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Active ingredients
Atorvastatin
Release form
Pills
Composition
Atorvastatin calcium 31.08 mg, which corresponds to the content of atorvastatin 30 mg adjuvants: lactose monohydrate - 175.24 mg, microcrystalline cellulose - 52.5 mg, hyprolosis - 6 mg, croscarmellose sodium - 15 mg, crospovidone type a - 15 mg, polysorbate 80 - 680 mg, sodium hydroxide - 1.5 mg, magnesium stearate - 3 mg. film coating composition: opadry ii hp 85f28751 white - 9 mg (polyvinyl alcohol - 3.6 mg, titanium dioxide (е171) - 2.25 mg, macrogol 3000 - 1.82 mg, talc - 1.33 mg) .
Indications
Hyperlipidemia: - primary hypercholesterolemia (heterozygous familial and non-familial hypercholesterolemia (type II according to Fredrikson); - combined (mixed) hyperlipidemia (type IIa and IIb according to Fredrikson); - dysbetalipoproteinemia (type III according to Fredrikdentemia (type III according to Fredriksente) familial endogenous hypertriglyceridemia (type IV according to Fredrikson), resistant to diet; - homozygous familial hypercholesterolemia with insufficient efficacy of diet therapy and other non-pharmacological treatments. Prevention of cardiovascular Diseases: - primary prevention of cardiovascular complications in patients without clinical signs of coronary heart disease, but having several risk factors for its development: age over 55 years old, nicotine dependence, arterial hypertension, diabetes mellitus, low levels of HDL-C HDL, genetic predisposition, including on the background of dyslipidemia; - secondary prevention of cardiovascular complications in patients with coronary artery disease in order to reduce the total mortality rate, myocardial infarction, stroke, re-hospitalization for okardii and the need for revascularization.
Contraindications
- liver diseases in the active stage (including active chronic hepatitis, chronic alcoholic hepatitis); - liver failure; - liver cirrhosis of various etiologies; - increased activity of hepatic transaminases of unclear genesis (more than 3 times in comparison with VGN); - skeletal diseases muscles; - pregnancy; - lactation period (breastfeeding); - age up to 18 years (efficacy and safety have not been established); - lactase deficiency, lactose intolerance, glucose / galactose malabsorption syndrome; - hypersensitivity any of the components preparata.S caution should be prescribed in alcoholism, hepatic diseases in history.
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
Prior to the use of the drug Atoris, the patient should be transferred to a diet that will reduce the concentration of lipids in the blood, which must be observed during therapy with the drug. Before starting therapy, you should try to control hypercholesterolemia through exercise and weight loss in patients with obesity, as well as therapy of the underlying disease. The drug is taken orally, regardless of the meal. Treatment begins with the recommended initial dose of 10 mg. The dose of the drug varies from 10 mg to 80 mg 1 time / day and is selected based on the initial concentration of LDL-C, the goal of therapy and the individual therapeutic effect. The administration can be taken once at any time of the day, but same time every day. The therapeutic effect is observed after 2 weeks of treatment, and the maximum effect develops after 4 weeks. Therefore, the dose should not be changed earlier than 4 weeks after the start of the use of the drug in the previous dose. At the beginning of therapy and / or during the dose increase, plasma concentrations of lipids should be monitored every 2-4 weeks and the dose should be adjusted accordingly. Primary (heterozygous hereditary and polygenic) hypercholesterolemia (type IIa) and mixed hyperlipidemia (type IIb) Treatment begins with the recommended initial dose, which is increased after 4 weeks depending on the patient's response. The maximum daily dose is 80 mg. Homozygous hereditary hypercholesterolemia. The dose range is the same as with other types of hyperlipidemia. The initial dose is adjusted individually depending on the severity of the disease. In most patients with homozygous hereditary hypercholesterolemia, the optimal effect is observed when using the drug in a daily dose of 80 mg (once).Atoris is used as an additional therapy to other methods of treatment (plasmapheresis) or as the main treatment if therapy with other methods is not possible. Elderly patients should not change the dose of Atoris. Patients with kidney disease should not change the dose of Atoris. Impaired renal function does not affect plasma plasma levels of atorvastatin or the degree of decrease in the concentration of Xc-LDL when using atorvastatin, therefore, changing the dose of the drug is not required. Patients with impaired liver function need to be careful (due to slower elimination of the drug from the body). In such a situation, clinical and laboratory parameters should be carefully monitored (regular monitoring of ACT and ALT activity) and if significant pathological changes are detected, the dose of Atoris should be reduced or treatment should be discontinued. If used in combination with other drugs, the daily dose should be used simultaneously with cyclosporine. Atoris should not exceed 10 mg. Recommendations for determining the goal of treatment. Recommendations of the National Cholesterol Education Program NCEP, USA
Side effects
Classification of the incidence of side effects WHO: very often (more than 1/10), often (from more than 1/100 to less than 1/10), infrequently (from more than 1/1000 to less than 1/100), rarely (from more than 1/10 000 to less than 1/1000 ), very rarely (from less than 1/10 000, including individual messages). From the nervous system: often - headache, insomnia, dizziness, paresthesia, asthenic syndrome; infrequently - peripheral neuropathy, amnesia, hypoesthesia, nightmares. For the senses: infrequently - tinnitus; rarely - nasopharyngitis, nasal bleeding; On the part of the cardiovascular system: heartbeat, vasodilation, migraine, postural hypotension, increased blood pressure, phlebitis, arrhythmia. On the side of the hematopoietic system: infrequently - thrombocytopenia. On the part of the respiratory system: often - chest pain. On the part of the digestive system: often - constipation, dyspepsia, nausea, diarrhea, flatulence (abdominal distension), abdominal pain; infrequently - anorexia, a violation of taste perception, vomiting, pancreatitis; rarely - hepatitis, cholestatic jaundice. From the musculoskeletal system: often - myalgia,arthralgia, back pain, swelling of the joints; infrequently - myopathy, muscle cramps; rarely - myositis, rhabdomyolysis, tendinopathy (in some cases with a tendon rupture). From the urogenital system: infrequently - impotence, secondary renal failure. From the skin: often skin rash, itching; infrequently - urticaria; very rarely - angioedema, alopecia, bullous rash, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. Allergic reactions: often - allergic reactions; very rarely - anaphylaxis. From the laboratory indicators: infrequently - an increase in the serum activity of aminotransferases (ACT, ALT), an increase in the activity of serum CPK; very rarely - hyperglycemia, hypoglycemia. Others: often - peripheral edema; infrequently - malaise, increased fatigue, fever, weight gain. The causal connection of some undesirable effects with the use of the drug Atoris, which is regarded as very rare, has not been established. If severe adverse effects occur, the use of the drug Atoris should be stopped.