Traykor tab n / 145mg film about 30 pc

Description

Composition
Active substance:
1 tablet contains: 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; microcrystalline cellulose – 84.28 mg; colloidal silicon dioxide – 1.72 mg; Hypromellose – 29.0 mg; sodium docusate – 2.9 mg; Magnesium stearate – 0.9 mg.
Sheath: Opadri® OY-B-28920 [polyvinyl alcohol – 11.43 mg; titanium dioxide – 8.03 mg; talc – 5.02 mg; soy lecithin – 0.50 mg; xanthan gum – 0.12 mg] – 25.1 mg.
Description:
Oblong film-coated tablet White, labeled “145” on one side and a logo on the other side of the tablet.
Product form:
Film-coated tablet 145 mg.
10 tablets in PVC / PE / PVDC / Al blister. 1, 2, 3, 5, 9, 10 in the blister cardboard pack together with instructions for use.
14 tablets in PVC / PE / PVDC / Al blister. 2, 6, 7 of blisters in a pack carton along with instructions for use.
10 tablets in PVC / PE / PVDC / Al blister. 28, 30 blisters in cardboard boxes (packaging for hospitals).
Contraindications
Hypersensitivity to fenofibrate or other components of the drug; severe liver – class C Child-Pugh (including biliary cirrhosis and persistent abnormal liver function of unknown etiology); moderate and severe renal impairment (creatinine clearance less than 60 mL / min for a given dosage of the drug); age 18 years (effectiveness and safety have been established); a history of photosensitivity or phototoxicity in the treatment of fibrates or ketoprofen; gallbladder disease history; breastfeeding; congenital galactosemia, lactase deficiency, malabsorption of glucose and galactose (formulation contains lactose); congenital fruktozemiya, sucrase-isomaltase deficiency (preparation contains sucrose); Patients with allergy to peanut, peanut oil, soybean lecithin or a history of related products (due to the risk of hypersensitivity reactions); Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia.
Carefully
In patients with predisposing factors for myopathy and / or rhabdomyolysis, including age above 70 years, weighed down by a history of hereditary muscle disease, hypothyroidism and alcohol abuse (see “Special Instructions” section). use during pregnancy; while receiving oral anticoagulants, inhibitors of HMG-CoA reductase (see. See “The interaction with other drugs”).
Dosage
145 mg
Indications
Hypercholesterolemia and hypertriglyceridemia isolated or mixed (dyslipidemia type IIa, IIb, III, IV, V classification Fredrickson) in patients for whom diet or other non-therapeutic activities (e.g., reduction in body weight or increase in physical activity) were ineffective, especially in the presence of dyslipidemia associated with risk factors such as hypertension and smoking.
For the treatment of hyperlipoproteinemia secondary drug is used in cases when hyperlipoproteinaemia persists despite effective treatment of the underlying disease (e.g., dyslipidemia, diabetes).
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 is recommended for the control of the INR (international normalized ratio).
cyclosporine
It describes several severe cases of reversible renal impairment during simultaneous treatment with fenofibrate and cyclosporin. Therefore it is necessary to carefully monitor the state 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. Such combination therapy should be undertaken with caution and carefully monitor the condition of patients for signs of toxic effects on muscle tissue. (See. “Special Instructions” section).
Thiazolidinedione derivatives (glitazones)
With simultaneous use of fenofibrate and glitazones reported a few cases of reversible paradoxical decrease in the concentration of HDL cholesterol.
It is therefore recommended control HDL cholesterol concentration and cholesterol concentration in the case of significant decrease in HDL formulations cancel during concurrent therapy.
Cytochrome P450 isozymes
microsomes in vitro studies of human liver have shown that fenofibrate and fenofibric acid are not inhibitors of the following isozymes of cytochrome
P450 (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.
Patients applying fenofibrate together with drugs, metabolized isozymes CYP2C19, CYP2A6 and CYP2C9 in particular with a narrow therapeutic index should be monitored carefully, and it is recommended to adjust the dose of these preparations, if necessary.
Overdose
There are only a few reports of overdose. In most cases, the symptoms of overdose have been reported. A specific antidote is not known. In case of suspected overdose should designate symptomatic and, if necessary, maintenance treatment. Hemodialysis is ineffective.
pharmachologic effect
Pharmacological group:
Lipid-lowering agents – fibrate.
Pharmacodynamics:
Activating PPAR-alpha (alpha receptors, peroxisome proliferator-activated), fenofibrate enhances lipolysis and clearance from the plasma atherogenic lipoprotein concentrations with high triglyceride levels by activating lipoprotein lipase and apolipoprotein CIII reducing the synthesis. Activation of PPAR-alpha also results in increased synthesis of apoprotein AI and AII.
Fenofibrate is a fibric acid derivative, wherein the ability to change the concentration of lipids in humans is mediated by activation of PPAR alpha.
The above-described effects fenofibrate on lipoproteins lead to a decrease in the concentration of lipoprotein fraction (LDL) and very low density lipoproteins (VLDL), which include the apoprotein B, and increasing the fraction of high density lipoprotein cholesterol concentration (HDL), which include apoproteins AI and AII .
Furthermore, by correcting the disturbances synthesis and catabolism of VLDL fenofibrate increases the LDL clearance, and reduces the concentration of dense and small particle size
LDL, 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%, the use of fenofibrate reduction ratio “total cholesterol / HDL-cholesterol”, “LDL-cholesterol / HDL-cholesterol” and “Apo B / Apo AI “are markers of atherogenic risk.
Considering the influence on the concentration of fenofibrate in LDL-cholesterol and triglycerides, use of the 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 and even disappear completely extravascular deposition of cholesterol (tendon and tuberous xanthomas) .u patients with high concentrations of fibrinogen treated with fenofibrate, a marked reduction of the indicator, as well as in patients with high concentrations 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:
Traykor 145 mg film-coated tablets containing 145 mg of micronized fenofibrate nanoparticle.
Source fenofibrate plasma can not be detected. The major plasma metabolite is fenofibric acid.
Absorption: Maximum plasma concentration is achieved 2-4 hours after ingestion. With prolonged use of the drug concentration in the blood plasma remains stable regardless of the individual patient.
Unlike previous fenofibrate formulations, the maximum concentration in plasma and the overall effect of fenofibrate nanoparticle does not depend on the time of food intake. Therefore Traykor 145 mg can be taken at any time regardless of the meal.
Distribution: fenofibric acid binds strongly to albumin in blood plasma (99%).
The half-life: the half-life of fenofibric acid – about 20 hours.
Metabolism and excretion: After oral administration, fenofibrate is rapidly hydrolyzed by esterases. The blood plasma is found only the main active metabolite of fenofibrate – fenofibric acid. Fenofibrate is not a substrate for CYP3A4 isoenzyme and is not involved in the microsomal metabolism.
Write 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 defined in elderly patients who do not change.
The drug does not accumulates after a single dose and long-term use.
When hemodialysis is not displayed.
Pregnancy and breast-feeding
fertility
Clinical data on the effect of the drug on fertility in men or women available, but animal studies have shown reversible effects on fertility Traykor drug.
Pregnancy
No sufficient data on the use of fenofibrate pregnant. 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, to use the drug during pregnancy only after careful assessment of the expected benefit ratio for the possible risk.
Breastfeeding
Insufficient information about the excretion of fenofibrate and / or its metabolites in breast milk. It is impossible to eliminate the risk to infants. Do not apply the drug during breast-feeding. If necessary, use during lactation, breast-feeding should be discontinued.
Conditions of supply of pharmacies
Prescription.
side effects
During the placebo-controlled clinical studies were observed following undesirable effects are classified as follows: very common (> 1/10), common (> 1/100,
special instructions
Before treatment drug Traykor 145 mg, 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.
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, increasing the lipid concentration may be caused by intake of estrogens.
Liver function: When receiving Traykor drug 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. It is recommended to control the activity of transaminase (alanine aminotransferase (ALT), aspartate aminotransferase (AST)) every 3 months during the first 12 months and periodically during the further treatment.
Patients on background therapy increased activity “liver” transaminases require attention and in the case of increasing the activity of ALT and AST is more than 3-fold compared with the upper limit of normal stop taking the drug. When the symptoms of hepatitis (jaundice, itchy skin) should be carried out laboratory tests and, in the case of confirmation of the diagnosis of hepatitis, stop the drug Traykor.
Pancreatitis: cases of pancreatitis have been described during treatment with
Traykor. Possible causes for pancreatitis in these instances were inadequate efficacy in patients with severe hypertriglyceridemia, direct effects of the drug, as well as secondary phenomena associated with the presence or formation of a precipitate stones in the bile ducts involving obstruction of common bile duct.
Muscles: Traykor When receiving the drug and other drugs that reduce the concentration of lipids described cases toxic effect on muscle tissue, with or without renal failure, including very rare cases of rhabdomyolysis. The frequency of such disorders is increased in the case of hypoalbuminemia and renal insufficiency history.
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 145 mg Traykor must stop.
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 muscle diseases, hypothyroidism, alcohol abuse.
Such patients should be prescribed only if the expected benefits outweigh the potential risk of rhabdomyolysis.
Before the drug Traykor 145 mg simultaneously with inhibitors of HMG-CoA reductase inhibitors or fibrates other increases the risk of serious toxic effects on muscle fiber, especially if the patient had prior to treatment of muscle disease.
In this regard, the co-administration of the drug Traykor 145 mg and of statin is permissible only if the patient has severe mixed dyslipidaemia and high cardiovascular risk, without a history of muscle diseases and conditions scrutiny, aiming at identification of signs of toxic effects on muscle the cloth.
Renal function: If increasing concentration of creatinine more than 50% above the upper limit of normal treatment should be stopped. It is recommended to determine the concentration of creatinine in the first 3 months and periodically during the further treatment.
Effects on ability to drive vehicles and other mechanisms
Traykor 145 mg does not affect or minimally affects the ability to drive the vehicle and management mechanisms (risk of dizziness).
Storage conditions
In a dry place at a temperature not higher than 25 ° C in their original packaging.
Keep out of the reach of children!.
Dosing and Administration
It is necessary to continue to observe hypocholesterolemic diet, which adhered to the patient prior to treatment with 145 mg Traykor.
Traykor 145 mg Tablets should be swallowed whole, not chewed with water.
Traykor 145 mg can be administered at any time of the day regardless of mealtime.
Adults. For one drug tablet Traykor 145 mg once a day.
Patients taking one capsule of micronized fenofibrate or 200 mg one tablet 160 mg of micronized fenofibrate (Traykor possible to use the drug in a dose of 160 mg) daily, can go to the reception of the preparation of 1 tablet
Traykor 145 mg dose without further corrections.
Elderly patients without renal failure. It advised to take the standard dose for adults (1 tablet per day).
Efficacy of therapy should be evaluated on the concentrations of lipids (total cholesterol, LDL cholesterol, triglyceride) 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 impaired liver function
Due to insufficient amount of the accumulated data on the drug administration
Traykor in patients with impaired hepatic function, it is not possible to make recommendations on the use of the drug in these patients.
Patients with impaired renal function
Patients with mild chronic renal failure (creatinine clearance greater than 60 mL / min) a dose adjustment is required.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist