Trakor - instructions for use, reviews, analogs and formulations (tablets 145 mg and 160 mg) of a statin drug from the group of fibrates for the treatment of hyperlipidemia and cholesterol reduction in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Traicor. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Tracor 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 Traykor with available structural analogues.Use to treat hyperlipidemia and reduce cholesterol in adults, children, as well as during pregnancy and lactation. Composition of statin from the pharmacological group of fibrates.

Traicor - lipid-lowering agent from the group of derivatives of fibroic acid. Reduces the blood levels of triglycerides and (to a lesser extent) - cholesterol. Helps reduce the content of VLDL, LDL (to a lesser extent), increase the content of anti-atherogenic HDL. The mechanism of action is not finally clarified. The effect at the TG level is mainly associated with the activation of the lipoprotein lipase enzyme. Apparently, fenofibrate also disrupts the synthesis of fatty acids; promotes an increase in the number of LDL receptors in the liver, disrupting the synthesis of cholesterol. Fenofibrate reduces platelet aggregation, reduces the elevated fibrinogen level in the plasma, can somewhat lower the blood glucose level in diabetic patients; reduces the level of uric acid in the blood.

Composition

Fenofibrate (micronized) + auxiliary substances.

Pharmacokinetics

After taking fenofibrate inside Cmax is reached within 5 hours. Binding to plasma proteins (albumin) - high.In tissues, fenofibrate is converted into an active metabolite, fenofibroic acid. Metabolised in the liver. It is excreted by the kidneys and through the intestines. Do not cumulate; not excreted by hemodialysis.

Indications

• hypercholesterolemia and hypertriglyceridemia isolated or mixed (dyslipidemia type 2a, 2b, 3, 4, 5) (145 mg tablets) and (dyslipidemia type 2a, 2b, 3, 4, 5) (160 mg tablets) in patients for whom a diet or other non-medicamentous medical interventions (eg, weight loss or increased physical activity) have proven ineffective, especially when there are dyslipidemic-related risk factors such as hypertension and smoking;
• secondary hyperlipoproteinemia in cases where hyperlipoproteinemia persists despite effective treatment of the underlying disease (eg, dyslipidemia in diabetes mellitus).

Forms of release

Tablets coated with 145 mg and 160 mg.

Instructions for use and dosage

Inside, swallowing whole, without chewing, drinking a glass of water, at any time of the day, regardless of food intake (145 mg tablets) and at the same time with eating (160 mg tablets).

Adults, 1 tablet once a day.Patients taking 1 capsule of Lipantil 200 M or 1 tablet of Traicor 160 mg per day can switch to taking 1 tablet of Tracor 145 mg without additional dose adjustment. Patients taking 1 capsule of Lipantil 200 M per day can switch to taking 1 tablet of Tracor 160 mg without additional dose adjustment.

Elderly: it is recommended to take a standard dose for adults (1 tablet of Tracor once a day).

Patients with renal failure require a dose reduction.

The drug should be taken for a long time, while continuing to follow the diet, which the patient adhered to before the beginning of treatment by Tracor. The effectiveness of drug treatment should be periodically evaluated by a doctor.

The effectiveness of therapy should be assessed by the content of lipids (total cholesterol, LDL, triglycerides) in serum. In the absence of a therapeutic effect after several months of therapy (usually after 3 months), the advisability of concomitant or alternative therapy should be considered.

Side effect

• abdominal pain;
• nausea, vomiting;
• diarrhea;
• flatulence;
• pancreatitis;
• moderate increase in the concentration of serum transaminases;
• the formation of gallstones;
• hepatitis;
• diffuse myalgia;
• myositis;
• muscle spasms;
• weakness;
• rhabdomyolysis (acute necrosis of skeletal muscles);
• venous thromboembolism (pulmonary embolism, deep vein thrombosis);
• increase in hemoglobin and leukocyte count;
• sexual dysfunction;
• headache;
• interstitial pneumopathy;
• rash;
• itching;
• hives;
• reaction of photosensitivity;
• alopecia (baldness);
• photosensitization accompanied by erythema, the formation of blisters or nodules in areas of skin exposed to sunlight or artificial UV radiation, such as a quartz lamp;
• increase serum creatinine and urea levels.

Contraindications

• hypersensitivity to fenofibrate or other components of the drug;
• severe hepatic insufficiency (including cirrhosis of the liver);
• severe renal failure (creatinine clearance less than 20ml / min);
• age to 18 years;
• the presence in the anamnesis of photosensitization or phototoxicity in the treatment of fibrates or ketoprofen;
• diseases of the gallbladder;
• the period of breastfeeding;
• congenital galactosemia, insufficiency of lactase, impaired absorption of glucose and galactose (the preparation contains lactose);
• congenital fructoemia, insufficiency of sucrose-isomaltase (the preparation contains sucrose) (Table 145 mg);
• allergic reaction to peanuts, peanut butter, soy lecithin or related products in history (due to the risk of developing a hypersensitivity reaction).

Carefully:

• hepatic and / or renal insufficiency;
• hypothyroidism;
• patients who abuse alcohol;
• patients of advanced age;
• patients with a history of hereditary muscle diseases;
• simultaneous administration of oral anticoagulants, inhibitors of HMG-CoA reductase.

Application in pregnancy and lactation

Trakor is contraindicated for use in pregnancy and lactation (breastfeeding).

Use in children

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

special instructions

Before starting treatment with Tracor, appropriate treatment should be performed to eliminate the cause of secondary hypercholesterolemia, for example, in conditions and diseases such as uncontrolled type 2 diabetes mellitus,hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, the consequences of drug therapy, alcoholism.

The effectiveness of therapy should be assessed by the content of lipids (total cholesterol, LDL, triglycerides) in 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.

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

Liver function: when taking Tracor and other drugs that reduce lipid concentrations, some patients describe an increase in the level of hepatic transaminases. In most cases, this increase was temporary, minor and asymptomatic. During the first 12 months of treatment, it is recommended to monitor the level of transaminases (ALT, AST) every 3 months.Patients who have increased concentrations of transaminases against the background of treatment require attention, and if the concentration of ALT and AST is more than 3 times higher than the upper limit of the norm, the drug is stopped.

Pancreatitis: cases of development of pancreatitis during the treatment with Tracor were described. Possible causes of pancreatitis in these cases were: insufficient effectiveness of the drug in patients with severe hypertriglyceridemia, direct exposure to the drug, as well as secondary phenomena associated with the presence of stones or the formation of sediment in the gallbladder, accompanied by obstruction of the common bile duct.

Muscles: when taking Tracor and other drugs that reduce lipid concentrations, cases of toxic effects on muscle tissue are described, including very rare cases of rhabdomyolysis. The frequency of such a disorder is increased in the case of hypoalbuminemia and renal insufficiency in the anamnesis. The possibility of this complication increases in cases of hypoalbuminemia and renal failure.

The toxic effect on muscle tissue can be suspected on the basis of the patient's complaints of weakness, diffuse myalgia, myositis,muscle spasms and convulsions and / or a pronounced increase in the activity of creatine phosphokinase (more than 5 times compared with the upper limit of the norm). In these cases, treatment with Tracor should be discontinued.

The risk of rhabdomyolysis may increase in patients with a predisposition to myopathy and / or rhabdomyolysis, including age over 70 years, a history of hereditary muscle diseases, renal dysfunction, hypothyroidism, alcohol abuse. Such patients should be prescribed a drug only if the expected benefit exceeds the possible risk of rhabdomyolysis.

When taking Tracor simultaneously with HMG-CoA reductase inhibitors or other fibrates, the risk of serious toxic effects on muscle fibers increases, especially if the patient suffered from muscle disease before starting treatment. In this regard, the joint appointment of Tracor and statin is permissible only if the patient has severe mixed dyslipidemia and high cardiovascular risk, in the absence of a history of muscle disease and under close monitoring aimed at revealing signs of the development of toxic effects on muscle tissue.

Renal function: if the creatinine concentration is increased by more than 50% above the upper limit of the norm, treatment should be stopped. In the first 3 months of treatment it is recommended to determine the concentration of creatinine.

Impact on the ability to drive vehicles and manage mechanisms

When applying the drug, there was no effect on the ability to drive and control machinery.

Drug Interactions

With the simultaneous use of hypoglycemic agents with derivatives of sulfonylureas, there are reports of increased hypoglycemic effects.

With the simultaneous use of indirect anticoagulants (including acenocoumarol, warfarin), their effects are intensified. It is believed that fibrates increase the affinity of anticoagulants to the corresponding receptors or, possibly, disrupt their metabolism.

At the beginning of Trekor's treatment, it is recommended that the dose of anticoagulants be reduced by about a third, followed by a gradual dose selection. The choice of a dose is recommended to be carried out under the control of the INR level.

Cyclosporin: Several severe cases of reversible reduction in renal function have been described during simultaneous treatment with fenofibrate and cyclosporin.Therefore, it is necessary to monitor the state of renal function in such patients and to abolish fenofibrate in the event of a serious change in laboratory parameters.

HMG-CoA reductase inhibitors and other fibrates: when taking Tracor simultaneously with HMG-CoA reductase inhibitors or other fibrates, the risk of serious toxic effects on muscle fibers increases.

Enzymes of cytochrome P450: studies of microsomes from human liver have shown that fenofibrate and fenofibroic acid are not inhibitors of the following cytochrome P450 isoenzymes: CYP3A4, CYP2D6, CYP2E1 or CYP1A2. In therapeutic concentrations, these compounds are weak inhibitors of CYP2C19 and CYP2A6 isoenzymes and weak or moderate inhibitors of CYP2C9.

Analogues of the drug Traicor

Structural analogs for the active substance:

• Grofibrate;
• Lipantil 200 M;
• Fenofibrate;
• Excl.

Analogues on the pharmacological group (lipid-lowering drugs):

• Akorta;
• Anistat;
• Apexstatin;
• Ateroclephitis;
• Atherostat;
• Ator;
• Atorvastatin;
• Atorvox;
• Atoris;
• The Vasator;
• Vazilip;
• Grinterol;
• Grofibrate;
• Guarem;
• Zocor;
• Zokor forte;
• Inegi;
• Cardiostatin;
• The Cross;
• Xantinol nicotinate;
• Courdlepid;
• Leskol;
• Lipanor;
• Lipobay;
• Lipbon;
• Lipoic acid;
• Lipon;
• Lipostat;
• Lipofford;
• Liprimar;
• Listat;
• Lovacor;
• Lovastatin;
• Lovasterol;
• Medostatin;
• Mertenil;
• A nicotinic acid;
• Novostat;
• Ovenkor;
• Omakor;
• Orlistat;
• Pravastatin;
• Rosystark;
• Rosuvastatin;
• Rosewood;
• Rosulip;
• Simvastatin;
• Tioctacid;
• Thioctic acid;
• Torvacard;
• Torvalip;
• Trilipix;
• Tulip;
• Fenofibrate;
• Holvasim;
• Holletar;
• Ezetrol;
• Excl.

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