Buy Cardiolip pills 20 mg 30 pcs
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Clinical Pharmacology

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, an enzyme that converts 3-hydroxy-3-methylglutarycoenzyme A to mevalonate, which is a precursor of cholesterol. The main target of rosuvastatin action is the liver, where cholesterol (cholesterol) synthesis and low density lipoprotein catabolism (LDL) are performed.

Rosuvastatin increases the number of “hepatic” LDL receptors on the cell surface, increasing the uptake and catabolism of LDL.

It also inhibits the synthesis of very low density lipoprotein cholesterol (VLDL) in liver cells, thereby reducing the total content of LDL and VLDL.

Rosuvastatin reduces high cholesterol - LDL (cholesterol-LDL), total cholesterol and triglycerides (TG), increases the cholesterol content of high-density lipoprotein (cholesterol-HDL cholesterol) less cholesterol, HDL cholesterol, cholesterol-VLDL, TG-VLDL and increases the level of apolipoprotein A-1 (ApoA-1). ApoB / ApoA-1.

The therapeutic effect can be achieved and within one week after the start of treatment, after 2 weeks, 90% of the maximum possible effect is achieved. Usually, the maximum possible therapeutic effect is achieved after 4 weeks and is maintained with the further intake of the drug.

- Clinical efficacy Rosuvastatin is effective in the treatment of adult patients with hypercholesterolemia with or without symptoms of hypertriglyceridemia, regardless of their race, gender, or age, as well as in the treatment of a special category of patients with diabetes mellitus or the hereditary form of familial hypercholesterolemia. Rosuvastatin is effective for treating patients with hypercholesterolemia type IIa and IIb according to Frederickson (the mean baseline level of LDL-C LDL is 4.8 mmol / l). In 80% of patients who received 10 mg of rosuvastatin, the target values ​​of cholesterol-LDL levels established by the European Society for Atherosclerosis (less than 3 mmol / l) were achieved. In patients with heterozygous familial hypercholesterolemia who took rosuvastatin in doses of 20 to 80 mg according to the forced dose titration scheme, all the doses taken had a significant impact on the change in parameters characterizing lipid content and on achieving the goal of therapy. As a result of dose titration up to 40 mg per day (12 weeks of therapy), LDL-C content decreased by 53%. In 33% of patients, LDL-C LDL values ​​(below 3 mmol / l) were achieved, corresponding to the target guidelines of the European Atherosclerosis Society. In patients with homozygous familial hypercholesterolemia who took rosuvastatin at doses of 20 and 40 mg, the average decrease in LDL-C content was 22%. An additive effect is observed in combination with fenofibrate with respect to the TG content and with nicotinic acid (more than 1 g per day) with respect to the content of HDL-C. Studies on the effect of rosuvastatin on reducing the number of complications caused by lipid disorders, such as coronary artery disease, have not yet been completed. In patients with a low risk of coronary heart disease (defined as framingham risk less than 10% over a period of more than 10 years), with an average LDL-C content of 4.0 mmol / L (154.5 mg / dL) rosuvastatin a dose of 40 mg / day significantly slowed down the increase in the maximum value characterizing the thickening of the carotid artery wall in 12 segments, compared with placebo at a rate of -0,0145 mm / year (95% confidence interval: from -0,0196 to-0, 0093, with p


- Hypercholesterolemia and combined (mixed) dyslipidemic conditions to reduce elevated concentrations of total cholesterol, low-density lipoprotein cholesterol, apo-lipoprotein B and serum triglycerides as a supplement to diet therapy when dieting and other non-drug methods (for example,exercise, weight loss) are insufficient.
- Familial homozygous hypercholesterolemia as an adjunct to diet therapy and other methods of lipid-lowering therapy (for example, LDL-apheresis) or in cases when this therapy is not effective enough.

Rosuvastatin is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Rosuvastatin Vertex Russia pills
Rosuvastatin Izvarino Pharma Russia pills
Rosucard Zentiva KS Czech pills
Rosuvastatin-SZ North Star Russia pills
Crestor AstraZeneca UK pills
SUVARDIO Lek dd Slovenia pills
Rosart Actavis Ltd Iceland pills
Rosistark Belupo Croatia pills
Roxera Krka dd Novo mesto AO Slovenia pills
Rosuvastatin Canonpharma Russia pills
Acorta Pharmstandard-Tomsk Russia pills
Tevastor Teva Israel pills
Rosulip Egis Hungary pills
Merten Gedeon Richter Hungary pills

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Dosage and Administration

The drug is taken orally. Do not chew a tablet or crush it, swallow it whole, drinking plenty of water, it can be taken at any time of the day, regardless of the meal. If necessary, taking the drug in a dose of 5 mg should be divided tablet with a dosage of 10 mg.

Before starting treatment with Cardiolip, 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 chosen individually depending on the goals of therapy and the therapeutic response to treatment, taking into account the current recommendations on target lipid levels.

The recommended initial dose for patients starting to take the drug, or for patients transferred from taking other HMG-CoA reductase inhibitors, should be 5 mg (1/2 tablet 10 mg) or 10 mg of the drug 1 time per day.

At the same time taking cardiolip with gemfibrozil, fibrates, nicotinic acid in a dose of more than 1 g / day, the recommended initial dose of the drug is 5 mg (1/2 pills of 10 mg).

When choosing the initial dose, one should be guided by the individual cholesterol level and take into account the possible risk of cardiovascular complications, as well as the potential risk of side effects. If necessary, the dose may be increased to a maximum after 4 weeks.

Due to the possible development of side effects when taking a dose of 40 mg, compared with lower doses of the drug, increasing the dose to 40 mg, after an additional dose of the dose above the recommended initial dose during 4 weeks of therapy, can be carried out only in patients the degree of hypercholesterolemia and a high risk of cardiovascular complications (especially in patients with familial hypercholesterolemia) who have not achieved the desired result of therapy when taking a dose of 20 mg cha Especially careful monitoring of patients receiving the drug at a dose of 40 mg is recommended.

It is not recommended to use a dose of 40 mg in patients who have not previously consulted a doctor. After 2-4 weeks of therapy and / or with an increase in the dose of the drug, control of lipid metabolism indices is necessary (if necessary, dose adjustment is required).

Elderly patients: dose adjustment is not required.

In patients with mild to moderate renal insufficiency, dose adjustment is not required. The use of all dosages of the drug in patients with severe renal insufficiency (CC less than 30 ml / min) is contraindicated. Use of the drug in a dose of 40 mg is contraindicated in patients with moderately impaired renal function (CC less than 60 ml / min). Patients with moderately impaired renal function are recommended an initial dose of 5 mg (1/2 pills of 10 mg).

Patients with liver failure: Rosuvastatin is contraindicated in patients with liver disease in the active phase. Experience with the use of the drug in patients with liver failure above 9 on the Child-Pugh scale is absent.

Special populations

When studying the pharmacokinetic parameters of rosuvastatin in patients belonging to different ethnic groups, an increase in the systemic concentration of rosuvastatin among Japanese and Chinese was observed. This fact should be taken into account when Rosuvastatin is used in this group of patients. At doses of 10 mg and 20 mg, the recommended starting dose for patients of the Asian race is 5 mg (1/2 pills of 10 mg). The drug is contraindicated in a dose of 40 mg in patients of the Asian race.

Patients predisposed to myopathy

The drug is contraindicated in a dose of 40 mg in patients with factors indicating a predisposition to the development of myopathy. When applying doses of 10 mg and 20 mg, the recommended initial dose for this group of patients is 5 mg (1/2 pills of 10 mg).

When used with gemfibrozil, the dose of the drug should not exceed 10 mg / day.

Adverse reactions

From the side of the central nervous system: often - headache, dizziness, asthenic syndrome; very rarely - polyneuropathy, loss of memory.

On the part of the digestive system: often - constipation, nausea, abdominal pain; rarely - pancreatitis; very rarely - jaundice, hepatitis; unspecified frequency - diarrhea.

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

From the musculoskeletal system: often - myalgia; rarely, myopathy (including myositis), rhabdomyolysis with or without acute renal failure; very rarely - arthralgia.

On the part of the urinary system: proteinuria (less than 1% of cases - for doses of 10 mg and 20 mg, 3% of cases - for a dose of 40 mg); unspecified frequency - peripheral edema; very rarely - hematuria.

On the part of the endocrine system: diabetes mellitus type 2.

Allergic reactions: rarely - hypersensitivity reactions, including angioedema; infrequently - pruritus, rash, urticaria; unspecified frequency - Stevens-Johnson syndrome.

Laboratory indicators: transient dose-dependent increase in the activity of creatine phosphokinase (CPK) (with an increase in the activity of CPK by more than 5 times compared with the upper limit of the norm, therapy should be temporarily suspended); reversible transient dose-dependent increase in the activity of liver transaminases; increasing the concentration of glucose, bilirubin, the activity of gamma-glutamyl transpeptidase, alkaline phosphatase, changes in the level of thyroid hormones.

When using some HMG-CoA reductase inhibitors (statins), the following side effects were reported: depression, sleep disturbances, including insomnia and nightmares, sexual dysfunction. It was reported on isolated cases of interstitial lung disease, especially with prolonged use of drugs.

When several daily doses are taken simultaneously, the pharmacokinetic parameters of rosuvastatin do not change. Overdose treatment is symptomatic, control of liver function and CPK activity is necessary; there is no specific antidote, hemodialysis is ineffective.



Presence of risk of myopathy / rhabdomyolysis development - renal failure, hypothyroidism, personal or family history of hereditary muscular diseases and a previous history of muscle toxicity when using other HMG-CoA reductase inhibitors or fibrates; alcohol addiction; age over 65; conditions in which there is an increase in the plasma concentration of rosuvastatin; race (Asian race - Japanese and Chinese); simultaneous use with fibrates; history of liver disease; sepsis; hypotension; extensive surgical intervention, trauma, severe metabolic, endocrine or electrolyte disturbances, or uncontrolled seizures.

Patients with liver failure: there is no data or experience of using the drug in patients with a score higher than 9 on the Child-Pugh scale.

Use during pregnancy and during breastfeeding: Rosuvastatin is contraindicated during pregnancy and lactation. Since cholesterol and substances synthesized from cholesterol are important for fetal development, the potential risk of inhibition of HMG-CoA reductase exceeds the benefits of using the drug during pregnancy.

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

Women of reproductive age should use adequate methods of contraception.

Drug interactions

Cyclosporine: with the simultaneous use of cardiolip and cyclosporine, AUC of rosuvastatin is on average 7 times higher than that observed in healthy volunteers.Combined use with rosuvastatin leads to an increase in Cmax in the blood plasma by 11 times. It does not affect the plasma concentration of cyclosporine.

Vitamin K antagonists: starting therapy with rosuvastatin or increasing the dose of a drug in patients receiving vitamin K antagonists (for example, warfarin) can lead to an increase in prothrombin time (International Normalized Ratio - INR). Canceling rosuvastatin or reducing the dose of a drug can lead to a decrease in INR (it is recommended to control INR).

Gemfibrozil and other hypolipidemic agents: the combined use of rosuvastatin and gemfibrozil leads to a 2-fold increase in Cmax and AUC of rosuvastatin. 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 (large doses or equivalent 1 g per day) increase the risk of myopathy when used simultaneously with HMG-CoA reductase inhibitors, possibly due to the fact that they can cause myopathy and when used in monotherapy. At the same time taking the drug with gemfibrozil, fibrates, nicotinic acid in a dose of more than 1 g / day, patients are recommended an initial dose of 5 mg (1/2 pills of 10 mg).

Ezetimibe: the simultaneous use of rosuvastatin and ezetimibe was not accompanied by a change in the AUC and Cmax of both drugs.

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. Therefore, concomitant use of rosuvastatin and HIV protease inhibitors in the treatment of patients with human immunodeficiency virus (HIV) is not recommended.

Antacids: the simultaneous use of rosuvastatin and suspensions of antacids containing aluminum and magnesium hydroxide, reduces the plasma concentration of rosuvastatin by about 50%. This effect is less pronounced if antacids are applied 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 Cmax by 30%. Such an interaction may occur as a result of increased intestinal motility caused by taking erythromycin.

Oral contraceptives / hormone replacement therapy: co-administration of rosuvastatin and oral contraceptives increases AUC of ethinyl estradiol and AUC of norgestrel by 26% and 34%, respectively. Such an increase in plasma concentration should be taken into account 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.

Other medications: the clinically significant interaction of rosuvastatin with digoxin is not expected.

Cytochrome P450: the results of in vivo and in vitro studies showed that rosuvastatin is neither an inhibitor nor an inducer of cytochrome P450 isoenzymes. In addition, rosuvastatin is a non-core substrate for these isoenzymes. There was no clinically significant interaction between rosuvastatin and fluconazole and ketoconazole. The combined use of rosuvastatin and itraconazole increases the AUC of rosuvastatin by 28% (clinically insignificant). Thus, interactions associated with metabolism through the cytochrome P450 system are not expected.

Special instructions

Before initiating therapy and throughout the entire period of treatment, a standard lipid-lowering diet should be observed.During treatment, every 2 to 4 weeks, the lipid profile should be monitored and, according to it, the dose of the drug should be adjusted if necessary.

With the use of rosuvastatin in all doses, and in particular at a dose in excess of 20 mg, short-term proteinuria can be observed. In patients taking the drug in a dose of 40 mg, it is recommended to monitor indicators of renal function.

Patients taking rosuvastatin in a dose exceeding 20 mg may experience myalgia, myopathy, and rarely, rhabdomyolysis. Determination of CPK activity should not be carried out after intense physical exertion or in the presence of other possible reasons for increasing CPK, which may lead to an incorrect interpretation of the results. With an increase in CPK 5 times higher than the upper limit of normal after 5-7 days should be repeated measurement. It is not necessary to begin therapy if the repeated test confirms the initial increased activity of KFK more than 5 times in comparison with the upper limit of norm.

In patients at risk of developing myopathy / rhabdomyolysis, it is necessary to consider the ratio of risk and possible benefit of therapy and to carry out clinical observation throughout the course of treatment.

The patient should be informed of the need to immediately report to the doctor in cases of sudden onset of muscle pain, muscle weakness or spasms, especially in combination with indisposition and fever. In such patients, CPK activity should be monitored. Therapy should be discontinued if the activity of CPK is increased by more than 5 times compared with the upper limit of the norm, or if the muscular symptoms are pronounced and cause daily discomfort (even if the activity of CPK is 5 times less than the upper limit of the norm). If the symptoms disappear, and the activity of CPK returns to normal, consideration should be given to the repeated use of the drug or other HMG-CoA reductase inhibitors in smaller doses under close medical supervision. Routine monitoring of CPK in the absence of rhabdomyolysis symptoms is not appropriate.

An increase in the incidence of myositis and myopathy was reported in patients taking other HMG-CoA reductase inhibitors in combination with fibrin acid derivatives, including gemfibrozil, cyclosporine, nicotinic acid in lipid-lowering doses, azole antifungal agents, HIV protease inhibitors and macrolide antibiotics. Gemfibrozil increases the risk of myopathy in combination with certain inhibitors of HMG-CoA reductase. Thus, the simultaneous use of rosuvastatin and gemfibrozil is not recommended. The balance of risk and potential benefit should be carefully weighed when rosuvastatin is used together with fibrates or nicotinic acid in lipid-lowering doses.

It is recommended to determine the indicators of liver function before the start of therapy and 3 months after the start of therapy. If the activity of liver transaminases in serum is 3 times higher than the upper limit of normal, the dose of the drug should be reduced or discontinued.

With a combination of hypercholesterolemia and hypothyroidism or nephrotic syndrome, the treatment of major diseases should be carried out before starting treatment with rosuvastatin.

There was an increase in the plasma concentration of rosuvastatin in patients of the Asian race compared with patients of the European race.

In patients with a blood glucose concentration of 5.6 to 6.9 mmol / l, rosuvastatin therapy was associated with an increased risk of developing type 2 diabetes.

Women of reproductive age should use adequate methods of contraception.

During treatment, dizziness, weakness may occur, so care must be taken when driving and engaging in other potentially hazardous activities that require increased concentration and psychomotor speed.

  • Brand name: Cardiolip
  • Active ingredient: Rosuvastatin
  • Manufacturer: Materia Medica

Studies and clinical trials of Rosuvastatin (Click to expand)

  1. Expression of interleukin (IL)-12 mRNA in gastric carcinoma specimens: Cellular antitumor immune responses
  2. High-dose systemic interleukin-2 therapy in stage IV neuroblastoma for one year after autologous bone marrow transplantation: Pilot study
  3. Phase I trial of subcutaneous interleukin-1α in children with malignant solid tumors
  4. Langerhans cell histiocytosis in children: does soluble interleukin-2-receptor correlate with both disease extent and activity?
  5. Increased Soluble Interleukin-2 Receptor Concentrations in Patients with Insulin-dependent Diabetes Mellitus
  6. Interleukin-1? and its type 1 receptor are expressed in developing neural circuits in the frog,Xenopus laevis
  7. Temporal and spatial patterns ofc-fos mRNA induced by intravenous interleukin-1: A cascade of non-neuronal cellular activation at the blood-brain barrier
  8. Proenkephalin transgene regulation in the paraventricular nucleus of the hypothalamus by lipopolysaccharide and interleukin-1?
  9. Oxidative stability of the meat of broilers supplemented with rosemary leaves, rosehip fruits, chokeberry pomace, and entire nettle, and effects on performance and meat quality
  10. Calculation of the Effective Diffusion Coefficients in Drying of Chemical and Mechanical Pretreated Rosehip Fruits (Rosa eglanteria L.) with Selected Mass Transfer Models
  11. Physico-chemical, antioxidant activity and sensory analysis of new beverages based on milk, cranberry, rosehip fruits and horseradish
  12. Determination of fatty acids and volatile compounds in fruits of rosehip(Rosa L.) species by HS-SPME/GC-MS and Im-SPME/GC-MS techniques
  13. Effects of rosuvastatin on vascular biomarkers and carotid atherosclerosis in lupus: A randomized, double-blind, placebo-controlled trial
  14. Analysis of five HMG-CoA reductase inhibitors— atorvastatin, lovastatin, pravastatin, rosuvastatin and simvastatin: pharmacological, pharmacokinetic and analytical overview and development of a new method for use in pharmaceutical formulations analysis and in vitro metabolism studies
  15. Determination of rosuvastatin in rat plasma by HPLC: validation and its application to pharmacokinetic studies
  16. Simultaneous quantification of atorvastatin and active metabolites in human plasma by liquid chromatography–tandem mass spectrometry using rosuvastatin as internal standard
  17. Simultaneous quantitation of rosuvastatin and gemfibrozil in human plasma by high-performance liquid chromatography and its application to a pharmacokinetic study
  18. ChemInform Abstract: A Series Dedicated to the Synthesis of Statins. Part 4. A New Approach to the Total Synthesis of Rosuvastatin.
  19. ChemInform Abstract: Advances in the Development of Methods for the Synthesis of Second-Generation HMG-CoA Reductase Inhibitors [Fluvastatin Sodium (Lescol), Rosuvastatin Calcium (Crestor), Pitavastatin Calcium (Livalo)]
  20. ChemInform Abstract: Chemoenzymic Route to the Side Chain of Rosuvastatin
  21. High-performance Liquid Chromatographic Analysis of Pioglitazone, Gliquidone, Rosuvastatin and Simvastatin in Formulations and Human Serum
  22. Validated Method for the Simultaneous Determination of Lisinopril, Pravastatin, Atorvastatin and Rosuvastatin in API, Formulations and Human Serum by RP-HPLC
  23. Rosuvastatin positively changes nerve electrophysiology in diabetic rats
  24. A New Approach to the Total Synthesis of Rosuvastatin

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