Index of drugs

The drug is indicated for use as an additive to diet and other non-pharmacological treatments (eg physical exercise, weight loss) in the following cases: treatment of severe hypertriglyceridemia with low levels of high density (HDL) cholesterol or without; mixed hyperlipidemia, if the use of statins is contraindicated or they are not tolerated; mixed hyperlipidemia in patients at high risk of cardiovascular disease, as an adjunct to statin therapy, if the concentration of triglycerides and high density (HDL) cholesterol are not sufficiently controlled.

One capsule contains 200 mg of micronized fenofibrate. The preparation contains lactose.

A lipid-lowering drug, a fibrin derivative. It works by activating alpha-type nuclear receptors (PPARα), which increases lipolysis and elimination of atherogenic triglyceride-rich particles from plasma by activating lipoprotein lipase and decreasing the production of apoprotein CIII. PPARα activation also increases the synthesis of AI and AII apoproteins. The effect of fenofibrate on lipoproteins leads to a reduction of the VLDL and LDL fractions containing apoprotein B, as well as an increase in the HDL fraction containing apoprotein AI and AII. In addition, as a result of modifying the synthesis and breakdown of the VLDL fraction, fenofibrate increases LDL clearance and reduces LDL levels, which are increased in patients at risk of coronary heart disease (atherogenic hyperlipidemia phenotype). Fenofibrate reduces total cholesterol from 20 to 25%, triglycerides from 40 to 50%, and increases HDL cholesterol from 10 to 30%. Absorption of fenofibrate is 35% greater if the medicine is taken with food. Fenofibrate is a pharmacologically inactive drug precursor; in the body it immediately undergoes hydrolysis to fenofibric acid, which is responsible for the action of the drug. Fenofibric acid is 99% bound to plasma proteins. T_0,5 fenofibric acid is about 20 h. About 60% of the administered dose of fenofibrate is excreted in the urine within 2 days in the form of glucuronides; the remainder is excreted with faeces.

Hypersensitivity to fenofibrate or other components of the preparation. Severe hepatic or renal impairment (creatinine clearance <20 ml / min). Symptomatic disorders of the gall bladder (cholelithiasis, cholecystitis). Sensitization to light or phototoxic reactions when using fibrates or ketoprofen. Patients with type I hyperlipoproteinaemia, with increased plasma concentrations of chylomicrons and triglycerides but with normal levels of very low density lipoproteins (VLDL). Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia. Do not use this medicine in children.

Before starting treatment, appropriate treatment of diseases that are the cause of secondary hypercholesterolemia should be implemented, ie: type 2 diabetes, hypothyroidism, nephrotic syndrome, dysproteinemia, liver problems with difficult bile outflow, alcoholism. The dose should be reduced in patients with mild to moderate renal impairment (creatinine clearance <50 ml / min). Fenofibrate should be discontinued if the level of creatinine exceeds the upper limit of normal by 50%; Monitoring of creatinine level during the first 3 months is recommended. Do not give with other medicines from the group of fibrates. Data bank on concomitant use with preparations of the HMG-CoA reductase inhibitors such as Atorvastatin, cerivastatin, fluvastatin, lovastatin, pravastatin, simvastatin. Caution is advised when using the drug in patients with hepatic impairment (due to lack of testing), in patients with impaired renal function (creatinine clearance 20 ml / min - 100 ml / min) and in the elderly. Hepatic impairment may occur during treatment; if they persist, you should decide to change the method of treatment. The drug should be discontinued if aminotransferases are elevated 2-3 times over the normal value and in the case of a 5-fold increase above the norm of creatine kinase activity.Exercise caution in patients with a history of pancreatitis. Use with caution in patients taking anticoagulants. The risk-benefit ratio should be assessed in patients with factors that promote the occurrence of myopathy and / or decay of striated muscles (age> 70 years, individual or familial tendency to muscle diseases, kidney problems, hypothyroidism, alcoholism). Patients with diabetes or hypothyroidism should be constantly under the supervision of a physician. Before starting treatment, it should be noted that the patient does not take hypertriglyceridaemic agents, eg beta-adrenergic blockers, diuretic drugs, thiazides or estrogens. If after 2 months of using the drug at the maximum daily dose does not achieve a satisfactory reduction in triglycerides and cholesterol levels, you should decide to change the method of treatment. In patients with hyperlipidemia taking oestrogens or contraceptives containing estrogens, it should be checked whether the hyperlipidaemia is primary or secondary. The efficacy and safety of use in children have not been fully established. Due to the lactose content, the preparation should not be used in patients with galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

The preparation can be used in pregnancy only after thorough assessment of benefits and risks. Do not use the product during breastfeeding.

Common: digestive, gastrointestinal (intestinal pain, nausea, vomiting, diarrhea, gas) disorders of moderate severity; slight elevation of transaminases. Uncommon: cholelithiasis; rash, pruritus, urticaria, hypersensitivity to light; increase in creatinine and uric acid. Rare: baldness; sclerosis, inflammation, cramps and muscle weakness; decrease in hemoglobin and leucocytes; decreased libido, tiredness, pain and dizziness. Very rare: pancreatitis; hepatitis; allergic reaction to light, may occur in the form of erythema, blebs or bumps on the skin exposed to sunlight or to artificial UV light (tanning lamps), even after many months of use; breakdown of striated muscles; interstitial lung disease. You may also experience: insomnia, back pain, flu-like symptoms, impotence, weight loss, hair loss. At the beginning of treatment, transient decreases in hemoglobin, hematocrit and leucocytes may occur. Thrombocytopenia and agranulocytosis have been very rare.

Orally. Adults: 100 mg of non-micronized fenofibrate per day initially; if the cholesterol and triglyceride levels do not decrease accordingly, after 4-8 weeks the dose can be increased. The maximum daily dose is 200 mg of micronized fenofibrate in a single dose (1 capsule Apo-Feno 200 M). In elderly patients and in renal impairment (creatinine clearance above 20 ml / min, below 100 ml / min), treatment should start at a daily dose of 100 mg. If you miss one or more doses, do not increase the number of capsules you take while taking your Next dose. Take the capsules during the meal, swallow whole with a small amount of liquid.