Fenofibrate tablets 145mg, No. 30

• decrease in the concentration of triglycerides with hyperglyceridemia;

• combination therapy with statins for mixed dyslipidemia in patients with coronary artery disease, vascular atherosclerosis, diabetes mellitus;

• primary hyperlipidemia.

Fenofibrate Canon is taken 145 mg once a day, which is the maximum daily dose. The tablet is swallowed whole during meals.

Fenofibrate tablets should be taken for a long time, following a cholesterol-lowering diet.

The effectiveness of treatment is assessed by the content of blood lipids (usually after 3 months). During the first year of treatment, transaminase activity is monitored every 3 months. If there is an increase in the level of more than 3 times, the drug is canceled.

Treatment is also stopped if there is a toxic effect on the muscles and the level of creatinine phosphokinase is 5 times higher. Concomitant administration with statins is acceptable in severe mixed dyslipidemia and a high risk of cardiovascular disease. In case of renal failure, the elderly and patients with diabetes mellitus, renal function is monitored - determination of creatinine every 2-3 months.

In 1 tablet:

Active substance:

Fenofibrate - 145 mg

Excipients:

Corn starch, silicon dioxide, croscarmellose sodium mannitol, magnesium stearate, povidone, MCC, as auxiliary components.

• hypersensitivity;

• age under 18;

• liver failure;

• severe renal failure;

• gallbladder disease;

• chronic or acute pancreatitis;

• lactation.

With caution: it is prescribed for hypothyroidism, alcohol abuse in old age, if heredity is burdened by muscle diseases.

Composition:

In 1 tablet:

Active substance:

Fenofibrate - 145 mg

Excipients:

Corn starch, silicon dioxide, croscarmellose sodium mannitol, magnesium stearate, povidone, MCC, as auxiliary components.

Release form

Coated tablets

pharmachologic effect

Reduces lipid levels (hypolipidemic).

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Lipid-lowering drug, a derivative of fibric acid. By activating alpha receptors, it enhances the lipolysis of atherogenic lipoproteins. Promotes a decrease in the level of VLDL and LDL and an increase in the fraction of HDL. Reduces the content of triglycerides and cholesterol by 40-55% (to a lesser extent - by 20-25%).

Given these effects, the use of Fenofibrate is indicated in patients with hypercholesterolemia, combined with hypertriglyceridemia (or without it). During treatment, tendon xanthomas (cholesterol deposits) are significantly reduced, increased levels of fibrinogen and C-reactive protein, uric acid concentration are reduced (by 25%). In addition, the active ingredient reduces platelet aggregation and blood sugar levels in diabetes mellitus.

Pharmacokinetics

The preparation in the form of a micronized active substance has a higher bioavailability. Absorption is enhanced when taken with food. Cmax is determined after 4-5 hours. With constant long-term administration, the plasma concentration remains stable. The main metabolite is fenofibric acid, which is detected in plasma. Strongly binds to albumin.

It is excreted by the kidneys and the half-life is 20 hours. It is completely excreted within a week. The drug does not accumulate even with prolonged use.

Indications for use

• decrease in the concentration of triglycerides with hyperglyceridemia;

• combination therapy with statins for mixed dyslipidemia in patients with coronary artery disease, vascular atherosclerosis, diabetes mellitus;

• primary hyperlipidemia.

Contraindications

• hypersensitivity;

• age under 18;

• liver failure;

• severe renal failure;

• gallbladder disease;

• chronic or acute pancreatitis;

• lactation.

With caution: it is prescribed for hypothyroidism, alcohol abuse in old age, if heredity is burdened by muscle diseases.

Side effects

• nausea, loss of appetite, heaviness and pain in the epigastrium;

• decrease in hemoglobin;

• hair loss;

• leukopenia;

• increased transaminases;

• myositis and the possibility of rhabdomyolysis (with impaired renal function).

Method of administration and dosage:

Fenofibrate Canon is taken 145 mg once a day, which is the maximum daily dose. The tablet is swallowed whole during meals.

Fenofibrate tablets should be taken for a long time, following a cholesterol-lowering diet.

The effectiveness of treatment is assessed by the content of blood lipids (usually after 3 months). During the first year of treatment, transaminase activity is monitored every 3 months. If there is an increase in the level of more than 3 times, the drug is canceled.

Treatment is also stopped if there is a toxic effect on the muscles and the level of creatinine phosphokinase is 5 times higher. Concomitant administration with statins is acceptable in severe mixed dyslipidemia and a high risk of cardiovascular disease. In case of renal failure, the elderly and patients with diabetes mellitus, renal function is monitored - determination of creatinine every 2-3 months.

Overdose

Overdose cases are not known.

The antidote is unknown.

Hemodialysis is ineffective. In case of an overdose, symptomatic treatment is carried out.

Interaction

Strengthens the effect of anticoagulants - there is a risk of bleeding. It is recommended to reduce the dose of anticoagulants.

The combination with MAO inhibitors and cyclosporine may impair renal function. Cholestyramine reduces absorption. When taken with other fibrates and statins, there is a risk of muscle toxicity.

Storage conditions

Store at temperatures up to 25 ? C. Out of the reach of children.

Shelf life

2 years.

Terms of sale

On prescription.