Traikor
Traikor: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Tricor
ATX code: C10AB05
Active ingredient: Fenofibrate (Fenofibrate)
Manufacturer: Recipharm Fontaine (France)
Description and photo update: 2018-17-05
Prices in pharmacies: from 804 rubles.
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Traikor is a drug with hypolipidemic action.
Release form and composition
The dosage form of Traikor's release is film-coated tablets: oblong, white, on one side the inscription "145" or "160" (depending on the dosage), on the other - the company logo (in blisters of 10 pcs., In a cardboard box 1 –5, 9 or 10 blisters; in blisters of 14 pcs., In a carton box of 2, 6 or 7 blisters).
Composition of 1 tablet:
- active substance: fenofibrate - 145 (micronized) or 160 mg;
- excipients (145/160 mg): sucrose - 145/0 mg; sodium lauryl sulfate - 10.2 / 5.6 mg; lactose monohydrate - 132 / 138.4 mg; crospovidone - 75.5 / 96 mg; microcrystalline cellulose - 84.28 / 115 mg; colloidal silicon dioxide - 1.72 / 12.6 mg; hypromellose - 29/0 mg; sodium docusate - 2.9 / 0 mg; magnesium stearate - 0.9 / 0 mg; sodium stearyl fumarate - 0 / 6.4 mg; povidone - 0/160 mg;
- shell (145/160 mg): Opadry OY-B-28920 (titanium dioxide - 8.03 / 8.96 mg; polyvinyl alcohol - 11.43 / 12.75 mg; soy lecithin - 0.5 / 0.56 mg; talc - 5.02 / 5.6 mg; xanthan gum - 0.12 / 0.13 mg) - 25.1 / 28 mg.
Pharmacological properties
Pharmacodynamics
Fenofibrate is a fibric acid derivative. Its ability to alter the lipid content in the human body is mediated by PPARα activation. Due to this, lipolysis and excretion of atherogenic lipoproteins with a high triglyceride content from the plasma are enhanced (activation of lipoprotein lipase and a decrease in the synthesis of apolipoprotein CIII). Also, PPARα activation leads to an increase in the synthesis of apolipoproteins AI and AII.
These effects of fenofibrate on lipoproteins contribute to a decrease in the content of the fraction of LDL and VLDL (low density lipoprotein and very low density lipoprotein), which includes apolipoprotein B, and an increase in the content of the HDL fraction, which includes apolipoproteins AI and AII.
Also, by correcting violations of catabolism and synthesis of VLDL, fenofibrate increases the clearance of LDL and lowers the content of small and dense LDL particles, which increase in patients with atherogenic lipid phenotype (a frequent violation at the risk of coronary heart disease).
The use of Traikor is effective in patients with hypercholesterolemia with and without hypertriglyceridemia, including secondary hyperlipoproteinemia, in particular, in type 2 diabetes mellitus.
During therapy, extravascular cholesterol deposits (tuberous and tendon xanthomas) can significantly decrease and even completely disappear. With an increased level of fibrinogen, there is a significant decrease in this indicator, as in patients with an increased level of LP (a). In addition, other markers of inflammation are reduced, including C-reactive protein.
An additional benefit for patients with hyperuricemia and dyslipidemia is the uricosuric effect of fenofibrate, resulting in a decrease in uric acid concentration by about 25%.
There is also information about a decrease in platelet aggregation caused by adenosine diphosphate, epinephrine and arachidonic acid.
Pharmacokinetics
The original fenofibrate is not detected in plasma. The main plasma metabolite is fenofibric acid.
The maximum concentration of the substance in the blood plasma is reached after 2-4 hours (145 mg each) or 4-5 hours (160 mg each) after oral administration of Traikor. The concentration of the drug in plasma during a long course remains stable and does not depend on the individual characteristics of the patient.
Traikor contains 145 mg micronized fenofibrate in the form of nanoparticles. The difference between this form of release from previous dosage forms of fenofibrate is in the maximum concentration in blood plasma and the overall effect of fenofibrate in the form of nanoparticles. The effectiveness of the drug does not depend on food intake, and therefore it can be used regardless of food intake at any time.
The absorption of fenofibrate when using Traikor 160 mg is enhanced when taken simultaneously with food.
More than 99% of fenofibric acid binds strongly to plasma albumin.
The half-life of fenofibric acid is approximately 20 hours.
Fenofibrate is rapidly hydrolyzed by esterases after oral administration. Only its main active metabolite, fenofibric acid, is found in plasma.
Fenofibrate is not a substrate for CYP3A4. Does not take part in microsomal metabolism.
Excretion occurs mainly in the urine in the form of a conjugate of glucuronide and fenofibric acid. Fenofibrate is eliminated almost completely within 6 days.
After a single dose and during a long course, the drug does not accumulate.
It is not excreted during hemodialysis.
Indications for use
- hypercholesterolemia and hypertriglyceridemia, mixed or isolated (dyslipidemia types IIa, IIb, III, IV, V) with ineffective dietary or other non-drug treatment measures (in particular, weight loss or increased physical activity), especially in cases of risk factors associated with dyslipidemia including smoking and arterial hypertension;
- secondary hyperlipoproteinemia in cases where hyperlipoproteinemia persists despite effective therapy of the underlying disease (including dyslipidemia associated with diabetes mellitus).
During therapy, it is necessary to continue to follow the diet, which the patients adhered to before starting the use of Traikor.
Contraindications
Absolute:
- severe renal failure (with creatinine clearance <20 ml / min);
- severe liver failure, including cirrhosis of the liver;
- gallbladder disease;
- congenital fructosemia, sucrase / isomaltase deficiency (for tablets of 145 mg);
- congenital lactase deficiency, galactosemia, impaired absorption of glucose and galactose;
- a history of allergic reactions to peanuts, soy lecithin, peanut butter, or related products;
- burdened history of photosensitivity / phototoxicity during therapy with ketoprofen or fibrates;
- lactation period;
- age up to 18 years;
- individual intolerance to the components of the drug.
Relative (diseases / conditions in the presence of which the appointment of Traikor requires caution):
- hypothyroidism;
- renal or hepatic impairment;
- burdened history of hereditary muscle diseases;
- excessive alcohol consumption;
- combination therapy with oral anticoagulants, HMG-CoA reductase inhibitors;
- elderly age;
- pregnancy.
Instructions for use of Traikor: method and dosage
The drug is taken orally with a glass of water without chewing, whole. Traykor 145 mg tablets can be taken with or without food at any time of the day, 160 mg - preferably with meals.
Traikor is prescribed 1 tablet per day.
Possible transition without dose adjustment:
- 1 capsule Lipantil 200 M or 1 tablet of Traikor 160 mg: for 1 tablet of Traikor 145 mg;
- 1 capsule Lipantil 200 M: for 1 tablet of Traikor 160 mg.
Elderly patients do not need dose adjustment.
In renal failure, the drug is prescribed in a reduced dose.
Therapy should be carried out for a long time while adhering to the diet.
Side effects
Possible adverse reactions (> 10% - very common;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare):
- lymphatic / circulatory system: rarely - an increase in the content of leukocytes and hemoglobin;
- digestive system: often - abdominal pain, vomiting, nausea, flatulence and diarrhea of moderate severity; sometimes - cases of pancreatitis;
- musculoskeletal system and connective tissue: rarely - myositis, diffuse myalgia, weakness, muscle spasms; very rarely - rhabdomyolysis;
- liver: often - a moderate increase in the concentration of serum transaminases; sometimes - the formation of gallstones; very rarely - episodes of hepatitis (in cases of the onset of symptoms - jaundice, itching - laboratory tests are required, in cases of confirmation of the diagnosis, the drug is canceled);
- nervous system: rarely - headache, sexual dysfunction;
- cardiovascular system: sometimes - venous thromboembolism (deep vein thrombosis, pulmonary embolism);
- skin and subcutaneous fat: sometimes - itching, rash, photosensitivity reactions, urticaria; rarely - alopecia; very rarely - photosensitization, proceeding with erythema, the formation of nodules or blisters on areas of the skin exposed to artificial UV radiation or sunlight (in some cases, after prolonged use without the development of any complications);
- respiratory organs: very rarely - interstitial pneumopathies;
- laboratory tests: sometimes - an increase in the level of urea and serum creatinine.
Overdose
There are no reports of overdose cases.
The specific antidote is unknown. If an overdose is suspected, symptomatic and (if necessary) supportive therapy is performed.
Hemodialysis is ineffective.
special instructions
Prior to the appointment of Traikor, appropriate treatment is required to eliminate the cause of secondary hypercholesterolemia. In particular, this applies to diseases / conditions such as dysproteinemia, uncontrolled type 2 diabetes mellitus, nephrotic syndrome, hypothyroidism, obstructive liver disease, alcoholism, and the consequences of drug therapy.
The effectiveness of the drug should be assessed by the serum lipid content in the blood. If there is no effect after 3 months of therapy, the doctor may consider concomitant / alternative treatment.
If patients with hyperlipidemia take estrogens or hormonal contraceptives containing estrogen, it is necessary to find out whether the disease is of a primary or secondary nature. In these cases, the increase in lipid levels may be associated with the intake of estrogens.
During the first year of therapy, it is recommended to monitor the level of transaminases (alanine aminotransferase, aspartate aminotransferase) every 3 months. Patients who, while taking Traikor, have an increase in the concentration of transaminases, need special attention. If the indicators increase more than 3 times in comparison with the upper limit of the norm, the drug is canceled.
There is information about the occurrence of pancreatitis. Possible reasons for its development are insufficient effectiveness of Traikor in severe hypertriglyceridemia, direct exposure to the drug, as well as secondary events associated with the formation of sediment or stones in the gallbladder against the background of obstruction of the common bile duct.
Cases of toxic effects of Traikor on muscle tissue have been described, including very rare cases of rhabdomyolysis. The frequency of this disorder increases in the presence of a burdened history of hypoalbuminemia and renal failure. The possibility of complications increases in cases of renal failure and hypoalbuminemia.
It is possible to suspect a toxic effect on muscle tissue on the basis of complaints of diffuse myalgia, weakness, myositis, convulsions, muscle spasms and / or with a pronounced (5 times higher than the upper limit of the norm) increase in the activity of creatine phosphokinase. In such cases, the drug is canceled.
The likelihood of rhabdomyolysis may increase in patients with a predisposition to rhabdomyolysis / myopathy, including hypothyroidism, age 70 years, impaired renal function, a history of hereditary muscle diseases, alcohol abuse. This group of patients should be treated with caution.
The risk of serious toxic effects on muscle fibers increases when combined with HMG-CoA reductase inhibitors or other fibrates, especially in cases where the patient had muscle disease prior to treatment. Combined use is allowed only if the patient has a high cardiovascular risk and severe mixed dyslipidemia, in the absence of indications of a history of muscle disease, under close medical supervision, which is aimed at identifying these signs.
If the increase in creatinine concentration is more than 50% of the upper limit of the norm, therapy is stopped. In the first 3 months of use, it is recommended to determine the concentration of creatinine.
Application during pregnancy and lactation
Due to the lack of the necessary information, Traikor can be prescribed to pregnant women with caution only after evaluating the benefit-risk ratio. During breastfeeding, the drug is contraindicated.
Pediatric use
Traikor is not prescribed for patients under 18 years of age.
With impaired renal function
- with severe renal failure - Traikor is contraindicated;
- with renal failure - the drug should be used with caution.
For violations of liver function
- with severe hepatic insufficiency - Traikor is contraindicated;
- with liver failure - the drug should be used with caution.
Use in the elderly
According to the instructions, Traikor is prescribed with caution to elderly patients.
Drug interactions
With the simultaneous use of Traikor with some drugs / substances, side effects may develop:
- with oral anticoagulants: their effect is enhanced and the risk of bleeding increases; at the beginning of combined use, it is recommended to reduce the dose of anticoagulants by approximately 1/3, after which gradually select the dose, controlling the INR level;
- with inhibitors of HMG-CoA reductase and other fibrates: the risk of serious toxic effects on muscle fibers increases;
- with cyclosporine: there is a decrease in renal function of a reversible nature; therapy should be carried out under the control of the patient's condition, with a serious change in laboratory parameters, Traikor is canceled.
Analogs
Analogs of Traikor are Lipantil 200 M, Fenofibrat Canon, Exlip.
Terms and conditions of storage
Store in a place protected from moisture at temperatures up to 25 ° C. Keep out of the reach of children.
Shelf life:
- tablets of 145 mg - 3 years;
- 160 mg tablets - 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Traikor
According to reviews, Traikor is an effective cholesterol-lowering drug. However, many patients indicate the development of serious side effects, mainly from the digestive system, which in some cases lead to the cancellation of therapy.
Price for Traikor in pharmacies
The approximate price for Traikor (30 tablets in a pack of 145 mg) is 790–890 rubles.
Traikor: prices in online pharmacies
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Drug name Price Pharmacy |
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Traikor 145 mg film-coated tablets 30 pcs. 804 RUB Buy |
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Traikor tablets p.p. 145mg 30 pcs. 880 RUB Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
