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Active ingredients
Rosuvastatin
Release form
Pills
Composition
Rosuvastatin calcium 10.42 mg, which corresponds to the content of rozuvastatin 10 mg. Supplementary substances: microcrystalline cellulose - 89.87 mg, lactose - 40 mg, crospovidone - 7.5 mg, colloidal silicon dioxide - 0.33 mg, magnesium stearate - 1.88 mg. methyl methacrylate copolymer (1: 2: 1) - 1.1 mg, macrogol 6000 - 0.9 mg, titanium dioxide - 0.5 mg, lactose monohydrate - 2 mg.
Indications
- primary hypercholesterolemia (type IIa according to Fredrikson) or mixed dyslipidemia (type IIb according to Fredrikson) as a supplement to the diet with ineffective diet and other non-drug methods of treatment (for example, exercise, weight loss); - familial homozygous hypercholesterolemia as an addition to the diet and other lipid-lowering therapy (for example, LDL-apheresis) or if such therapy is not effective; - hypertriglyceridemia (type IV by Fredrickson) as an addition to the diet; - to slow the progression of atherosclerosis in as a supplement to the diet in patients who have been shown therapy to reduce plasma concentrations of Xc and Xc-LDL; primary prevention of major cardiovascular complications (stroke, myocardial infarction, arterial revascularization) in adult patients without clinical signs of CHD, but with an increased risk of it development (age over 50 years for men and over 60 years for women, increased plasma concentration of C-reactive protein (≥2 g / l) with at least one of the additional risk factors such as arterial hype tensor, the low plasma concentration of HDL-Xc, smoking, early coronary artery disease in family history).
Contraindications
With a daily dose of up to 30 mg, liver disease in the active phase (including a persistent increase in liver transaminase activity and an increase in serum hepatic transaminase activity by more than 3 times compared to VGN); severe renal failure (CC less than 30 ml / min) - myopathy; - concomitant use of cyclosporine; - patients predisposed to the development of myotoxic complications; - pregnancy; - breastfeeding period; - use in women of childbearing age who do not use adequate methods of contraception; the nature of lactose,lactase deficiency, glucose-galactose malabsorption syndrome; - age up to 18 years; - hypersensitivity to rosuvastatin or any of the drug components. At a daily dose of 30 mg and more, liver disease in the active phase (including a persistent increase in liver transaminase activity and an increase in liver activity serum transaminases more than 3 times compared with VGN); - moderate to severe renal failure (CC less than 60 ml / min); - myopathy; - simultaneous use of cyclosporine; - patients predisposed the development of myotoxic complications; - pregnancy; - breastfeeding period; - use in women of childbearing age who do not use adequate methods of contraception; - hypothyroidism; - muscle diseases in history (including in the family); - myotoxicity when using other HMG inhibitors. History of CoA reductase or fibrates; excessive alcohol use; conditions that can lead to an increase in plasma concentration of rosuvastatin; simultaneous use of fibrates; lactose intolerance, lactase deficiency, syndrome ohm glucose-galactose malabsorption; - patients of the Mongoloid race; - age up to 18 years; - hypersensitivity to rosuvastatin or any of the components of the preparation. muscles in history (including in the family) and previous history of muscle toxicity with the use of other HMG-CoA reductase inhibitors or fibrates; excessive alcohol consumption; age over 65 years; conditions in which plasma concentrations of rosuvastatin increased; race (Mongoloid race — Japanese and Chinese); - simultaneous use with fibrates; - history of liver disease; - sepsis; - arterial hypotension; - extensive surgical interventions, injuries, severe metabolic, endocrine or electrolyte disturbances I or uncontrolled seizures; - simultaneous use with ezetimibe. At a daily dose of 30 mg and mild severity or renal insufficiency (CC more than 60 ml / min); - age over 65 years; - history of liver disease; - sepsis; - arterial hypotension; - extensive surgery, trauma, severe metabolic, endocrine or electrolyte disturbances or uncontrolled seizures; - simultaneous use with ezetimibe.
Precautionary measures
Application for violations of liver functionWith caution, you should prescribe the drug for violations of the liver.It is not necessary to change the dose in case of renal dysfunction. The concentration of amplodipine in the blood plasma does not depend on the degree of reduction of renal function. Use in children It is contraindicated in children and adolescents under the age of 18. Application in elderly patients With caution in elderly patients.
Dosage and administration
The drug is taken orally. The tablet should not be chewed or crushed, swallowed whole, washed down with water, can be taken at any time of the day, regardless of the meal. Before the patient starts treatment with Roxer, 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 selected individually depending on the goals of therapy and the therapeutic response to treatment, taking into account national recommendations on plasma target lipid concentrations. The recommended starting dose for patients starting the drug or for patients transferred from other HMG inhibitors CoA reductase should be 5 or 10 mg 1 time / day. When used simultaneously with gemfibrozil, fibrates, nicotinic acid in a dose of more than 1 g / day, patients are recommended to start. The total dose of the drug is 5 mg. When choosing the initial dose, one should be guided by the individual concentration of cholesterol in the blood plasma and take into account the possible risk of developing cardiovascular complications; the potential risk of side effects must also be considered. If necessary, the dose may be increased after 4 weeks. Due to the possible development of side effects when using a dose of 40 mg / day, compared with lower doses of the drug, increasing the dose to 40 mg / day after an additional dose higher than the recommended initial dose during 4 weeks of therapy, can be performed only in patients with severe hypercholesterolemia and with a high risk of developing cardiovascular complications (especially in patients with familial hypercholesterolemia) who have not achieved the desired minutes therapy result in the application of a dose of 20 mg / day, and which will be under the supervision of a physician.Particularly careful monitoring of patients receiving the drug at a dose of 40 mg / day is recommended. It is not recommended to use a dose of 40 mg / day in patients who have not previously visited a doctor. After 2-4 weeks of therapy and / or with an increase in the dose of Roxer's drug, monitoring of lipid metabolism indices is necessary (if necessary, dose adjustment is required). In patients with mild or moderate renal insufficiency, dose adjustment is not required. In patients with severe renal insufficiency (CK less than 30 ml / min), the use of Roxera is contraindicated. The use of the drug in a dose of more than 30 mg / day is contraindicated in patients with moderate to severe renal failure (CC less than 60 ml / min). In patients with moderate renal insufficiency, the recommended initial dose of the drug is 5 mg / day. Roxer's preparation is contraindicated in patients with liver diseases in the active phase. The experience of using the drug in patients with hepatic insufficiency is higher than 9 points (class C) on the Child-Pugh scale is not available. Patients over the age of 65 are advised to start using the drug with a dose of 5 mg / day. Specific Populations When studying the pharmacokinetic parameters of rosuvastatin in patients belonging to to different ethnic groups, an increase in the systemic concentration of rosuvastatin among Japanese and Chinese has been noted. This fact should be taken into account when using this Roxer preparation for these groups of patients. At doses of 10 and 20 mg / day, the recommended initial dose for patients of the Mongoloid race is 5 mg / day. The use of the drug in a dose of 40 mg is contraindicated for patients of the Mongoloid race. The use of the drug in a dose of 40 mg is contraindicated in patients who are predisposed to the development of myotoxic complications. If you need to use doses of 10 and 20 mg / day, the recommended initial dose for this group of patients is 5 mg. When used with gemfibrazil, the dose of Roxer should not exceed 10 mg / day.
Side effects
Classification of the incidence of side effects: very often (more than 1/10), often (more than 1/100, but less than 1/10), infrequently (more than 1/1000, but less than 1/100), rarely (more than 1 / 10,000, but less than 1/1000) , very rarely (less than 1/10 000), including individual messages. The frequency of side effects depends on the dose taken. From the immune system: rarely - hypersensitivity reactions, including angioedema. From the CNS: often - headache, dizziness; very rarely - polyneuropathy, loss of memory. On the part of the digestive system: often - constipation, nausea,abdominal pain; rarely - pancreatitis, increased activity of hepatic transaminases; very rarely - jaundice, hepatitis, diarrhea. On the skin side: infrequently - pruritus, rash, urticaria; very rarely - Stevens-Johnson syndrome. For the musculoskeletal system: often - myalgia; rarely, myopathy (including myositis) and rhabdomyolysis; very rarely - arthralgia. A dose-dependent increase in CPK activity is observed in a small number of patients taking rosuvastatin. In most cases, it is minor, asymptomatic and temporary. In case of increase in CPK activity more than 5 times higher than VGN, therapy should be suspended. From the urinary system: often - proteinuria (less than 1% of patients receiving a dose of 10-20 mg / day, and about 3% of patients receiving a dose of 40 mg / day). In most cases, proteinuria decreases or disappears during therapy and does not mean the onset of acute or progressive concomitant kidney disease. Very rarely - hematuria. General disorders: often - asthenia. Laboratory parameters: increased activity of CPK, glucose, bilirubin concentration, GGT, ALP activity, change in plasma concentration of thyroid hormones.