Roxera film coated pills 5mg N90
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Active ingredients
Rosuvastatin
Release form
Pills
Composition
Active ingredient: Rosuvastatin (Rosuvastatin); Concentration of the active substance (mg): 5
Indications
Fredrikson's primary hypercholesterolemia (type IIa) or mixed dyslipidemia (type IIb) as a supplement to the diet with the ineffectiveness of the diet and other non-pharmacological treatment methods (eg exercise, weight loss); familial homozygous hypercholesterolemia as an adjunct to diet and other lipid-lowering therapy (for example, LDL-apheresis) or if such therapy is not effective; hypertriglyceridemia (type IV according to Fredrickson) as an addition 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 plasma concentration of cholesterol and LDL-C; primary prevention of major cardiovascular complications (stroke, myocardial infarction, 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 plasma concentration of C-reactive protein (≥2 g / l) in the presence of at least one of the additional risk factors, such as: hypertension, low plasma concentration of HDL-C, smoking, early onset of ischemic heart disease in familial en amnesis).
Contraindications
Daily dose up to 30 mg, hypersensitivity to rosuvastatin or any of the components of the drug; liver diseases in the active phase (including a persistent increase in the activity of hepatic transaminases and an increase in the activity of hepatic transaminases in the blood serum by more than 3 times as compared with VGN); severe renal impairment (Cl creatinine less than 30 ml / min); myopathy; simultaneous administration of cyclosporine; patients predisposed to the development of myotoxic complications; pregnancy, breastfeeding period; use in women of childbearing age, not using adequate methods of contraception; lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome; age up to 18 years old .; Daily dose of 30 mg or more; hypersensitivity to rosuvastatin or any of the components of the drug; active liver disease (including persistent increase inthe activity of hepatic transaminases and an increase in the activity of hepatic transaminases in the blood serum by more than 3 times as compared with VGN); moderate to severe renal failure (Cl creatinine less than 60 ml / min); myopathy; simultaneous use of cyclosporine; patients predisposed to the development of myotoxic complications; pregnancy, breastfeeding period; use in women of childbearing age, not using adequate methods of contraception; hypothyroidism; diseases of the muscles in history (including in the family); myotoxicity with the use of other inhibitors of HMG-CoA reductase or fibrates in history; excessive drinking; conditions that can lead to increased plasma concentrations of rosuvastatin; simultaneous use of fibrates; lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome; Mongoloid patients; age up to 18 years old .; With a daily dose of up to 30 mg; Presence of a risk of myopathy / rhabdomyolysis - renal failure, hypothyroidism, hereditary muscle diseases in history (including family) and previous history of muscular toxicity with the use of other HMG-CoA reductase inhibitors or fibrates; excessive drinking; age over 65; conditions in which there is an increase in the plasma concentration of rosuvastatin; race (Mongoloid race - Japanese and Chinese); simultaneous use with fibrates; history of liver disease; sepsis; hypotension; extensive surgical interventions, injuries, severe metabolic, endocrine or electrolyte disturbances or uncontrolled seizures, simultaneous use with ezetimibe .; Daily dose of 30 mg or more; Renal failure, mild severity (Cl creatinine more than 60 ml / min); age over 65; history of liver disease; sepsis; hypotension; extensive surgical interventions, injuries, severe metabolic, endocrine or electrolyte disturbances or uncontrolled seizures, simultaneous use with ezetimibe.
Dosage and administration
Inside, do not chew or pill the pill, swallow it whole with water, it can be taken at any time of the day, regardless of the meal .; Before starting therapy 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 chosen individually, depending on the goals of therapy and the therapeutic response to treatment, taking into account the recommendations on the target plasma lipid concentrations .; The recommended initial dose for patients starting to take the drug, or for patients transferred from taking other HMG-CoA reductase inhibitors, should be 5 or 10 mg of Roxer 1 time per day .; With simultaneous use of the drug with gemfibrozil, fibrates, nicotinic acid in a dose of more than 1 g / day, an initial dose of 5 mg is recommended for patients. 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 can 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 of the dose above the recommended initial dose during 4 weeks of therapy can be carried out only in patients with severe the degree of hypercholesterolemia and a high risk of cardiovascular complications (especially in patients with familial hypercholesterolemia) who have not achieved the desired result of therapy with a dose of 20 mg / day and who will find stay under the supervision of a doctor. 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 consulted 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) .; Patients with renal failure. In patients with mild to moderate renal insufficiency, dose adjustment is not required. In patients with severe renal insufficiency (Cl creatinine less than 30 ml / min), the use of Roxer is contraindicated. Use of the drug in a dose of more than 30 mg / day in patients with moderate to severe renal insufficiency (Cl creatinine less than 60 ml / min) is contraindicated.In patients with moderate renal insufficiency, the recommended initial dose of the drug is 5 mg / day; Patients with liver failure. Roxera is contraindicated in patients with liver disease in the active phase. The experience of using the drug in patients with liver failure is higher than 9 points (class C) on the Child-Pugh scale is absent .; Use in elderly patients. Patients over the age of 65 are advised to start using the drug with a dose of 5 mg / day; Special populations; When studying the pharmacokinetic parameters of rosuvastatin in patients belonging to different ethnic groups, an increase in the systemic concentration of rosuvastatin among Japanese and Chinese was observed. This fact should be taken into account when using Roxer's drug in this group of patients. At doses of 10 and 20 mg / day, the recommended initial dose for patients of the Mongoloid race is 5 mg / day. Patients of the Mongoloid race use of the drug in a dose of 40 mg is contraindicated .; Patients predisposed to myotoxic complications. The use of the drug at a dose of 40 mg in patients predisposed to the development of myotoxic complications is contraindicated. If necessary, the use of doses of 10 and 20 mg / day, the recommended initial dose for this group of patients is 5 mg. When used with gemfibrozil, the dose of Roxer should not exceed 10 mg / day.
Side effects
Classification of the incidence of side effects: very often -> 1/10; often -> 1/100, but 1/1000, but 1/10000, but; The frequency of side effects depends on the dose taken .; On the part of the immune system: rarely - hypersensitivity reactions, including angioedema .; From the side of the central nervous system: often - headache, dizziness; very rarely - polyneuropathy, memory loss .; 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 part of the skin: infrequently - itchy skin, rash, urticaria; very rarely - Stevens-Johnson syndrome .; From the musculoskeletal system and connective tissue: often - myalgia; rarely, myopathy (including myositis) and rhabdomyolysis; very rarely - arthralgia .; A dose-dependent increase in the activity of creatine phosphokinase (CPK) is observed in a small number of patients taking rosuvastatin. In most cases, it is minor, asymptomatic and temporary.In the case of increased activity of CPK more than 5 times higher than VGN therapy should be suspended .; On the part of 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; hematuria is very rare; General disorders: often - asthenia .; Laboratory indicators: increased activity of CPK, the concentration of glucose, bilirubin, the activity of GGTP, alkaline phosphatase, the change in plasma concentration of thyroid hormones.