Rosucard tablets coated 40 mg film, 90 pcs. (rosuvastatin)

Packing

90 pcs.

Pharmacological action

Rosucard - is a lipid lipid statins A selective competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, an enzyme that converts HMG-CoA to mevalonate, a cholesterol precursor (cholesterol).

Increases the number of low density lipoprotein receptors (LDL) on the surface of hepatocytes, which leads to increased uptake and catabolism of LDL, inhibition of very low density lipoprotein synthesis (VLDL), reducing the total concentration of LDL and VLDL. Reduces the concentration of LDL cholesterol, high-density non-lipiprotein cholesterol (non-HDL cholesterol), cholesterol-VLDL, total cholesterol, triglycerides (TG), TG-VLDL, apolipoprotein B (ApoV), reduces the ratio of LDL-C / LDL cholesterol Cholesterol-cholesterol-HDL, cholesterol-HDL / cholesterol-HDL, ApoV / apolipoprotein A-1 (ApoA-I), increases the concentration of HDL-cholesterol and ApoA-I.

Hypolipidemic effect is directly proportional to the size of the prescribed dose. The therapeutic effect appears within 1 week after the start of therapy, after 2 weeks it reaches 90% of the maximum, by 4 weeks it reaches a maximum and after that it remains constant. Effective in adult patients with hypercholesterolemia with or without hypertriglyceridemia (regardless of race, gender or age), including patients with diabetes mellitus and familial hypercholesterolemia. In 80% of patients with type IIa and IIb hypercholesterolemia (Fredrickson classification) with an average initial concentration of LDL-C about 4.8 mmol / L while taking the drug at a dose of 10 mg, the concentration of LDL-C reaches less than 3 mmol / L. In patients with homozygous familial hypercholesterolemia, taking the drug at a dose of 20 mg and 40 mg, the average decrease in the concentration of LDL-C is 22%.

The additive effect is observed in combination with fenofibrate (in relation to a decrease in the concentration of TG and with nicotinic acid in lipid lowering doses (at least 1 g / day) (in relation to a decrease in the concentration of HDL-C).

Indications

Primary hypercholesterolemia (type IIa according to Fredrickson), including heterozygous hereditary hypercholesterolemia or mixed (combined) hypercholesterolemia (type IIb according to Fredrickson), as an addition to diet and other non-drug measures (physical activity and weight loss) with the ineffectiveness of diet therapy and non-drug measures

Homozygous form of hereditary hypercholesterolemia and with insufficient effectiveness of diet therapy and other types of treatment aimed at lowering lipids (for example, LDL apheresis), or if such treatments are not suitable for the patient.

Hypertriglyceridemia (type IV Fredrickson supplementation) as a diet supplement.

To slow the progression of atherosclerosis as a supplement to the diet in patients who are shown therapy to reduce the concentration of total cholesterol and cholesterol - LDL.

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

Contraindications

The presence of the following risk factors for the development of myopathy / rhabdomyolysis: 1. Myotoxicity when taking other inhibitors of HMG-CoA reductase or fibrates in the anamnesis of

2. Hypothyroidism

3. Moderate renal failure (KK 30 - 60 ml / min)

4. Excessive alcohol consumption

5. Conditions that can lead to increase the plasma concentration of rosuvastatin

6. Simultaneous administration of

fibrates Patients of the Mongoloid race

Family history of muscle diseases.

Use during pregnancy and lactation

The use of Rosucard in women of reproductive age is possible only if reliable contraception methods are used and if the patient is informed about the possible risk of treatment for the fetus.

Since cholesterol and substances synthesized from cholesterol are important for fetal development, the potential risk of inhibiting HMG-CoA reductase exceeds the benefit of using the drug during pregnancy. Rosucard is contraindicated in pregnancy and lactation. If pregnancy is diagnosed during the course of drug therapy, Rosucard should be stopped immediately, and the patient should be warned of the potential risk to the fetus.

If it is necessary to use the drug during lactation, given the possibility of adverse events in infants, the issue of stopping breastfeeding should be addressed.

Composition

1 tab. - rosuvastatin calcium 41.6 mg, which corresponds to the content of rosuvastatin 40 mg.

Excipients: lactose monohydrate - 240 mg, microcrystalline cellulose - 181.6 mg, croscarmellose sodium - 4.8 mg, colloidal silicon dioxide - 2.4 mg, magnesium stearate - 9.6 mg.

The composition of the film coat: hypromellose 2910/5 - 10 mg, macrogol 6000 - 1.6 mg, titanium dioxide - 1.3 mg, talc - 1.9 mg, iron dye red oxide - 200 μg.

Dosage and administration

Inside, without chewing or grinding, swallow whole, washed down with water, at any time of the day, regardless of food intake.

Before starting therapy with Rosucard, the patient should begin to follow a standard lipid-lowering diet and continue to follow it during treatment. The dose of the drug should be selected individually depending on the indications and therapeutic response, taking into account current generally accepted recommendations for target lipid levels. If it is necessary to take the drug in a dose of 5 mg, a 10 mg tablet should be divided into two parts at risk.

The recommended starting dose of Rosucard for patients starting to take the drug, or for patients transferred from other HMG-CoA reductase inhibitors, is 5 or 10 mg once daily. When choosing an initial dose, one should be guided by the patient’s cholesterol content and take into account the risk of developing cardiovascular complications, and it is also necessary to assess the potential risk of side effects. If necessary, after 4 weeks the dose of the drug can be increased.

Due to the possible development of side effects when taking a dose of 40 mg compared to lower doses of the drug, the final titration to a maximum dose of 40 mg should be performed only in patients with severe hypercholesterolemia and a high risk of cardiovascular complications (especially in patients with hereditary hypercholesterolemia ), in which when taking a dose of 20 mg, the target cholesterol level was not achieved, and which will be under medical supervision.

Patients with hepatic insufficiency

In patients with hepatic insufficiency with values ​​on the Child-Pugh scale below 7 Rosucard dose adjustment points are not required.

Patients with renal failure

Dose adjustment is not required in patients with mild renal failure. The recommended initial dose of Rosucard is 5 mg per day.

In patients with severe renal failure (CC less than 30 ml / min), the use of Rosucard is contraindicated.

In patients with moderate renal insufficiency (CC 30 - 60 ml / min), the use of Rosucard at a dose of 40 mg per day is contraindicated.

Special Populations. Elderly

patients Dose adjustment is not required in patients over 65 years of age.

Patients with a predisposition to myopathy

The use of rosucard at a dose of 40 mg per day is contraindicated in patients with a predisposition to myopathy. When prescribing doses of 10 mg and 20 mg per day, the recommended initial dose of Rosucard for this group of patients is 5 mg per day.

Ethnic groups

When studying the pharmacokinetic parameters of rosuvastatin, an increase in the systemic concentration of the drug was observed in representatives of the Mongoloid race. This fact should be taken into account when prescribing Rosucard to patients of the Mongoloid race. When prescribing doses of 10 and 20 mg, the recommended initial dose of Rosucard for this group of patients is 5 mg per day. The use of Rosucard at a dose of 40 mg per day in representatives of the Mongoloid race is contraindicated.

When prescribing Rosucard with gemfibrozil, the dose should not exceed 10 mg per day.

Side effects

The frequency of adverse reactions was determined according to the following gradation (World Health Organization classification):

very often - more than 1/10,

often - more than 1/100 to less than 1/10,

infrequently - more than 1/1000 to less than 1/100,

rarely - from more than 1/10000 to less than 1/1000,

very rarely - from less than 1/10000, including individual messages.

unspecified frequency.

From the central nervous system: often - headache, dizziness, asthenic syndrome is very rare - peripheral neuropathy, memory loss.

From the digestive system: often - nausea, constipation, abdominal pain is rare - vomiting is rare - pancreatitis is very rare - hepatitis, jaundice of unspecified frequency - diarrhea.

From the respiratory system: infrequently - cough, dyspnea.

From the endocrine system: often - type 2 diabetes.

From the musculoskeletal system: often - myalgia is very rare - arthralgia is rare - myopathy (including myositis), rhabdomyolysis.

Allergic reactions: infrequently - skin itching, urticaria, rash rarely - angioedema.

Skin and subcutaneous tissue: unspecified frequency - Stevens-Johnson syndrome, peripheral edema.

From the urinary system: often - proteinuria (with a frequency of more than 3% in patients receiving a dose of 40 mg), decreasing during therapy and not associated with the occurrence of kidney disease, urinary tract infection is very rare - hematuria.

Laboratory indicators: infrequently - transient dose-dependent increase in serum creatine phosphokinase (CPK) activity, with an increase of more than 5 times compared with the upper limit of normal therapy should be temporarily suspended rarely - a transient increase in the activity of aspartate aminotransferase and alanine aminotransferase.

As with other HMG-CoA reductase inhibitors, the incidence is dose-dependent, side effects are usually mild and go away on their own.

When using Rosucard, changes in the following laboratory parameters were noted: increased concentrations of glucose, bilirubin, alkaline phosphatase activity, gamma-glutamyl transferase.

When using other statins, the following side effects have been reported: depression, insomnia, decreased potency.

With prolonged use of rosuvastatin, isolated cases of interstitial lung disease have been reported.

Drug Interaction

Co-administration of rosuvastatin and cyclosporine does not affect the plasma concentration of cyclosporine, however, the effect of rosuvastatin is enhanced (its withdrawal is slower, the AUC is increased 7-fold, C max - 11-fold).

Erythromycin increases intestinal motility, which leads to a decrease in the effect of rosuvastatin (AUC is reduced by 20% and C max by 30%).

In patients receiving vitamin K antagonists (eg, warfarin), monitoring of an international normalized ratio (INR) is recommended because initiation of rosuvastatin therapy or an increase in the dose of the drug may lead to an increase in INR and a decrease in rosuvastatin or a decrease in its dose may lead to a decrease in it. Gemfibrozil enhances the effect of rosuvastatin (increases Cmax and AUC by 2-fold). Concomitant administration of rosuvastatin and antacids containing aluminum and magnesium hydroxide results in a decrease in the plasma concentration of rosuvastatin by about 50%. This effect is less pronounced, if antacids are administered 2 hours after taking rosuvastatin.

Concomitant administration of rosuvastatin and oral contraceptives increases the AUC of ethinylestradiol and the AUC of norgestrel by 26% and 34%, respectively, which should be considered when selecting oral contraceptives. There are no pharmacokinetic data on the concomitant use of rosuvastatin and hormone replacement therapy, and therefore, a similar effect cannot be ruled out when using this combination.

Studies have shown that rosuvastatin is neither an inhibitor nor an inducer of cytochrome P450 isoenzymes. Rosuvastatin is a non-core substrate for these isoenzymes. No clinically relevant interaction with drugs such as fluconazole, ketoconazole and itraconazole was observed, metabolism-related cytochrome P450 system.

No clinically relevant interaction of rosuvastatin with digoxin or phenofibrate, Gemfibrozil, other fibrates and hypolipidemic doses of nicotinic acid (at least 1 g / day) increased the risk of myopathy when co-administered with other GM inhibitors. This may be due to the fact that they can cause myopathy even when used as monotherapy.

The combined use of rosuvastatin and ezetimibe did not alter the AUC or Cmax of both drugs.

The use of HIV protease inhibitors (human immunodeficiency virus) with rosuvastatin can significantly increase the effect of rosuvastatin. A pharmacokinetic study of the co-administration of 20 mg rosuvastatin with healthy volunteers and a combination of two HIV protease inhibitors (400 mg lopinavir / 100 mg ritonavir) resulted in approximately two and fivefold increases in AUC (0-24) and C max, respectively. Therefore, co-administration of rosuvastatin with HIV protease inhibitors is not recommended in HIV-infected patients.

Overdose

When co-administered with multiple daily doses, the pharmacokinetic parameters of rosuvastatin do not change.

Treatment: no specific treatment, symptomatic therapy is performed to maintain the functions of vital organs and systems. Monitoring of liver function and CPF activity is required. Hemodialysis is ineffective.

Storage conditions

At a temperature not exceeding 25 oС in the original packaging.

Active ingredient

Rosuvastatin

dosage form

tablets

Possible product names

ROSUKARD 0,04 N90 TABLE S / L

ROSUKARD TAB. P / O CAPTURE. 40MG No. 90

Rosucard tablet p.p. 40 mg N90 Czech Republic

Rosucard tablets 40 mg, 90 pcs.

Rosucard tablets coated with film about 40 mg, 90 pcs.



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