Tricor tabs 145mg #30

Tricor user manual

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Composition

One tablet contains 145 mg / 160 mg of micronized fenofibrate.
In addition: MCC, docusate sodium, sucrose, magnesium stearate, sodium lauryl sulfate, lactose monohydrate, crospovidone, colloidal silicon dioxide, hypromellose, Opadry OY-B-28920 (sheath).

Form of issue

Tricor is produced in the form of tablets of 145 mg, 10 to 300 pieces per pack and 160 mg tablets, 10 to 100 pieces per pack.

pharmachologic effect

Lipid-lowering.

Pharmacodynamics and pharmacokinetics

Trekor belongs to the group of lipid-lowering drugs - fibrates. The active ingredient of the drug, fenofibrate (a fibrolic acid derivative), is characterized by an activating effect on PPARα, and due to a decrease in the synthesis of apo-protein CIII and stimulation of lipoprotein lipase, the lipolysis is increased and the number of atherogenic lipoproteins containing a large number of triglycerides is increased. Activation of PPARα also increases the synthesis of AI and AII apoproteins.
This effect of fenofibrate on lipoproteins contributes to the reduction of fractions of VLDL and LDL containing apoprotein B, and an increase in the fraction of HDL, including AI and AII apoproteins. In addition, the effect of fenofibrate is aimed at correcting the production processes and catabolism of VLDL, which leads to an increase in LDL clearance and a decrease in the content of dense and small LDL particles (an increase in LDL is observed in patients with an atherogenic lipid phenotype and is accompanied by an increased risk of coronary heart disease).
Clinical studies of lipid-lowering properties of fenofibrate showed a 40-55% decrease in triglyceride content and a total cholesterol increase of 20-25% against a 10-30% increase in HDL. In patients with hypercholesterolemia, whose LDL level was lowered by 20-35%, treatment with fenofibrate led to a decrease in the ratio of total cholesterol and HDL; apoprotein B and apoprotein AI; HDL and LDL, which are markers of the risk of atherogenicity.
Considering the significant effect of fenofibrate on triglyceride and LDL, its use is effective for patients with hypercholesterolemia, whether it is accompanied by hypertriglyceridemia or not, including secondary hyperlipoproteinemia, such as in type 2 diabetes mellitus (Tricor's effectiveness in sugar diabetes). In the process of therapy with fenofibrate, a significant reduction and even complete disappearance of extravascular deposits of cholesterol (tuberous and tendon xanthomas) is possible.
In patients with an overestimated lipoprotein or fibrinogen that was treated with fenofibrate, a significant decrease in this index was observed. Therapy with fenofibrate led to a decrease in the level of C-reactive protein and other markers of inflammation.
Patients with hyperuricemia and dyslipidemia received an additional advantage of treatment with fenofibrate, which consisted of a uricosuric effect leading to a decrease in the uric acid content by approximately 25%.
Animal studies and subsequent clinical studies have demonstrated a reduction in fenofibrate aggregation of platelets that resulted from the effects of adenosine diphosphate, epinephrine and arachidonic acid.
Tricor 145 mg tablets include micronized fenofibrate in the form of nanoparticles.
In human plasma, the initial fenofibrate is not detected. The main plasma product of the drug metabolism is fenofibroic acid.
Plasma Cmax fenofibrate is observed after 2-4 hours after oral administration of the drug. Prolonged intake of fenofibrate does not lead to a change in its plasma concentration, which, regardless of the individual characteristics of the patient's body, remains stable.
Unlike precursor preparations, oral administration of this dosage form of fenofibrate (nanoparticles) can be carried out at any time of the day, regardless of food, which in this case does not affect the maximum plasma concentration of fenofibrate and its overall effect.
After internal administration, fenofibrate undergoes rapid hydrolysis with esterases, releasing fenofibroic acid (the main metabolite) into the plasma. In the blood plasma, there is a stable association of fenofibroic acid with albumin (more than 99%). T1 / 2 of the main metabolite of the drug is about 20 hours. Fenofibrate does not participate in microsomal metabolism and does not represent a substrate for CYP3A4.
Excretion of the drug with urine is carried out mainly in the form of fenofibroic acid, as well as glucuronide conjugate. For 6 days, almost complete elimination of fenofibrate is observed.
The index of total clearance of fenofibric acid with age of the patient does not change. Cumulation of the drug does not occur. The use of hemodialysis for the induction of fenofibrate is ineffective.
Tablets Tricor 160 mg, in comparison with the earlier therapeutic forms of fenofibrate are more bioavailable.
In human plasma, the initial fenofibrate is not detected. The main plasma product of the drug metabolism is fenofibroic acid.
Plasma Cmax is observed after 4-5 hours after oral administration of the drug. Prolonged intake of fenofibrate does not lead to a change in its plasma concentration, which, regardless of the individual characteristics of the patient's body, remains stable. The absorption of this therapeutic form of fenofibrate increases with its combined intake with food.
In plasma, only the main product of fenofibrate metabolism is detected - fenofibroic acid, which stably binds to albumin more than 99%. T1 / 2 of the main metabolite of the drug is about 20 hours.
Excretion of the drug with urine is carried out mainly in the form of fenofibroic acid, as well as glucuronide conjugate. For 6 days, almost complete elimination of fenofibrate is observed.
The index of total clearance of fenofibric acid with age of the patient does not change. Cumulation of the drug does not occur. The use of hemodialysis for the induction of fenofibrate is ineffective.

Indications for use

Tricor is shown for use in order to:
    treatment of isolated or mixed hypercholesterolemia and hypertriglyceridemia (dyslipidemia IIa, IIb, III, IV, V type) in the case of ineffectiveness of dietary therapy or other non-medicamentous therapeutic methods (including weight loss, increased exercise, etc.), especially in the presence of additional risk factors associated with with dyslipidemia (smoking, arterial hypertension);
    treatment of secondary hyperlipoproteinemia, while maintaining hyperlipoproteinemia even against the background of effective treatment of the underlying pathology (eg, dyslipidemia observed in diabetes mellitus).

Contraindications

The administration of the drug Tricor is contraindicated when:
    severe liver diseases (including cirrhosis) or kidneys (with CC less than 20ml / min);
    personal hypersensitivity to fenofibrate or other pill components;
    breastfeeding;
    intolerance to sugars;
    pathologies of the gallbladder;
    mentioning in the patient's history of phototoxicity or photosensitivity with a previous intake of fibrates or Ketoprofen;
    previous allergic reactions to soybean lecithin, peanuts or its oil, as well as related foods (risk of hypersensitivity);
    up to 18 years.
Tricor is used with extreme caution when:
    failure of hepatic / renal function;
    alcoholism;
    hypothyroidism;
    weighed down anamnesis in relation to hereditary muscle pathologies;
    parallel to taking statins;
    in old age.

Side effects

Sometimes in the course of therapy, Tricor observed:
    stomach ache;
    muscle weakness and spasms;
    nausea / vomiting;
    diffuse myalgia;
    headache;
    flatulence / diarrhea;
    increased levels of leukocytes and hemoglobin;
    pancreatitis;
    rash / itching;
    increased serum transaminase (moderate);
    interstitial pneumopathy;
    occurrence of gallstones;
    sexual dysfunction;
    episodes of hepatitis;
    hives or phenomena of photosensitivity;
    myositis;
    increase in serum urea and creatinine;
    rhabdomyolysis;
    alopecia;
    venous thromboembolism (deep vein thrombosis, pulmonary embolism);
    photosensitization with concomitant erythema, the development of nodules or blisters on the skin areas exposed to natural or artificial UV irradiation (in some cases, manifested after months of therapy without any previous complications).

Tricor, instructions for use (Method and dosage)

Tablets of the drug Tricor are intended for oral administration in a general form together with water (200-250 ml). Instructions for use Tricor 145 mg allows the taking of tablets of the drug, regardless of food, at any time of day convenient for the patient. Tablets Trirocor 160 mg should be taken while eating.
The dosage regimen of Tricor therapy involves a one-time daily intake by adults of one tablet of 145 mg or 160 mg. These tracer dosage forms, as well as precursor preparations containing 200 mg fenofibrate (for example, Lipantil 200 M), are considered equivalent, and therefore, the transition from taking one drug to another is carried out without any dosage adjustments.
Patients with insufficient renal function require treatment with reduced doses of the drug. Elderly patients do not need to adjust doses. The use of Tricor for the treatment of patients with liver pathologies has not been studied.
Therapeutic therapy Tricor should be carried out for a long time, in parallel with the diet prescribed to the patient before the treatment. The attending physician should periodically evaluate the effectiveness of the therapy. The criterion for this assessment is the serum lipid content (including total cholesterol, triglycerides and LDL). In the absence of the effect of treatment after several months (usually after 3 months) of taking Tricor tablets, the question of the advisability of its further application and the possibility of alternative therapy should be reconsidered.

Overdose

Episodes of an overdose by Tricor are not described at this time. Antidote to the drug is unknown. In case of suspicion of a possible overdose, treatment should be prescribed corresponding to the reported negative symptoms. Conducting hemodialysis will not be effective.

Interaction

Parallel use of fenofibrate with oral anticoagulants leads to an increase in their effect and, as a result, an increased risk of bleeding, due to the displacement of the anticoagulant from the protein bonds. At the beginning of therapy, fenofibrate is recommended to lower the dosage of patient anticoagulants by about a third, with a further targeted selection of their adequate doses. Dosages of anticoagulant are selected in accordance with the level of INR.
With the joint administration of fenofibrate and Cyclosporine, several severe episodes of reversible decline in renal function were noted. This combination of drugs requires control over the state of renal function and the timely withdrawal of fenofibrate in the case of a significant change in laboratory parameters.
The combined use of fenofibrate with other fibrates or statins increases the possibility of severe toxic effects on muscle fibers.
Studies of human liver microsomes (in vitro) revealed the absence of inhibitory effects of fenofibrate and its main metabolite, fenofibric acid, on cytochrome P450: CYP2D6, CYP1A2, CYP3A4, CYP2E1B isoenzymes, as well as a weak inhibitory effect on CYP2C19 and CYP2C9 isoenzymes and moderate on CYP2C9.

Terms of sale

You can buy Tricor without a prescription.

Storage conditions

Tablets Tricor should be stored at a temperature of up to 25 ° C in the manufacturer's packaging.
Shelf life - 3 years for tablets 145 mg and 2 years for tablets 160 mg.

special instructions

To appoint Tricor for type 2 diabetes mellitus, nephrotic syndrome, hypothyroidism, dysproteinemia, the negative consequences of drug treatment, obstructive liver diseases, alcoholism and other similar morbid conditions, it is possible only after preliminary treatment of secondary hypercholesterolemia directed at elimination of factors.
The attending physician should periodically evaluate the effectiveness of the therapy. The criterion for this assessment is the serum lipid content (including total cholesterol, triglycerides and LDL). In the absence of the effect of treatment after several months (usually after 3 months) of taking Tricor tablets, the question of the advisability of its further application and the possibility of alternative therapy should be reconsidered.
In patients with hyperlipidemia who are treated with estrogen drugs or who take oral hormonal contraceptives that include estrogens, the primary or secondary cause of hyperlipidemia should be determined, since an increase in lipid levels is possible due to the intake of estrogens.
Against the background of the use of Tricor and other therapeutic agents that reduce the level of lipids, sometimes an increase in the level of hepatic transaminases was observed. Most often, this increase was temporary, was minor and asymptomatic. During the first 12 months of therapy, Tricor is recommended to monitor transaminase concentrations (AST, ALT) every 3 months. In case the patient has an elevated transaminase level, it is necessary to carefully monitor his further condition and, when the AST and ALT content is increased three times as compared with the VGN, the reception of Tricor is canceled.
During the period of therapy with Tricor, episodes of development of pancreatitis were described. Probable causes of this pathology in this case are: unsatisfactory effectiveness of treatment in patients with severe hypertriglyceridemia, direct effects of the remedy itself, and secondary factors associated with the presence of gallstones or the formation of sediment in it, accompanied by obstruction of the common bile duct.
The use of Tricor, as well as other lipid lowering drugs, can cause toxic effects on muscle tissue, up to the development of rhabdomyolysis (in rare cases). The frequency of such cases increases with the indication in the patient's history of renal failure and hypoalbuminemia. Suspicion of the toxic effect of the drug on muscle tissue is justified in case of patient complaints of myositis, weakness, muscle cramps and spasms, diffuse myalgia, and also with a marked increase in the activity of creatine phosphokinase (five times higher than UGN). In these cases, therapy should be canceled by Tricor.
The risk of rhabdomyolysis is increased in patients predisposed to rhabdomyolysis and / or myopathy, including elderly age (more than 70 years), alcohol abuse, a hereditary anamnesis concerning muscular diseases, hypothyroidism, renal function impairment. Patients of such groups can be prescribed Tricor only in the case of a significant excess of the benefits of treatment in comparison with the possible risk of rhabdomyolysis.
The combined use of fenofibrate with other fibrates or statins increases the possibility of severe toxic effects on muscle fibers, especially with previous muscle diseases. For this reason, parallel treatment with Tricor and statins is justified only if the patient has a mixed dyslipidemia of a serious nature and an increased risk of cardiovascular complications, in the absence of his anamnesis of muscle diseases and in the constant monitoring of toxic effects on muscle tissue.
In the case of an increase in the level of creatinine more than one and a half times higher than UGN, therapy should be stopped by Tricor. During the first 3 months of treatment should periodically monitor the concentration of creatinine.

Children

The use of Tricor in pediatrics (up to 18 years) is contraindicated.

In pregnancy and lactation

There are few evidence of the use of fenofibrate for the therapy of pregnant women. In experiments conducted on animals, the teratogenic effect of fenofibrate was not found. Embryotoxicity was observed in preclinical studies using dosages toxic to the mother's body. Potential risk is not fully established. In this regard, Tricor during pregnancy can be appointed only after thorough analysis of the benefit / risk ratio.
Due to the lack of comprehensive data on the safety of Tricor regarding its use by nursing women, the drug is contraindicated for prescription when breastfeeding.

Reviews of Tricor

Reviews about Tricor 145 mg and 160 mg are few and ambiguous. Some doctors will successfully apply it to normalize the lipid profile of their patients, observe the high effectiveness of this drug and are completely satisfied with the results of therapy with its use. Other specialists refer to the action of Tricor with caution and note that possible side effects of the drug (formation of stones, rhabdomyolysis, photosensitivity) prevail over its potential effects. In any case, the appointment of Medicare-like remedies to Tricor remains at the doctor's discretion and in the event that the patient has no contraindications to their use or the risk factors for the negative consequences of such treatment is likely to lead to the expected positive result.