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

What's better?

List of cheap and effective analogues of the drug Canephron
Of course, the American one has established itself as a high-quality manufacturer that has been on the market for a long time. Large companies try to monitor their name and product quality, so they conduct a lot of clinical studies on the effects of the drugs they sell. Even in the instructions for Liprimar you can find many references to ongoing research. This guarantees safe use.

"Atoris" is produced by a good company, the drug is completely safe for use.

Independent studies were conducted that showed similar pharmacological effectiveness of both drugs.

Among the advantages of Atoris is its lower price. Statins must be taken regularly, even for life. And the higher cost of Liprimar may be an obstacle to this.

Therefore, based on almost the same effect, in conditions of a limited budget, it is better to take Atoris than to drink Liprimar for several months and then stop therapy.

If funds allow, then you can drink the original drug. Still, some pharmacologists argue that a copy, by definition, cannot be better than the original.

As a result, choosing one drug over another will not be a gross mistake.

This does not apply to other atorvastatins. Almost every company, conscientious or not, produces “its own” atorvastatin, calling it, of course, “Atorvastatin” to attract buyers. Very often, a buyer comes to a pharmacy for the original atorvastatin, meaning Lipimar, but receives a cheap copy.

This entails unpleasant consequences, since statins, if production rules are not followed, can have a negative effect on the liver, even leading to its necrosis.

Even the original atorvastatin has many contraindications for the combined use of certain substances, for example, with pomegranate juice or the drug diltiazem, which is often prescribed to patients with coronary heart disease.

Trusted companies such as Pfizer (produces Liprimar) and KPKA (produces Atoris) ensure that there are as few unexpected side effects as possible, which does not apply to small companies. Therefore, in these cases you need to be very careful and, if possible, consult a clinical pharmacologist.

Compound

Atorvastatin or Rosuvastatin: which is better?

Each subsequent synthesis of an active drug substance causes the appearance of other pharmacological characteristics; accordingly, the later Rosuvastatin differs from Atorvastatin in new qualities that make drugs based on it more effective and safer.

Comparison of drugs Atorvastatin and Rosuvastatin (table):

The use of Atorvastatin and Rosuvastatin at medium doses reduces the level of “bad” cholesterol almost equally well – by 48–54% and 52–63%, so the final choice of the drug in each case is made taking into account the individual characteristics of the patient’s body:

• gender, age, heredity and hypersensitivity to the composition;
• diseases of the digestive and urinary system;
• concurrent medications, nutrition and lifestyle;
• results of laboratory and instrumental studies.

Rosuvastatin is better for treating hypercholesterolemia in people with liver and pancreas problems. Unlike previous statins, it does not require conversion, but immediately enters the bloodstream. It is also primarily excreted through the intestines, which reduces the functional load on these organs.

If a person with high cholesterol has diagnosed obesity, then in this case it is worth giving preference to Atorvastatin. Due to its fat solubility, it actively participates in the breakdown of simple lipids and prevents the conversion of cholesterol from existing fat deposits.

Side Effects Comparison Chart

If we rely on medical practice and reviews of patients taking statins for a long time, then when using high doses of the active substance of both the III and IV generations, in rare cases (up to 3%) side effects of varying severity may be observed on the part of some body systems.

Comparison of the side effects of Atorvastatin and Rosuvastatin (table):

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%.

Side effects

3rd generation statins, just like drugs of previous generations and modern drugs, have a large list of side effects on all organs. For this reason, statins are not intended for self-medication, because if taken incorrectly, they can be fatal. A correctly selected dose of the drug by a doctor reduces the risk of developing negative reactions in the body:

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).

Comparison of the effectiveness of Atorvastatin-teva and Atoris

The effectiveness of Atorvastatin-teva is quite similar to Atoris - this means that the ability of the drug substance to provide the maximum possible effect is similar. For example, if the therapeutic effect of Atorvastatin-teva is more pronounced, then using Atoris even in large doses will not achieve this effect. Also the speed of therapy is an indicator of the speed of therapeutic action in Atorvastatin-teva and Atoris are approximately the same. And bioavailability, that is, the amount of a drug reaching its site of action in the body, is similar. The higher the bioavailability, the less it will be lost during absorption and use by the body.

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.

Characteristics of drugs

Atoris was developed as an analogue of the German-made statin Liprimar. The latter was expensive and therefore was inaccessible to some patients. Atoris is almost identical to the original in composition and effectiveness in lowering cholesterol levels. Its active ingredient is atorvastatin.

While taking Atoris, the following happens:

• acceleration of blood flow;
• decrease in triglyceride levels in the blood;
• blood thinning;
• suppression of the production of substances that can accumulate on the intravascular wall;
• slowing down platelet pooling;
• restoration of blood movement through the vessels;
• prevention of rupture of cholesterol plaques.

Atorvastatin is a drug from the group of 3rd generation statins. It is produced by both Russian and Israeli pharmaceutical companies. This drug actively affects reductase, resulting in a decrease in cholesterol levels and a halt in atherosclerotic processes. Atorvastatin is available in three dosages - 10, 20 and 40 mg.

Atorvastatin is produced in Russia and is an analogue of Atoris

The excipient composition varies depending on the country in which it is produced and the specific pharmaceutical company. Among domestic manufacturers, Atorvastatin is produced by the following companies: Kanonpharma, Severnaya Zvezda, Vertex, Izvarino Pharma, Irbitsky HFZ. The cost of a Russian-made drug varies from 120 to 800 rubles, depending on the dosage and number of tablets in the package.

Atoris is produced by the Slovenian pharmaceutical company KRKA. The cost of the drug is higher than the price of Atorvastatin, and averages 600 rubles. Despite the different price categories, both drugs have a good therapeutic effect and can effectively reduce blood cholesterol levels.

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.

Pharmacological kinetics

The percentage of absorption of the main drug component atorvastatin by the cells of the gastrointestinal tract is quite high - it is almost 80.0%.

The percentage of absorption depends on the dosage that was taken by the patient at the time of drug therapeutic treatment:

• The maximum percentage of Atoris drug concentration in the blood is determined after one hour, a maximum of two hours after taking the drug orally;
• The pharmaceutical therapeutic effect of Atoris does not depend on the age and gender category of the patient;
• If the patient suffers from chronic alcoholism and has developed cirrhosis of the liver cells as a result, then after taking the drug, the concentration of the active component exceeds the standard values ​​in the liver cells by about 16 times;
• If you take Atoris after a meal, then the absorption of the active ingredient is reduced;
• The bioavailability of the drug when it passes through liver cells is quite low - it is only 12.0%;
• The biological availability of the drug in the bloodstream, which affects the activation of reductase, fluctuates within 30.0%;
• The relationship between the statin Atoris and plasma proteins reaches almost 98.0%;
• Metabolism of statins occurs at the cellular level in liver tissue and does not affect the blood-brain barrier;
• Metabolites that are formed in liver cells can provide good protection for up to 30 hours;
• The release of the medication from the body begins after 14 hours from the moment of taking the tablets. Less than half begins to be excreted together with bile acid - this is 45.0%, and the rest is excreted through feces.

The percentage of absorption of the main drug component atorvastatin by the cells of the gastrointestinal tract is quite high

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.

Comparison of safety of Atorvastatin-teva and Roxera

Review of mydocalm analogues

The safety of the drug includes many factors. At the same time, with Atorvastatin-teva it is quite similar to Roxera

It is important where the drug is metabolized: drugs are excreted from the body either unchanged or in the form of products of their biochemical transformations. Metabolism occurs spontaneously, but most often involves major organs such as the liver, kidneys, lungs, skin, brain and others

When assessing the metabolism of Atorvastatin-teva, as well as Roxera, we look at which organ is the metabolizing organ and how critical the effect on it is. The risk-to-benefit ratio is when the prescription of a drug is undesirable, but justified under certain conditions and circumstances, with mandatory compliance caution of use. At the same time, Atorvastatin-teva does not have any risks when used, just like Roxera. Also, when calculating safety, it is taken into account whether only allergic reactions occur or possible dysfunction of the main organs

In other matters, as well as the reversibility of the consequences of using Atorvastatin-teva and Roxera.

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.

Reviews

Sergey, 49 years old, Krasnodar: After a course of Atoris and an anti-cholesterol diet, my blood counts improved slightly, but my health worsened. It seems that all the side effects affected the psycho-emotional well-being. My mood is unstable, I am worried about insomnia, which gives way to nightmares. The taste buds also changed, I stopped feeling the taste of food. Some time after finishing the treatment, everything returned to normal.

Valentina, 55 years old, Moscow: Despite the fact that the instructions for Atorvastatin contain many side effects, the attending physician prescribed it. Apparently, he was not mistaken, since the drug reduced cholesterol levels well. I took it for 3 months, my lipid profile was close to normal, with the exception of triglycerides. To improve the effect, the doctor supplemented the treatment with another drug. I feel better and will continue to take this medicine.

Igor, 53 years old, Nalchik: After a stroke, the doctor prescribed Atorvastatin. Before that, I took other, more expensive medications. I was pleased with the price of Atorvastatin. But after a full course of treatment of 3 months, cholesterol levels did not decrease significantly. Headaches and attacks of nausea appeared. I will ask the attending physician to replace it with another medicine, apparently it is not suitable for me.

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.

Interaction with other medications and analogues

For complex therapy, it is necessary to carefully select drugs with which statins can interact in order to avoid side effects from joint therapy:

• Cyclosporine - joint use is contraindicated because the AUC concentration in the blood may greatly increase;
• combined use of statins and fibrates, and niacin leads to the occurrence and progression of myopathy;
• combined treatment with statins and fusidic acid leads to the development of rhabdomyolysis;

  
  Rhabdomyolysis

• Erythromycin. When treated together with a statin and an antibiotic, the concentration of the drug atorvastatin exceeds the norm by 8 times, which is dangerous to health;
• protease inhibitors. Combined use may cause disruption in metabolic processes.

Below are analogs of Atoris and Russian Atorvastatin, which are used in the treatment of systemic atherosclerosis and high cholesterol concentrations in the blood. The main active component in these analogues is atorvastatin:

1. Liprimar is the original 3rd generation statin drug. Manufactured in Germany (Pfizer), where it underwent all clinical studies. The safest and most effective statin in its subgroup. The only drawback is the very high price.
2. The Indian analogue of Atomax is a drug prescribed for the prevention of cardiac diseases and systemic atherosclerosis.
3. Torvacard (Zentiva, Slovenia) is the most popular analogue in Russia. An effective medication that has an affordable price.

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.

Key differences and effectiveness?

What is the difference between Atoris and Atorvastatin? Both medications are generics of the original drug Liprimar. There is a difference in the country of origin: Atorvastatin is produced in Russia, and Atoris is its foreign analogue. The cost of these two drugs is also different. Atorvastatin costs 2-3 times less than the foreign drug. The effectiveness of both medications in the treatment is almost the same.

The effectiveness of the drug depends not only on the active component, but also on the correctly selected composition of auxiliary components. The difference in the therapeutic effect of both medications is insignificant, but it still exists and must be taken into account when choosing a drug for treatment - Atoris or Atorvastatin.

Benefits of Atorvastatin

Atorvastatin with a dosage of 10 mg shows the following therapeutic effect:

• decrease in total cholesterol – by 33%;
• LDL – decrease by 47%;
• triglycerides decrease by 9%;
• apo B decreases by 37%;
• apo A (3%) and HDL increase by 9-10%.

Therapeutic effect of Atoris with a dosage of 10 mg:

• total cholesterol index – decrease by 38%;
• decrease in LDL by 50%;
• TG are reduced by 13%;
• apo B is reduced by 42%;
• HDL levels increase by 10-12%
• increase in apo A - by 4%.

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).

Instructions for use of drugs

TOP 9 analogues of the drug Omeprazole

Sugar level

Each of the drugs has its own fixed instructions for use.

Atoris is available in tablet form. The course of therapy usually begins with a dosage of 10 milligrams per day. After just a month, the number of tablets can be increased to enhance the effect. Maximum – 80 milligrams per day.

The dosage is different for each age group; you need to be especially careful about the amount for older people and women during menopause. In addition to the obvious advantages, the drug has some side effects.

It has been noted that taking Atoris often causes muscle pain, stomach upset, headaches, increased fatigue, and slight impairment of memory and thinking functions. Despite this, the pills do more good than harm, and they should be stopped if the side effects are difficult for patients to tolerate.

No cases of drug overdose were found.

When taking pills, you need to follow a special diet, lead an active lifestyle, and preferably exercise. If the patient has problems with weight, they should lose weight. Treatment will be more effective if a person leads a healthy lifestyle.

If the patient is bothered by muscle pain and general weakness, you should consult a specialist. During treatment, you need to keep your liver and kidney function under control, so you should undergo an examination at 6 and 12 weeks.

It must be remembered that the drug can increase glucose levels in diabetics. The drug should be stored out of the reach of children, in a cool, dark place. The price of the drug in Russia is from 357 rubles

Rosuvastatin is available in tablet form. Should be taken orally with plenty of water. It is necessary to start treatment with 10 milligrams per day, then, if necessary, you can increase the dose. In case of renal failure, the dose should be halved at the very beginning of the course of therapy. The maximum effect can be observed within three weeks after the start of therapy. The drug also has side effects in the form of:

1. myalgia;
2. muscle hypertonicity;
3. arthritis; bronchial asthma;
4. insomnia; depression; pneumonia;
5. increased pressure; increased anxiety;
6. rhinitis; angina pectoris; allergies;
7. angioedema;
8. diabetes mellitus; increased heart rate.

Jaundice and hepatitis occur very rarely

To avoid negative effects, you should coordinate the use of the drug with your doctor and use it with extreme caution. The cost of the drug in Russia is from 275 rubles

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.

Causes and development of atherosclerosis

The main reason for the clinical manifestations of obliterating atherosclerosis is a person’s ability to live more than 40 years. Early mortality in previous centuries did not allow diagnosing arterial damage. Most diseases that lead to death or disability are in one way or another associated with atherosclerosis. Age-related atherosclerosis appears in all people sooner or later. However, a number of patients exhibit an innate tendency to atherosclerosis - hyperlipedemia (hereditary increase in cholesterol in the blood).

The main changes in atherosclerosis develop in the intima (inner lining) of the arteries. Cholesterol and fatty inclusions (lipids) begin to be deposited here, forming yellowish spots on the inner wall of the vessel. Subsequently, the formation of an atherosclerotic plaque occurs. Platelets and clots of fibrin and calcium salts settle on the plaques.

With an abundant accumulation of lipids and calcium, blood circulation in the plaques is impaired, the necrosis of which causes the appearance of atheroma cavities filled with disintegrating masses. The artery wall in the area of ​​such a plaque is rock hard and crumbles easily. Crumb-like masses are rejected into the lumen of the vessel. Getting through the bloodstream into the underlying blood vessels, pieces of crumbled atherosclerotic plaque can cause blockage (embolism) and lead to thrombosis of the arteries of the limb with the development of gangrene (death). In addition, a large plaque leads to a significant disruption of blood flow, which reduces the delivery of oxygen to the tissues. During physical activity, muscles that do not receive sufficient nutrition refuse to work, pain occurs, which disappears only after rest. A large plaque promotes the development of a blood clot at the site of narrowing of the vessel, which can lead to acute ischemia and gangrene.

Drug therapy can be aimed at the causes of the disease (etiotropic treatment), the mechanisms of its development (pathogenetic treatment), the symptoms of the disease (symptomatic therapy) and the prevention of complications. The treatment of vascular patients should use a regimen that addresses all aspects of the disease.

Etiotropic and pathogenetic treatment.

Obliterating atherosclerosis . Treatment is aimed at preventing the development of atherosclerotic plaques. In addition to diet, drugs that reduce high cholesterol levels - statins - are used. Their list is quite extensive. In our practice, we use lovastatin, pravastatin, simvastatin, fluvastatin, atorvastatin, rosuvastatin. Statins have vascular effects. At the level of the vascular wall, by reducing the formation of cholesterol and low-density lipoproteins, they reduce the inclusion of cholesterol in the vascular subintima, help stabilize existing atherosclerotic plaques by reducing the lipid core, and therefore reduce the risk of plaque rupture and thrombus formation. Improvement in the functional state of the vascular endothelium during statin therapy is associated not only with their main effect, but also with pleiotropic effects. Taking statins should be long-term.

Diabetic macroangiopathy. In addition to statin therapy, the drug Vessel Due F, an organic glypolysaccharide, which helps restore the endothelium and reduces the risk of vascular thrombosis, is used to improve the condition of the vascular wall. To treat neuropathy in patients with diabetes, B vitamins (milgamma) and thioctacid are used.

Thromboangiitis obliterans (Buerger's disease) is an inflammatory disease of the arteries. For pathogenetic treatment, anti-inflammatory drugs are used - adrenal hormones in shock doses (pulse therapy). Most often, methylprednisolone (solu-medrol) is used for a short course. Targeted pulse therapy can improve the prognosis for patients with obliterating endarteritis.

Drugs that improve blood flow and affect collateral circulation.

Prostaglandins (vazaprostan, alprostan, ilomedine).
These drugs have a vasodilating effect on small arterioles, which increases the volume of blood flowing through the tissue. Sometimes this effect allows you to stop critical ischemia and delay the development of gangrene. However, without restoring the main blood flow, these drugs rarely help save a limb when gangrene develops. The drugs are antispasmodics. Modern data on such antispasmodics as papaverine, noshpa, nicotinic acid indicate their ineffectiveness and even harmfulness for patients with obliterating diseases. By dilating large unaffected arteries, they cause steal in small vessels and aggravate arterial insufficiency, and therefore should be excluded from the arsenal of vascular surgeons.

Pentoxifylline (trental, vasonite) is still widely used in domestic clinical practice, although many studies have shown their low effectiveness.

Cilastozol (Pletal) is a drug with a proven effect in intermittent claudication. However, it is not registered in the Russian Federation.

Actovegin and solcoseryl are drugs popular in domestic practice (deproteinized extracts from cattle plasma) contain a set of vitamins and minerals, some plasma hormones. Unfortunately, their effect does not meet expectations. In our practice, these drugs are not used.

Neovasculgen is a new genetic drug that stimulates the production of endothelial growth factor in tissues. According to the creators, it should stimulate the development of collateral circulation. Our limited experience does not confirm the effectiveness of the drug in patients with critical ischemia due to Buerger's disease. The high cost of the drug does not allow large-scale research into this issue.

Symptomatic therapy.

Implies a reduction in the symptoms of vascular diseases. Effective pathogenetic treatment helps eliminate the symptoms of chronic arterial insufficiency. In critical ischemia, pain relief is an important aspect of treatment. For these purposes, non-narcotic analgesics (ketorol, baralgin, diclofenac) are used. For neuralgic pain, Finlepsin and other sedatives are prescribed. In difficult cases, it is possible to prescribe narcotic analgesics (tramadol, promedol, morphine) or prolonged epidural anesthesia.

Prevention of complications.

The main complication associated with obliterating diseases is arterial thrombosis with the development of acute limb ischemia. Currently, the possibilities of modern therapy make it possible to significantly reduce the risk of thrombosis. The most effective drugs are clopidogrel (Plavix, Zilt, Thrombostop). Aspirin preparations (thromboass, cardiomagnyl) can be used in a dose of at least 100 mg per day, but they are weaker. In patients with a tendency to venous thrombosis and atrial fibrillation, indirect anticoagulants (warfarin), direct thrombin inhibitors (Prodaxa), low molecular weight heparins (Fraxiparine, Clexane) can be used to prevent thromboembolism.

High levels of cholesterol in the blood lead to the risk of developing atherosclerotic plaques. Due to blockage of blood vessels by atherosclerotic plaques, myocardial infarction, ischemic stroke or gangrene of the extremities develops.

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.

Atorvastatin analogs and substitutes

The original drug is not the only one of its kind. Based on the main active ingredient, a lot of generics have been created with similar (for example, Atoris, Atokor, Atormak or Atorvox), and sometimes completely different (Torvacard, Tulip, Vasator), trade names, differing in the composition of additional components. Some of them are cheaper, and some are downright more expensive. They can be replaced one with another, but only with the knowledge of the attending physician.

Which statin based on atorvastatin is better?

On pharmacy packaging, next to the original name there is often an abbreviation or another word, for example, Atorvastatin SZ or Atorvastatin MS. These particles represent different manufacturers. In these cases we are talking about Russian pharmaceuticals and Medisorb. On other packages you can see additional words “Pranafarm”, “Ozone”, “LEKSVM”, “Vertex”, “Canonpharma”, “Akrikhin”, “Actavis”, “Biocom”, “ALSI Pharma”.

Among the imported analogues you can find Atorvastatin Alkaloid (Macedonia), Atorvastatin Teva (Israel), Ananta (India), Pfizer (USA), Bluefish (Sweden), Ratiopharm (Germany), “ Avexima (international company)… It is impossible to reliably say which company’s drugs are better. In fact, these are synonyms, direct analogues. Statins called Atorvastatin contain the same active substance. They differ only in their auxiliary components: tablets can be replaced using those with fewer side effects in an individual treatment regimen. However, like drugs based on atorvastatin with other trade names.

This is evidenced by reviews from specialists and patients: well-tolerated drugs based on atorvastatin were selected for patients, and the replacement did not affect the results of the lipid profile. But no one has yet succeeded in fully replacing pharmacological products with folk remedies.

The difference between Atorvastatin and Rosuvastatin, Simvastatin and Lovastatin

The drug under discussion is a third-generation synthetic statin. Below it in rank and older in terms of time of release into therapeutic practice are synthetic Fluvastatin, semi-synthetic Simvastatin and Pravastatin and natural Lovastatin. More modern lipid-lowering drugs include the latest generation synthetic drugs Pitavastatin and Rosuvastatin. What is the difference between them?

Lovastatin is made from waste products of Aspergillus fungi. Its production is troublesome, time consuming and not worth the money spent. The same raw materials are used in the manufacturing process of Simvastatin and Fluvastatin. These statins are prodrugs: their metabolites act on lipid metabolism, not themselves. Therefore, a certain time must pass before the desired effect is achieved. In contrast, Atorvastatin, Pitavastatin or Rosuvastatin are already ready to fight “bad” cholesterol immediately after entering the blood.

The situation is similar with the degree and speed of influence on the body: drugs of the 3rd and 4th generations are much more effective (Simvastatin - 2 times, Pravastatin and Lovastatin - 4 times, Fluvastatin - 8 times). However, both doctors and patients are interested in which statin is safer. And here it all depends on the chemical formula of the drug. Fat-soluble Lovastatin, Simvastatin and Atorvastatin penetrate brain cells more easily. And side effects from the central nervous system become more likely compared to water-soluble Rosuvastatin, Fluvastatin and Pravastatin. But the latter have a stronger effect on liver cells, which can be manifested by an increase in the level of liver enzymes in the blood.

Comparison of statins in terms of their effect on HDL and LDL cholesterol levels

If we compare drugs of the latest generations, the main thing that distinguishes Atorvastatin from Rosuvastatin and Pitavastatin is that it is less effective (2 times) and, accordingly, has a smaller list of adverse reactions. In addition, the concentration of the most modern drugs in the blood is not affected by food intake, while the content of other statins depends on the time of eating.

Lovastatin, Simvastatin or Atorvastatin, Rosuvastatin: which of them is better to tell the doctor. But from the standpoint of evidence-based medicine, the choice fell on statins with synthetic active ingredients atorvastatin or rosuvastatin. The latter include Rosart, Rosucard, Mertenil, Crestor, Suvardio, Cardiolip and many others. But if patients intend to take medications only based on medicinal herbs, then clover extract (Atheroclephyte Evalar) can replace synthetics.

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.