Fenofibrate Canon 145 mg – [30 tablets]

By activating RAPP-alpha (peroxisome proliferator-activated receptor alpha), fenofibrate enhances lipolysis and excretion of atherogenic triglyceride-rich lipoproteins from plasma by activating lipoprotein lipase and decreasing the synthesis of apoprotein CIII. Activation of RAPP-alpha also leads to increased synthesis of apoproteins AI and AII.

Fenofibrate is a derivative of fibric acid whose ability to change lipid content in humans is mediated by activation of RAPP-alpha. The above described effects of fenofibrate on lipoproteins lead to a decrease in low density lipoprotein (LDL) and very low density lipoprotein (VLDL) fractions, which include apoprotein B, and an increase in high density lipoprotein (HDL) fractions, which include apoproteins AI and AII.

In addition, by correcting disorders of synthesis and catabolism of HDL, fenofibrate increases clearance of LDL and reduces the content of dense and small-sized LDL particles, the increase of which is observed in patients with atherogenic lipid phenotype, a frequent disorder in patients at risk of coronary heart disease. In clinical studies, it was noted that the use of fenofibrate reduces the concentration of total cholesterol by 20 – 25% and triglycerides by 40 – 55% while increasing HDL-cholesterol concentration by 10 – 30%. In patients with hypercholesterolemia in whom LDL-cholesterol concentration decreased by 20 – 35 %, the use of fenofibrate led to a decrease in ratios: “total cholesterol/ HDL-cholesterol”, “LDL-cholesterol/ HDL-cholesterol” and “A by B/A by AI”, which are markers of atherogenic risk.

Given the significant effect on LDL-cholesterol and triglyceride concentrations, the use of fenofibrate is effective in patients with hypercholesterolemia, both accompanied and not accompanied by hypertriglyceridemia, including secondary hyperlipoproteinemia, such as type 2 diabetes. During treatment with fenofibrate, extravascular cholesterol deposits (tendinous and tuberous xanthomas) may significantly decrease or even completely disappear. In patients with elevated levels of fibrinogen treated with fenofibrate, a significant decrease in this indicator was noted, as well as in patients with elevated levels of lipoproteins. Other inflammatory markers, such as C-reactive protein, are also reduced by treatment with fenofibrate.

For patients with dyslipidemia and hyperuricemia an additional benefit is the uricosuric effect of fenofibrate leading to a decrease in uric acid concentration by approximately 25%.

Fenofibrate has been shown to reduce platelet aggregation caused by adenosine diphosphate, arachidonic acid and epinephrine in clinical studies and in animal experiments.

Fenofibrate Canon drug is indicated in combination with diet:

Combination therapy with HMG-CoA reductase inhibitors (statins) of mixed dyslipidemia (type IIa, IIb according to Fredrickson), in order to reduce triglycerides (TG) and increase HDL concentration in patients with CHD or with high risk of CHD (other clinical forms of atherosclerotic disease: peripheral arterial atherosclerosis, abdominal aortic aneurysm, and symptomatic carotid atherosclerosis; diabetes mellitus; multiple risk factors that correspond to a 10-year risk of coronary complications >20%);

in order to reduce the concentration of TG in patients with severe hyperglyceridemia (dyslipidemia type IV, V according to Fredrickson);

in order to decrease high concentration of LDL, total cholesterol, triglycerides and apoB (apolipoprotein B) and increase HDL concentration in patients with primary hyperlipidemia or mixed dyslipidemia (type IIa, IIb, III, IV according to Fredrickson).

The drug is strictly contraindicated in the following cases:

Hypersensitivity to fenofibrate or other components of the drug,

Liver failure (including biliary cirrhosis and persistent liver dysfunction of unclear etiology),

severe renal insufficiency (creatinine clearance < 20 ml/min),

under 18 years of age (efficacy and safety have not been established),

history of photosensitivity or phototoxicity during treatment with fibrates or ketoprofen,

a history of gallbladder disease,

period of breastfeeding,

chronic or acute pancreatitis, except in cases of acute pancreatitis due to severe hypertriglyceridemia.

 

• Tablets should be swallowed whole, without chewing, simultaneously with meals.
• Adults. One tablet once a day. Patients who take one capsule of fenofibrate 200 mg can switch to taking one tablet of the drug Fenofibrate Canon 145 mg without additional dose adjustments. The maximum daily dose is 145 mg.
• Elderly patients. It is recommended to take 1 tablet of 145 mg for adults (one tablet once a day).
• Patients with liver diseases. The use of the drug in patients with liver diseases has not been studied.
• The drug should be taken for a long time, while continuing to follow the diet to which the patient adhered before treatment with Fenofibrate Canon.