Traykor tablets p/o 145mg №10×3

Name:
Trikor tabl p/pl.ob. 145mg in bl. in pack. №10×3
Description:
Oblong film-coated tablets, white, with the inscription “145” on one side, and the logo “FOURNIER” on the other side of the tablet. The main active ingredient Fenofibrate Release form 10 tablets in PVC / PE / PVDC / Al blister. 3 blisters in a cardboard box along with instructions for medical use. Dosage 145mg in bl. in pack. No. 10×3 Pharmacodynamics Fenofibrate is a fibric acid derivative whose lipid-modifying effects in the human body are mediated by activation of peroxisome proliferator-activated α-receptors (PPARα). Through PPAR activation? fenofibrate enhances lipolysis and the excretion of atherogenic particles rich in triglycerides (TG) from blood plasma by activating lipoprotein lipase and reducing the formation of apoprotein CIII. PPAR activation? also causes an increase in the synthesis of apoproteins AI and AII. The aforementioned effects of fenofibrate on lipoproteins lead to a decrease in the very low and low density fractions (VLDL and LDL), which contain apoprotein B, and an increase in the high density lipoprotein (HDL) fraction, which contain apoproteins AI and AII. In addition, by modulating the synthesis and catabolism of VLDL fractions, fenofibrate increases LDL clearance and reduces small, dense LDL, which are elevated in the atherogenic lipoprotein phenotype, a common disorder in patients at risk for coronary heart disease. During clinical studies with fenofibrate, total cholesterol was reduced by 20-25%, triglycerides by 40-55%, and HDL cholesterol was increased by 10-30%. In patients with hypercholesterolemia, in whom the level of LDL cholesterol decreased 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. There is evidence that fibrate treatment may reduce the incidence of coronary heart disease events, but fibrates have not been shown to reduce overall mortality in primary or secondary prevention of cardiovascular disease. The ACCORD-Lipid (The Action to Control Cardiovascular Risk in Diabetes-Lipid) randomized, placebo-controlled trial included 5518 patients with type 2 diabetes treated with fenofibrate in addition to simvastatin. Fenofibrate therapy, in combination with simvastatin, compared with simvastatin alone, showed no significant difference in effect on the primary composite endpoint of non-fatal myocardial infarction, non-fatal stroke, and death from cardiovascular causes (hazard ratio RR 0.92, 95% CI 0.79 -1.08, p = 0.32, absolute risk reduction: 0.74%). In a pre-designated subgroup of patients with dyslipidaemia, characterized by baseline HDL-cholesterol levels ? 34 mg/dl or 0.88 mmol/l (lower tertile) and TG level ? 204 mg/dl or 2.3 mmol/l (upper tertile), combination therapy with fenofibrate and simvastatin compared with simvastatin alone demonstrated a 31% relative risk reduction for the combined primary endpoint (hazard ratio 0.69, 95% CI 0.49 -0.97, p = 0.03, absolute risk reduction: 4.95%). Analysis of another planned subgroup revealed a statistically significant relationship between treatment effect and patient gender (p = 0.01), indicating a possible benefit of combination therapy for men (p = 0.037), but potentially a higher risk of the primary endpoint for women, compared with simvastatin monotherapy (p=0.069). This effect was not observed in the above subset of dyslipidemia patients, but there was also no clear evidence of benefit in dyslipidemia women treated with fenofibrate with simvastatin, and the possibility of an adverse effect in this subset of patients cannot be ruled out. During fenofibrate therapy, extravascular cholesterol deposits (tendon and tuberous xanthomas) may be significantly reduced or even completely eliminated. In patients with elevated levels of fibrinogen, when using fenofibrate, there was a significant decrease in this indicator, as well as in patients with elevated levels of lipoprotein (a). Fenofibrate reduces levels of other inflammatory markers such as C-reactive protein. The uricosuric effect of fenofibrate, which leads to a decrease in uric acid levels by approximately 25%, should be considered an additional beneficial effect of the drug in patients with dyslipidemia and hyperuricemia. In animal studies and in clinical studies, fenofibrate has been shown to have an anti-aggregatory effect on platelets, which is demonstrated in the reduction of platelet aggregation caused by ADP, arachidonic acid and adrenaline. PharmacokineticsTrycore® – film-coated tablets contain 145 mg of fenofibrate in the form of nanoparticles. Absorption Peak plasma concentrations (Cmax) are reached 2-4 hours after oral administration of the drug. With constant use in all patients, stable plasma concentrations are maintained. Unlike previous fenofibrate preparations, food intake does not affect the maximum plasma concentration and the level of total exposure of the drug, which contains fenofibrate nanoparticles. Therefore, Tricor®, in the form of film-coated tablets containing 145 mg of nanoparticulate fenofibrate, can be taken with or without food. A food impact study in which the new formulation of fenofibrate (145 mg tablets) was taken by healthy men and women on an empty stomach and during a high-fat meal showed that food intake did not affect the absorption rates (AUC and Cmax) of fenofibric acid. Distribution Fenofibric acid binds well to plasma albumin (more than 99%). Metabolism and excretion After oral administration, fenofibrate is rapidly hydrolyzed by esterases to form the active metabolite, fenofibric acid. Unchanged fenofibrate is not detected in plasma. Fenofibrate is not a CYP 3A4 substrate. Microsomal liver enzymes are not involved in the metabolism of fenofibrate. The drug is excreted mainly in the urine. The drug is almost completely eliminated within 6 days. Fenofibrate is mainly excreted in the form of fenofibric acid and a glucuronide conjugate. In elderly patients, the total clearance of fenofibric acid does not change. Kinetic studies after a single dose and with continuous use have shown that the drug does not accumulate in the body. Fenofibric acid is not excreted by hemodialysis. The plasma half-life of fenofibric acid is approximately 20 hours. Impaired renal function In patients with severe renal insufficiency, compared with healthy subjects, exposure to fenofibric acid is increased and cumulation is observed with repeated administration. Traycor® is not recommended for patients with severely impaired renal function. In case of impaired renal function of mild to moderate degree, it is necessary to prescribe a lower dose of the drug. Impaired liver function Pharmacokinetic studies in patients with hepatic insufficiency have not been conducted. Indications for use Tricor® is indicated as an adjunct to diet and other non-pharmacological treatments (eg, exercise, weight loss) for the following conditions: severe hypertriglyceridemia, with or without low HDL cholesterol; mixed hyperlipidemia, in the presence of contraindications to the use of statins or intolerance to statins; mixed hyperlipidemia, in patients with high cardiovascular risk, in addition to a statin, in the absence of adequate control of triglycerides and HDL cholesterol. Route of administration and dosage The effectiveness of therapy should be monitored by determining the level of lipids in the blood serum. If, after several months of therapy (eg 3 months), an adequate effect is not achieved, additional or other treatments should be considered. Traykor® is taken at any time of the day, regardless of food intake. The tablet should be swallowed whole, without chewing, with a glass of water. The recommended dose is one tablet of Traycor® once a day. Patients taking one 200 mg capsule (or one 160 mg tablet) of fenofibrate may switch to one tablet of Tricor® 145 mg once daily without further dose adjustment. If a dose is missed, the next dose should be taken at the usual time the next day. Do not take a double dose to make up for the missed one. Elderly patients For elderly patients without renal insufficiency, the usual adult dose is recommended. Pediatric Use The safety and efficacy of fenofibrate in children and adolescents under 18 years of age have not been established due to lack of data. Therefore, the use of fenofibrate is not recommended in children and adolescents under 18 years of age. Impaired renal function Patients with impaired renal function should be given a lower dose. In chronic kidney disease of moderate severity (creatinine clearance from 30 to 60 ml / min), if the drug in a lower dosage is available, treatment should be started with one capsule of the drug (100 mg) in the usual dosage form or with one capsule of the drug (67 mg) in micronized dosage form 1 time per day. If a lower dose is not available, fenofibrate is not recommended. Fenofibrate is contraindicated in patients with severe chronic kidney disease (creatinine clearance < 30 ml/min). Impaired liver function Due to lack of data, Tricor® 145 mg is not recommended for use in patients with impaired liver function. Use during pregnancy and lactation Pregnancy: There are no relevant data on the use of fenofibrate during pregnancy. Animal studies have not shown teratogenic effects. Embryotoxic effects have been demonstrated in the maternally toxic dose range. The possible risk to humans is unknown. Therefore, during pregnancy, the drug should be used only after a thorough assessment of the benefit-risk ratio. Lactation: It is not known if fenofibrate and/or its metabolites are excreted in human milk. A risk to breastfed children cannot be excluded. Therefore, fenofibrate should not be taken while breastfeeding. Fertility. Reversible effects on fertility have been observed in animal studies. There are no clinical data on the effect on fertility when using the drug Tricor®. Precautions Secondary hyperlipidemia Before initiating treatment with fenofibrate, appropriate treatment should be undertaken to eliminate the cause of secondary hypercholesterolemia, for example, in diseases such as uncontrolled type 2 diabetes, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, effects of drug therapy, alcoholism. In patients with hypercholesterolemia taking estrogens, progestins, combined estrogen-progestogen contraceptives, diuretics, beta-blockers, immunosuppressants, or protease inhibitors, it should be determined whether hyperlipidemia is primary or secondary (possibly increased lipid levels due to taking these drugs). Liver function As with other lipid-lowering drugs, elevated transaminase levels have been reported in some patients. In most cases, these abnormalities were transient, minor, and asymptomatic. It is recommended to monitor transaminase levels every 3 months during the first 12 months of treatment and periodically thereafter. Attention should be paid to patients who develop transaminase levels, therapy should be discontinued if the levels of ACT and ALT are more than 3 times the upper limit of normal. If symptoms suggest the onset of hepatitis (eg, jaundice, pruritus) and the diagnosis is confirmed by laboratory tests, fenofibrate therapy should be discontinued. Pancreas Cases of pancreatitis have been reported in patients taking fenofibrate (see sections "Contraindications" and "Side Effects"). This may indicate a lack of efficacy in patients with severe hypertriglyceridemia, a direct effect of the drug, or a secondary event due to the formation of stones in the biliary tract or the formation of sludge with obstruction of the common bile duct. Muscle Muscle toxicity, including rare cases of rhabdomyolysis, with or without renal failure, has been reported with fibrates and other lipid-lowering drugs. The incidence of this disorder increases with hypoalbuminemia and a history of renal failure. Patients with predisposing factors for the development of myopathy and/or rhabdomyolysis, including age over 70 years, a personal or family history of hereditary muscle disease, impaired renal function, hypothyroidism, and alcohol abuse, may be at an increased risk of developing rhabdomyolysis. When prescribing fenofibrate to these patients, the benefits and risks of fenofibrate therapy should be carefully weighed. Toxic effects on muscles should be suspected in patients with diffuse myalgia, myositis, muscle spasms and weakness and / or a significant increase in CPK levels (5 times higher than normal). In such cases, treatment with fenofibrate should be discontinued. The risk of muscle toxicity may be increased when the drug is co-administered with another fibrate or HMG-CoA reductase inhibitor, especially in the case of pre-existing muscle disease. Therefore, co-administration of fenofibrate with an HMG-CoA reductase inhibitor or other fibrate should only be given to patients with severe mixed dyslipidemia or high cardiovascular risk, without a history of muscle disease, and subject to careful monitoring of possible toxic effects on muscle. Renal function In the event of an increase in creatine levels > 50% of the upper limit of normal, treatment with the drug should be stopped. It is recommended to determine the level of creatinine during the first 3 months after the start of treatment, then periodically (for dose recommendations, see the section “Method of application and dosage”). Excipients The drug contains lactose. Therefore, patients with congenital galactose intolerance, lactase deficiency and malabsorption of glucose and galactose should not take the drug. The medicinal product contains sucrose and therefore should not be taken by patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency. Interaction with other drugs Oral anticoagulants The combination of fenofibrate with oral anticoagulants is not recommended. Fenofibrate enhances the effect of oral anticoagulants and may increase the risk of bleeding. If such a combination is necessary, it is recommended to reduce the dose of anticoagulants by about a third at the beginning of treatment and then, if necessary, gradually adjust according to the INR (International Normalized Ratio). Cyclosporine With the simultaneous use of fenofibrate and cyclosporine, several severe cases of reversible renal dysfunction have been reported. Therefore, it is necessary to carefully monitor renal function in these patients, and stop treatment with fenofibrate in case of severe laboratory abnormalities. HMG-CoA reductase inhibitors and other fibrates The risk of serious muscle toxicity is increased when fibrate is co-administered with HMG-CoA reductase inhibitors or other fibrates. Such combination therapy should be used with caution and patients should be carefully monitored for signs of muscle toxicity (see section “Precautions for Medical Use”). Glitazones With the concomitant use of fenofibrate and glitazones, cases of a reversible paradoxical decrease in HDL cholesterol levels have been reported. Therefore, it is recommended that HDL cholesterol levels be monitored when these drugs are used in combination, and therapy should be discontinued if HDL cholesterol levels are too low. Cytochrome P450 Enzymes In vitro studies using human liver microsomes indicate that fenofibrate and fenofibric acid are not inhibitors of the cytochrome (CYP) P450 isoforms CYP3A4, CYP2D6, CYP2E1, or CYP1A2. They are weak inhibitors of CYP2C19 and CYP2A6 and weak to moderate inhibitors of CYP2C9 at therapeutic concentrations. Patients who take fenofibrate concomitantly with drugs metabolized by CYP2C19, CYP2A6 and especially CYP2C9 with a narrow therapeutic index should be closely monitored and, if necessary, the doses of these drugs should be adjusted. Contraindications liver failure (including biliary cirrhosis and persistent liver dysfunction of unknown etiology); established gallbladder disease; severe chronic kidney disease; chronic or acute pancreatitis, with the exception of acute pancreatitis due to severe hypertriglyceridemia; established photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen; children under 18; hypersensitivity to the active substance or any of the excipients (see section “Composition”); In addition, Tricor should not be taken by patients allergic to peanuts, peanut butter, soy lecithin or derivatives due to the risk of hypersensitivity reactions. Composition 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; silicified microcrystalline cellulose – 86.0 mg (microcrystalline cellulose – 84.28 mg; anhydrous colloidal silicon dioxide – 1.72 mg); hypromellose 2910 (3 cp) – 29.0 mg; sodium docusate – 2.9 mg; magnesium stearate – 0.9 mg; Shell: Opadry® 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). Overdose Only a few reports of fenofibrate overdose have been received. In most cases, overdose symptoms were not reported. The specific antidote is unknown. If an overdose is suspected, symptomatic treatment and the necessary supportive measures should be carried out. Fenofibrate is not excreted by hemodialysis. Side effectsThe frequency of adverse reactions listed below was determined as follows: very often (?1/10), often (>1/100, <1/10); sometimes (>1/1000, <1/100); rarely (>1/10000, <1/1000); very rarely (<1/10000), including individual messages. From the gastrointestinal tract: often - abdominal pain, nausea, vomiting, diarrhea and moderate flatulence; sometimes - cases of pancreatitis. From the side of the liver: often - a moderate increase in the concentration of serum transaminases; sometimes - the formation of gallstones; very rarely - episodes of hepatitis. If symptoms of hepatitis appear (jaundice, itching), laboratory tests should be carried out and, if hepatitis is confirmed, fenofibrate should be discontinued. (See "Special Instructions"). From the musculoskeletal system and connective tissue: rarely - diffuse myalgia, myositis, muscle spasms and weakness; very rarely - rhabdomyolysis (acute necrosis of skeletal muscles). Vascular disorders: sometimes - venous thromboembolism (pulmonary embolism, deep vein thrombosis). From the circulatory and lymphatic system: rarely - an increase in the content of hemoglobin and leukocytes. From the nervous system: rarely - sexual dysfunction, headache. On the part of the respiratory system: very rarely - interstitial pneumopathy. From the skin and subcutaneous fat: sometimes - rash, itching, urticaria or photosensitivity reactions; rarely - alopecia; very rarely - photosensitivity, accompanied by erythema, the formation of blisters or nodules on areas of the skin exposed to sunlight or artificial UV radiation, such as a quartz lamp (in some cases - after many months of use without any complications). Laboratory studies: sometimes - an increase in the level of creatinine and urea in serum. Storage conditionsStore in the original packaging at a temperature not exceeding 25°C. Keep out of the reach of children. Buy Traykor tablets p/o 145mg No. 10x3