDL receptors on the surface of liver parenchyma cells, increasing the uptake and catabolism of LDL, as a result of which it inhibits the production of very low density lipoproteins (VLDL), thereby reducing the total number of LDL and VLDL.

The lipid-lowering agent provides a decrease in the increased level of total cholesterol, LDL-C, triglycerides (TG) and an increase in the level of HDL-C, and also helps to reduce the level of apolipoprotein B (ApoV), VLDL-C, non-HDL cholesterol, TG-VLDL. The drug promotes an increase in the concentration of apolipoprotein A-I (ApoA-I), a decrease in the ratio of total cholesterol / HDL-C, LDL-C / HDL-C and non-HDL-C / HDL-C and the ApoV / ApoA-I ratio.

After the start of treatment, a clinically significant effect is noted within 7 days, and after 14 days it is 90% of the maximum possible, the latter is usually achieved by 28 days of therapy and is maintained with regular use of the drug.

The use of Rosuvastatin-SZ is effective in adult patients with or without hypercholesterolemia, regardless of gender, age or race, including in patients with diabetes mellitus and familial hypercholesterolemia.

In 80% of patients with Fredrickson type IIa and IIb hypercholesterolemia (average initial level of LDL-C content of about 4.8 mmol / L) during the period of use of the drug at a dose of 10 mg, the level of LDL-C reaches values below 3 mmol / L.

On the background of treatment with Rosuvastatin-SZ in doses of 20–80 mg, in patients with heterozygous familial hypercholesterolemia, there is a positive dynamics of lipid profile parameters. A 53% decrease in the concentration of LDL-C is recorded after titrating the drug to a daily dose of 40 mg (12 weeks of the course), the level of LDL-C less than 3 mmol / l is achieved in 33% of patients. In patients with homozygous familial hypercholesterolemia, who used the drug at a dose of 20 and 40 mg, the decrease in the concentration of LDL-C was on average 22%.

Against the background of hypertriglyceridemia with initial levels of TG concentration of 273–817 mg / dL during the period of taking the drug at a dose of 5 to 40 mg 1 time per day for 6 weeks, the content of TG in the blood plasma significantly decreased.

With the combined use of Rosuvastatin-SZ with nicotinic acid in lipid-lowering doses, an additive effect was recorded on the level of HDL-C, and with fenofibrate - on the level of TG.

According to the results of clinical studies, in patients with a high risk of developing cardiovascular diseases and severe hypercholesterolemia, Rosuvastatin-SZ should be used at a dose of 40 mg.

Pharmacokinetics

The maximum concentration of rosuvastatin (C max) in blood plasma is observed approximately 5 hours after oral administration. The absolute bioavailability of the drug is approximately 20%, the volume of distribution (V d) is about 134 liters. Rosuvastatin binds to plasma proteins, mainly albumin, by about 90%. The systemic exposure (AUC) of the active substance increases in proportion to the dose. With daily intake, the pharmacokinetic characteristics do not change.

Rosuvastatin is metabolized mainly by the liver - the main site of cholesterol production and metabolic transformation of LDL-C. It is metabolized to a small extent (approximately 10%), the active substance is a non-core substrate for biotransformation by enzymes of the cytochrome P450 system. The main isoenzyme responsible for the metabolism of the substance is the isoenzyme CYP2C9; isoenzymes CYP2C19, CYP3A4 and CYP2D6 are less involved in the metabolism. The main metabolites of rosuvastatin identified are lactone metabolites and N-desmethylrosuvastatin. The latter is approximately 50% less active than rosuvastatin. Lactone metabolites are considered pharmacologically inactive. More than 90% of the pharmacological activity to suppress circulating HMG-CoA reductase is provided by rosuvastatin and 10% by its metabolites.

Approximately 90% of the dose of rosuvastatin is excreted through the intestine unchanged (including absorbed and unabsorbed substances), the remainder is excreted by the kidneys. The half-life (T 1/2) from plasma is approximately 19 hours and does not change with increasing dose. The geometric mean plasma clearance is approximately 50 l / h (coefficient of variation 21.7%). In the hepatic uptake of rosuvastatin, the membrane transporter of cholesterol is involved, which plays an important role in the process of hepatic elimination of this substance.

The pharmacokinetic parameters of rosuvastatin do not depend on the sex and age of the patient.

Rosuvastatin, like other HMG-CoA reductase inhibitors, binds to transport proteins such as BCRP (efflux transporter) and OATP1B1 (organic anion transport polypeptide involved in the uptake of statins by the liver cells). In carriers of the ABCG2 (BCRP) c.421AA and SLC01B1 (OATP1B1) c.521CC genotypes, an increase in rosuvastatin AUC was recorded by 2.4 and 1.6 times, respectively, compared with carriers of the ABCG2 c.421CC and SLCO1B1 c.521TT genotypes.

Indications for use

  • primary hypercholesterolemia according to the Fredrickson classification (type IIa, including familial heterozygous hypercholesterolemia) or mixed hypercholesterolemia (type IIb): as an addition to diet in the case when special diet, exercise, weight loss and other non-drug methods of therapy show insufficient effect;
  • familial homozygous hypercholesterolemia: as an adjunct to diet and other lipid-lowering treatments (eg, LDL apheresis) or in cases where such treatment is not effective enough;
  • hypertriglyceridemia (type IV according to Fredrickson): as an addition to the diet;
  • atherosclerosis: in order to slow the progression of the disease as an addition to the diet in cases where treatment is indicated to reduce the level of total cholesterol and LDL cholesterol;
  • stroke, heart attack, arterial revascularization and other major cardiovascular complications: for primary prevention in adult patients without clinical signs of coronary heart disease (CHD), but with a high probability of its development (age after 60 years for women and after 50 years for men, the level of C-reactive protein is higher than 2 mg / l, in the presence of at least one of the additional risk factors, such as low levels of HDL-C, arterial hypertension, family history of early development of coronary artery disease, smoking).

Contraindications

Absolute contraindications for all doses:

  • myopathy;
  • pregnancy and lactation period;
  • lack of reliable methods of contraception;
  • age up to 18 years;
  • glucose-galactose malabsorption, lactase deficiency, lactose intolerance (the drug contains lactose);
  • an increase in the concentration of creatine phosphokinase (CPK) in the blood, more than 5 times higher than the upper limit of the norm (UGN);
  • combined with cyclosporine or HIV protease inhibitors;
  • hypersensitivity to any of the components of Rosuvastatin-SZ tablets.

Additional absolute contraindications for doses of 5, 10 and 20 mg:

  • renal failure, severe with creatinine clearance (Cl) below 30 ml / min;
  • liver disease in the active phase, including a persistent increase in the serum activity of transaminases and any increase in their activity exceeding the VGN by more than 3 times;
  • predisposition to the occurrence of myotoxic complications.

Additional absolute contraindications for the 40 mg dose:

  • renal failure of moderate / severe degree with Cl creatinine below 60 ml / min;
  • personal / family history of muscle damage;
  • liver disease in the active stage, including a persistent increase in the serum activity of transaminases and any increase in their activity, exceeding the VGN by more than 3 times in patients with risk factors for the development of myopathy / rhabdomyolysis, which include: hypothyroidism; a history of myotoxicity when using other HMG-CoA reductase inhibitors or fibrates; combined reception with fibrates; conditions that can cause an increase in the plasma level of rosuvastatin; alcohol abuse;
  • belonging to the Mongoloid race.

Relative contraindications for all doses (Rosuvastatin-SZ tablets should be used with caution):

  • sepsis;
  • history of liver damage;
  • arterial hypotension;
  • trauma, major surgical interventions;
  • severe metabolic, endocrine or electrolyte disturbances;
  • uncontrolled seizures;
  • combined use with ezetimibe and colchicine;
  • age over 65.

Additional relative contraindications for Rosuvastatin-SZ in doses of 5, 10 and 20 mg:

  • hypothyroidism;
  • personal / family history of hereditary muscle lesions and a previous history of muscle toxicity with the use of other HMG-CoA reductase inhibitors or fibrates;
  • the presence of a threat of the development of myopathy / rhabdomyolysis - renal failure;
  • conditions in which an increase in the plasma concentration of rosuvastatin is recorded;
  • simultaneous use with fibrates;
  • belonging to the Mongoloid race;
  • excessive alcohol consumption.

An additional relative contraindication for Rosuvastatin-SZ at a dose of 40 mg is the presence of mild renal failure with creatinine Cl above 60 ml / min.

Rosuvastatin-SZ, instructions for use: method and dosage

Rosuvastatin-SZ is taken orally. The tablets, without crushing or chewing, should be swallowed whole with water.

The lipid-lowering agent can be used regardless of food intake, at any time of the day.

Before the start of the course, the patient should switch to a standard diet with a low content of cholesterol and then follow it throughout the entire period of therapy. The dose is selected individually, taking into account the therapeutic response to the drug intake and the purpose of treatment, as well as in accordance with the current recommendations for target lipid levels.

For patients who have not previously received statin therapy, or who have taken other HMG-CoA reductase inhibitors before starting the course, the recommended starting dose of Rosuvastatin-SZ is 5/10 mg 1 time per day. The initial dose is set based on the individual concentration of cholesterol and taking into account the likelihood of cardiovascular complications, as well as the possible threat of adverse reactions. The dose can be increased if necessary after 4 weeks.

Due to the possible occurrence of side effects while taking 40 mg / day, in comparison with lower daily doses, it is possible to increase the dose to 40 mg / day (after taking an additional dose exceeding the recommended initial dose for 4 weeks of the course) the degree of hypercholesterolemia and a high risk of developing cardiovascular complications. Up to 40 mg / day is predominantly prescribed to patients with familial hypercholesterolemia who have not been able to achieve the desired treatment result when taking 20 mg / day, and who will be under strict medical supervision. Patients receiving Rosuvastatin-SZ in a daily dose of 40 mg especially need careful medical supervision.

Patients who have not previously consulted a specialist are not recommended to take Rosuvastatin-SZ 40 mg tablets.

After 2–4 weeks after the start of the course of therapy and / or with an increase in the dose, lipid metabolism parameters should be monitored and, if necessary, the dose should be adjusted.

Carriers of genotypes c.421AA or c.521CC are not recommended to use Rosuvastatin-SZ in doses exceeding 20 mg once a day.

In the process of studying the pharmacokinetics of rosuvastatin in patients belonging to different ethnic groups, when the drug was taken by the Japanese and the Chinese, an increase in the systemic concentration of rosuvastatin was revealed. This phenomenon must be taken into account when prescribing a hypolipidemic agent to representatives of the Mongoloid race. For this group of patients, when treating at doses of 10 and 20 mg, one should start with taking 5 mg / day, tablets at a dosage of 40 mg are contraindicated.

Patients with a predisposition to the development of myopathy are recommended to take Rosuvastatin-SZ at an initial dose of 5 mg.

Side effects

Adverse reactions noted with the use of rosuvastatin are usually mild and go away on their own. The appearance of side effects is in most cases dose-dependent.

The reported incidence of adverse reactions during therapy with Rosuvastatin-SZ:

  • endocrine system: often - type 2 diabetes mellitus;
  • immune system: rarely - hypersensitivity reactions, including angioedema;
  • digestive tract: often - abdominal pain, nausea, constipation; rarely - pancreatitis; in a small number of patients, there is a dose-dependent increase in the activity of hepatic transaminases, which is mainly insignificant, asymptomatic and transient;
  • central and peripheral nervous system: often - dizziness, headache;
  • skin: infrequently - rash, skin itching, urticaria;
  • urinary system: proteinuria (when taking Rosuvastatin-SZ mainly at a dose of 40 mg, tubular proteinuria was observed, which, as a rule, was transient, and did not indicate acute damage or worsening of kidney disease);
  • musculoskeletal system: often - myalgia; rarely - myopathy (including myositis), rhabdomyolysis (with or without acute renal failure); in rare cases, a dose-dependent increase in CPK activity is possible, usually insignificant, transient and asymptomatic; in case of increased activity of CPK, exceeding more than 5 times the VGN, therapy should be suspended;
  • laboratory indicators: an increase in the concentration of bilirubin, glucose, the activity of gamma-glutamyl transpeptidase (GGTP), alkaline phosphatase (ALP), a violation of the thyroid gland;
  • other reactions: often - asthenic syndrome.

Violations recorded during the post-marketing use of Rosuvastatin-SZ:

  • hematopoietic system: with an unknown frequency - thrombocytopenia;
  • central and peripheral nervous system: extremely rarely - polyneuropathy, memory loss;
  • musculoskeletal system: extremely rare - arthralgia; with an unknown frequency - immune-mediated necrotizing myopathy (clinical manifestations are persistent weakness of the proximal muscles and an increase in serum CPK levels during therapy or after its termination; the use of immunosuppressive drugs may be necessary);
  • digestive system: extremely rare - jaundice, hepatitis; rarely - an increase in the activity of hepatic transaminases; with an unknown frequency - diarrhea;
  • urinary system: extremely rare - hematuria;
  • respiratory system: with an unknown frequency - shortness of breath, cough;
  • reproductive system and mammary gland: with an unknown frequency - gynecomastia;
  • skin and subcutaneous tissue: with an unknown frequency - Stevens-Johnson syndrome;
  • others: with an unknown frequency - peripheral edema.

In the treatment of some statins, the appearance of such side effects was recorded: sexual dysfunction, sleep disorders (including insomnia and nightmares), depression; in isolated cases - interstitial lung disease (especially with prolonged therapy).

Overdose

In the case of the simultaneous administration of several daily doses of Rosuvastatin-SZ, no change in the pharmacokinetic parameters of rosuvastatin was recorded.

In case of an overdose, symptomatic treatment and measures are prescribed to maintain the functions of vital systems and organs. Monitoring of liver activity and CPK levels is required. It is assumed that hemodialysis is impractical.

special instructions

It is not recommended to determine the activity of CPK after significant physical exertion or in the presence of other possible reasons for the increase in its activity, since this may cause an incorrect interpretation of the results of the tests performed. In the case when the initial activity of CPK is 5 times higher than that of VGN, a repeated test is required after 5-7 days. You should not start therapy if repeated measurement data confirm a preliminary result (CPK activity exceeds GV by more than 5 times).

During the period of application of Rosuvastatin-SZ, patients should immediately inform their doctor about cases of unexpected occurrence of muscle weakness, muscle pain or spasms, especially with the concomitant occurrence of malaise and fever. In such patients, it is necessary to determine the activity of CPK. In the presence of pronounced muscle symptoms that cause daily discomfort, even with a CPK level less than 5 times higher than the ULN, therapy should be discontinued. After relieving symptoms and normalizing CPK activity, you can consider resuming the intake of Rosuvastatin-SZ or using another HMG-CoA reductase inhibitor at a lower dose and while monitoring the patient's condition. In the absence of such symptoms, constant monitoring of CPK activity is not necessary.

In patients with hypercholesterolemia due to nephrotic syndrome or hypothyroidism, treatment of the underlying disease should be carried out before starting to take Rosuvastatin-SZ.

If patients had glucose concentrations from 5.6 to 6.9 mmol / L, the use of the drug was associated with an aggravated risk of developing type 2 diabetes mellitus.

In the course of treatment with some statins, especially over a long course, there were reports of isolated cases of interstitial lung disease. Signs of this complication can include unproductive cough, shortness of breath, weight loss, weakness, and fever. In this case, it is necessary to stop therapy.

Influence on the ability to drive vehicles and complex mechanisms

Studies to study the possible effect of Rosuvastatin-SZ on the ability to drive transport and use complex mechanisms in work have not been carried out. Patients need to be careful when performing potentially hazardous activities, since dizziness may develop during treatment.

Application during pregnancy and lactation

Rosuvastatin-SZ is contraindicated for use during pregnancy and lactation. Women of childbearing age need to use reliable contraception.

Since cholesterol and cholesterol biosynthesis products are extremely important for the development of the fetus, the possible risk of suppression of HMG-CoA reductase outweighs the benefits of taking Rosuvastatin-C3 in pregnant women. In case of pregnancy during treatment with the drug, its intake should be stopped immediately.

There is no data on the release of rosuvastatin in breast milk, therefore, during lactation, it is necessary to stop taking Rosuvastatin-SZ.

Pediatric use

Treatment with the drug is contraindicated in patients under 18 years of age.

With impaired renal function

In patients with mild to moderate renal failure, there was no significant change in the plasma level of rosuvastatin or N-desmethylrosuvastatin. In severe renal failure, the level of rosuvastatin in the blood plasma was 3 times, and N-desmethylrosuvastatin was 9 times higher than that in healthy volunteers. The plasma concentration of rosuvastatin in patients on hemodialysis treatment was approximately 50% higher than in healthy volunteers.

Taking Rosuvastatin-SZ is contraindicated in the presence of severe renal impairment (Cl creatinine below 30 ml / min).

For patients with moderate functional impairment of the kidneys (Cl creatinine 30-60 ml / min), Rosuvastatin-SZ at a dose of 40 mg is contraindicated, and at a dose of 5, 10 and 20 mg should be used with caution.

Patients with mild renal impairment (Cl creatinine above 60 ml / min) should be treated with a 40 mg dose with caution, monitoring renal function parameters. When using the drug in patients with moderate renal impairment, the initial dose should be 5 mg.

For violations of liver function

In the presence of liver failure of 7 points and below on the Child-Pugh scale, an increase in T 1/2 of rosuvastatin was not detected, in two patients with 8 and 9 points an increase in T 1/2 was recorded at least 2 times. There is no experience of using Rosuvastatin-SZ in patients whose condition is assessed higher than 9 points on the Child-Pugh scale.

Treatment with the drug is contraindicated in patients with liver disease in the acute phase, including with a persistent increase in serum transaminase activity and any increase in transaminase activity, more than 3 times higher than VGN. It is recommended to use Rosuvastatin-SZ with caution in patients with a history of liver damage. It is necessary to determine the indicators of liver activity before treatment and 3 months after the start of the course.

Use in the elderly

Elderly patients do not need individual dose selection.

Persons over 65 years of age should be treated with caution with Rosuvastatin-SZ.

Drug interactions

Possible effect of concurrently used drugs / agents on rosuvastatin:

  • cyclosporine (at a dose of 75-200 mg 2 times a day): there was an increase in the AUC of rosuvastatin, received in a daily dose of 10 mg, approximately 7 times compared with the AUC recorded in healthy volunteers, while the plasma concentration of cyclosporin did not change; this combination is contraindicated;
  • HIV protease inhibitors (including the combination of ritonavir with atazanavir, tipranavir and / or lopinavir): the exact mechanism of this interaction has not been established, however, the combined use of these drugs caused a significant increase in the exposure of rosuvastatin and exacerbated the risk of myopathy (including rhabdomyolysis); when using rosuvastatin at a dose of 20 mg in combination with a drug containing 400 mg lopinavir / 100 mg ritonavir, there was an approximately five-fold and two-fold increase in C max and AUC (0-24) of rosuvastatin, respectively; the combination of rosuvastatin with HIV protease inhibitors is contraindicated;
  • lipid-lowering drugs (fenofibrate, gemfibrozil and other fibrates; nicotinic acid in lipid-lowering doses): the combined use of rosuvastatin and gemfibrozil led to an increase in plasma C maxin blood and AUC of rosuvastatin 2 times, therefore, the simultaneous use of these substances is not recommended; according to the available research data, no pharmacokinetically significant interaction with fenofibrate is expected, however, pharmacodynamic interaction is possible; fibrates (including gemfibrozil and fenofibrate) and nicotinic acid (in daily doses above 1000 mg), when combined with HMG-CoA reductase inhibitors, aggravate the risk of myopathy, presumably due to the fact that they can lead to the appearance of myopathy in the regimen monotherapy; if necessary, these combinations are recommended to take rosuvastatin at an initial dose of 5 mg, after a careful assessment of the ratio of the possible risk and the expected benefit from the combined use of these substances;in combination therapy with fibrates, taking the drug at a dose of 40 mg is contraindicated;
  • itraconazole (in a daily dose of 200 mg for 5 days): a 1.4-fold increase in the AUC of rosuvastatin taken as a single dose of 10 or 80 mg was recorded;
  • erythromycin: the C max and AUC of rosuvastatin may decrease by 30 and 20%, respectively, these effects are possibly associated with an increase in intestinal motility due to the intake of erythromycin;
  • ezetimibe: in patients with hypercholesterolemia, there was an increase in the AUC of rosuvastatin by 1.2 times, when the latter was combined at a dose of 10 mg with ezetimibe at the same dose; possible aggravation of the risk of developing adverse events due to the pharmacodynamic interaction between these substances;
  • antacids: a decrease in plasma C max of rosuvastatin by approximately 50% was recorded against the background of its simultaneous administration with a suspension of antacids, including aluminum and magnesium hydroxide; the severity of this effect decreased with the use of antacids 2 hours after taking rosuvastatin; the clinical significance of this interaction has not been studied;
  • cytochrome P450 isozymes: according to the results of in vivo and in vitro studies, rosuvastatin does not belong to inhibitors / inducers of cytochrome P450 isoenzymes, it has also been established that it is a weak substrate for these enzymes, in this regard, the interaction of rosuvastatin at the metabolic level with other medicinal substances / means with the participation of cytochrome P450 isoenzymes are not expected;
  • eltrombopag (at a daily dose of 75 mg): there was an increase in the AUC of rosuvastatin by 1.6 times with a single dose of the latter at a dose of 10 mg;
  • ketoconazole (inhibitor of CYP3A4 and CYP2A6 isoenzymes), fluconazole (inhibitor of CYP3A4 and CYP2C9 isoenzymes): no clinically significant interaction of rosuvastatin with these substances was observed;
  • dronedarone (at a dose of 400 mg 2 times a day): there was an increase in the AUC of rosuvastatin by 1.4 times;
  • digoxin: No clinically significant interaction expected.

Possible effect of rosuvastatin on concomitantly used drugs / agents:

  • ethinyl estradiol, norgestrel (oral contraceptives / hormone replacement therapy): there was an increase in the AUC values of norgestrel and ethinyl estradiol by 34 and 26%, respectively; this fact should be taken into account when determining the dose of oral contraceptives; there is no pharmacokinetic data on the combined use of Rosuvastatin-SZ and hormone replacement therapy, therefore, a similar effect cannot be excluded with this combination, however, such a combination was widely used and well tolerated in clinical trials;
  • vitamin K antagonists (including warfarin): in patients receiving these drugs, an increase in the international normalized ratio (INR) was observed during the beginning of the course of rosuvastatin or an increase in its dose, and with a decrease in the dose or withdrawal of rosuvastatin, a decrease in the INR; in such cases, it is recommended to monitor the INR.

Analogs

Rosuvastatin-SZ analogues are Rosuvastatin, Krestor, Rosufast, Mertenil, Rozistark, Reddistatin, Lipoprime, Roxera, Rosucard, Rosart, etc.

Terms and conditions of storage

Store out of the reach of children, protected from moisture and light, at a temperature not exceeding 25 ° C.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Rosuvastatin-SZ

According to reviews, Rosuvastatin-C3 is an effective hypolipidemic agent used to treat hypercholesterolemia, slow the progression of atherosclerosis and prevent cardiovascular complications. Many patients observe the initial effect of treatment within a week of admission, and the maximum effect is observed 1 month after the start of the course. According to reviews, due to the action of the drug, the level of cholesterol in the blood decreases, blood pressure stabilizes, the general condition improves, and shortness of breath when walking decreases. Against the background of treatment, in some cases, increased body weight decreases due to the combined use of the drug with a low-cholesterol diet.

The disadvantages of Rosuvastatin-SZ include a large number of contraindications and adverse reactions. In some reviews, patients express dissatisfaction with the price of the drug, since it is often taken for a rather long time, the cost of the drug necessary for the full course of treatment, in their opinion, is quite high.

The price of Rosuvastatin-SZ in pharmacies

The price of Rosuvastatin-SZ, film-coated tablets, depends on the dosage and quantity in the package, and on average is:

  • dosage 5 mg: 30 pcs. - 180 rubles;
  • dosage 10 mg: 30 pcs. - 350 rubles, 90 pcs. - 800 rubles;
  • dosage 20 mg: 30 pcs. - 400 rubles, 90 pcs. - 950 rubles;
  • dosage 40 mg: 30 pcs. - 750 rubles.

Rosuvastatin-SZ: prices in online pharmacies

Drug name

Price

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Rosuvastatin-SZ 5 mg film-coated tablets 30 pcs.

166 r

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Rosuvastatin-SZ tablets p.o. 5mg 30 pcs.

262 RUB

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Rosuvastatin-SZ tablets p.o. 10mg 30 pcs.

307 r

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Rosuvastatin-SZ 10 mg film-coated tablets 30 pcs.

307 r

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Rosuvastatin-SZ tablets p.o. 20mg 30 pcs.

RUB 360

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Rosuvastatin-SZ 20 mg film-coated tablets 30 pcs.

RUB 360

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Rosuvastatin-SZ 10 mg film-coated tablets 60 pcs.

RUB 525

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Rosuvastatin-SZ 20 mg film-coated tablets 60 pcs.

569 r

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Rosuvastatin-SZ 10 mg film-coated tablets 90 pcs.

640 RUB

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Rosuvastatin-SZ 40 mg film-coated tablets 30 pcs.

640 RUB

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Rosuvastatin-SZ tablets p.o. 10mg 90 pcs.

662 RUB

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Rosuvastatin-SZ 20 mg film-coated tablets 90 pcs.

815 RUB

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Rosuvastatin-SZ tablets p.o. 20mg 90 pcs.

821 RUB

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Anna Kozlova
Anna Kozlova

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!

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