Traykor 160 mg film-coated tablets have a higher bioavailability compared with earlier fenofibrate dosage forms. Source fenofibrate in plasma can not be detected. Plazmennm aromisin main metabolite is fenofibric acid.
Suction: maximum plasma concentration is reached after 4-5 hours after ingestion. With prolonged use of the drug concentration in the plasma remains stable. The absorption of fenofibrate is enhanced when taken with food.
Distribution: fenofibric acid binds strongly to plasma albumin (more than 99%).
Half-life: the half-life of fenofibric acid – about 20 hours.
Metabolism and Elimination: the plasma is found only major metabolite of fenofibrate – fenofibric acid. Fenofibrate is not a substrate for aromisin. Do not participate in the microsomal metabolism.
It is shown mainly in the urine in the form of fenofibric acid and the glucuronide conjugate. During the 6 days of fenofibrate appears almost completely. The total clearance of fenofibric acid, determined not altered in elderly patients.
The drug is not cumulated after a single dose and long-term use. When hemodialysis is not deduced.
Hypercholesterolemia and hypertriglyceridemia isolated or mixed in patients for whom diet and other non-drug therapeutic measures (eg weight reduction or increased physical activity) have been ineffective, especially in the presence of dyslipidemia associated with risk factors.
For the treatment of hyperlipoproteinemia secondary drug is used in cases where hyperlipoproteinemia persists despite effective treatment of the underlying disease
* In a clinical study involved only a few patients with dyslipidemia III and V type.
The drug is strictly contraindicated in the following cases:
- Hypersensitivity to the fenofibrate or the other components of the drug
- liver failure (including cirrhosis),
- severe renal insufficiency aromisin
- age of 18 years (effectiveness and safety have been established),
- a history of photosensitivity or phototoxicity during treatment with fibrates or ketoprofen,
- gallbladder disease,
- congenital galactosemia, lactase deficiency, malabsorption of glucose and galactose (a drug contains lactose)
- congenital fruktozemiya, lactase deficiency, malabsorption of glucose and galactose (a preparation containing sucrose)
- allergic to peanuts, peanut oil, soy lecithin or a history of related products (due to the risk of hypersensitivity reaction).
in hepatic and / or renal failure, hypothyroidism; patients who abuse alcohol; older, with a history burdened by hereditary muscular diseases; while receiving oral anticoagulants, aromisin reductase inhibitors .
Pregnancy and lactation
There are limited data on the use of fenofibrate in pregnant women. In animal experiments, a teratogenic effect of fenofibrate was observed. Embryotoxicity was observed when administered during preclinical trials doses toxic to the mother’s body. The potential risk for humans is unknown. Therefore, during pregnancy Traykor tablets 160 mg may be used only after careful evaluation of the risk-benefit ratio.
The drug is contraindicated during breast-feeding (insufficient data on the use of the drug during this period).
Dosing and Administration
Traykora tablets 160 mg should be swallowed whole without chewing, together with the meal.
Adults. By Traykora one tablet of 160 mg once a day. Patients taking one capsule of 200 mg fenofibrate, can go to the reception of 1 tablet aromisin without further dose adjustment.
Elderly patients. It is recommended to take a unit dose for adults.