Roxera film coated pills 20mg N90
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Active ingredients
Rosuvastatin
Release form
Pills
Composition
Rosuvastatin calcium 20.83 mg, which corresponds to the content of rozuvastatin 20 mg. Excipients: microcrystalline cellulose - 179.75 mg, lactose - 80 mg, crospovidone - 15 mg, colloidal silicon dioxide - 0.66 mg, magnesium stearate - 3.76 mg. The composition of the film shell: butyl methacrylate, dimethylaminoethyl methacrylate and methyl methacrylate copolymer (1: 2: 1) - 2.2 mg, macrogol 6000 - 1.8 mg, titanium dioxide - 1 mg, lactose monohydrate - 4 mg.
Indications
- primary hypercholesterolemia (type IIa according to Fredrikson) or mixed dyslipidemia (type IIb according to Fredrikson) as a supplement to the diet with the ineffectiveness of the diet and other non-drug methods of treatment (for example, 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 Xc and Xc-LDL. - primary prevention of major cardiovascular complications (stroke, myocardial infarction, arterial revascularization) in adult patients without clinical signs of coronary heart disease, but with an increased risk of its development (age over 50 years for men and over 60 years for women, elevated plasma concentrations of C- reactive protein (& # 8805 .2 g / l) in the presence of at least one of the additional risk factors such as arterial hypertension, low plasma concentrations of HDL-HDL, smoking, early onset of coronary artery disease in the family history.
Contraindications
With a daily dose of up to 30 mg, liver disease 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 failure (CC less than 30 ml / min). - myopathy. - simultaneous reception 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. - Hypersensitivity to rosuvastatin or any of the components of the drug.With a daily dose of 30 mg or more, liver disease 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). - moderate to severe renal insufficiency (CC 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 who do not use adequate methods of contraception. - hypothyroidism. - diseases of the muscles in history (including in the family). - myotoxicity with the use of other HMG-CoA reductase inhibitors or fibrates in history. - excessive use of alcohol. - conditions that can lead to an increase in the concentration of rosuvastatin in the blood plasma. - simultaneous use of fibrates. - lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome. - patients of the Mongoloid race. - age up to 18 years. - Hypersensitivity to rosuvastatin or any of the components of the drug. With caution With a daily dose of up to 30 mg, there is a risk of myopathy / rhabdomyolysis - renal failure, hypothyroidism, hereditary muscle diseases in history (including family), and previous history of muscle toxicity when using other HMG-CoA reductase inhibitors or fibrates. - excessive use of alcohol. - age over 65 years. - conditions in which there is an increase in the plasma concentration of rosuvastatin. - Race (Mongoloid race - Japanese and Chinese). - simultaneous use with fibrates. - Liver disease in history. - sepsis. - arterial hypotension. - extensive surgical interventions, injuries, severe metabolic, endocrine or electrolyte disorders or uncontrolled seizures. - simultaneous use with ezetimibe. With a daily dose of 30 mg or more, renal failure is of mild severity (CC more than 60 ml / min). - age over 65 years. - Liver disease in history. - sepsis. - arterial hypotension. - extensive surgical interventions, injuries, severe metabolic, endocrine or electrolyte disorders or uncontrolled seizures. - simultaneous use with ezetimibe.
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 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 national recommendations on 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 1 time / 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 may be increased after 4 weeks. In connection with the possible development of side effects when applying 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 drug above the recommended initial dose during 4 weeks of therapy can only be carried out 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 result of therapy with a dose of 20 mg / day and who will be under the supervision of a physician. It is recommended especially careful monitoring of patients receiving the drug at a dose of 40 mg / day. 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 (dose adjustment is required if necessary). In patients with renal insufficiency, mild or moderate severity of 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). For patients with moderate renal insufficiency, the recommended initial dose of the drug is 5 mg / day. Roxera is contraindicated in patients with liver disease in the active phase. Experience with the use of the drug in patients with liver failure above 9 points (class C) on the Child-Pugh scale is absent. 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 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 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 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. 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, loss of memory. On the part of the digestive system: often - constipation, nausea, abdominal pain. rarely - pancreatitis, increased activity of liver transaminases. very rarely - jaundice, hepatitis, diarrhea. On the part of the skin: infrequently - itching, rash, hives. very rarely - Stevens-Johnson syndrome.From 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 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. Very rarely - hematuria. General disorders: often - asthenia. Laboratory indicators: an increase in the activity of CPK, the concentration of glucose, bilirubin, the activity of GGT, alkaline phosphatase, a change in the plasma concentration of thyroid hormones.
special instructions
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. 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, loss of memory. On the part of the digestive system: often - constipation, nausea, abdominal pain. rarely - pancreatitis, increased activity of liver transaminases. very rarely - jaundice, hepatitis, diarrhea. On the part of the skin: infrequently - itching, rash, hives. very rarely - Stevens-Johnson syndrome. From 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 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. Very rarely - hematuria. General disorders: often - asthenia. Laboratory indicators: an increase in the activity of CPK, the concentration of glucose, bilirubin, the activity of GGT, alkaline phosphatase, a change in the plasma concentration of thyroid hormones.