rosuvastatin | Rosart tablets are coated. 20 mg 90 pcs.

release form

tablets

Packing

90 pcs.

Pharmacological action

Rosart - a lipid-lowering drug from the group of statins. Selective competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) - reductase - an enzyme that converts HMG-CoA to mevalonate, a precursor of 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 number of LDL and VLDL. Reduces elevated cholesterol-LDL cholesterol-high-density non-lipoprotein (non-HDL) cholesterol, cholesterol-VLDL, total cholesterol, triglycerides (TG), TG-VLDL, apolipoprotein B (ApoV), lowers the ratio of total LDL-cholesterol, LDL-cholesterol / HDL cholesterol, non-HDL cholesterol / HDL cholesterol, ApoB / apolipoprotein AI (ApoA-I), increases the concentration of HDL cholesterol, ApoA-I level.

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 in patients with diabetes mellitus and familial hypercholesterolemia. In 80% of patients with type IIa and IIb hypercholesterolemia (Fredrickson classification) with an average baseline LDL cholesterol of about 4.8 mmol / L while taking the drug at a dose of 10 mg, LDL cholesterol reaches values ​​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 LDL cholesterol is 22%.

The additive effect is observed in combination with fenofibrate (in relation to a decrease in triglyceride (TG) concentration and with nicotinic acid in lipid lowering doses (in relation to a decrease in HDL cholesterol).

Indications

Primary hypercholesterolemia (type IIa according to Fredrickson), including heterozygous hereditary hypercholesterolemia) or mixed (combined) hyperlipidemia (type IIb according to Fredrickson), as an adjunct to diet and other non-severe physical activity a form of hereditary hypercholesterolemia with insufficient effectiveness of diet therapy and other types of treatment, aimed at lowering lipid levels (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 lower total cholesterol and LDL cholesterol.

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 (over 50 years old for men and over 60 years old for women, increased concentration 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 cholesterol, smoking, family history of early onset of coronary heart disease).

Contraindications

Hypersensitivity to rosuvastatin or other components of the

preparation Liver diseases in the active phase, including a persistent increase in serum activity of “liver” transaminases (more than 3 times compared with the upper limit of the norm (VGN)) of unclear genesis of srdlp function kidney (CC less than 30 ml / min)

Myopathy

Concomitant use of cyclosporine

Women of reproductive age not using adequate contraception

Pregnancy and lactation s rdlkp Under 18 years of age (efficacy and safety not established)

Lactose intolerance, lactase deficiency, glucose-galactose malabsorption (the drug contains lactose monohydrate).

Caution: The presence of risk factors for the development of myopathy and / or rhabdomyolysis is renal failure (CC greater than 30 ml / min), hypothyroidism, a personal or family history of hereditary muscle diseases, and a previous history of myotoxicity with other HMG-CoA reductase inhibitors or excessive fibrates alcohol consumption, age over 70 years of age, conditions in which there is an increase in the plasma concentration of rosuvastatin race (Mongoloid race), simultaneous use with fibrates, diseases history of liver disease, sepsis, arterial hypotension, extensive surgery, trauma, severe metabolic, endocrine or electrolyte disturbances or uncontrolled epilepsy.

Use during pregnancy and lactation

Rosart is contraindicated in pregnancy and lactation.

The use of Rosart in women of reproductive age is possible only if reliable methods of contraception 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 benefits of using the drug during pregnancy. In the case of diagnosing pregnancy during therapy with Rosart, the drug should be stopped immediately, and patients should be warned of the potential risk to the fetus.

There are no data on the excretion of rosuvastatin with breast milk, so if you need to use the drug during lactation, given the possibility of adverse events in infants, you should decide whether to stop breastfeeding.

Composition

1 tablet contains:

Active ingredient: rosuvastatin 20 mg

Excipients: cellul Oz microcrystalline type 102, crospovidone, type A, calcium phosphate dihydrate, lactose monohydrate, magnesium stearate

Film coating: Opadry White II 33G28435 (hypromellose, titanium dioxide, lactose monohydrate, macrogol 3350, triacetin).

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 Rosart, 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. The recommended initial dose of Rosart for patients starting to take the drug, or for patients transferred from taking other HMG-CoA reductase inhibitors, is 5 or 10 mg 1 time / day. 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 with lower doses of the drug (see section "Side effects"), final titration to a maximum dose of 40 mg should be carried out only in patients with severe hypercholesterolemia and a high risk of cardiovascular complications (especially in patients with hereditary hypercholesterolemia) who, when taking a dose of 20 mg, did not achieve the target cholesterol level, and who will be under medical supervision.

Especially careful monitoring of patients receiving the drug in a dose of 40 mg is recommended. After 2-4 weeks of therapy and / or increasing the dose of the drug, monitoring of lipid metabolism is necessary.

Dose adjustment is not required in elderly patients.

In patients with hepatic insufficiency on a Child-Pugh scale below 7, dose adjustment is not required. In patients with values ​​of 8 and 9 on the Child-Pugh scale, a preliminary assessment of renal function should be performed. There is no experience with the use of rosuvastatin in patients with liver failure above 9 points on the Child-Pugh scale.

Dosage adjustment is not required for mild or moderate renal failure. An initial dose of 5 mg is recommended for patients with moderate renal failure (CC less than 60 ml / min). In patients with moderate renal failure (CC less than 30-60 ml / min), a dose of 40 mg is contraindicated. Taking Rosart is contraindicated in all doses to patients with severe renal failure (CC less than 30 ml / min).

Ethnic groups

In patients of the Asian race, an increase in the systemic concentration of rosuvastatin is possible. When prescribing doses of 10 and 20 mg, the initial recommended dose for patients of Asian origin is 5 mg. The use of the drug in a dose of 40 mg is contraindicated in such patients.

Patients predisposed to the development of myopathy

When prescribing doses of 10 and 20 mg, the initial recommended dose for such patients is 5 mg. The use of the drug in a dose of 40 mg in such patients is contraindicated.

Side effects

From the central nervous system: often - headache, dizziness, asthenic syndrome infrequently - depression, anxiety, insomnia, paresthesia very rarely - peripheral neuropathy, memory loss.

From the digestive system: often - nausea, constipation, abdominal pain infrequently - vomiting, diarrhea, flatulence rarely - pancreatitis is very rare - hepatitis, jaundice.

From the respiratory system: often - pharyngitis infrequently - rhinitis, sinusitis, bronchial asthma, bronchitis, cough, dyspnea, pneumonia.

From the cardiovascular system: infrequently - angina pectoris, increased blood pressure, palpitations, vasodilation.

From the endocrine system: often - diabetes 1. (The overall frequency of 2.8% in the rosuvastatin group and 2.3% in the placebo group, mainly in patients with fasting glucose of 5.6 - 6.9 mmol / l, was reported in the JUPITER study.

From the musculoskeletal system: often - myalgia rarely - arthralgia myopathy (including myositis), rhabdomyolysis, back pain, muscle hypertonicity, pathological fracture of the extremities is very rare - immune-mediated necrotizing myopathy.

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

Skin and subcutaneous tissue: frequency unknown - Stevens-Johnson syndrome.

From the urinary system: often - proteinuria (mainly in patients receiving a dose of 40 mg), decreasing during therapy and not related to the occurrence of kidney disease, urinary tract infections infrequently - peripheral edema, pain in the lower abdomen is very rare - hematuria.

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

Other: often - back pain, rhinopharyngitis rarely - decreased potency.

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

overdose

Treatment: no specific treatment, symptomatic therapy under the control of liver function and CPK activity. Hemodialysis is ineffective.

Storage Conditions

No special storage conditions required. Keep out of reach of children!

Shelf life

30 months.

Deystvuyushtee substance

rosuvastatin

Terms and conditions

prescription

dosage form

tablets

Possible product names

ROZART 0.02 N90 TABLE P / O

ROZART 20MG. No. 90 TAB. P / O

ROSART TAB P / O 20MG No. 90

ROSART TAB. P.P.O. 20MG No. 90

ROSART TAB. P / O CAPTURE. 20MG No. 90

Actavis Ltd, Iceland