Atorvastatin, 10 mg, film-coated tablets, 30 pcs.

Compound

Therapeutic effect of the drug

Atorvastatin SZ tablets help reduce cholesterol in the blood. When using the medicine, the likelihood of the patient developing the following pathologies of the cardiovascular system is reduced:

• stroke;
• myocardial infarction.

The drug reduces the risk of complications of atherosclerosis in the presence of the following provoking factors:

• elderly age;
• presence of nicotine addiction;
• hypertonic disease;
• increased blood sugar concentration.

The drug Atorvastatin SZ helps reduce blood viscosity. It improves the condition of the hematopoietic system and prevents the rupture of atherosclerotic plaques.

The main task of atorvastatin is to reduce the amount of cholesterol in the human body.

Directions for use and doses

Inside.

Before prescribing Atorvastatin, the patient should be recommended a standard lipid-lowering diet, which he should continue to follow throughout the entire period of therapy.

The initial dose averages 10 mg/day. The dose varies from 10 to 80 mg/day.

The drug can be taken at any time of the day with food or regardless of meal time. The dose is adjusted based on baseline LDL/C cholesterol levels, goals of therapy, and individual response. At the beginning of treatment and/or during dose increases of Atorvastatin, plasma lipid levels should be monitored every 2–4 weeks and the dose adjusted accordingly.

Primary hypercholesterolemia and mixed hyperlipidemia, as well as Fredrickson types III and IV. In most cases, a dose of 10 mg of Atorvastatin once a day is sufficient. A significant therapeutic effect is observed after 2 weeks, and the maximum therapeutic effect is usually observed after 4 weeks. With long-term treatment, this effect persists.

Homozygous familial hypercholesterolemia. Prescribed at a dose of 80 mg (4 tablets of 20 mg each) 1 time per day.

Special patient groups

Renal dysfunction. The use of the drug in patients with renal failure and kidney disease does not affect the level of Atorvastatin in the blood plasma or the degree of reduction in cholesterol/LDL levels during its use, so a change in the dose of the drug is not required.

Liver dysfunction. In case of liver failure, the dose must be reduced.

Elderly patients. When using the drug in elderly patients, there were no differences in safety, effectiveness, or achievement of lipid-lowering therapy goals compared to the general population.

ATORVASTATIN-TEVA

Interaction

Effects of drugs on the effects of atorvastatin
The risk of myopathy during treatment with HMG-CoA reductase inhibitors increases when used concomitantly with cyclosporine, fibrates, macrolides (including erythromycin), azole antifungals or nicotinic acid.

In some rare cases, these combinations may cause rhabdomyolysis, accompanied by renal failure. In this regard, a careful assessment of the ratio of possible risks and expected benefits of combination treatment is necessary (see section “Special instructions”).

CYP3A4 isoenzyme inhibitors

Atorvastatin is metabolized with the participation of the CYP3A4 isoenzyme. When atorvastatin is used concomitantly with inhibitors of the CYP3A4 isoenzyme (for example, cyclosporine, macrolide antibiotics, for example, erythromycin and clarithromycin, nefazodone, azole antifungals, for example, itraconazole, and HIV protease inhibitors), drug interactions may occur.

With the combined use of drugs, increased concentrations of atorvastatin in the blood plasma may be observed. 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.

OATP1B1 transport protein inhibitors

Atorvastatin and its metabolites are substrates for the transport protein OATP1B1. Inhibitors of the OATP1B1 transport protein (for example, cyclosporine) may increase the bioavailability of atorvastatin.

Itraconazole

With simultaneous use of atorvastatin and itraconazole, an increase in AUC was found to be three times higher than normal

Protease inhibitors

The simultaneous use of atorvastatin with protease inhibitors, known as inhibitors of the CYP3A4 isoenzyme, was accompanied by an increase in the concentration of atorvastatin in the blood plasma.

Grapefruit juice

Grapefruit juice contains at least one ingredient that is a CYP3A4 inhibitor and may cause increased plasma concentrations other than those drugs metabolized by CYP3A4. Daily consumption of 240 ml of grapefruit juice increased the AUC of atorvastatin by 37% and decreased the AUC of the active orthohydroxy metabolite by 20.4%. Consumption of large amounts of grapefruit juice (more than 1.2 liters per day for 5 days) increased the AUC of atorvastatin by 2.5 times, and the AUC of active HMG-CoA reductase inhibitors (atorvastatin + its metabolites) by 1.3 times. In this regard, consumption of large quantities of grapefruit juice during treatment with atorvastatin is not recommended.

Inducers of the CYP3A4 isoenzyme

The simultaneous use of atorvastatin with drugs that induce the CYP3A4 isoenzyme (rifampicin, phenazone, efavirenz, St. John's wort preparations) can significantly reduce the concentration of atorvastatin in the blood plasma. The mechanism of interaction with atorvastatin and other substrates of the CYP3A4 isoenzyme is unknown; however, the possibility of these interactions should be taken into account when using drugs with a low therapeutic index - in particular, class III antiarrhythmic drugs, for example, amiodarone.

Ezetimibe, fusidic acid

With simultaneous use, the risk of adverse effects from the musculoskeletal system, including rhabdomyolysis, increases.

Gemfibrozil/fibrates

The risk of atorvastatin-induced myopathy may be increased when used concomitantly with fibrates. In vitro studies suggest that gemfibrozil may also interact with atorvastatin by inhibiting its glucuronidation, which may result in increased plasma concentrations of atorvastatin (see Precautions).

Colestipol

When used concomitantly with colestipol, a decrease in plasma concentrations of atorvastatin by approximately 25% was observed. However, when atorvastatin and colestipol were used in combination, the effects on lipids were greater than when either drug was used alone.

Antacids

With simultaneous oral administration of atorvastatin and a suspension containing magnesium and aluminum hydroxide, the concentration of atorvastatin in the blood plasma decreased by approximately 35%; however, LDL concentration did not change.

Phenazone

With simultaneous use, atorvastatin does not affect the pharmacokinetics of phenazone, so it can be assumed that interaction with other drugs that are metabolized by the same cytochrome P450 isoenzymes is not expected.

Cimetidine

A study of the simultaneous use of cimetidine and atorvastatin did not reveal a significant interaction between these drugs.

Amlodipine

With simultaneous use of 80 mg of atorvastatin and 10 mg of amlodipine, no changes in atorvastatin at steady state were detected.

Others

There were no clinically significant adverse interactions between atorvastatin and antihypertensive drugs.

Atorvastatin did not have a clinically significant effect on the plasma concentration of terfenadine, which is metalysed by the CYP3A4 isoenzyme. In this regard, it seems unlikely that atorvastatin can significantly affect the pharmacokinetic parameters of other drugs that are metabolized by the CYP3A4 isoenzyme.

Table 1. Effect of drugs on the pharmacokinetics of atorvastatin during simultaneous use

Effect of atorvastatin on other drugs

Digoxin

With repeated administration of digoxin and atorvastatin at a dose of 10 mg, the equilibrium concentrations of digoxin in the blood plasma did not change. However, when digoxin was used in combination with atorvastatin at a dose of 80 mg/day, digoxin concentrations increased by approximately 20%.

Oral contraceptives

When atorvastatin was used concomitantly with an oral contraceptive containing norethisterone and ethinyl estradiol, an increase in plasma concentrations of norethisterone and ethinyl estradiol was observed. These increases in concentrations should be taken into account when choosing dosages of oral contraceptives. When atorvastatin was co-administered with an oral contraceptive containing norethisterone and ethinyl estradiol, a significant increase in the AUC of norethisterone and ethinyl estradiol by 30% and 20%, respectively, was observed. This effect should be taken into account when choosing an oral contraceptive for a woman receiving atorvastatin.

Warfarin

With simultaneous use of atorvastatin with warfarin, a slight decrease in prothrombin time was observed in the first days of taking atorvastatin; however, over the next 15 days, the prothrombin time returned to normal.

Table 2.
Effects of atorvastatin on the pharmacokinetics of other drugs when used concomitantly

How to enhance the effect of the medicine?

To enhance the therapeutic effect of the drug, it is recommended to adhere to a strict diet. Its main goal is to improve lipid metabolism.

If the level of cholesterol in the body is high, you need to limit the consumption of foods that contain animal fats. The diet includes dishes that saturate the body with fiber.

If you have high cholesterol, you should eat foods that contain large amounts of phytosterols. These include:

• sesame seeds;
• products containing wheat germ;
• sunflower seeds;
• flax seeds;
• olive oil;
• avocado;
• oil squeezed from grape seeds.

The diet should also include foods enriched with pectin: citrus fruits, apples, watermelons. If you have high cholesterol levels in your blood, the following foods are also helpful:

• spinach;
• green salad leaves;
• artichoke;
• sorrel;
• dill;
• parsley.

When using the drug Atorvastatin SZ, it is recommended to avoid eating pork, duck meat, offal, smoked meats, and sausages. Fatty fish, red caviar, shrimp, and canned fish are also prohibited.

It is recommended to exclude the following dishes from the diet:

• baked goods;
• mushroom broth;
• cream;
• high fat cottage cheese;
• sour cream;
• ice cream;
• chocolate products;
• palm oil products;
• mayonnaise;
• ketchup.

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Side effects

When using the medicine, side effects from the nervous system may occur:

• pain in the head;
• dizziness;
• worsening sleep;
• the occurrence of asthenic syndrome;
• paresthesia;
• peripheral neuropathy.

When using the drug, the following side effects may also occur:

• the occurrence of tinnitus;
• cardiopalmus;
• increased blood pressure;
• arrhythmia;
• nosebleeds;
• thrombocytopenia;
• nausea;
• flatulence;
• pain in the abdominal area;
• deterioration of taste perception;
• decreased sex drive;
• the appearance of swelling in the joint area;
• muscle cramps;
• liver failure;
• hair loss;
• skin itching;
• peripheral edema;
• chest pain;
• lethargy;
• a veil before the eyes;
• memory impairment;
• increase in the concentration of glycosylated hemoglobin.

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Features of interaction with other medications

Atorvastatin SZ is not recommended for use simultaneously with Varvarin. A medicine intended to reduce cholesterol in the body interacts poorly with the following drugs:

• drugs with an antifungal effect;
• antibiotics from the macrolide group;
• drugs that have an immunosuppressive effect.

When using antacids intended to neutralize hydrochloric acid, the content of the active component of the drug in the plasma may decrease. If it is necessary to use such drugs simultaneously with Atorvastatin SZ, the decision to increase the dosage of the lipid-lowering drug should be made by the doctor.

Only a specialist should prescribe statins. Self-medication is dangerous for your health!

The shelf life of the medicine is three years. The medicine should be stored in a place protected from direct sunlight. The optimal temperature for storing the drug is 25 degrees.

Analogues of "Atorvastatin"

Currently, three generations of drugs are actively used to treat atherosclerosis, dyslipidemia and hypercholesterolemia. Modern analogues of Atorvastatin are the drugs Rosuvastatin, Simvastatin, Pravastatin, Fluvastatin and others. Depending on the manufacturer of the product, its trade name may also change.

The original drug with the active ingredient atorvastatin is called “Liprimar”. Its substitutes, or imported analogues, have the names: “Atoris”, “Tulip”, “Liptonorm”. Such drugs are generics - drugs under an international name, or under a patented name that differs from the original one, and is registered to another pharmaceutical developer (company). It should be borne in mind that such medications can be produced in different dosages and different numbers of tablets per package.

Contraindications

According to the instructions for use, it is recommended to avoid using the medication while expecting a baby and breastfeeding. The medicine should not be taken while planning pregnancy. It is contraindicated in patients under 18 years of age. The medication should not be taken if you are hypersensitive to its components. The drug is contraindicated in cases of lactose intolerance and glucose-galactose malabsorption.

The drug is used with caution in the presence of the following pathologies:

• arterial hypertension;
• epilepsy;
• diabetes;
• pathologies of the muscular system;
• water-electrolyte imbalance.

With long-term use of drugs from the group of statins, it is necessary to monitor liver function