Atorvastatin 20 mg., 30 pcs.

Active substance:

 atorvastatin calcium trihydrate;

Excipients :

 calcium carbonate;

MCC;

StarKap1500 (corn starch and pregelatinized starch);

colloidal silicon dioxide (aerosil);

talc; magnesium stearate;

 Opadry II (Series 85) (polyvinyl alcohol, macrogol, talc, titanium dioxide, iron oxide yellow, iron oxide red).

Atorvastatin is a third generation hypolipidemic drug from the statin group.

- in combination with a diet to reduce elevated levels of total cholesterol, LDL-C, apolipoprotein B and TG and increase HDL cholesterol levels in patients with primary hypercholesterolemia, heterozygous familial and non-familial hypercholesterolemia and combined (mixed) hyperlipidemia according to Fredrikson IIa and IIb types );

- in combination with a diet for the treatment of patients with elevated serum TG levels (type IV according to Fredrickson) and patients with dysbetalipoproteinemia (type III according to Fredrickson), in whom diet therapy does not give an adequate effect;

- to reduce the levels of total cholesterol and cholesterol-LDL in patients with homozygous familial hypercholesterolemia, when diet therapy and other non-pharmacological methods of treatment are not effective enough.

- active liver disease;

- increased activity of hepatic enzymes of unknown origin (more than 3 times compared with VHN);

- liver failure (classes A and B on the Child-Pugh scale);

- pregnancy;

- lactation period;

- age up to 18 years (efficacy and safety have not been established);

- hypersensitivity to drug components.

The drug should be used with caution in patients with chronic alcoholism, with a history of liver disease, severe electrolyte imbalance, endocrine and metabolic disorders, arterial hypotension, severe acute infections (sepsis), uncontrolled epilepsy, major surgical interventions, trauma, diseases of skeletal muscles.

In controlled clinical trials (n = 2502), less than 2% of patients discontinued treatment due to atorvastatin-induced side effects. The most common adverse events associated with atorvastatin were constipation, flatulence, dyspepsia, and abdominal pain.

From the nervous system and sensory organs: ≥2% - headache, asthenic syndrome, insomnia, dizziness;

On the part of the cardiovascular system: ≥2% - chest pain; blood pressure, phlebitis, arrhythmia, angina pectoris, anemia, lymphadenopathy, thrombocytopenia.

From the respiratory system: ≥2% - sinusitis, pharyngitis, bronchitis, rhinitis;

From the digestive tract: ≥2% - abdominal pain, constipation or diarrhea, dyspepsia, flatulence, nausea;

On the part of the musculoskeletal system: ≥2% - arthralgia, myalgia, arthritis;

From the genitourinary system: ≥2% - urogenital infections, peripheral edema;

On the part of the skin: Allergic reactions: ≥2% - skin rash;

Others: ≥2% - infections, accidental injury, flu-like syndrome, back pain; ALP, increased ALT or AST, exacerbation of gout.

Side effects noted in post-marketing studies during therapy with atorvastatin: anaphylaxis, angioedema, bullous rash (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), rhabdomyolysis, tendon rupture.

The risk of myopathy in the treatment of statins increases when they are used in combination with cyclosporine, fibrates, erythromycin, nicotinic acid in lipid-lowering doses, strong CYP3A4 inhibitors (including clarithromycin, HIV protease inhibitors, itraconazole).

When using atorvastatin in combination with inhibitors of the CYP3A4 isoenzyme (for example, cyclosporine, macrolide antibiotics - erythromycin and clarithromycin; itraconazole, HIV protease inhibitors), plasma concentrations of atorvastatin may increase (atorvastatin is metabolized with the participation of CYP3A4); special care should be taken when using atorvastatin in combination with the aforementioned agents (see "Special instructions").

With the combined use of atorvastatin at a dose of 40 mg and itraconazole at a dose of 200 mg once a day, an increase in the AUC of atorvastatin by 3 times compared with the AUC with monotherapy was revealed. The simultaneous use of atorvastatin with protease inhibitors (lopinavir / ritonavir, ritonavir / saquinavir) was accompanied by an increase in the concentration of atorvastatin in the blood plasma.

With the simultaneous use of atorvastatin at a dose of 40 mg and a combination of lopinavir + ritonavir (at a dose of 400/100 mg 2 times a day), an increase in the AUC of atorvastatin by 5.9 times was revealed compared to the AUC with monotherapy. When using atorvastatin at a dose of 40 mg with a combination of ritonavir + saquinavir (at a dose of 400/400 mg 2 times a day), its AUC increased 3.9 times.

Antacids reduce the concentration of atorvastatin by 35% (the effect on LDL cholesterol does not change). With repeated intake of digoxin and atorvastatin, the Css of digoxin increases by about 20% (patients must be monitored).

With the combined use of atorvastatin and oral contraceptives, the AUC of norethindrone and ethinyl estradiol increases by about 30 and 20% (this effect should be taken into account when choosing an oral contraceptive for a woman receiving atorvastatin).

When taken simultaneously with erythromycin (a CYP3A4 inhibitor), the plasma concentration of atorvastatin increases by about 40%.

The hypolipidemic effect of the combination of atorvastatin with colestipol is superior to that for each drug separately.

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

With the simultaneous administration of atorvastatin and a suspension containing magnesium and aluminum hydroxide, plasma concentrations of atorvastatin decreased by about 35%, but the degree of reduction in cholesterol / LDL levels did not change.

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

The initial dose is on average 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 taking into account the baseline cholesterol / LDL levels, the goal of therapy and the individual effect. At the beginning of treatment and / or during an increase in the dose of Atorvastatin, it is necessary to monitor plasma lipids every 2-4 weeks and adjust the dose accordingly.

To ensure the following dosage regimen of the drug, it is possible to use the drug Atorvastatin in another dosage form: film-coated tablets, 10 mg and 20 mg.

The maximum daily dose of the drug is 80 mg. With simultaneous use with cyclosporine, the daily dose of Atorvastatin should not exceed 10 mg.

Primary hypercholesterolemia and mixed hyperlipidemia. In most cases, it is sufficient to prescribe a dose of 10 mg of the drug Atorvastatin 1 time per day.

A significant therapeutic effect is observed after 2 weeks, and the maximum therapeutic effect is usually observed after 4 weeks. With prolonged treatment, this effect persists.

Special groups of patients Renal dysfunction.

The use of the drug in patients with renal insufficiency and kidney disease does not affect the level of atorvastatin in the blood plasma or the degree of lowering of cholesterol / LDL cholesterol levels during its use, therefore, a change in the dose of the drug is not required. Liver dysfunction.

With hepatic insufficiency, the dose should be reduced. Elderly patients. When using the drug in elderly patients, there were no differences in safety, efficacy or achievement of the goals of lipid-lowering therapy in comparison with the general population.

Treatment: there is no specific antidote, symptomatic therapy is performed.

Hemodialysis is ineffective.

Before starting therapy with Atorvastatin, the patient must be prescribed a standard hypocholesterol diet, which he must follow during the entire period of treatment.

The use of HMG-CoA reductase inhibitors to lower blood lipids can lead to changes in biochemical parameters reflecting liver function. Liver function should be monitored before starting therapy, 6 weeks, 12 weeks after starting atorvastatin and after each dose increase, as well as periodically, for example, every 6 months.

An increase in the activity of "liver" enzymes in the blood serum can be observed during therapy with Atorvastatin. Patients with elevated enzyme levels should be monitored until enzyme levels return to normal. In the event that the values ​​of alanine aminotransferase (ALT) or asparagine aminotransferase (AST) are more than 3 times higher than the upper limit, it is recommended to reduce the dose of Atorvastatin or stop treatment.

Atorvastatin should be used with caution in patients with alcohol abuse and / or liver disease. Active liver disease or a persistent increase in the activity of aminotransferases of unknown origin are contraindications to the appointment of Atorvastatin. Treatment with Atorvastatin can cause myopathy.

The diagnosis of myopathy (pain and weakness in muscles in combination with an increase in creatine phosphokinase (CPK) activity more than 10 times compared to the upper limit of normal) should be discussed in patients with widespread myalgias, muscle soreness or weakness and / or a pronounced increase in CPK activity.

Patients should be warned to tell their doctor immediately if they experience unexplained muscle pain or weakness if accompanied by malaise or fever. Atorvastatin therapy should be discontinued in the event of a pronounced increase in CPK activity or in the presence of confirmed or suspected myopathy.

The risk of myopathy in the treatment of other drugs of this class increased with the simultaneous use of cyclosporine, fibrates, erythromycin, nicotinic acid or azole antifungal agents. Many of these drugs inhibit cytochrome P450 3A4-mediated metabolism and / or drug transport.

Atorvastatin is biotransformed by CYP 3A4. Prescribing Atorvastatin in combination with fibrates, erythromycin, immunosuppressive agents, azole antifungal agents or nicotinic acid in lipid-lowering doses, the expected benefits and risks of treatment should be carefully weighed and patients should be monitored regularly to detect muscle pain or weakness, especially during the first months of treatment and during periods of increasing doses of any drug.

In such situations, periodic determination of CPK activity can be recommended, although such control does not prevent the development of severe myopathy.

When using Atorvastatin, like other drugs of this class, cases of rhabdomyolysis with acute renal failure due to myoglobinuria have been described. Atorvastatin therapy should be temporarily discontinued or completely canceled if signs of possible myopathy or a risk factor for the development of renal failure associated with rhabdomyolysis appear (for example, severe acute infection, arterial hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disturbances and uncontrolled convulsions).

Before starting therapy with Atorvastatin, it is necessary to try to achieve control of hypercholesterolemia by adequate diet therapy, increasing physical activity, reducing body weight in obese patients and treating other conditions. Patients should be warned to seek immediate medical attention if they develop unexplained muscle pain or weakness, especially if accompanied by malaise or fever.

Round biconvex film-coated tablets of white or almost white color.

In cross section, the core is white or almost white.