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- TRIKOR® International Nonproprietary Name Fenofibrate Pharmaceutical Form, Dosage Film-coated Tablets, 145 mg Pharmacotherapeutic Group Cardiovascular System. Lipid-modifying agents. Lipid-modifying agents, simple. Fibrates. Fenofibrate. ATC Code: C10AB05 Indications for Use TRIKOR® is indicated as an adjunct to diet and other non-drug measures (e.g., exercise, weight loss) in the following conditions: - For the treatment of severe hypertriglyceridemia, with or without low levels of high-density lipoprotein cholesterol - Mixed hyperlipidemia in cases of contraindication or intolerance to statins - Mixed hyperlipidemia in patients with high cardiovascular risk, in addition to statins, where the correction of triglyceride and high-density lipoprotein cholesterol levels has been insufficient. List of Information Required Before Using the Product Contraindications - Hypersensitivity to the active substance or any of the excipients - Hepatic insufficiency (including biliary cirrhosis and persistent liver dysfunction of unknown etiology) - Severe chronic kidney disease - Known gallbladder disease - Chronic or acute pancreatitis, except for acute pancreatitis caused by severe hypertriglyceridemia - Congenital galactosemia, lactase deficiency, glucose-galactose malabsorption (the product contains lactose) - Congenital fructose intolerance, sucrase-isomaltase deficiency (the product contains sucrose) - Photoallergic or phototoxic reaction caused by treatment with fibrates or ketoprofen - Children and adolescents under 18 years of age - Pregnancy and lactation Additionally, TRIKOR® should not be taken by patients with hypersensitivity to peanuts, peanut butter, soy lecithin, or related products due to the risk of hypersensitivity reactions. Precautions for Use of the Product Secondary Causes of Hyperlipidemia Before starting TRIKOR® therapy, appropriate treatment should be carried out to eliminate the cause of secondary hyperlipidemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological therapy, alcoholism. In patients with hyperlipidemia who are taking estrogens or estrogen-containing contraceptives, it is necessary to determine whether the hyperlipidemia is primary or secondary. Liver Function It is recommended to monitor transaminase levels every 3 months during the first 12 months of treatment and then periodically. Patients with elevated transaminase levels should be monitored, and therapy should be discontinued if AST and ALT levels exceed 3 times the upper limit of normal. If symptoms indicate the development of hepatitis (e.g., jaundice, itching) and the diagnosis is confirmed by laboratory tests, fenofibrate therapy should be discontinued. Pancreas Cases of pancreatitis have been reported in patients taking fenofibrate. This may indicate a lack of efficacy in patients with severe hypertriglyceridemia, a direct effect of the drug, or a secondary phenomenon associated with the presence of gallstones or obstruction of the common bile duct. Muscles Cases of muscle toxicity, including rare cases of rhabdomyolysis, with or without renal failure, have been observed with the use of fibrates and other lipid-lowering agents. The incidence of this disorder increases in cases of hypoalbuminemia and pre-existing renal insufficiency. In patients with predisposing factors for myopathy and/or rhabdomyolysis, including those over 70 years of age, a personal or family history of hereditary muscle diseases, renal insufficiency, hypothyroidism, and alcohol abuse, the risk of developing rhabdomyolysis may increase. The benefit and risk of fenofibrate treatment in such patients should be carefully assessed. Muscle toxicity may develop in patients with diffuse myalgia, myositis, muscle cramps and weakness, and/or significantly elevated CPK levels (more than 5 times the normal level). In such cases, fenofibrate treatment should be discontinued. The risk of muscle toxicity may increase when the drug is taken with another fibrate or HMG-CoA reductase inhibitor, especially in cases of pre-existing muscle disease. Therefore, the concomitant use of fenofibrate with an HMG-CoA reductase inhibitor or another fibrate should only be done in patients with severe mixed dyslipidemia and high cardiovascular risk without a history of muscle disease, and close monitoring for potential muscle toxicity is required. Renal Function Treatment should be discontinued if serum creatinine levels increase by more than 50% compared to the upper limit of the normal range. It is recommended to determine creatinine levels within the first 3 months of treatment and then periodically. Drug Interactions Oral Anticoagulants Fenofibrate enhances the effect of oral anticoagulants and may increase the risk of bleeding. Cyclosporine Close monitoring of renal function is required in patients with renal dysfunction, and fenofibrate treatment should be discontinued in case of significant changes in laboratory parameters. HMG-CoA Reductase Inhibitors and Other Fibrates The risk of severe muscle toxicity increases when fenofibrate is taken concomitantly with HMG-CoA reductase inhibitors or other fibrates. This combination should be used with caution, and patients should be carefully monitored for signs of muscle toxicity. Glitazones Monitoring of HDL cholesterol levels is recommended if one of these components is added to the other, and treatment should be discontinued if HDL cholesterol levels are too low. Cytochrome P450 Enzymes In patients taking TRIKOR® concomitantly with drugs with a narrow therapeutic index metabolized by CYP2C19, CYP2A6, and especially CYP2C9, close monitoring is required, and dose adjustments of these drugs are recommended if necessary. Special Warnings Excipients TRIKOR® contains lactose; therefore, patients with rare hereditary disorders involving galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this product. TRIKOR® contains sucrose; therefore, patients with rare hereditary problems including fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not take this product. Influence on the Ability to Drive or Operate Machinery TRIKOR® has no or negligible influence on the ability to drive and operate machinery. Recommendations for Use of the Product Dosage Regimen Control of Treatment Efficacy The efficacy of treatment should be monitored by determining serum lipid levels. If adequate efficacy is not achieved several months after the start of therapy (e.g., 3 months), additional or different treatment methods should be considered. Adults The recommended dose is one TRIKOR® tablet once daily. Patients taking one capsule of fenofibrate 200 mg (or a 160 mg tablet) can switch to one TRIKOR® tablet 145 mg once daily without further dose adjustment. Elderly Patients For elderly patients without renal insufficiency, the usual adult dose is recommended. Renal Dysfunction Dose reduction is required in patients with renal dysfunction. In cases of mild/moderate chronic kidney disease (creatinine clearance 30-60 ml/min) and when using low doses of the drug, treatment is initiated with one capsule of 100 mg standard or 67 mg micronized preparation once daily. If the recommendation for using low doses of the drug is not applicable, TRIKOR® is not allowed. In patients with severe chronic renal failure (creatinine clearance <30 ml/min), the use of fenofibrate is contraindicated. Hepatic Dysfunction Due to a lack of data, the use of TRIKOR® is not recommended in patients with hepatic dysfunction. Children The safety and efficacy of TRIKOR® in children and adolescents under 18 years of age have not been established. Therefore, the use of TRIKOR® 145 mg in children and adolescents under 18 years of age is not recommended. Method and Route of Administration TRIKOR® should be taken at any time of the day, regardless of food intake. The tablet should be swallowed whole, without chewing, with a glass of water. Measures in Case of Overdose There are reports of isolated cases of TRIKOR® overdose. In most cases, overdose symptoms were not observed. Treatment: No specific antidote is known. In case of suspected overdose, symptomatic treatment and necessary supportive therapy should be carried out. Fenofibrate is not removed by hemodialysis. Description of Side Reactions That Develop During Standard Use of the Product and Measures to Be Taken in Such Cases The most frequently reported side reactions during TRIKOR® treatment are digestive disorders, gastrointestinal disorders. Very common - Increased homocysteine levels in the blood Common - Signs and symptoms of gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea, flatulence - Increased transaminase levels Uncommon - Headache - Thromboembolism (deep vein thrombosis, pulmonary embolism) - Pancreatitis - Cholelithiasis - Hypersensitivity skin reactions (e.g., rash, itching, urticaria) - Muscle disorders (e.g., myalgia, myositis, muscle cramps and weakness) - Sexual dysfunction - Increased serum creatinine levels Rare - Decreased hemoglobin levels, decreased leukocyte count - Hypersensitivity (including anaphylactic reaction) - Hepatitis - Alopecia, photosensitivity reactions - Increased blood urea levels Frequency unknown - Interstitial lung disease - Rhabdomyolysis - Jaundice, complications of cholelithiasis (e.g., cholecystitis, cholangitis, biliary colic) - Severe skin reactions (e.g., erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) - Fatigue In case of development of side reactions to the product, contact your healthcare professional, pharmacist, or the drug's adverse reaction reporting database directly, which also includes reporting of drug ineffectiveness. Additional Information Composition of the Medicinal Product One tablet contains: Active substance – micronized fenofibrate 145 mg, Excipients: hypromellose, docusate sodium, sucrose, sodium lauryl sulfate, lactose monohydrate, microcrystalline siliconized cellulose, crospovidone, magnesium stearate. Coating composition: Opadry OY-B-289202 (polyvinyl alcohol, titanium dioxide E171, talc, soy lecithin, xanthan gum). Description of Appearance, Odor, Taste White, oval, film-coated tablets, embossed with "145" on one side and the company logo on the other. Dosage Form and Packaging of the Product 10 tablets are placed in a contour cell package made of polyvinyl chloride film and printed aluminum foil. 3 contour packages, along with the medical use instructions in state and Russian languages, are placed in a cardboard box. Shelf Life 3 years Do not use the product after the expiry date! Storage Conditions Store the product in its original packaging at a temperature not exceeding 25°C. Keep the product out of reach of children! Conditions for Dispensing from Pharmacies Pharmaceutical product group II, dispensed by prescription form №3.
- Active
- fenofibrate
What is it?
TRIKOR® International Nonproprietary Name Fenofibrate Pharmaceutical Form, Dosage Film-coated Tablets, 145 mg Pharmacotherapeutic Group Cardiovascular System. Lipid-modifying agents. Lipid-modifying agents, simple. Fibrates. Fenofibrate. ATC Code: C10AB05 Indications for Use TRIKOR® is indicated as an adjunct to diet and other non-drug measures (e.g., exercise, weight loss) in the following conditions: - For the treatment of severe hypertriglyceridemia, with or without low levels of high-density lipoprotein cholesterol - Mixed hyperlipidemia in cases of contraindication or intolerance to statins - Mixed hyperlipidemia in patients with high cardiovascular risk, in addition to statins, where the correction of triglyceride and high-density lipoprotein cholesterol levels has been insufficient. List of Information Required Before Using the Product Contraindications - Hypersensitivity to the active substance or any of the excipients - Hepatic insufficiency (including biliary cirrhosis and persistent liver dysfunction of unknown etiology) - Severe chronic kidney disease - Known gallbladder disease - Chronic or acute pancreatitis, except for acute pancreatitis caused by severe hypertriglyceridemia - Congenital galactosemia, lactase deficiency, glucose-galactose malabsorption (the product contains lactose) - Congenital fructose intolerance, sucrase-isomaltase deficiency (the product contains sucrose) - Photoallergic or phototoxic reaction caused by treatment with fibrates or ketoprofen - Children and adolescents under 18 years of age - Pregnancy and lactation Additionally, TRIKOR® should not be taken by patients with hypersensitivity to peanuts, peanut butter, soy lecithin, or related products due to the risk of hypersensitivity reactions. Precautions for Use of the Product Secondary Causes of Hyperlipidemia Before starting TRIKOR® therapy, appropriate treatment should be carried out to eliminate the cause of secondary hyperlipidemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological therapy, alcoholism. In patients with hyperlipidemia who are taking estrogens or estrogen-containing contraceptives, it is necessary to determine whether the hyperlipidemia is primary or secondary. Liver Function It is recommended to monitor transaminase levels every 3 months during the first 12 months of treatment and then periodically. Patients with elevated transaminase levels should be monitored, and therapy should be discontinued if AST and ALT levels exceed 3 times the upper limit of normal. If symptoms indicate the development of hepatitis (e.g., jaundice, itching) and the diagnosis is confirmed by laboratory tests, fenofibrate therapy should be discontinued. Pancreas Cases of pancreatitis have been reported in patients taking fenofibrate. This may indicate a lack of efficacy in patients with severe hypertriglyceridemia, a direct effect of the drug, or a secondary phenomenon associated with the presence of gallstones or obstruction of the common bile duct. Muscles Cases of muscle toxicity, including rare cases of rhabdomyolysis, with or without renal failure, have been observed with the use of fibrates and other lipid-lowering agents. The incidence of this disorder increases in cases of hypoalbuminemia and pre-existing renal insufficiency. In patients with predisposing factors for myopathy and/or rhabdomyolysis, including those over 70 years of age, a personal or family history of hereditary muscle diseases, renal insufficiency, hypothyroidism, and alcohol abuse, the risk of developing rhabdomyolysis may increase. The benefit and risk of fenofibrate treatment in such patients should be carefully assessed. Muscle toxicity may develop in patients with diffuse myalgia, myositis, muscle cramps and weakness, and/or significantly elevated CPK levels (more than 5 times the normal level). In such cases, fenofibrate treatment should be discontinued. The risk of muscle toxicity may increase when the drug is taken with another fibrate or HMG-CoA reductase inhibitor, especially in cases of pre-existing muscle disease. Therefore, the concomitant use of fenofibrate with an HMG-CoA reductase inhibitor or another fibrate should only be done in patients with severe mixed dyslipidemia and high cardiovascular risk without a history of muscle disease, and close monitoring for potential muscle toxicity is required. Renal Function Treatment should be discontinued if serum creatinine levels increase by more than 50% compared to the upper limit of the normal range. It is recommended to determine creatinine levels within the first 3 months of treatment and then periodically. Drug Interactions Oral Anticoagulants Fenofibrate enhances the effect of oral anticoagulants and may increase the risk of bleeding. Cyclosporine Close monitoring of renal function is required in patients with renal dysfunction, and fenofibrate treatment should be discontinued in case of significant changes in laboratory parameters. HMG-CoA Reductase Inhibitors and Other Fibrates The risk of severe muscle toxicity increases when fenofibrate is taken concomitantly with HMG-CoA reductase inhibitors or other fibrates. This combination should be used with caution, and patients should be carefully monitored for signs of muscle toxicity. Glitazones Monitoring of HDL cholesterol levels is recommended if one of these components is added to the other, and treatment should be discontinued if HDL cholesterol levels are too low. Cytochrome P450 Enzymes In patients taking TRIKOR® concomitantly with drugs with a narrow therapeutic index metabolized by CYP2C19, CYP2A6, and especially CYP2C9, close monitoring is required, and dose adjustments of these drugs are recommended if necessary. Special Warnings Excipients TRIKOR® contains lactose; therefore, patients with rare hereditary disorders involving galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this product. TRIKOR® contains sucrose; therefore, patients with rare hereditary problems including fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not take this product. Influence on the Ability to Drive or Operate Machinery TRIKOR® has no or negligible influence on the ability to drive and operate machinery. Recommendations for Use of the Product Dosage Regimen Control of Treatment Efficacy The efficacy of treatment should be monitored by determining serum lipid levels. If adequate efficacy is not achieved several months after the start of therapy (e.g., 3 months), additional or different treatment methods should be considered. Adults The recommended dose is one TRIKOR® tablet once daily. Patients taking one capsule of fenofibrate 200 mg (or a 160 mg tablet) can switch to one TRIKOR® tablet 145 mg once daily without further dose adjustment. Elderly Patients For elderly patients without renal insufficiency, the usual adult dose is recommended. Renal Dysfunction Dose reduction is required in patients with renal dysfunction. In cases of mild/moderate chronic kidney disease (creatinine clearance 30-60 ml/min) and when using low doses of the drug, treatment is initiated with one capsule of 100 mg standard or 67 mg micronized preparation once daily. If the recommendation for using low doses of the drug is not applicable, TRIKOR® is not allowed. In patients with severe chronic renal failure (creatinine clearance <30 ml/min), the use of fenofibrate is contraindicated. Hepatic Dysfunction Due to a lack of data, the use of TRIKOR® is not recommended in patients with hepatic dysfunction. Children The safety and efficacy of TRIKOR® in children and adolescents under 18 years of age have not been established. Therefore, the use of TRIKOR® 145 mg in children and adolescents under 18 years of age is not recommended. Method and Route of Administration TRIKOR® should be taken at any time of the day, regardless of food intake. The tablet should be swallowed whole, without chewing, with a glass of water. Measures in Case of Overdose There are reports of isolated cases of TRIKOR® overdose. In most cases, overdose symptoms were not observed. Treatment: No specific antidote is known. In case of suspected overdose, symptomatic treatment and necessary supportive therapy should be carried out. Fenofibrate is not removed by hemodialysis. Description of Side Reactions That Develop During Standard Use of the Product and Measures to Be Taken in Such Cases The most frequently reported side reactions during TRIKOR® treatment are digestive disorders, gastrointestinal disorders. Very common - Increased homocysteine levels in the blood Common - Signs and symptoms of gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea, flatulence - Increased transaminase levels Uncommon - Headache - Thromboembolism (deep vein thrombosis, pulmonary embolism) - Pancreatitis - Cholelithiasis - Hypersensitivity skin reactions (e.g., rash, itching, urticaria) - Muscle disorders (e.g., myalgia, myositis, muscle cramps and weakness) - Sexual dysfunction - Increased serum creatinine levels Rare - Decreased hemoglobin levels, decreased leukocyte count - Hypersensitivity (including anaphylactic reaction) - Hepatitis - Alopecia, photosensitivity reactions - Increased blood urea levels Frequency unknown - Interstitial lung disease - Rhabdomyolysis - Jaundice, complications of cholelithiasis (e.g., cholecystitis, cholangitis, biliary colic) - Severe skin reactions (e.g., erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) - Fatigue In case of development of side reactions to the product, contact your healthcare professional, pharmacist, or the drug's adverse reaction reporting database directly, which also includes reporting of drug ineffectiveness. Additional Information Composition of the Medicinal Product One tablet contains: Active substance – micronized fenofibrate 145 mg, Excipients: hypromellose, docusate sodium, sucrose, sodium lauryl sulfate, lactose monohydrate, microcrystalline siliconized cellulose, crospovidone, magnesium stearate. Coating composition: Opadry OY-B-289202 (polyvinyl alcohol, titanium dioxide E171, talc, soy lecithin, xanthan gum). Description of Appearance, Odor, Taste White, oval, film-coated tablets, embossed with "145" on one side and the company logo on the other. Dosage Form and Packaging of the Product 10 tablets are placed in a contour cell package made of polyvinyl chloride film and printed aluminum foil. 3 contour packages, along with the medical use instructions in state and Russian languages, are placed in a cardboard box. Shelf Life 3 years Do not use the product after the expiry date! Storage Conditions Store the product in its original packaging at a temperature not exceeding 25°C. Keep the product out of reach of children! Conditions for Dispensing from Pharmacies Pharmaceutical product group II, dispensed by prescription form №3.