Traicor (Tricor)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceFenofibrateFenofibrate
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    • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet, film-coated, contains:

    Active substance:

    Fenofibrate (micronized) 145.0 mg

    Excipients:

    Sucrose 145.0 mg

    Sodium lauryl sulfate 10.2 mg

    Lactose monohydrate - 132.0 mg

    Crospovidone 75.5 mg

    Cellulose microcrystalline - 84.28 mg

    Silicon dioxide colloid - 1,72 mg

    Hypromellose - 29.0 mg

    Dokazate sodium - 2.9 mg

    Magnesium stearate 0.9 mg

    Shell (Opalo® OY-B-28920): 25.1 mg

    Polyvinyl alcohol - 11.43 mg

    Titanium dioxide - 8.03 mg

    Talc - 5.02 mg

    Soy lecithin - 0.50 mg

    Xanthan gum - 0.12 mg
    Description:

    Oblong tablets covered with a white film shell, with the inscription "145" on one side, and a logo on the other side of the tablet.

    Pharmacotherapeutic group:lipid-lowering agent - fibrate
    ATX: & nbsp

    C.10.A.B.05   Fenofibrate

    Pharmacodynamics:

    Activating PAPP-alpha (alpha receptors activated by the peroxisome proliferator), fenofibrate enhances lipolysis and the removal of atherogenic lipoproteins from the plasma with a high concentration of triglycerides by activating the lipoprotein lipase and reducing the synthesis of apoprotein CIII. Activation of PPA-alpha also results in increased synthesis of apoproteins AI and AII.

    Fenofibrate is a derivative of fibroic acid, whose ability to change the lipid content in the human body, is mediated by the activation of RAPP-alpha. The effects of fenofibrate on lipoproteins described above lead to a decrease in the concentration of the fraction of low-density lipoproteins (LDL) and very low density (VLDL), including apoprotein B, and an increase in the concentration of high-density lipoprotein (HDL) fraction, including apoproteins AI and AII.

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

    In clinical trials, it was noted that the use of fenofibrate reduces the level of total cholesterol by 20-25% and triglycerides by 40-55% with an increase in the level of HDL-cholesterol by 10-30%. In patients with hypercholesterolemia, whose LDL-cholesterol level is reduced by 20-35%, the use of fenofibrate led to a decrease in the ratios "total cholesterol / HDL cholesterol","LDL cholesterol / HDL cholesterol" and "Apo B / Apo AI", which are markers of atherogenic risk.

    Given the influence of fenofibrate on the level of LDL cholesterol and triglycerides, the drug is effective in patients with hypercholesterolemia, either accompanied or not accompanied by hypertriglyceridemia, including secondary hyperlipoproteinemia, for example, in type 2 diabetes mellitus.

    During treatment with fenofibrate, extravascular deposits of cholesterol (tendon and tuberous xanthomas) can be significantly reduced and even completely lost. In patients with elevated fibrinogen levels who received fenofibrate treatment, there was a significant decrease in this indicator, as well as in patients with elevated lipoprotein levels. Other markers of inflammation, such as C-reactive protein, also decrease with fenofibrate treatment.

    For patients with dyslipidemia and hyperuricemia, an additional advantage is the uricosuric effect of fenofibrate, which leads to a decrease in the uric acid concentration by approximately 25%.

    In a clinical trial and in animal experiments, it was shown that fenofibrate reduces aggregation of platelets caused by adenosine diphosphate, arachidonic acid and epinephrine.

    Pharmacokinetics:

    Trakor 145 mg, film-coated tablets, contain 145 mg of micronized fenofibrate in the form of nanoparticles.

    Initial fenofibrate in plasma is not found. The main plasma metabolite is fenofibroic acid.

    Suction: the maximum concentration in the blood plasma (CmOh) is achieved 2-4 hours after ingestion. With prolonged use, the concentration of the drug in the plasma remains stable, regardless of the individual characteristics of the patient.

    Unlike previous dosage forms of fenofibrate, the maximum concentration in the blood plasma and the overall effect of fenofibrate in the form of nanoparticles does not depend on the intake of food. Therefore, Tracor 145 mg can be taken at any time, regardless of food intake.

    Distribution: fenofibroevaya acid strongly binds to plasma albumin (more than 99%).

    Half-life: the half-life of fenofibroic acid (T1/2) - about 20 hours.

    Metabolism and excretion: after oral administration fenofibrate quickly hydrolyzed by esterases.In the plasma, only the main active metabolite of fenofibrate, fenofibroic acid, is found. Fenofibrate It is not a substratum for CYP3A4. Does not participate in microsomal metabolism.

    It is excreted mainly with urine in the form of fenofibroic acid and glucuronide conjugate. Within 6 days fenofibrate is output almost completely. The total clearance of fenofibric acid, determined in elderly patients does not change.

    The drug is not cumulated after a single dose and with prolonged use.

    When hemodialysis is not withdrawn.

    Indications:

    Hypercholesterolemia and hypertriglyceridemia isolated or mixed (dyslipidemia type IIa, IIb, III, IV, V) in patients for whom diet or other non-medicinal treatment measures (for example, weight loss or increased physical activity) have been ineffective, especially if there are dyslipidemic-related 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 (eg, dyslipidemia in diabetes mellitus).

    Contraindications:

    - Hypersensitivity to fenofibrate or other components of the drug;

    - hepatic insufficiency (including biliary cirrhosis and persistent impaired liver function of unknown etiology);

    - severe renal failure (creatinine clearance <30 mL / min);

    - age under 18 years (effectiveness and safety not established);

    - the presence in the anamnesis of photosensitization or phototoxicity in the treatment of fibrates or ketoprofen;

    - a history of gallbladder disease;

    - 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);

    - Patients with allergies to peanuts, peanut butter, soy lecithin or related products in history (due to the risk of developing a hypersensitivity reaction);

    - chronic or acute pancreatitis, except for cases of acute pancreatitis due to severe hypertriglyceridemia.

    Patients with impaired renal function should be prescribed a lower dose of the drug.However, given the absence of fenofibrate in the Russian market at a lower dosage, the use of Tracor 145 mg is contraindicated in patients with impaired renal function of any severity.

    Carefully:

    In patients with factors predisposing to the development of myopathy and / or rhabdomyolysis. including elderly age (over 70 years), a history of hereditary muscle diseases, kidney failure, hypothyroidism and alcohol abuse (see section "Special instructions"); use during pregnancy; with the simultaneous administration of oral anticoagulants, inhibitors of HMG-CoA reductase (see section "Interaction with other drugs").

    Pregnancy and lactation:

    Pregnancy

    There is insufficient data on the use of fenofibrate in pregnant women. In experiments with animals, the teratogenic effect of fenofibrate was not observed. Embryotoxicity was noted with the appointment in the pre-clinical trial of doses, toxic to the mother's body. The potential risk to humans is unknown. Therefore, use the drug during pregnancy can only be after a thorough assessment of the ratio of expected benefits to possible risks.

    Breastfeeding period

    There is insufficient information on the excretion of fenofibrate and / or its metabolites into breast milk. It is impossible to exclude the risk for infants. The drug is contraindicated for use during breastfeeding.

    Dosing and Administration:

    It is necessary to continue to observe the hypocholesterolemic diet, which the patient adhered to before the beginning of treatment with Tracor 145 mg.

    Tablets Trakora 145 mg should be swallowed whole, without chewing, washed down with water. Trakor 145 mg can be taken at any time of the day, regardless of food intake.

    Adults. One tablet of Tracor 145 mg once a day.

    Patients taking one capsule of fenofibrate 200 mg or one tablet of fenofibrate 160 mg per day can switch to taking 1 tablet of Tracor 145 mg without additional dose adjustment.

    Elderly patients without renal failure. It is recommended to take a standard dose for adults (1 tablet per day).

    The effectiveness of therapy should be assessed by the concentration of lipids (total cholesterol, LDL, triglycerides) in the blood serum. In the absence of therapeutic effect after several months of therapy (usually after 3 months), consideration should be given to the appropriateness of concomitant or alternative therapy.

    Side effects:

    During placebo-controlled clinical trials, the following undesirable effects classified as follows; very often (≥1 / 10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥1 / 10000, <1/1000) and very rarely (<1/10000), the frequency is unknown (can not be calculated from the available data):

    From the digestive system:

    Often: signs and symptoms of a disorder of the gastrointestinal tract (pain in the living, nausea, vomiting, diarrhea, flatulence).

    Infrequently: pancreatitis *.

    From the liver and bile ducts:

    Often: increased activity of serum transaminases.

    Infrequently: cholelithiasis.

    Rarely: hepatitis.

    From the musculoskeletal system and connective tissue:

    Infrequent: mice are affected (eg, diffuse myalgia, myositis, muscle spasm and muscle weakness).

    VesselBasic violations:

    Infrequently: thromboembolism (pulmonary embolism and deep vein thrombosis of the lower extremities) *.

    From the blood and lymphatic system:

    Rarely: a decrease in hemoglobin and leukocytes.

    From the nervous system:

    Infrequently: a headache.

    Rarely: increased fatigue, dizziness.

    On the part of the genitals:

    Infrequent: erectile dysfunction.

    From the skin and subcutaneous fat:

    Infrequent: skin reactions of hypersensitivity (eg, skin rash, itching, urticaria).

    Rarely: alopecia, photosensitivity reactions.

    From the immune system:

    Rarely: hypersensitivity reactions.

    Laboratory Indicatorsand:

    Infrequent: increased serum creatinine concentration.

    Rarely: an increase in the concentration of urea nitrogen in the blood serum.

    * In a clinical study in patients with type 2 diabetes mellitus who received fenofibrate, a statistically significant increase in the incidence of pancreatitis and pulmonary embolism was observed compared with placebo. In the same study, a statistically unreliable increase in cases of deep vein thrombosis was revealed.

    In the period of post-marketing application there were spontaneous reports of a number of side effects. According to available data, it is impossible to establish the exact frequency of these effects, therefore it is classified as "frequency unknown".

    On the part of the respiratory system: interstitial lung disease.

    From the musculoskeletal system and connective tissue: rhabdomyolysis.

    From the liver and bile ducts: jaundice, complications of cholelithiasis (eg, cholecystitis, cholangitis, biliary colic).

    From the skin and subcutaneous fat: severe skin reactions (eg, erythema multiforme, Stephen-Johnson syndrome, toxic epidermal necrolysis).

    Overdose:There are only single reports of overdose. In most cases, no symptoms of overdose have been reported. The specific antidote is unknown. If you suspect an overdose, you should prescribe a symptomatic and, if necessary, supportive treatment. When hemodialysis is not withdrawn.
    Interaction:

    Oral anticoagulants

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

    At the beginning of treatment with fenofibrate, it is recommended that the dose of anticoagulants be reduced by about a third, followed by a gradual selection of a dose. The choice of a dose is recommended to be carried out under the control of the INR level (the international normalized relationship).

    Cyclosporin

    Several severe cases of reversible reduction of renal function during simultaneous treatment with fenofibrate and cyclosporine have been described. Therefore, it is necessary to carefully monitor the state of renal function in such patients and to cancel fenofibrate in the case of a serious change in laboratory parameters.

    HMG-CoA reductase inhibitors and other fibrates

    When taking fenofibrate concomitantly with HMG-CoA reductase inhibitors or other fibrates, the risk of serious toxic effects on muscle fibers increases. Such combination therapy should be conducted with caution and carefully monitor the condition of patients for signs of toxic effects on muscle tissue (see section "Special instructions").

    The thiazolidinedione derivatives (glitazones)

    With simultaneous application fenofibrate and glitazones, several cases of reversible paradoxical reduction concentrations HDL cholesterol. Therefore, during simultaneous therapy, it is recommended to control the concentration of HDL cholesterol and, if too low concentrations of HDL cholesterol are detected, drugs should be discarded.

    Enzymes of cytochrome P450

    Studies of microsomes from human liver in vitro showed 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 isoenzymes CYP2C19 and CYP2A6 and mild or moderate inhibitors CYP2C9.

    Patients using fenofibrate together with drugs metabolized by isoenzymes CYP2C19, CYP2A6 and especially CYP2C9 with narrow therapeutic indices, should be carefully monitored and, if necessary, it is recommended to adjust the doses of these drugs.

    Special instructions:

    Before treatment Traykorom 145 mg, should conduct an appropriate treatment to eliminate the cause of secondary hypercholesterolaemia, e.g., in diseases such as 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 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 145 mg and other drugs that reduce lipid concentrations, some patients described an increase in the level of "liver" transaminases. In most cases, this increase was temporary, minor and asymptomatic. It is recommended to control the level of transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (ACT)) every 3 months for the first 12 months and periodically during further treatment. Patients who have increased transaminase activity against the background of treatment require attention and, in the case of increased ALT activity and ACT more than 3 times compared with the upper limit of the norm, the drug is stopped. When symptoms of hepatitis (jaundice, pruritus) appear, laboratory tests should be performed and, if confirmed with a diagnosis of hepatitis, cancel fenofibrate.

    Pancreatitis: Cases of pancreatitis development during the treatment with Tracor 145 mg have been described. Possible causes of pancreatitis in these cases were: inadequate drug efficacy in patients with severe hypertriglyceridemia, direct drug exposure,as well as secondary phenomena associated with the presence of stones or the formation of sediment in the bile ducts, accompanied by obstruction of the common bile duct.

    Muscles: When receiving the 145 mg Traykora and other drugs that reduce the concentration of lipids described cases toxic effect on muscle tissue, 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 toxic effect on muscle tissue may be suspected on the basis of patient complaints of weakness, diffuse myalgia, myositis, muscle spasms and cramps and / or expressed increasing creatinine phosphokinase (CPK) (more than 5 times compared with the upper limit of normal). In these cases, treatment with Tracorum 145 mg 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, 145 mg concomitantly with HMG-CoA reductase inhibitors or other fibrates, the risk of serious toxic effects on muscle fibers increases, especially if the patient suffered from a muscle disease before starting treatment. In this regard, the joint appointment of Tracor 145 mg 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. It is recommended to determine the concentration of creatinine in the first 3 months and periodically during further treatment.

    Effect on the ability to drive transp. cf. and fur:

    Trakor 145 mg does not affect or affects to a minimum the ability to drive a vehicle and control mechanisms (risk of developing dizziness).

    Form release / dosage:

    Tablets, film-coated, 145 mg.

    Packaging:

    For 10 tablets in PVC / PE / PVDC / Al blister.

    For 1, 2, 3, 5, 9, 10 blisters in a cardboard pack together with instructions for use.

    For 14 tablets in PVC / PE / PVDC / Al blister. For 2, 6, 7 blisters in a cardboard pack together with instructions for use.

    For 10 tablets in PVC / PE / PVDC / Al blister. For 28, 30 blisters per carton boxes (packing for hospitals).

    Storage conditions:

    In a dry place at a temperature of no higher than 25 ° C in the original packaging.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-002450/08
    Date of registration:03.04.2008
    The owner of the registration certificate:Laboratories SA Fournier.Laboratories SA Fournier. France
    Manufacturer: & nbsp
    Representation: & nbspABBOTT LABORATORIES LLC ABBOTT LABORATORIES LLC Russia
    Information update date: & nbsp20.09.2015
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