RO-STATIN CAPSULES 5MG

Composition

1 capsule contains: in terms of Rosuvastatin - 5, 10, 20 or 40 mg

Pharmacotherapeutic group

Hypolipidemic agent - HMG-CoA reductase inhibitor

pharmachologic effect

Rosuvastatin is a selective, competitive inhibitor of HMG-CoA reductase, an enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, 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 “liver” LDL receptors on the cell surface, increasing the uptake and catabolism of LDL, which in turn leads to inhibition of the synthesis of very low density lipoproteins (VLDL), thereby reducing the total amount of LDL and VLDL.
Rosuvastatin reduces the elevated concentration of LDL cholesterol (LDL-C), total cholesterol, triglycerides (TG), increases the concentration of high-density cholesterol-HDL-C (LDL-C), and also decreases the concentration of apolipoprotein B (ApoV), LDL-HDLP, LDL-C, and VLDL, TG-VLDL and increases the level of apolipoprotein A-I (ApoA-I), reduces the ratio of cholesterol-LDL / cholesterol-HDL, total cholesterol-cholesterol-HDL cholesterol and cholesterol-cholesterol-LPVP and the ratio ApoB / ApoA-I.
The therapeutic effect appears within one week after the start of therapy with Ro-statin, after 2 weeks of treatment it reaches 90% of the maximum possible effect.The maximum therapeutic effect is usually achieved by the 4th week and is maintained with regular use of the drug.
Clinical efficacy Rosuvastatin is effective in adult patients with hypercholesterolemia with or without hypertriglyceridemia; regardless of race, gender or age, incl. in patients with diabetes and familial hypercholesterolemia. In 80% of patients with hypercholesterolemia IIa and IIb of the type according to Fredrickson's classification (the average initial concentration of LDL-C is about 4.8 mmol / l) while receiving the drug at a dose of 10 mg, the concentration of LDL-C makes up less than 3 mmol / l. Patients with heterozygous familial hypercholesterolemia receiving rosuvastatin at a dose of 20-80 mg show a positive dynamics of lipid profile parameters.
After titration to a daily dose of 40 mg (12 weeks of therapy), a decrease in the concentration of LDL-C by 53% is noted. In patients with homozygous familial iperholesterolemia, taking rosuvastatin at a dose of 20 mg and 40 mg, the average decrease in the concentration of LDL-C is 22%.
An additive effect is observed in combination with fenofibrate in relation to the concentration of triglycerides and with nicotinic acid in lipid-lowering doses (more than 1 g / day) in relation to the concentration of HDL-C.

Indications for use

• Primary hypercholesterolemia according to Fredrickson's classification (type IIa, including familial heterozygous hypercholesterolemia) or mixed hypercholesterolemia (type IIb) as a supplement to the diet when diet and other non-drug therapies (eg, exercise, weight loss) are insufficient.
  Familial homozygous hypercholesterolemia as an adjunct to diet and other lipid-lowering therapy (for example, LDL-apheresis), or in cases where similar therapy is not effective enough.
  Hypertriglyceridemia (type IV by Fredrickson classification) as a supplement to the diet.
  To slow the progression of atherosclerosis as a supplement to the diet in patients who have been shown 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 coronary heart disease (CHD), but with an increased risk of its development (women older than 50 years for men and older than 60 years for women, increased concentration C -reactive protein (≥ 2 mg / l) in the presence of at least one of the additional risk factors, such as hypertension, low concentrations of HDL-C, smoking, family history of early onset of CHD).

Contraindications

For capsules of 5 mg, 10 mg and 20 mg:
• hypersensitivity to rosuvastatin or any of the components of the drug;
• liver diseases 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 the upper limit of normal);

• severe renal dysfunction (CC less than 30 ml / min.);
• myopathy;
• simultaneous use of cyclosporine;
• children and adolescents up to 18 years;

• in women: pregnancy, breastfeeding, lack of adequate methods of contraception;

• patients predisposed to the development of myotoxic complications;

• lactose intolerance, lactase deficiency or glucose galactose malabsorption (the product contains lactose).
For 40 mg capsules:
• hypersensitivity to rosuvastatin or any of the components of the drug;

• simultaneous use of cyclosporine;

• liver diseases 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 the upper limit of the norm);

• patients with risk factors for myopathy / rhabdomyolysis, namely:

- renal failure of moderate severity (CC less than 60 ml / min);
- hypothyroidism;
- personal or family history of muscular diseases;
- myotoxicity against the background of taking other HMG-CoA reductase inhibitors or a history of fibrates;
• in women: pregnancy, breastfeeding, lack of adequate methods of contraception;

• excessive drinking;

• conditions that can lead to increased plasma concentrations of rosuvastatin;

• simultaneous reception of fibrates;
• Mongoloid patients;

• lactose intolerance, lactase deficiency or glucose galactose malabsorption (the product contains lactose).

Dosage and administration

Inside, do not chew or open the capsule, swallow whole, washed down with water.
The drug can be administered at any time of the day, regardless of the time of the meal. Before starting therapy with Ro-statin, the patient should begin to follow the 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 the target lipid concentration.

Release form

Capsules 5 mg, 10 mg, 20 mg and 40 mg.
On 5, 6, 7, 10 capsules in a blister strip packaging from a film of polyvinyl chloride and aluminum foil printed lacquered.

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