Atoris - instructions for use, analogs, reviews and release forms (tablets 10 mg, 20 mg, 30 mg and 40 mg) of statin drugs for lowering cholesterol in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Atoris. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of statin Atoris in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Atoris in the presence of existing structural analogues. Use to reduce cholesterol in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Atoris - a hypolipidemic drug from the group of statins.

The main mechanism of action of Atorvastatin (active ingredient of the drug Atoris) is the inhibition of the activity of HMG-CoA reductase, an enzyme that catalyzes the conversion of HMG-CoA into mevalonic acid. This transformation is one of the early stages in the chain of cholesterol synthesis (Xc) in the body. Suppression of the synthesis of Xc leads to an increased reactivity of the LDL receptors in the liver and extrahepatic tissues. These receptors bind the LDL particles and remove them from the blood plasma, which leads to a decrease in the level of LDL-C in the blood.

Anti-atherosclerotic effect of the drug is manifested by the effect of atorvastatin on the walls of blood vessels and blood components. Atorvastatin suppresses the synthesis of isoprenoids, which are the growth factors of the inner shell of the vessels. Under the influence of atorvastatin, the endothelium-dependent dilatation of blood vessels improves. Atorvastatin reduces the content of total cholesterol, LDL, apolipoprotein B, TG. Causes an increase in the content of Xc-HDL and apolipoprotein A.

The action of Atoris develops 2 weeks after the start of the drug, the maximum effect is achieved after 4 weeks.

Composition

Atorvastatin calcium + excipients.

Pharmacokinetics

After oral administration, it is well absorbed from the digestive tract (80%). Due to the intensive metabolism at the "first passage" through the liver, the bioavailability of atorvastatin is 12%. Atorvastatin does not penetrate the blood-brain barrier (BBB). It is excreted mainly with bile (it does not undergo significant intestinal hepatic recirculation). About 46% is excreted with feces, less than 2% with urine.

Indications

Hyperlipidemia:

• for reduction of serum levels of total Xc, Xc-LDL, apolipoprotein B and triglycerides in patients with primary hyperlipidemia (types 2a and 2b according to Fredrickson), including polygenic hypercholesterolemia, familial heterozygous hypercholesterolemia and mixed hyperlipidemia;
• to reduce the elevated levels of total Xc, Xc-LDL, and apolipoprotein B in patients with homozygous familial hypercholesterolemia.

Atoris increases the concentration of Xc-LBVH in the blood serum and decreases the value of the ratio of LDL-C-HDL-C. It is used with insufficient effectiveness of diet therapy and other non-pharmacological methods of treatment.

Prevention of cardiovascular diseases:

• Primary prevention of cardiovascular complications in patients without clinical signs of IHD, but having several risk factors for its development: age over 55, nicotine dependence, arterial hypertension, diabetes mellitus, low concentration of HDL-C in blood plasma, genetic predisposition, h. against dyslipidemia;
• secondary prophylaxis of cardiovascular complications in patients with ischemic heart disease in order to reduce the total death rate, myocardial infarction, stroke, re-hospitalization for angina pectoris and the need for revascularization.

Forms of release

Tablets coated with 10 mg, 20 mg, 30 mg and 40 mg.

Instructions for use and reception scheme

Prior to the use of Atoris, the patient should be transferred to a diet that reduces the concentration of lipids in the blood, which must be observed during therapy with the drug.

The drug is taken orally, regardless of food intake.

The dose of the drug varies from 10 mg to 80 mg once a day and is selected taking into account the initial concentration of LDL-C, the purpose of therapy and individual therapeutic effect.It is possible to use the drug atorvastatin in another dosage form.

Atoris can be taken once at any time of the day, but at the same time every day. 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 drug in the previous dose.

At the beginning of therapy and / or during a dose increase, it is necessary to monitor the concentration of lipids in the blood plasma every 2-4 weeks and adjust the dose accordingly.

Primary (heterozygous hereditary and polygenic) hypercholesterolemia (type 2a) and mixed hyperlipidemia (type 2b)

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 range of doses 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 the drug is used in a daily dose of 80 mg (once).Atoris is used as an adjunctive therapy to other methods of treatment (plasmapheresis) or as the main treatment if therapy with other methods is impossible.

In patients of advanced age, the dose of Atoris should not be changed.

Care should be taken in patients with violations of the liver function (due to the delay in the removal of the drug from the body). In such a situation, clinical and laboratory indicators should be closely monitored. With a significant increase in hepatic transaminases, the dose of Atoris should be reduced or discontinued.

In patients with confirmed CHD and other patients at high risk of ischemic complications, the goal of treatment is to reduce the concentration of LDL-C <3 mmol / L (or <115 mg / dL) and total XC <5 mmol / L (or <190 mg / dl ).

Side effect

• headache;
• dizziness;
• insomnia or drowsiness;
• asthenic syndrome;
• nightmarish dreams;
• amnesia;
• paresthesia;
• peripheral neuropathy;
• emotional lability;
• depression;
• weakness;
• malaise;
• tinnitus;
• dryness of the conjunctiva;
• bleeding in the eyes;
• deafness;
• glaucoma;
• loss of taste;
• palpitation;
• migraine;
• increased blood pressure;
• phlebitis;
• arrhythmia;
• chest pain;
• vasculitis;
• anemia, lymphadenopathy, thrombocytopenia;
• bronchitis;
• rhinitis;
• bronchial asthma;
• nose bleed;
• nausea, vomiting;
• heartburn;
• constipation or diarrhea;
• flatulence;
• anorexia;
• increased appetite;
• dry mouth;
• eructation;
• stomatitis;
• esophagitis;
• glossitis;
• gastroenteritis;
• duodenal ulcer;
• rectal bleeding;
• melena;
• bleeding gums;
• tenesmus;
• leg cramps;
• bursitis;
• muscle weakness;
• myalgia;
• backache;
• urogenital infections;
• dysuria (including pollakiuria, nocturia, urinary incontinence or urinary retention, mandatory urges to urinate);
• hematuria;
• vaginal bleeding;
• uterine bleeding;
• urolithiasis disease;
• epididymitis;
• decreased libido;
• impotence;
• violation of ejaculation;
• sweating;
• eczema;
• seborrhea;
• itching;
• skin rash;
• contact dermatitis;
• hives;
• angioedema;
• vasculitis;
• photosensitization;
• anaphylaxis;
• exudative erythema multiforme;
• Stevens-Johnson syndrome;
• toxic epidermal necrolysis (Lyell's syndrome);
• hypoglycemia;
• peripheral edema;
• increase in body weight;
• gynecomastia;
• exacerbation of gout;
• fever;
• alopecia.

Contraindications

• liver diseases in the active stage (including active chronic hepatitis, chronic alcoholic hepatitis);
• liver failure;
• cirrhosis of the liver of various etiologies;
• increased activity of hepatic transaminases of unknown origin;
• diseases of skeletal muscles;
• pregnancy;
• galactosemia;
• lactation period (breastfeeding);
• use in women of reproductive age not using adequate methods of contraception;
• age to 18 years (efficacy and safety of use not established);
• hypersensitivity to the components of the drug.

Application in pregnancy and lactation

Atoris is contraindicated in pregnant and lactating mothers.

The drug is prescribed to women of reproductive age only if the probability of pregnancy is very low, and the patient is informed of the possible risk to the fetus. Women of reproductive age during treatment should use adequate methods of contraception. If a woman is planning a pregnancy, she should stop taking Atoris at least one month before the planned pregnancy.

If it is necessary to appoint Atoris, the question of stopping breastfeeding should be resolved.

Use in children

Contraindicated for children under the age of 18 (efficacy and safety not established).

special instructions

Before starting therapy with Atoris, the patient should be given a standard hypocholesterolemic diet, which he must observe during the entire treatment period.

When using the drug Atoris, there may be an increase in the activity of hepatic transaminases. This increase, as a rule, is small and has no clinical significance. However, it is necessary to regularly monitor liver function before treatment, 6 weeks and 12 weeks after the start of the drug and after increasing the dose. Treatment should be discontinued with an increase in the AST and ALT values ​​by more than 3 times relative to VGN.

Atorvastatin may cause an increase in the activity of CK and aminotransferases.

Patients should be warned that they should immediately consult a doctor if unexplained pain or weakness in the muscles occurs. Especially if these symptoms are accompanied by malaise and fever.

In the treatment with Atrisus, the development of myopathy is possible, which is sometimes accompanied by rhabdomyolysis leading to acute renal failure. The risk of this complication increases with simultaneous intake of one or more of the following drugs with atoris: fibrates, nicotinic acid, cyclosporine, nefazodone, some antibiotics, antifungal agents from the azole group, HIV protease inhibitors. In clinical manifestations of myopathy, it is recommended to determine plasma concentrations of CK. With a 10-fold increase in IGN activity, KFK treatment with Atoris should be discontinued.

There are reports of the development of atonic fasciitis against the background of atorvastatin, however, a connection with the use of the drug is possible, but has not been proven to date, the etiology is not known.

Impact on the ability to drive vehicles and manage mechanisms

The adverse effect of the drug Atoris on the ability to drive vehicles and control mechanisms was not reported.

Drug Interactions

With the simultaneous use of atorvastatin with cyclosporine,antibiotics (erythromycin, clarithromycin, quinupristin / dalfopristin), HIV protease inhibitors (indinavir, ritonavir), antifungal drugs from the azole group (fluconazole, itraconazole, ketoconazole), with nefazodone, an increase in the concentration of atorvastatin in plasma is possible, which increases the risk of myopathy with rhabdomyolysis and acute renal failure.

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

The simultaneous use of Atoris with phenytoin may lead to a decrease in the efficacy of atorvastatin.

When combined, antacids (a suspension of magnesium and aluminum hydroxides) reduce the concentration of atorvastatin in the blood plasma.

With simultaneous use of atorvastatin with colestipol, the concentration of atorvastatin in plasma is reduced by 25%, but the therapeutic effect of the combination is higher than that of atorvastatin alone.

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

In patients simultaneously receiving Atoris in a dose of 80 mg and digoxin, the Digoxin content in the plasma increases by approximately 20%. Patients receiving this combination should be under medical supervision in connection with an increased risk of developing unwanted effects of digoxin.

When used simultaneously with oral contraceptives (a combination of norethisterone and ethinyl estradiol), it is possible to increase the absorption of contraceptives and increase their concentrations in the blood plasma. Therefore, it is necessary to control the choice of contraceptives in women receiving atorvastatin.

Simultaneous reception of atorvastatin with Warfarin can intensify in the first days the effect of warfarin on the parameters of blood coagulation (reduction of prothrombin time). This effect disappears after 15 days of simultaneous administration of these drugs.

Simultaneous use of atorvastatin with protease inhibitors is accompanied by an increase in the concentration of atorvastatin in plasma.

Clinically significant interaction with cimetidine was not observed.

With the simultaneous use of Atoris in a dose of 80 mg and Amlodipine at a dose of 10 mg, the pharmacokinetics of atorvastatin does not change.

With simultaneous use of atorvastatin with antihypertensive agents, no clinically significant changes in interaction are noted.

With the simultaneous use of Atoris and fusidic acid, the risk of rhabdomyolysis increases.

The use of grapefruit juice in treatment with Atoris may lead to an increase in the concentration of atorvastatin in the blood plasma. In this regard, patients taking Atoris, should avoid the use of grapefruit juice more than 1.2 liters per day.

Analogues of the drug Atoris

Structural analogs for the active substance:

• Anistat;
• Atokord;
• Atomax;
• Atorvastatin;
• Atorvastatin calcium;
• Atorvox;
• The Vasator;
• Lipon;
• Lipofford;
• Liprimar;
• Liptonorm;
• TG-torus;
• Torvazine;
• Torvacard;
• Tulip.

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