Atoris, 20 mg, film-coated tablets, 30 pcs.

Nosological classification (ICD-10)

• E14 Diabetes mellitus, unspecified
• E78 Disorders of lipoprotein metabolism and other lipidemias
• E78.0 Pure hypercholesterolemia
• E78.1 Pure hyperglyceridemia
• E78.2 Mixed hyperlipidemia
• E78.5 Hyperlipidemia, unspecified
• E78.9 Disorders of lipoprotein metabolism, unspecified
• I10 Essential (primary) hypertension
• I15 Secondary hypertension
• I20.9 Angina pectoris, unspecified
• I21.9 Acute myocardial infarction, unspecified
• I25.9 Chronic ischemic heart disease, unspecified
• I64 Stroke not specified as hemorrhage or infarction
• Z72.0 Tobacco use
• Z82.4 Family history of coronary heart disease and other diseases of the cardiovascular system

Description, composition and properties

Atoris is a modern lipid-lowering medication aimed at reducing the amount of cholesterol and preventing the development of atherosclerosis, thrombosis and many other diseases of the cardiovascular system. The main component of the composition is atorvastatin. It reduces the growth processes of the inner lining of blood vessels, relaxes the circulatory system, reduces plasma viscosity, normalizes blood clotting, improves metabolic processes and prevents plaque ruptures.

Thanks to Atoris, mortality is reduced and the likelihood of ischemic complications is reduced.

The half-life of the medication is about two hours.

Residual components of the tablets are excreted primarily in bile. The medication is available by prescription. The average price per package in Russian pharmacy chains is about 400-1000 rubles, depending on the volume, manufacturer and region of sale.

Compound

Description of the dosage form

Tablets, 10 and 20 mg: round, slightly biconvex, white film-coated. Fracture appearance: white rough mass with a white or almost white film shell.

Tablets, 30 mg: round, slightly biconvex, film-coated, white or almost white, with a bevel.

Tablets, 60 mg: oval, biconvex, film-coated, white or almost white.

Tablets, 80 mg: capsule-shaped, biconvex, film-coated, white or almost white.

Tablets, 40 mg: round, slightly biconvex, white or almost white film-coated. Fracture appearance: white rough mass with a white or almost white film shell.

Pharmacodynamics

Atorvastatin is a lipid-lowering drug from the group of statins. The main mechanism of action of atorvastatin is the inhibition of the activity of HMG-CoA reductase, an enzyme that catalyzes the conversion of HMG-CoA to mevalonic acid. This transformation is one of the early stages in the chain of cholesterol (C) synthesis in the body. Suppression of cholesterol synthesis by atorvastatin leads to increased reactivity of LDL receptors in the liver, as well as in extrahepatic tissues. These receptors bind LDL particles and remove them from the blood plasma, which leads to a decrease in the concentration of LDL-C in the blood.

The antiatherosclerotic effect of atorvastatin is a consequence of its effect on the walls of blood vessels and blood components. Atorvastatin inhibits the synthesis of isoprenoids, which are growth factors for the cells of the inner lining of blood vessels. Under the influence of atorvastatin, endothelium-dependent dilation of blood vessels improves, the concentration of LDL-C, apolipoprotein B, and triglycerides (TG) decreases, and the concentration of HDL-C and apolipoprotein A increases.

Atorvastatin reduces the viscosity of blood plasma and the activity of certain coagulation factors and platelet aggregation. Thanks to this, it improves hemodynamics and normalizes the state of the coagulation system. HMG-CoA reductase inhibitors also affect the metabolism of macrophages, block their activation and prevent rupture of atherosclerotic plaque.

As a rule, the therapeutic effect of atorvastatin is observed after 2 weeks of treatment, and the maximum effect develops after 4 weeks.

Atorvastatin at a dose of 80 mg significantly reduces the risk of ischemic complications (including death from myocardial infarction) by 16%, and the risk of re-hospitalization for angina pectoris accompanied by signs of myocardial ischemia by 26%.

Pharmacological properties of the drug Atoris

Lipid-lowering agent. The active ingredient of the drug - atorvastatin - reduces the level of TG, total cholesterol, LDL cholesterol and increases the level of HDL cholesterol in the blood. The mechanism of action of atorvastatin is due to inhibition of the activity of HMG-CoA reductase, an enzyme that catalyzes the conversion of HMG-CoA to mevalonic acid. This transformation is one of the initial stages of cholesterol synthesis in the body. Blockade of cholesterol synthesis by atorvastatin leads to an increase in the ability of receptors to bind LDL cholesterol in the liver and other organs. Atorvastatin reduces the formation of LDL, thereby reducing the level of cholesterol in the blood. Atorvastatin also slows down the secretion of VLDL cholesterol in the liver, which is the most likely mechanism for reducing TG levels in the blood, since the connection with apolipoprotein B is weakened and thereby their clearance increases. The mechanism of the effect of atorvastatin on increasing HDL cholesterol levels is not clear. In addition to the effect on plasma lipids, atorvastatin also has other effects that enhance its antiatherosclerotic effect. It inhibits the synthesis of isoprenoids - substances that cause proliferation of vascular smooth muscle cells. Reduces the viscosity of blood plasma and the activity of some coagulation and aggregation factors, thereby improving hemodynamics and promoting the balance of blood coagulation processes. In addition, HMG-CoA reductase inhibitors affect the metabolism of macrophages - inhibiting their activation, reducing the rupture of atherosclerotic plaques. Atorvastatin is rapidly absorbed from the gastrointestinal tract by approximately 80%. The maximum concentration in blood plasma is reached after 1–4 hours. Eating reduces the absorption of atorvastatin, but this does not affect its effectiveness. The bioavailability of atorvastatin is low - only 12%, which is due to the intensity of the first round of metabolism. More than 98% of atorvastatin is bound to plasma proteins. Does not penetrate the BBB. The half-life is on average 14 hours, and the half-life of inhibitory activity towards the target enzyme is 20-30 hours. Approximately 46% of atorvastatin is excreted in the feces and less than 2% in the urine.

Pharmacokinetics

Absorption of atorvastatin is high, approximately 80% is absorbed from the gastrointestinal tract. The degree of absorption and plasma concentration increase in proportion to the dose. Tmax is on average 1–2 hours. In women, Tmax is 20% higher, and AUC is 10% lower. Differences in pharmacokinetics in patients by age and gender are insignificant and do not require dose adjustment.

In patients with alcoholic cirrhosis, Tmax is 16 times higher than normal. Eating slightly reduces the rate and duration of drug absorption (by 25 and 9%, respectively), but the decrease in LDL-C concentration is similar to that when using atorvastatin without food.

The bioavailability of atorvastatin is low (12%), systemic bioavailability of inhibitory activity against HMG-CoA reductase is 30%. Low systemic bioavailability is due to first-pass metabolism in the gastrointestinal mucosa and primary passage through the liver.

The average Vd of atorvastatin is 381 l. More than 98% of atorvastatin is bound to plasma proteins. Atorvastatin does not penetrate the BBB. Metabolized predominantly in the liver under the influence of the CYP3A4 isoenzyme of cytochrome P450 with the formation of pharmacologically active metabolites (ortho- and parahydroxylated metabolites, beta-oxidation products), which account for approximately 70% of the inhibitory activity against HMG-CoA reductase for 20–30 hours.

T1/2 of atorvastatin is 14 hours. It is excreted mainly in bile (it is not subject to pronounced enterohepatic recirculation and is not excreted during hemodialysis). Approximately 46% of atorvastatin is excreted through the intestines and less than 2% by the kidneys.

Special patient groups

Children. Pharmacokinetic studies have not been conducted in children.

Elderly patients. Cmax and AUC of the drug in elderly patients (over 65 years of age) are 40 and 30%, respectively, higher than those in young adult patients (no clinical significance).

Renal dysfunction. Impaired renal function does not affect the concentration of atorvastatin in the blood plasma or its effect on lipid metabolism; therefore, no change in the dose of the drug is required in patients with impaired renal function.

Liver dysfunction. The concentration of the drug is significantly increased (Cmax - approximately 16 times, AUC - approximately 11 times) in patients with alcoholic cirrhosis of the liver (Class B according to the Child-Pugh classification).

Indications for the drug Atoris®

For dosages of 10, 20 mg

primary hypercholesterolemia (heterozygous familial and non-familial hypercholesterolemia (Fredrickson type II);

combined (mixed) hyperlipidemia (Fredrickson types IIa and IIb);

dysbetalipoproteinemia (Fredrickson type III) (as an addition to the diet);

familial endogenous hypertriglyceridemia (Fredrickson type IV), resistant to diet;

homozygous familial hypercholesterolemia with insufficient effectiveness of diet therapy and other non-pharmacological treatments;

For dosages of 30, 40, 60, 80 mg

primary hypercholesterolemia (heterozygous familial and non-familial hypercholesterolemia (Fredrickson type II);

combined (mixed) hyperlipidemia (Fredrickson types IIa and IIb);

dysbetalipoproteinemia (Fredrickson type III) (as an addition to the diet);

familial endogenous hypertriglyceridemia (Fredrickson type IV), resistant to diet;

homozygous familial hypercholesterolemia with insufficient effectiveness of diet therapy and other non-pharmacological treatments;

For all dosages

Prevention of cardiovascular diseases:

primary prevention of cardiovascular complications in patients without clinical signs of coronary heart disease, but with several risk factors for its development: age over 55 years, nicotine addiction, arterial hypertension, diabetes mellitus, low levels of HDL-C in the blood plasma, genetic predisposition, in incl. against the background of dyslipidemia;

secondary prevention of cardiovascular complications in patients with coronary heart disease (CHD) in order to reduce the total mortality rate, myocardial infarction, stroke, readmission for angina pectoris and the need for revascularization.

Determination of dosages, instructions

The drug should be taken only as part of complex therapy with a therapeutic diet. Tablets increase the effectiveness of these measures and help regulate body weight and well-being. Direct administration is carried out after a meal or on an empty stomach. The initial dosage of the drug is 10 mg, and if well tolerated, it is increased to 20, 40 and 80 milligrams. The dose should be divided into several doses according to the recommendation of the attending physician.

For the treatment of hypercholesterolemia, as well as primary and mixed hyperlipidemia, a daily dose of 10 mg is administered for four weeks. After this, the dose is increased.

Patients who have liver damage should take the drug with caution due to the difficulty of eliminating the residue.

The medication can also be used before and after surgery, as well as before plasmapheresis. The method of administration and dosage are determined individually.

Contraindications

hypersensitivity to any of the components of the drug;

liver diseases in the active stage (including active chronic hepatitis, chronic alcoholic hepatitis);

liver failure;

liver cirrhosis of any etiology;

increased activity of liver transaminases of unknown origin by more than 3 times compared to ULN;

skeletal muscle diseases;

lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome;

pregnancy and breastfeeding;

age under 18 years (efficacy and safety of use have not been established).

With caution: alcoholism; history of liver disease.

Use during pregnancy and breastfeeding

Atoris® is contraindicated during pregnancy and breastfeeding. Results from animal studies suggest that the risk to the fetus may outweigh any possible benefit to the mother.

In women of reproductive age who do not use reliable methods of contraception, the use of Atoris® is not recommended. When planning pregnancy, you must stop using Atoris® at least 1 month before the planned pregnancy.

There is no information about the excretion of atorvastatin into breast milk. However, in some animal species the concentration of atorvastatin in the blood serum and milk of lactating animals is similar. If it is necessary to use the drug Atoris® during lactation, in order to avoid the risk of adverse events in infants, breastfeeding must be stopped.

Analogs and prices in pharmacies

Similar medications and analogues in composition and mode of action are cheaper or more expensive than Atoris, depending on the manufacturer and region of sale. Replacement can be made only in case of hypersensitivity to its composition or insufficient effectiveness of the medication in treatment.

Many publications write about how much modern life-saving medicines cost. Atoris is one of the most accessible and important in the treatment and prevention of diseases of the cardiovascular system. But while taking the pills, it is important to systematically monitor your well-being, since they can cause a number of negative side effects. In such cases, it is possible to select analogs based on the mechanism of action.

Side effects

WHO classification of the incidence of side effects: very often - ≥≥1/10; often - from ≥1/100 to <1/10; uncommon - from ≥1/1000 to <1/100; rarely - from ≥1/10000 to <1/1000; very rarely - from <1/10000; frequency unknown—cannot be estimated from available data.

From the nervous system: often - headache, insomnia, dizziness, paresthesia, asthenic syndrome; infrequently - peripheral neuropathy, amnesia, hypoesthesia.

From the senses: infrequently - tinnitus; rarely - nasopharyngitis, nosebleeds.

From the hematopoietic organs: infrequently - thrombocytopenia.

From the respiratory system: often - chest pain.

From the digestive system: often - constipation, dyspepsia, nausea, diarrhea, flatulence (bloating), abdominal pain; uncommon - anorexia, impaired taste perception, vomiting, pancreatitis; rarely - hepatitis, cholestatic jaundice.

From the musculoskeletal system: often - myalgia, arthralgia, back pain, swelling of the joints; uncommon - myopathy, muscle cramps; rarely - myositis, rhabdomyolysis, tendonopathy (in some cases with tendon rupture).

From the genitourinary system: infrequently - decreased potency, 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.

From the immune system: often - allergic reactions; very rarely - anaphylaxis.

Laboratory indicators: infrequently - increased activity of AST, ALT, increased activity of serum CPK; very rarely - hyperglycemia, hypoglycemia.

Other: often - peripheral edema; Uncommon: malaise, fatigue, fever, weight gain.

The cause-and-effect relationship of some undesirable effects with the use of Atoris®, which are considered very rare, has not been established. If severe adverse effects occur, use of Atoris should be discontinued.

Side effects of the drug Atoris

Side effects are minor and temporary in most patients. From the immune system: very rarely - allergic reactions. Metabolic and nutritional disorders: very rarely - anorexia. From the reproductive system: very rarely - impotence. From the central nervous system: insomnia, headache; very rarely - paresthesia, peripheral neuropathy, dizziness. From the respiratory system, chest and mediastinum: very rarely - chest pain. From the gastrointestinal tract: constipation, flatulence, dyspepsia, nausea, diarrhea, abdominal pain; very rarely - vomiting, pancreatitis. From the hepatobiliary system: very rarely - hepatitis, cholestasis. From the skin and subcutaneous tissues: very rarely - angioedema, rash, pruritis, alopecia. From the musculoskeletal system and connective tissue: myalgia, muscle weakness; very rarely - myopathy, muscle cramps, myositis. General disorders: asthenia. Violation of laboratory parameters: increased level of creatine kinase (CPK) in the blood; rarely - increased levels of liver transaminases (ALAT, AST), increased or decreased blood glucose levels. The increase in transaminase levels in blood plasma is dose-dependent. An increase in creatine kinase levels greater than 10 times the normal value was observed in 0.4% of patients. 0.1% of these patients experienced muscle pain, tenderness, or muscle weakness. If severe side effects are observed, treatment with the drug should be stopped.

Interaction

Concomitant use of atorvastatin with cyclosporine, antibiotics (erythromycin, clarithromycin, quinupristin/dalfopristin), HIV protease inhibitors (indinavir, ritonavir), antifungals (fluconazole, itraconazole, ketoconazole) or with nefazodone may lead to an increase in the concentration of atorvastatin in the blood serum, which increases the risk of developing myopathy with rhabdomyolysis and renal failure. Thus, when used simultaneously with erythromycin, the Tmax of atorvastatin increases by 40%. All of these drugs inhibit the CYP3A4 isoenzyme, which is involved in the metabolism of atorvastatin in the liver.

A similar interaction is possible with the simultaneous use of atorvastatin with fibrates and nicotinic acid in lipid-lowering doses (more than 1 g/day).

Concomitant use of atorvastatin at a dose of 40 mg with diltiazem at a dose of 240 mg leads to an increase in the concentration of atorvastatin in the blood plasma.

Concomitant use of atorvastatin with phenytoin and rifampicin, which are inducers of the CYP3A4 isoenzyme, may lead to a decrease in the effectiveness of atorvastatin. Since atorvastatin is metabolized by the CYP3A4 isoenzyme, simultaneous use of atorvastatin with inhibitors of the CYP3A4 isoenzyme may lead to an increase in the concentration of atorvastatin in the blood plasma.

Inhibitors of the OATP1B1 transport protein (for example, cyclosporine) may increase the bioavailability of atorvastatin.

When used simultaneously with antacids (suspension of magnesium and aluminum hydroxides), the concentration of atorvastatin in the blood plasma decreases.

When atorvastatin is taken concomitantly with colestipol, the plasma concentration of atorvastatin decreases by 25%, but the therapeutic effect of the combination is higher than the effect of atorvastatin alone.

Concomitant use with drugs that reduce the concentration of endogenous steroid hormones (including cimetidine, ketoconazole, spironolactone) increases the risk of a decrease in endogenous steroid hormones (caution should be exercised).

In patients simultaneously receiving atorvastatin 80 mg and digoxin, plasma digoxin levels increase by approximately 20%, so such patients should be monitored.

When atorvastatin is taken together with oral contraceptives (norethindrone and ethinyl estradiol), it is possible to enhance the absorption of contraceptives and increase their concentration in the blood plasma. The choice of contraceptives in women receiving atorvastatin should be monitored.

Concomitant use of atorvastatin with warfarin may enhance the effect of warfarin on blood coagulation parameters in the first days (decreased PT). This effect disappears after 15 days of taking these drugs together.

With simultaneous use of atorvastatin and terfenadine, no clinically significant changes in the pharmacokinetics of terfenadine were detected.

Atorvastatin does not affect the pharmacokinetics of phenazone.

Concomitant use with protease inhibitors leads to an increase in the concentration of atorvastatin in the blood plasma.

With simultaneous use of atorvastatin at a dose of 80 mg and amlodipine at a dose of 10 mg, the pharmacokinetics of atorvastatin at steady state did not change.

There have been cases of rhabdomyolysis in patients using atorvastatin and fusidic acid.

Concomitant therapy

When using atorvastatin with antihypertensive drugs and estrogens as part of replacement therapy, there were no signs of clinically significant adverse interactions.

Drinking grapefruit juice while taking Atoris may lead to an increase in the concentration of atorvastatin in the blood plasma. In this regard, patients taking Atoris® should avoid drinking more than 1.2 liters of grapefruit juice per day.

Directions for use and doses

Inside, regardless of food intake.

Before starting to use the drug Atoris®, the patient should be put on a diet that reduces the concentration of lipids in the blood, which must be followed throughout the entire therapy with the drug. Before starting therapy, an attempt should be made to control hypercholesterolemia through exercise and weight loss in obese patients, as well as treatment of the underlying disease.

Treatment begins with the recommended initial dose of 10 mg. The dose of the drug varies from 10 to 80 mg 1 time per day and is selected taking into account the initial concentration of LDL-C, the purpose of therapy and the individual therapeutic effect.

Atoris® can be taken once at any time of the day, but at the same time every day. The therapeutic effect is observed after 2 weeks of treatment, and the maximum effect develops after 4 weeks.

At the beginning of therapy and/or during dose increases, it is necessary to monitor plasma lipid concentrations every 2–4 weeks and adjust the dose accordingly.

Primary (heterozygous hereditary and polygenic) hypercholesterolemia (type IIa) and mixed hyperlipidemia (type IIb): treatment begins with the recommended initial dose of 10 mg, 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 for other types of hyperlipidemia. The initial dose is selected individually, depending on the severity of the disease. In most patients with homozygous hereditary hypercholesterolemia, the optimal effect is observed when using the drug at a daily dose of 80 mg (single dose). Atoris® is used as an additional therapy to other treatment methods (plasmapheresis) or as the main treatment if therapy with other methods is not possible.

Special patient groups

Elderly patients. In elderly patients, the dose of Atoris® should not be changed.

Renal dysfunction. It does not affect the concentration of atorvastatin in the blood plasma or the degree of reduction in the concentration of LDL-C when using atorvastatin, so a change in the dose of the drug is not required.

Liver dysfunction. In patients with impaired liver function, caution is required (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 AST and ALT activity). If there is a significant increase in the activity of liver transaminases, the dose of Atoris® should be reduced or treatment should be discontinued.

Use in combination with other drugs

If simultaneous use with cyclosporine is necessary, the daily dose of Atoris® should not exceed 10 mg.

Recommendations for determining the goal of treatment.

Recommendations from the National Cholesterol Education Program (NCEP), USA

* Some experts recommend the use of lipid-lowering agents that lower LDL-C concentrations if lifestyle changes do not reduce LDL-C concentrations to <100 mg/dL. Others prefer drugs that have a predominant effect on TG and HDL-C, such as nicotinic acid in lipid-lowering doses and fibrates. The physician may also delay pharmacotherapy in this subgroup.

** In the absence of risk factors or the presence of only 1 risk factor, almost all patients have a 10-year risk of <10%, so its assessment is not required.

If the target LDL-C concentration is achieved and the TG concentration is ≥200 mg/dL, then the secondary goal of therapy is to reduce the concentration of cholesterol (excluding HDL-C) to a concentration 30 mg/dL below the target in each risk category.

European Atherosclerosis Society Guidelines

In patients with a confirmed diagnosis of coronary artery disease and other patients with a very high risk of ischemic complications, the goal of treatment is to reduce the concentration of LDL-C in the blood plasma to a level of <1.8 mmol/l and/or if this cannot be achieved, it is recommended to reduce the level of LDL-C by 50% of the original value..

Recommendations of the Russian Society of Cardiology, the National Society for the Study of Atherosclerosis (NOA) and the Russian Society of Cardiosomatic Rehabilitation and Secondary Prevention (RosOKR) (V revision 2012): the optimal values ​​for LDL-C and total cholesterol (TC) levels for high-risk patients are: ≤2.5 mmol/L (or ≤100 mg/dL) and ≤4.5 mmol/L (or ≤175 mg/dL), respectively, and for very high risk patients: ≤1.8 mmol/L (or ≤70 mg/dL) and ≤4 mmol/L (or ≤150 mg/dL), respectively.

Use of the drug Atoris

Before prescribing Atoris, the patient should be placed on a low-lipid diet, which he must adhere to throughout the course of drug therapy. The recommended starting dose of Atoris is 1 tablet (10 mg) per day. If necessary, you can increase the daily dose of Atoris to 80 mg. The drug is taken once a day at the same time, before or after meals. The effect is observed after 2 weeks of treatment, the maximum - after 4 weeks. After 2–4 weeks from the start of treatment, it is necessary to take a lipid profile and adjust the dose based on its indicators. Primary (heterozygous familial or polygenic) hypercholesterolemia (type IIa) and mixed hyperlipidemia (type IIb) Treatment begins with the recommended initial dose (10 mg) per day, which is increased if necessary after 4 weeks (depending on the patient’s response). The maximum daily dose is 80 mg. Heterozygous familial hypercholesterolemia in children over 10 years of age It is recommended to prescribe an initial dose of 10 mg once daily. The maximum recommended dose is 20 mg once daily (doses greater than 20 mg have not been studied in patients in this age group). The dose is selected individually, dose adjustment can be carried out at intervals of 4 weeks or more. Homozygous familial hypercholesterolemia Adults: Dosage range is the same as for other forms of hyperlipidemia. The initial dose is adjusted depending on the condition of the disease. In most patients with homozygous familial hypercholesterolemia, the optimal effect is observed at a daily dose of 80 mg. Atoris is used as an adjuvant therapy with other treatments (plasmaphoresis) or as primary therapy if treatment with other methods is not possible. There is no need to reduce recommended doses in elderly patients and patients with impaired renal function. Patients with impaired liver function should use the drug with caution due to the slow elimination of atorvastatin from the body. Clinical and laboratory parameters should be constantly monitored; if pathological changes occur, the dose should be reduced or treatment should be stopped.

Overdose

Symptoms: with the development of myopathy followed by rhabdomyolysis and acute renal failure (a rare but severe side effect), the drug should be discontinued immediately.

Treatment: the patient must be administered a diuretic and sodium bicarbonate solution. If necessary, hemodialysis should be performed. Rhabdomyolysis can lead to hyperkalemia, which requires intravenous administration of calcium chloride or calcium gluconate, infusion of a 5% dextrose (glucose) solution with insulin, and the use of potassium exchange resins. Since atorvastatin is highly bound to plasma proteins, hemodialysis is ineffective. There is no specific antidote.

General measures: monitoring and maintaining vital functions of the body and preventing further absorption of the drug (gastric lavage, administration of activated charcoal or laxatives).

Negative effects during treatment

With long-term use with increased dosages, the following side effects are likely to develop:

• bronchitis, rhinitis;
• dryness and irritation of the conjunctiva;
• tinnitus;
• nausea and vomiting;

• sleep disturbance, drowsiness, insomnia, nightmares;
• feeling of heartbeat;
• chest pain;
• increased heart rate;
• pneumonia;
• exacerbation of asthma;
• disruption of the digestive system (constipation, diarrhea);
• dysfunctional liver lesions;
• bleeding;

• the formation of edema (mainly in the joint area);
• allergic reactions;
• increase and decrease in potassium in the body;
• erythema;
• hives.

WE RECOMMEND THE ARTICLE!

Angionorm is a drug aimed at normalizing blood flow. Read more >>

If the prescribed dosages are exceeded, side effects are likely to increase. According to the instructions, to prevent complications it is necessary to perform a gastric lavage, stop taking the medication and consult a doctor.

special instructions

Before starting therapy with Atoris®, the patient must be prescribed a standard cholesterol-lowering diet, which he must follow during the entire treatment period.

It is necessary to monitor liver function. During therapy with Atoris®, an increase in the activity of liver enzymes in the blood plasma may be observed. This increase is usually small and clinically insignificant. However, it is recommended to monitor the activity of liver enzymes in the blood plasma before starting therapy, after 6, 12 weeks and when increasing the dose of Atoris®. If there is a threefold increase in AST and/or ALT activity relative to ULN, treatment with Atoris should be discontinued.

The increase in aminotransferase activity in the blood serum depends on the dose of the drug and is reversible in all patients.

Atoris® should be used with caution in patients who abuse alcohol and in patients with a history of liver disease.

Myalgia is possible during the use of the drug Atoris®.

The diagnosis of myopathy (muscle pain or muscle weakness combined with increased CPK activity) is likely in patients with diffuse myalgia, muscle soreness or weakness and/or a marked increase in CPK activity. When using the drug Atoris®, as with the use of other statins, the development of rhabdomyolysis with acute renal failure caused by myoglobinuria is rare but possible. The risk of this complication increases when the following medications are used simultaneously with Atoris®: fibrates, nicotinic acid in lipid-lowering doses (more than 1 g/day), cyclosporine (the daily dose of Atoris® should not exceed 10 mg), nefazodone, some antibiotics, antifungals drugs from the group of azoles, HIV protease inhibitors.

If symptoms of myopathy appear or there are risk factors for the development of renal failure, it is recommended to determine serum CPK activity. If CPK activity exceeds ULN by more than 10 times, treatment should be discontinued. When making a differential diagnosis of chest pain, one should consider the possibility of an increase in serum CPK activity when using the drug Atoris®.

Patients should be regularly monitored for muscle pain or weakness, especially during the first months of therapy and during the period of increasing dosage of any of the above drugs.

The patient should be warned to seek immediate medical attention if unexplained pain or muscle weakness occurs, especially if accompanied by malaise or fever.

The drug Atoris® contains lactose, and therefore its use in patients with lactase deficiency, lactose intolerance and glucose-galactose malabsorption syndrome is contraindicated.

Impact on the ability to drive vehicles and other complex mechanisms. Given the possibility of developing dizziness, caution should be exercised when driving vehicles and other technical devices that require increased concentration and speed of psychomotor reactions.

Special instructions for the use of the drug Atoris

Prescribe with caution to patients who abuse alcohol or have a history of liver disease. During treatment with Atoris, an increase in the activity of liver enzymes may be observed. Such an increase is in most cases insignificant and has no clinical significance; however, it is recommended to monitor the activity of liver enzymes before starting treatment and regularly during treatment. If ALT and/or AST levels exceed normal levels by more than 3 times, treatment with atorvastatin should be discontinued. Atorvastatin is not recommended for use in women of reproductive age who do not use reliable methods of contraception. If during treatment with Atoris the patient decides to become pregnant, she must stop taking the drug no later than a month before the planned pregnancy. Treatment with atorvastatin may be associated with a risk of myopathy, rhabdomyolysis and renal dysfunction. The risk of such a complication increases when taking one or a combination of several drugs in parallel: fibric acid derivatives, niacin, cyclosporine, nefazodone, some antibiotics, azole antifungals and HIV protease inhibitors. If there are symptoms of myopathy, it is recommended to determine the activity of CPK in the blood serum. If it increases significantly, treatment should be stopped. The possibility of increased CPK activity in the blood serum during treatment with Atoris should also be paid attention to in the differential diagnosis of chest pain. If myopathy develops, followed by rhabdomyolysis and acute renal failure (a rare but extremely undesirable side effect), the drug is immediately discontinued and diuretics and sodium bicarbonate are prescribed. If necessary, hemodialysis is started. Rhabdomyolysis can lead to hyperkalemia, which is corrected by intravenous infusion of calcium chloride or calcium gluconate, glucose with insulin, and the use of ion exchange resins. Since atorvastatin is mainly bound to plasma proteins, hemodialysis is ineffective.

Release form

Film-coated tablets, 10 mg and 20 mg. 10 pcs. in a blister made of a combined material polyamide/aluminum foil/PVC-aluminum foil. 1, 3, 6 or 9 bl. in a cardboard box.

When packaging at the Russian enterprise KRKA-RUS LLC and Vector-Medica CJSC: 1, 3, 6 or 9 bl. in a cardboard pack.

Film-coated tablets, 30 mg, 60 mg and 80 mg. 10 pcs. in a blister made of a combined material of oriented polyamide/aluminum/PVC-aluminum foil. 3, 6 or 9 bl. in a cardboard pack.

Film-coated tablets, 40 mg. 10 pcs. in a blister (blister pack) made of a combined material polyamide/aluminum foil/PVC-aluminum foil. 1, 3, 6 or 9 bl. in a cardboard pack.

When packaging at the Russian enterprise KRKA-RUS LLC: 1, 3, 6 or 9 bl. in a cardboard pack.

In production at KRKA-RUS LLC, Russia: 10 tablets each. in a blister pack (blister) made of a combined material polyamide/aluminum foil/PVC in accordance with GOST 52145-2003 and aluminum foil in accordance with GOST 745-2003, or TU 48-21-270-94, or according to the specifications of JSC KRKA, d.d. , Novo Mesto”, Slovenia (Coldforming OPA/Al/PVC-Al).

1, 3, 6 or 9 blister packs (blisters) are placed in a cardboard pack in accordance with GOST 7933-89.

Manufacturer

1. JSC "KRKA, d.d., Novo Mesto". Šmarješka cesta 6, 8501 Novo Mesto, Slovenia.

When packaging and/or packaging at a Russian enterprise, the following is indicated: KRKA-RUS LLC. 143500, Russia, Moscow region, Istra, st. Moskovskaya, 50.

Tel.; Fax.

or

CJSC "Vector-Medica", 630559, Russia, Novosibirsk region, Novosibirsk district, settlement. Koltsovo, bldg. 13, bldg. 15.

Tel/fax

2. LLC "KRKA-RUS", 143500, Russia, Moscow region, Istra, st. Moskovskaya, 50; in cooperation with JSC "KRKA, d.d., Novo Mesto".

Tel.; Fax.

Representative office of JSC "KRKA, d.d., Novo Mesto" in the Russian Federation/organization receiving consumer complaints: 125212, Moscow, Golovinskoye Shosse, 5, bldg. 1, fl. 22.

Tel.; Fax.