Ro-statin caps. 10mg 30 units 1 + 1

Description

Composition
Active substance:
1 capsule contains: in terms of rosuvastatin – 5, 10, 20 or 40 mg.
Product form:
Capsules of 5 mg, 10 mg, 20 mg and 40 mg.
5, 6, 7, 10 capsules in blisters of PVC film and aluminum foil printed patent.
10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 capsules in cans or in cans PET polymer made from polypropylene for medicaments.
One jar or 1, 2, 3, 4, 5, 6, 9 or 10 contour of cellular packaging together with instructions for use placed in a cardboard box (pack).
Equipment is allowed to 2 or 3 cartons (packs) in multipacks (transportation) of paperboard for consumer packaging.
Contraindications
Capsule 5 mg, 10 mg and 20 mg: • hypersensitivity to rosuvastatin or any of the components; • liver disease in its active phase, including persistent elevation of serum transaminases and any increase in transaminase activity in serum (more than 3 times compared with the upper limit of normal); • severe renal impairment (creatinine clearance less than 30 mL / min.); • myopathy; • simultaneous reception cyclosporin; • Children and adolescents under 18 years of age; • women: pregnancy, breast feeding, lack of adequate contraceptive methods; • to patients predisposed to the development of complications miotoksicheskih; • lactose intolerance, lactase deficiency or malabsorption glyukozogalaktoznaya (formulation contains lactose). For the 40 mg capsules: • hypersensitivity to rosuvastatin or any of the components; • simultaneous reception cyclosporin; • liver disease in its active phase, including persistent elevation of serum transaminases and any increase in transaminase activity in serum (more than 3 times compared with the upper limit of normal); • patients with risk factors for myopathy / rhabdomyolysis, namely: – renal insufficiency moderate severity (CC less than 60 ml / min); – hypothyroidism; – personal or family history of muscle disease; – miotoksichnost in patients receiving other HMG-CoA reductase inhibitors or fibrates history; • women: pregnancy, breast feeding, lack of adequate contraceptive methods; • excessive use of alcohol; • conditions that can lead to increased plasma concentrations of rosuvastatin; • simultaneous reception of fibrates; • patients Mongoloid races; • lactose intolerance, lactase deficiency or malabsorption glyukozogalaktoznaya (formulation contains lactose).
Dosage
10 mg
Indications
– Primary hypercholesterolaemia Fredrickson classification (type IIa, including family heterozygous hypercholesterolemia) or mixed hypercholesterolaemia (type IIb) as an adjunct to diet when diet and other non-pharmacological treatments (eg exercise, weight loss) are not sufficient. – Homozygous Familial hypercholesterolemia as an adjunct to diet and other lipid-lowering therapy (e.g., LDL apheresis) or cases where such therapy is not effective enough. – Hypertriglyceridemia (type IV classification Fredrickson) as an adjunct to diet. – To slow the progression of atherosclerosis as an adjunct to diet in patients who have shown therapies to reduce the concentration of total cholesterol and LDL-C. – Primary prevention of major cardiovascular events (stroke, heart attack, arterial revascularization) in adult patients without clinical evidence of coronary heart disease (CHD), but with an increased risk of its development (age over 50 years for men and over 60 for women, increased C-reactive protein (> 2 mg / l) in the presence of at least one additional risk factors such as hypertension, low HDL-cholesterol concentrations, smoking, family history of early onset coronary heart disease).
pharmachologic effect
Pharmacological group:
Lipid-lowering drugs – HMG-CoA reductase inhibitor.
Pharmacological properties:
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 primary target of action of rosuvastatin is the liver, where the synthesis of cholesterol (LDL) and catabolism of low density lipoprotein (LDL). Rosuvastatin increases the number of “liver” LDL receptors on the cell surface, increasing the catabolism of LDL and grip, which in turn leads to inhibition of the synthesis of very low density lipoproteins (VLDL), thereby reducing the total amount of VLDL and LDL. Rosuvastatin decreases the increased concentration of LDL cholesterol (LDL-C), total cholesterol, triglycerides (TG) and increases high-density lipoprotein cholesterol (HDL-C) and also reduces the concentration of apolipoprotein B (apoB) neLPVP-cholesterol, HS- VLDL, triglycerides, VLDL and increases the level of apolipoprotein A-I (ApoA-I), decreases the ratio of LDL-C / LDL-HDL, total cholesterol / cholesterol-HDL cholesterol and LDL-neLPVP / cholesterol-HDL cholesterol and the ratio of ApoB / ApoA-I. The therapeutic effect appears within one week after the beginning of therapy with statin-Ro, after 2 weeks of treatment up to 90% of the maximum possible effect. Maximum therapeutic effect is usually achieved by the fourth week, and maintained at regular taking the drug. Clinical efficacy Rosuvastatin is effective in adults with hypercholesterolaemia, with or without hypertriglyceridemia; regardless of race, gender or age, including in patients with diabetes mellitus and familial hypercholesterolemia. In 80% of patients with hypercholesterolemia IIa and IIb type Fredrickson classification (average initial concentration of LDL-C about 4.8 mmol / L) in patients receiving the drug in a dose of 10 mg of LDL-C concentration reaches the values ​​less than 3 mmol / l. In patients with heterozygous familial hypercholesterolemia treated with rosuvastatin at a dose of 20-80 mg, the positive dynamics of lipid profile. After titration to a daily dose of 40 mg (12 weeks), decreased concentration of LDL cholesterol by 53%. Patients with homozygous familial iperholesterinemiey taking rosuvastatin 20 mg and 40 mg, the average reduction in the concentration of LDL cholesterol was 22%. An additive effect was seen in combination with fenofibrate in triglyceride concentration and with nicotinic acid in a lipid-lowering doses (more than 1 g / day) With respect to the concentration of HDL-C.
Conditions of supply of pharmacies
Prescription.
Dosing and Administration
Inside, do not chew or open the capsule swallowed whole with water. The drug can be administered at any time of the day regardless of meal times. Before the start of therapy with a statin Roh-patient should begin to comply with a standard hypocholesterolemic diet and continue to observe her during treatment. The dose should be individualized depending on the goals of therapy and therapeutic response to treatment, taking into account the current recommendations for target lipid concentrations.
The recommended starting dose for patients starting to take the drug, or for patients who switched from receiving other HMG-CoA reductase, should be 5 or 10 mg of the statin drug Rho-1 times a day. When selecting the starting dose should be guided by the individual cholesterol concentrations and to take into account the possible risk of cardiovascular complications, as well as the need to evaluate the potential risk of side effects. If necessary, the dose may be increased to greater after 4 weeks.
Due to the possibility of side-effects when receiving a 40 mg dose compared with lower doses of the drug, increasing the dose to 40 mg after supplementation doses above the recommended starting dose for 4 weeks of treatment, may be carried out only with severe patients degree of hypercholesterolemia and at high risk of cardiovascular complications (particularly in patients with familial hypercholesterolemia) in which the desired treatment result is not achieved when receiving a dose of 20 mg, and which will be monitored by spe ists. Recommended singularity but careful monitoring of the patients receiving the drug in a dose of 40 mg.
Not recommended dose of 40 mg assignment to patients not previously consulted a doctor.
After 2-4 weeks of therapy and / or with increasing doses Rho statin necessary control lipid metabolism (dose required correction if necessary).
elderly patients
The initial recommended dose for patients over the age of 70 years – 5 mg, otherwise no dose adjustment is required based on age.
Patients with renal insufficiency
In patients with renal insufficiency mild or moderate dose adjustment is required. Do not use this drug dosages of Rho-statin in patients with severe renal failure (creatinine clearance less than 30 mL / min.) (See. The section “Contra ‘). Do not use this drug in the dosage of 40 mg patsien- there with moderate renal impairment (creatinine clearance less than 60 mL / min.). Patients with moderate renal impairment (creatinine clearance less than 60 mL / min.) Is recommended initial dose of 5 mg.
Patients with hepatic insufficiency
Ro-statin drug is contraindicated in patients with liver disease in active phase.
Special populations. ethnic groups
In the study of the pharmacokinetic parameters of rosuvastatin in patients boiling belonging to different ethnic groups, marked increase in systemic concentrations of rosuvastatin among the Japanese and Chinese. Keep in mind this fact when administering the drug Ro-statin these groups of patients. At doses 10 and 20 mg of recommended starting dose for patients is the Mongoloid race 5 mg. Contraindications Zano use of the drug at a dose of 40 mg patients Mongoloid races (see. The section “Contra ‘).
Patients predisposed to myopathy
Medication contraindicated assignment 40mg patients with factors that may indicate a predisposition to the development of myopathy (see. The section “contraindications zaniya”). At doses 10 and 20 mg recommended starting dose for this patient is 5 mg.
genetic polymorphism
Carriers genotypes SLCO1B1 (OATP1B1) c.521CC and ABCG2 (BCRP) c.421AA marked increase exposure (AUC) to rosuvastatin as compared with native genotypes SLCO1B1 c.521TT and ABCG2 c.421CC. For patients carrying genotypes s.521SS or s.421AA recommended maximum dose statin Rho-1 is 20 mg once a day.
concomitant therapy
Rosuvastatin is associated with various transport proteins (in particular OATR1V1 and BCRP). With the simultaneous application of the drug Rho statin with drugs (such as cyclosporin, some HIV protease inhibitors, including a combination of ritonavir with atazanavir, lopinavir and / or tipranavir), increase the concentration of rosuvastatin in plasma due to the interaction with the transport proteins, may increase the risk of myopathy (including rhabdomyolysis). In such cases, you should evaluate the possibility of alternative therapies destination or temporary discontinuation Rho statin. If the use of the above formulations must should weigh the benefits and risks of concomitant therapy with statin-Ro and consider reducing the dose.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist