Traykor tablets 145mg, No. 30

• Hypercholesterolemia and hypertriglyceridemia, isolated or mixed (dyslipidemia type IIa, IIb, III, IV, V according to the Fredrickson classification) in patients for whom diet or other non-drug treatment measures (for example, weight loss or increased physical activity) are ineffective, especially in the presence of related with dyslipidemia, risk factors such as hypertension and smoking.

• For the treatment of secondary hyperlipoproteinemia, the drug is used in cases where hyperlipoproteinemia persists despite effective treatment of the underlying disease (for example, dyslipidemia in diabetes mellitus).

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen. Before and during treatment, the patient should follow a cholesterol-lowering diet.

It is taken orally 1 time / day.

The dose depends on the dosage form used.

The treatment is long-term. The effectiveness of therapy should be assessed by the concentration of lipids (total cholesterol, LDL, triglycerides) in the blood serum. In the absence of a therapeutic effect after several months of therapy (usually after 3 months), the advisability of prescribing concomitant or alternative therapy should be considered.

White film-coated tablets

Active substance:

fenofibrate (micronized)

• Hypersensitivity to fenofibrate;

• severe liver dysfunction - class C on the Child-Pugh scale (including biliary cirrhosis and persistent liver dysfunction of unknown etiology);

• history of gallbladder disease;

• severe and moderate renal impairment (CC <60 ml / min);

• chronic or acute pancreatitis, except in cases of acute pancreatitis due to severe hypertriglyceridemia;

• a history of photosensitization or phototoxicity when treated with fibrates or ketoprofen;

• breastfeeding period;

• age up to 18 years.

Carefully

In patients with factors predisposing to the development of myopathy and / or rhabdomyolysis, including age over 70 years, a burdened history of hereditary muscle diseases, hypothyroidism and alcohol abuse; use during pregnancy; while taking oral anticoagulants, HMG-CoA reductase inhibitors

pharmachologic effect

Lipid-lowering agent from the group of fibric acid derivatives.

By activating PPAR-alpha (?-receptors activated by the peroxisome proliferator), fenofibrate enhances lipolysis and excretion of atherogenic lipoproteins with a high concentration of triglycerides from blood plasma by activating lipoprotein lipase and decreasing the synthesis of apoprotein CIII. The activation of PPAR-alpha also leads to an increase in the synthesis of apoproteins AI and AII.

Fenofibrate is a derivative of fibric acid, the ability of which to alter the concentration of lipids in the human body is mediated by the activation of PPAR-alpha. The effects of fenofibrate on lipoproteins described above lead to a decrease in the concentration of LDL and VLDL, which include apoprotein B, and an increase in the concentration of HDL, which include apoproteins AI and AII.

In addition, due to the correction of disorders in the synthesis and catabolism of VLDL, fenofibrate increases the clearance of LDL and reduces the concentration of dense and small particle size of LDL particles, an increase in which is observed in patients with atherogenic lipid phenotype, a frequent disorder in patients at risk of coronary artery disease.

Fenofibrate reduces platelet aggregation, reduces elevated plasma fibrinogen levels, and is able to somewhat lower blood glucose levels in diabetic patients; reduces the level of uric acid in the blood.

Indications of the active substances of the drug Traikor

• Hypercholesterolemia and hypertriglyceridemia, isolated or mixed (dyslipidemia type IIa, IIb, III, IV, V according to the Fredrickson classification) in patients for whom diet or other non-drug treatment measures (for example, weight loss or increased physical activity) are ineffective, especially in the presence of related with dyslipidemia, risk factors such as hypertension and smoking.

• For the treatment of secondary hyperlipoproteinemia, the drug is used in cases where hyperlipoproteinemia persists despite effective treatment of the underlying disease (for example, dyslipidemia in diabetes mellitus).

Dosage regimen

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen. Before and during treatment, the patient should follow a cholesterol-lowering diet.

It is taken orally 1 time / day.

The dose depends on the dosage form used.

The treatment is long-term. The effectiveness of therapy should be assessed by the concentration of lipids (total cholesterol, LDL, triglycerides) in the blood serum. In the absence of a therapeutic effect after several months of therapy (usually after 3 months), the advisability of prescribing concomitant or alternative therapy should be considered.

Side effect

From the side of the blood and lymphatic system: rarely - a decrease in hemoglobin and leukocytes.

From the immune system: rarely - hypersensitivity reactions.

From the nervous system: infrequently - headache.

From the side of the vessels: infrequently - thromboembolism (thromboembolism of the pulmonary artery and deep vein thrombosis of the lower extremities).

From the digestive system: often - abdominal pain, nausea, vomiting, diarrhea, flatulence, increased activity of hepatic transaminases; infrequently - pancreatitis, cholelithiasis; rarely - hepatitis.

Skin and subcutaneous tissue disorders: rarely - alopecia, photosensitivity reactions.

Allergic reactions: infrequently - skin rash, pruritus, urticaria.

From the musculoskeletal system: infrequently - muscle damage, incl. diffuse myalgia, myositis, muscle spasm and muscle weakness.

From the genital organs: infrequently - erectile dysfunction.

On the part of laboratory parameters: very often - an increase in the concentration of homocysteine ??in the blood; infrequently - an increase in the concentration of creatinine in the blood serum; rarely - an increase in the concentration of urea nitrogen in the blood serum.

Contraindications for use

• Hypersensitivity to fenofibrate;

• severe liver dysfunction - class C on the Child-Pugh scale (including biliary cirrhosis and persistent liver dysfunction of unknown etiology);

• history of gallbladder disease;

• severe and moderate renal impairment (CC <60 ml / min);

• chronic or acute pancreatitis, except in cases of acute pancreatitis due to severe hypertriglyceridemia;

• a history of photosensitization or phototoxicity when treated with fibrates or ketoprofen;

• breastfeeding period;

• age up to 18 years.

Carefully

In patients with factors predisposing to the development of myopathy and / or rhabdomyolysis, including age over 70 years, a burdened history of hereditary muscle diseases, hypothyroidism and alcohol abuse; use during pregnancy; while taking oral anticoagulants, HMG-CoA reductase inhibitors

Application during pregnancy and lactation

The potential risk to humans is unknown, therefore, use during pregnancy is possible only after a careful assessment of the ratio of the expected benefits of therapy to the mother and the likely risk to the fetus.

Fenofibrate is contraindicated during breastfeeding.

Application for violations of liver function

It is contraindicated for use in severe liver dysfunctions - class C on the Child-Pugh scale (including biliary cirrhosis and persistent liver dysfunction of unknown etiology).

Application for impaired renal function

Use is contraindicated in severe and moderate renal impairment (CC <60 ml / min).

Use in children Contraindicated in children and adolescents under the age of 18 years.

Use in elderly patients

Use with caution in patients over 70 years of age.

special instructions

Before using fenofibrate, treatment should be carried out for diseases that can cause secondary hypercholesterolemia, including: uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, the effects of drug therapy, alcoholism.

In patients with hyperlipidemia taking estrogens or hormonal contraceptives containing estrogens, it is necessary to find out whether the hyperlipidemia is of a primary or secondary nature. In such cases, the increase in lipid concentration may be caused by the intake of estrogens.

It is recommended to monitor the activity of ALT, ACT every 3 months during the first 12 months and periodically during further treatment. Patients who have increased activity of hepatic transaminases during treatment require attention, and if the activity of ALT and ACT is more than 3 times higher than that of VGN, fenofibrate should be discontinued. If symptoms of hepatitis appear (jaundice, pruritus), laboratory tests should be carried out and, if the diagnosis of hepatitis is confirmed, fenofibrate should be discontinued.

The risk of developing rhabdomyolysis may increase in patients with a predisposition to myopathy and / or rhabdomyolysis, including age over 70 years, a history of hereditary muscle diseases, hypothyroidism, and alcohol abuse. In these patients, fenofibrate should only be used if the expected benefit outweighs the possible risk of rhabdomyolysis.

In the case of an increase in the concentration of creatinine by more than 50% above the ULN, treatment should be suspended. It is recommended to determine the concentration of creatinine in the first 3 months and periodically during further treatment.

During the first twelve months from the start of fenfibrate therapy, periodic monitoring of the content of erythrocytes and leukocytes is recommended.

If signs or symptoms of immediate hypersensitivity are observed, you should immediately consult a doctor and stop using fenofibrate.

Drug interactions

Fenofibrate enhances the effect of oral anticoagulants and may increase the risk of bleeding, which is associated with the displacement of the anticoagulant from the sites of binding to blood plasma proteins.

Several severe cases of reversible renal dysfunction have been reported during concomitant treatment with fenofibrate and cyclosporine. Therefore, it is necessary to carefully monitor the state of renal function in such patients and discontinue fenofibrate in the event of a serious change in laboratory parameters.

Taking fenofibrate with HMG-CoA reductase inhibitors or other fibrates increases the risk of serious toxic effects on muscle fibers. Such combination therapy should be carried out with caution and the condition of patients should be carefully monitored for signs of toxic effects on muscle tissue.

With the simultaneous use of fenofibrate and glitazones, several cases of a reversible paradoxical decrease in the concentration of HDL cholesterol have been reported. Therefore, when carrying out simultaneous therapy, it is recommended to control the concentration of HDL cholesterol, and in the case of a pronounced decrease in the concentration of HDL cholesterol, the drugs should be canceled.

Patients using fenofibrate in conjunction with drugs metabolized by isoenzymes CYP2C19, CYP2A6 and especially CYP2C9 with a narrow therapeutic index should be closely monitored and, if necessary, it is recommended to adjust the dose of these drugs.