Fenofibrate tab n / 145mg film about 30 pc

Description

Composition
Active substance:
1 tablet contains: 145 mg of fenofibrate.
Excipients:
Corn starch 137 mg colloidal silica 10 mg Sodium croscarmellose 33 mg Mannitol 170 mg Magnesium stearate 6 mg Povidone K-30 44 mg Microcrystalline cellulose 105 mg; film coating: Opadry II White 20 mg, including 9,38 mg polyvinyl alcohol, macrogol (polyethylene glycol 4000) 4.72 mg talc 3.48 mg titanium dioxide 2.42 mg.
Description:
Oval, biconvex tablets, film-coated white or almost white. The cross-sectional view – almost white color.
Product form:
Tablets, film-coated, 145 mg.
At 7, 10, 14 or 15 tablets in blisters of PVC film or PVC film / PVDC or PVC film / aluminum foil and PVTFE printed patent ..
At 4, 12, 14, the contour of cellular packages of 7 tablets or 1, 2, 3, 5, 6, 9, 10 contour cell packs of 10 tablets, or 2, 6, 7 contour cell packs of 14 tablets or 2, 4, 6 contour cell packs of 15 tablets together with instructions for use placed in a pile of cardboard.
Contraindications
Preparation strictly contraindicated in the following cases: Hypersensitivity to fenofibrate or other components of drug, liver failure (including biliary cirrhosis and persistent abnormal liver function of unknown etiology), severe renal failure (creatinine clearance
Carefully
In hypothyroidism; patients who abuse alcohol; patients with impaired renal function (creatinine clearance of more than 20 ml / min); elderly, burdened with a history of hereditary muscular disorders; while receiving oral anticoagulants, inhibitors of HMG-CoA reductase (see. See “The interaction with other drugs”).
Dosage
145 mg
Indications
The drug fenofibrate Canon shown in conjunction with a diet:
Combination therapy with HMG-CoA reductase inhibitors (statins) mixed dyslipidemia (type IIa, IIb according to Fredrickson), to reduce triglyceride (TG) and increase the concentration of HDL in patients with coronary heart disease or at high risk of coronary artery disease (other clinical forms of atherosclerotic disease: peripheral arterial disease, abdominal aortic aneurysm and symptomatic carotid atherosclerosis, diabetes, multiple risk factors that correspond to the 10-year risk of coronary events> 20%);
in order to reduce the concentration of triglycerides in patients with severe hypertriglyceridemia (dyslipidemia IV, V type according to Fredrickson);
to reduce the elevated LDL, total cholesterol, triglycerides and apolipoprotein (apolipoprotein B) and increasing the concentration of HDL in patients with primary hyperlipidemia or mixed dyslipidemia (type IIa, IIb, III, IV according to Fredrickson).
Overdose
Overdose cases are not described. A specific antidote is not known. In case of suspected overdose should designate symptomatic and, if necessary, maintenance treatment.
Hemodialysis is ineffective.
Interaction with other drugs
oral anticoagulants
Fenofibrate enhances oral anticoagulant effect and may increase the risk of bleeding, which is associated with the displacement of the anticoagulant from the binding sites to plasma proteins.
Early treatment with fenofibrate is advisable to reduce the dose of anticoagulants approximately one third followed by gradual titration. dose selection recommended by MHO level control (international normalized ratio).
cyclosporine
It describes several severe cases of reversible decrease in renal function during simultaneous treatment with fenofibrate and cyclosporin. It is therefore necessary to monitor the status of renal function in these patients, and to cancel the fenofibrate in the event of a serious change in laboratory parameters.
HMG-CoA reductase inhibitors (statins) and other fibrates
When receiving fenofibrate simultaneously with inhibitors of HMG-CoA reductase inhibitors or fibrates other increases the risk of serious toxic effects on muscle fibers (see. The section “Special instructions”).
Isozymes of cytochrome P450
microsomes in vitro studies of human liver have shown that fenofibrate and fenofibric acid are not inhibitors of the following cytochrome P450 isoenzymes (CYP3A4, CYP2D6, CYP2E1, or CYP1A2). At therapeutic concentrations of these compounds are weak inhibitors of CYP2C19 isozyme, and CYP2A6 and weak or moderate inhibitors of CYP2C9.
pharmachologic effect
Pharmacological group:
Lipid-lowering agents – fibrate.
Pharmacodynamics:
Activating PPAR-alpha (alpha receptors, peroxisome proliferator-activated), fenofibrate enhances lipolysis and clearance from plasma atherogenic lipoprotein with a high content of triglycerides by lipoprotein lipase activation and reduce apoproteins synthesis CIII. Activation of PPAR-alpha also results in increased synthesis of apoprotein AI and AII.
Fenofibrate is a fibric acid derivative, wherein the ability to alter the lipid content of the human body, is mediated by activation of PPAR alpha. The above-described effects fenofibrate on lipoproteins lead to a decrease in the fraction content lipoprotein (LDL) and very low density lipoproteins (VLDL), which include apoprotein B, and increasing the fraction of high density lipoprotein cholesterol content (HDL), which include apoproteins AI and AII .
In addition, due to the correction of violations of the synthesis and catabolism of VLDL, fenofibrate increases the LDL clearance and reduces the amount of dense and small LDL particles, which increase is observed in patients with atherogenic lipid phenotype, a frequent disorder in patients at risk for coronary heart disease. During clinical studies it was noted that the use of fenofibrate reduces the concentration of total cholesterol by 20 – 25% and triglycerides by 40 – 55% with increasing concentrations of HDL-cholesterol by 10 – 30%. In patients with hypercholesterolemia, in which the LDL-cholesterol concentration decreased by 20 – 35% use fenofibrate reduction ratio “total cholesterol / HDL-cholesterol”, “LDL-cholesterol / HDL-cholesterol” and “A with respect to B / A of AI “, which are markers of atherogenic risk.
Given the significant effect of the concentration of LDL-cholesterol and triglycerides, fenofibrate drug effective in patients with hypercholesterolemia as accompanied and not accompanied by hypertriglyceridemia, hyperlipoproteinemia including secondary, such as type 2 diabetes. During treatment with fenofibrate can be significantly reduced or even disappear entirely extravascular deposits of cholesterol (tendinous and tuberous xanthoma). In patients with elevated levels of fibrinogen, received treatment with fenofibrate, a marked decrease in this indicator, as well as in patients with elevated levels of lipoproteins. Other markers of inflammation such as C-reactive protein is also reduced when the treatment with fenofibrate.
For patients with dyslipidemia and hyperuricemia additional advantage is fenofibrate uricosuric effect, resulting in a reduction of uric acid concentration is approximately 25%.
During clinical studies and animal experiments have shown that fenofibrate reduces platelet aggregation induced by adenosine diphosphate, arachidonic acid and epinephrine.
Pharmacokinetics:
Canon Fenofibrate 145 mg film-coated tablets containing 145 mg of micronized fenofibrate.
Canon drug fenofibrate in micronized fenofibrate has a higher bioavailability.
Source fenofibrate plasma can not be detected. The major plasma metabolite is fenofibric acid.
Absorption: maximum plasma concentration (Cmax) is achieved within 4-5 hours after ingestion. With prolonged use of the drug concentration in the blood plasma remains stable. Absorption of fenofibrate increases at the same time taking with food.
Distribution: fenofibric acid binds strongly to albumin in blood plasma (99%).
The half-life: the half-life of fenofibric acid (T1 / 2) – about 20 hours.
Metabolism and Elimination: the plasma is detected only major metabolite of fenofibrate – fenofibric acid. Fenofibrate is not a substrate for CYP3A4 isoenzyme. Does not participate in the microsomal metabolism.
Derived mainly kidneys in the form of fenofibric acid and glucuronide conjugate. During the 6 days of fenofibrate is derived almost entirely. Total clearance of fenofibric acid is determined is not changed in elderly patients.
The drug is not cumulated after a single dose and long-term use. When hemodialysis is not displayed.
Pregnancy and breast-feeding
There are few data on the use of fenofibrate in pregnant women. In animal experiments teratogenic effect of fenofibrate was observed. Embryotoxicity was observed when administered in preclinical trials doses toxic to the mother’s body. The potential risk for humans is unknown. Therefore, during pregnancy, the drug fenofibrate Canon can only be applied after careful assessment of the risk-benefit ratio.
Fenofibrate Canon drug contraindicated during breastfeeding (insufficient data on the use of the drug during this period).
Conditions of supply of pharmacies
Prescription.
side effects
Adverse effects to the therapeutic dose given to the distribution of the frequency and system-organ class classification according to WHO: very often> 1/10 assignments (> 10%) often by> 1/100 to 1%, and
special instructions
Before treatment drug fenofibrate Canon should conduct an appropriate treatment to eliminate the cause of secondary hypercholesterolaemia, e.g., in diseases such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, Dysproteinemia, obstructive liver disease, the effects of drug therapy, alcoholism.
The effectiveness of therapy should be evaluated for lipid content (total cholesterol, LDL, triglycerides) in the blood serum. In the absence of a therapeutic effect after a few months of therapy (usually after 3 months) should consider whether or alternative destination concomitant therapy.
Patients with hyperlipidemia, taking estrogen or hormonal contraceptives containing estrogen, it is necessary to find out whether hyperlipidemia primary or secondary nature. In such cases, an increase of lipid levels may be due to estrogen.
Liver function: when receiving fenofibrate and other drugs that reduce the concentration of lipids in some patients described increase in “liver” transaminases. In most cases, this increase was temporary, minor and asymptomatic. During the first 12 months of treatment to monitor the activity of transaminase (alanine aminotransferase (ALT), aspartate aminotransferase (ACT)) every 3 months. Patients on background therapy increased transaminase concentrations require attention and in the case of increasing the concentration of ALT and ACT more than 3-fold compared with the upper limit of normal stop taking the drug.
Pancreatitis: cases have been described of pancreatitis during treatment with fenofibrate. Possible causes of pancreatitis in these cases were: a lack of efficacy in patients with severe hypertriglyceridemia, a direct effect of the drug, as well as the secondary effects associated with the presence of stones or sludge formation in the gall bladder, accompanied by obstruction of the common bile duct.
Muscles: when receiving fenofibrate and other drugs that reduce the concentration of lipids described cases toxic effect on muscle tissue, including very rare cases of rhabdomyolysis. The frequency of such disorders is increased in the case of hypoalbuminemia and renal insufficiency history. The possibility of this complication increases in cases of hypoalbuminaemia and renal failure.
The toxic effect on muscle tissue may be suspected on the basis of patient complaints of weakness, diffuse myalgia, myositis, muscle spasms and cramps and / or enhance the activity of the expressed creatinine phosphokinase (CPK) (more than 5 times compared with the upper limit of normal). In these cases, treatment with fenofibrate should be stopped.
The risk of rhabdomyolysis may be increased in patients with a predisposition to myopathy and / or rhabdomyolysis, including age above 70 years, weighed down by a history of hereditary muscular disorders, renal failure, hypothyroidism, alcohol abuse. Such patients should be prescribed only if the expected benefits outweigh the potential risk of rhabdomyolysis. Before the drug fenofibrate Canon concurrently with HMG-CoA reductase inhibitors or other fibrates increased risk of serious toxic effects on muscle fibers especially if the patient prior to treatment suffered muscle disease. In this regard, the co-administration of the drug fenofibrate Canon and a statin is permissible only if the patient has severe mixed dyslipidemia and high cardiovascular risk, in the absence of muscle disease in history and in the conditions of close monitoring aimed at identifying signs of toxic effects on muscle tissue .
Renal function: Using the drug fenofibrate Canon as monotherapy or in combination with statins, patients noted a reversible increase in creatinine concentration in the serum. Increased creatinine concentration, overall, was stable over time with no signs of a further increase in creatinine concentration in the serum during prolonged therapy with a tendency to return to their initial values ​​after treatment discontinuation. The clinical significance of these observations is not established. In patients with renal failure while taking the drug fenofibrate Canon advisable to check kidney function. Monitoring of renal function should be carried out in patients at risk of renal failure, namely elderly patients and patients with diabetes mellitus. Treatment should be reversed in case of an increase in creatinine concentration> 50% of the upper limit of normal. It is recommended to determine the concentration of creatinine in the first 3 months after initiation of treatment and periodically thereafter.
Impact on the ability to drive a car and other mechanisms
In applying the drug was not observed effect on the ability to drive a car and other mechanisms.
Storage conditions
In a dry, dark place at a temperature not higher than 25 C. Keep out of reach of children.
Dosing and Administration
The tablets should be swallowed whole without chewing, together with the meal.
Adults. One tablet once a day. Patients taking one capsule 200 mg fenofibrate, can go to the reception of one tablet Canon formulation Fenofibrate 145 mg dose without further corrections. The maximum daily dose of 145 mg.
Elderly patients. It is recommended to take 1 tablet of 145 mg for adults (one tablet once per day).
Patients with liver disease. Use of the drug in patients with liver disease has not been studied.
The drug should be taken for a long time, while continuing to follow a diet that is adhered to the patient prior to treatment with fenofibrate Canon.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist