Tricor tabs 145mg #30

Instruction for Tricor

You can buy Tricor here

Tricor is a drug with hypolipidemic action.

Release form and composition

The dosage form of Tricor'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 cardboard box 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.

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 from the plasma of atherogenic lipoproteins with a high triglyceride content (activation of lipoprotein lipase and a decrease in the synthesis of apolipoprotein CIII) are enhanced. Also PPARα activation leads to increased synthesis of apolipoproteins AI and AII.
These effects of fenofibrate on lipoproteins contribute to a decrease in the content of the LDL and VLDL (low density lipoprotein and very low density lipoprotein) fraction, 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 particles of LDL, the increase in which occurs in patients with atherogenic lipid phenotype (a frequent violation at risk of coronary heart disease).
The use of Tricor 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 parental 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 Tricor. The concentration of the drug in plasma during a long course remains stable and does not depend on the individual characteristics of the patient.
Tricor contains 145 mg micronized fenofibrate in the form of nanoparticles. The difference between this form of release from previous dosage forms of fenofibrate consists 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 Tricor 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. It does not participate 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 is not cumulated.
It is not excreted during hemodialysis.

Indications for use

    mixed or isolated hypercholesterolemia and hypertriglyceridemia (dyslipidemia types IIa, IIb, III, IV, V) with ineffective diet 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 against the background of diabetes mellitus).
During therapy, it is necessary to continue to follow the diet, which the patients adhered to before starting the use of Tricor.

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 photosensitization / phototoxicity during therapy with ketoprofen or fibrates;
    lactation period;
    age under 18;
    individual intolerance to the components of the drug.
Relative (diseases / conditions in the presence of which the appointment of Tricor 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: method and dosage

The drug is taken orally with a glass of water, without chewing, whole. Tricor tablets 145 mg can be taken with or without food at any time of the day, 160 mg - preferably with meals.
Tricor is prescribed 1 tablet per day.
Possible transition without dose adjustment:
    1 capsule of Lipantil 200 M or 1 tablet of Tricor 160 mg: for 1 tablet of Tricor 145 mg;
    1 capsule Lipantil 200 M: for 1 tablet of Tricor 160 mg.
Elderly patients do not need dose adjustment.
In case of 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 often;> 1% and <10% - often;> 0.1% and <1% - infrequently;> 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 Tricor, appropriate treatment is required to eliminate the cause of secondary hypercholesterolemia. In particular, this applies to such diseases / conditions as dysproteinemia, uncontrolled type 2 diabetes mellitus, nephrotic syndrome, hypothyroidism, obstructive liver disease, alcoholism, the consequences of drug therapy.
The effectiveness of the drug should be assessed by the serum lipid content in the blood. If after 3 months of therapy there is no effect, 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 Tricor, 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 Tricor in severe hypertriglyceridemia, direct exposure to the drug, as well as secondary phenomena associated with the formation of sediment or the presence of stones in the gallbladder against the background of obstruction of the common bile duct.
Cases of toxic effects of Tricor 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 creatine phosphokinase activity. 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 suspended. 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, Tricor can be prescribed to pregnant women with caution only after evaluating the benefit-risk ratio. During breastfeeding, the drug is contraindicated.

Childhood use

Tricor is not prescribed for patients under 18 years of age.

With impaired renal function

    with severe renal failure - Tricor is contraindicated;
    with renal failure - the drug should be used with caution.

For violations of liver function

    with severe hepatic impairment - Tricor is contraindicated;
    with liver failure - the drug should be used with caution.

Use in the elderly

According to the instructions, Tricor is prescribed with caution to elderly patients.

Drug interactions

With the simultaneous use of Tricor 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, Tricor is canceled.

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.

Reviews

According to reviews, Tricor is a drug that effectively reduces cholesterol levels. 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.

Terms of sell

You don't need a doctor's prescription to buy Tricor.