Traykor

Трайкор Drug photo

The description is actual on 08.06.2016

  • Latin name: Tricor
  • ATH code: C10AB05
  • Active ingredient: Fenofibrat (Fenofibrate)
  • Producer: Recipharm Fontaine (France)

Structure

One tablet includes 145 mg / 160 mg of the micronized fenofibrat.

In addition: MKTs, sodium docusate, sucrose, magnesium stearate, sodium lauryl sulfate, monohydrate of lactose, krospovidon, colloid silicon dioxide, gipromelloza, Opadry OY-B-28920 (cover).

Release form

Traykor is made in the form of tablets on 145 mg, from 10 to 300 pieces in packaging and tablets on 160 mg, from 10 to 100 pieces in packaging.

Pharmacological action

Hypolipidemic.

Pharmacodynamics and pharmacokinetics

Medicine Traykor belongs to group of hypolipidemic means – fibrat. Active ingredient of drug – fenofibrat (derivative fibroyevy acid) is characterized by the activating impact on PPARα and thanks to lowering of synthesis of apoprotein CIII and stimulation of lipoproteinlipase leads to strengthening of a lipolysis and increase in quantity of the atherogenous lipoproteids brought out of a blood plasma containing a large number of triglycerides. Activation of PPARα also increases synthesis of AI and AII of apoproteins.

Such impact of a fenofibrat on lipoproteids promotes decrease in fractions of LPONP and LPNP containing apoprotein B and increase of the LPVP fraction including AI and AII apoproteins. In addition, action of a fenofibrat directionally on correction of processes of production and a catabolism of LPONP that the maintenance of dense and fine particles of LPNP leads to increase in clearance of LPNP and reduction (increase in data of LPNP is observed at patients with an atherogenous lipidic phenotype and is followed by the increased risk of an ischemic heart disease).

The conducted clinical trials of hypolipidemic properties of a fenofibrat showed reduction of content of triglycerides by 40-55% and the general cholesterol for 20-25% against increase in maintenance of LPVP by 10-30%. At patients with a hypercholesterolemia whose LPNP level is lowered for 20-35% treatment fenofibraty led to reduction of a ratio: general cholesterol and LPVP; apoprotein B and AI apoprotein; LPVP and LPNP which are markers of risk of an aterogennost.

In view of considerable influence of a fenofibrat on the content of triglycerides and LPNP, its use it is effective concerning patients with a hypercholesterolemia irrespective of, it is followed by a gipertriglitseridemiya or not, inclusive with a secondary giperlipoproteinemiya, such as, at the 2nd type of a diabetes mellitus (Traykor's efficiency at a diabetes mellitus is noted). In the course of carrying out therapy fenofibraty perhaps considerable decrease and even a total disappearance of extravasated deposits of cholesterol (tuberous and tendinous xanthomas).

At patients with the overestimated maintenance of lipoproteids or fibrinogen which took place treatment fenofibraty, observed considerable reduction of this indicator. Therapy fenofibraty led to decrease in level of S-reactive protein and other markers of an inflammation.

Patients with a hyperuricemia and a dislipidemiya got an additional benefit of treatment fenofibraty which consisted in the uricosuric effect leading to lowering of content of uric acid approximately for 25%.

The conducted researches on animals and the subsequent clinical trials proved decrease fenofibraty to the aggregation of thrombocytes which arose owing to influence of adenosinediphosphate, Epinephrinum and arachidonic acid.

Traykor 145 mg include tablets in the structure micronized fenofibrat in the form of nanoparticles.

In plasma of the person initial fenofibrat it is not found. Fenofibroyevy acid is considered the main plasma product of a metabolism of drug.

Plasma Cmax of a fenofibrat is noted after 2-4 hours after oral administration of drug. Long reception of a fenofibrat does not lead to change of its plasma concentration which, regardless of specific features of an organism of the patient, remains stable.

Unlike drugs of predecessors, oral administration of this dosage form of a fenofibrat (nanoparticle) can be carried out at any time irrespective of food which in this case does not influence the maximum plasma concentration of a fenofibrat and its systemic effect.

After internal reception fenofibrat is exposed to a fast hydrolyzation esterases, with allocation in plasma of fenofibroyevy acid (the main metabolite). In a blood plasma stable communication of fenofibroyevy acid with albumine (more than 99%) is observed. T1/2 of the main metabolite of drug makes about 20 hours. Fenofibrat does not participate in a microsomal metabolism and does not represent substrate for CYP3A4.

Removal of drug with urine is carried out mainly in the form of fenofibroyevy acid, and also a glucuronide conjugate. For 6 days almost full removal of a fenofibrat is observed.

The indicator of the general clearance of fenofibroyevy acid of the patient does not change with age. Cumulation of drug does not happen. Use of a hemodialysis for removal of a fenofibrat is inefficient.

Tablets Traykor of 160 mg, in comparison with earlier medical forms of a fenofibrat are characterized by bigger bioavailability.

In plasma of the person initial fenofibrat it is not found. Fenofibroyevy acid is considered the main plasma product of a metabolism of drug.

Plasma Cmax is noted after 4-5 hours after oral administration of drug. Long reception fenofibrat does not lead to change of its plasma concentration which, regardless of specific features of an organism of the patient, remains stable. Absorption of this medical form of a fenofibrat increases at its combined reception with food.

In plasma reveal only the main product of a metabolism of a fenofibrat – fenofibroyevy acid which steadily contacts albumine more than for 99%. T1/2 of the main metabolite of drug makes about 20 hours.

Removal of drug with urine is carried out mainly in the form of fenofibroyevy acid, and also a glucuronide conjugate. For 6 days almost full removal of a fenofibrat is observed.

The indicator of the general clearance of fenofibroyevy acid of the patient does not change with age. Cumulation of drug does not happen. Use of a hemodialysis for removal of a fenofibrat is inefficient.

Indications to use

Traykor is shown to use on purpose:

  • treatments of the isolated or mixed hypercholesterolemia and gipertriglitseridemiya (dislipidemiya of IIa, IIb, III, IV, V types) in case of inefficiency of a dietotherapy or other non-drug therapeutic methods (including weight reduction, increase in exercise stresses and so forth), in particular in the presence of the accessory factors of risk connected with a dislipidemiya (smoking, an arterial hypertension);
  • therapies of a secondary giperlipoproteinemiya, at preservation of a giperlipoproteinemiya even against effective treatment of the main pathology (for example, the dislipidemiya observed at a diabetes mellitus).

Contraindications

Purpose of drug Traykor contraindicated at:

  • heavy pathologies of a liver (including cirrhosis) or kidneys (at KK there is less 20ml/mines);
  • personal hypersensitivity to a fenofibrat or other components of tablets;
  • feeding by a breast;
  • intolerance of sugars;
  • pathologies of a gall bladder;
  • mentioning in the anamnesis of the patient of phototoxicity or a photosensitization at the previous reception of fibrat or Ketoprofen;
  • the previous allergic reactions to soy Lecithin, peanut or its oil, and also related food stuffs (risk of manifestations of hypersensitivity);
  • till 18 years.

Traykor apply with extra care at:

  • insufficiency of hepatic/renal function;
  • alcoholism;
  • hypothyroidism;
  • the burdened anamnesis concerning hereditary muscular pathologies;
  • parallel reception of statines;
  • at advanced age.

Side effects

Sometimes in the course of therapy by Traykor observed:

Traykor, application instruction (Way and dosage)

Drug tablets Traykor are intended for oral administration in the whole look together with water (200-250 ml). The application instruction Traykor of 145 mg allows reception of tablets of drug irrespective of food in any time of day convenient to the patient. A pill Traykor of 160 mg should be taken during meal.

The dosing mode of therapy by drug Traykor assumes one-time daily reception by adult patients of one tablet on 145 mg or 160 mg. These dosage forms of Traykor, as well as drugs predecessors with the maintenance of a fenofibrat of 200 mg (for example, Lipantil of 200 M), are considered equivalent in this connection, transition from reception of one medicine to another is carried out without any corrections of dosages.

Patients with insufficiency of renal function demand carrying out treatment using the lowered drug doses. Elderly patients do not need correction of doses. Traykor's use for therapy of patients with pathologies of a liver is not studied.

Therapy by a remedy Traykor should be carried out throughout a long time, in parallel with the diet prescribed the patient prior to treatment. The attending physician has to estimate efficiency of the carried-out therapy periodically. Criterion of such assessment is the serumal maintenance of lipids (including the general cholesterol, triglycerides and LPNP). In case of absence of effect of treatment after several months (usually after 3 months) reception of tablets Traykor, it is necessary to reconsider a question of expediency of its further use and a possibility of carrying out alternative therapy.

Overdose

Episodes of overdose by Traykor for this time are not described. The antidote to drug is unknown. In case of suspicions it is necessary to appoint treatment to probable overdose corresponding to noted negative symptoms. Carrying out a hemodialysis will not be effective.

Interaction

Parallel use of a fenofibrat with peroral anticoagulants leads to strengthening of their effect and, as a result, to increase of risk of developing of bleedings, because of replacement of anticoagulant from proteinaceous bonds. At the beginning of therapy fenofibraty recommend to lower dosages of the anticoagulants accepted by the patient approximately on a third, with further purposeful selection of their adequate doses. Dosages of anticoagulant select being coordinated with the MNO level.

At joint reception of a fenofibrat and Cyclosporine several heavy episodes of reversible depression of function of kidneys were noted. Such combination of medicines demands control over a condition of renal functionality and timely cancellation of a fenofibrat in case of significant change of laboratory indicators.

The combined reception of a fenofibrat with other fibrata or statines increases a possibility of heavy toxic influence concerning muscle fibers.

Researches of microsomes of a human liver (in vitro) revealed lack of an inhibiting effect of a fenofibrat and its main metabolite – fenofibroyevy acid on P450 cytochrome isoenzymes: CYP2D6, CYP1A2, CYP3A4, CYP2E1V, and also a weak inhibiting effect on isoenzymes of CYP2C19 and CYP2A6 and moderated on CYP2C9.

Terms of sale

The remedy Traykor is prescription.

Storage conditions

Tablets Traykor should be kept at a temperature up to 25 °C in packaging of the producer.

Period of validity

3 years for tablets of 145 mg and 2 years for tablets of 160 mg.

Special instructions

To appoint Traykor at a diabetes mellitus of the 2nd type, a nephrotic syndrome, a hypothyroidism, a disproteinemia, negative effects of drug treatment, obstructive pathologies of a liver, alcoholism and other similar painful states, it is possible only after carrying out the preliminary treatment directed to elimination of factors of a secondary hypercholesterolemia.

The attending physician has to estimate efficiency of the carried-out therapy periodically. Criterion of such assessment is the serumal maintenance of lipids (including the general cholesterol, triglycerides and LPNP). In case of absence of effect of treatment after several months (usually after 3 months) reception of tablets Traykor, it is necessary to reconsider a question of expediency of its further use and a possibility of carrying out alternative therapy.

At the patients with a lipidemia passing treatment by drugs with estrogen or accepting the oral hormonal contraceptives including estrogen it is necessary to define primary or secondary reason of forming of a lipidemia as increase in level of lipids is possible owing to reception of estrogen.

Against Traykor's use and other remedies reducing the level of lipids sometimes observed increase of content of hepatic transaminases. Most often such increase was temporary, was insignificant and took place asymptomatically. For the first 12 months of therapy by Traykor recommend to trace concentration of transaminases (nuclear heating plant, ALT) each 3 months. In case of identification at the patient of the increased level of transaminases it is necessary to trace carefully its further state and at increase in maintenance of nuclear heating plant and ALT three times in comparison with VGN to cancel Traykor's reception.

During therapy by Traykor episodes of development of pancreatitis were described. As probable causes of this pathology in this case consider: unsatisfactory efficiency of treatment at patients with a heavy gipertriglitseridemiya, the immediate effects of the remedy, and also the secondary factors connected with presence of stones at a gall bladder or forming in it of a deposit, which are followed by impassability of the general bilious channel.

Traykor's use, as well as the other drugs lowering the maintenance of lipids can become the reason of toxic impact on muscular tissue, up to development of a rabdomioliz (in rare instances). Frequency of such cases increases at instructions in the anamnesis of the patient on a renal failure and a hypoalbuminemia. The suspicion on toxic impact of drug on muscular tissue is reasonable in case of complaints of the patient to a miositis, weakness, muscular spasms and spasms, a diffusion mialgiya, and also at the expressed increase in activity of a kreatinfosfokinaza (VGN is five times higher). In these cases therapy by Traykor should be cancelled.

The risk of forming of a rabdomioliz increases at the patients predisposed to a rabdomioliz and/or a myopathy including advanced age (it is more than 70 years), an alcohol abuse, the burdened hereditary anamnesis concerning muscular diseases, a hypothyroidism, disturbance of renal function. Patients of such groups can appoint Traykor only in case of considerable exceeding of advantage of treatment in comparison with possible risk of forming of a rabdomioliz.

The combined reception of a fenofibrat with other fibrata or statines increases a possibility of heavy toxic influence concerning muscle fibers, in particular at the previous diseases of muscles. For this reason parallel treatment by Traykor and statines is justified only in case of existence at the patient of the mixed dislipidemiya of difficult character and the increased risk of cardiovascular complications, at absence in its anamnesis of diseases of muscles and in the conditions of a constant control of toxic impact on muscular tissue.

In case of increase in level of creatinine VGN is more than one and a half times higher, therapy by Traykor should be suspended. For the first 3 months of treatment it is necessary to trace concentration of creatinine periodically.

Traykor's analogs

Coincidence on the ATH code of the 4th level:

    Traykor's analogs are provided by remedies: Lipanor, Gemfibrozil, Trilipiks.

    Zdravzona

    • Traykor of 145 mg No. 30 of a tablet

    Drugstore of IFC

    • Traykor tbl p / about 145 mg No. 30, Fournier Groupe Lab.Frantion
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    BIOSPHERE

    • Traykor of 145 mg No. 30 tabl.p.p.o.
    to show still
    Section: Cardiovascular
    in more detail

    Education: Graduated from the Vinnytsia national medical university of N. I. Pirogov, pharmaceutical faculty, the higher pharmaceutical education – the specialty "Pharmacist".

    Experience: Work in Koneks and Bios-Media pharmacy chains as "Druggist". Work as "Pharmacist" in Avicenna pharmacy chain of the city of Vinnytsia.

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