Traicor (fenofibrate) coated tablets 145 mg. №20

Description

Traicor (fenofibrate) coated tablets 145 mg. №20

Composition

active substance: fenofibrate;

1 tablet contains 145 mg of fenofibrate;

Excipients: hypromellose, docusate sodium, sucrose, sodium lauryl sulfate, lactose monohydrate, microcrystalline silicate cellulose, crospovidone, magnesium stearate, Opadry OY-B-28920 (polyvinyl alcohol, titanium dioxide (E 171), talc, soy lecithin, xanthan gum).

Dosage form

Film-coated tablets.

Main physical and chemical properties: white, oval, film-coated tablets marked “145” on one side and the Fournier logo on the other.

Pharmacotherapeutic group

Hypolipidemic drugs. Drugs that lower serum cholesterol and triglycerides. Fibrates.
ATX code C10A B05.

Pharmacological properties

This is a hypolipidemic (reducing the concentration of certain lipid fractions in the blood) agent. The action of the drug is due to the activation of PPARα receptors. This leads to an increase in the intensity of lipolysis, elimination of triglyceride-rich particles from the plasma, and stimulation of the synthesis of apoproteins. As a result, the fraction of very low and low density lipoproteins containing apoprotein B decreases, the amount of which is increased in individuals with a risk of coronary heart disease. In addition, it helps to increase the high density lipoprotein fraction.

Indications

Traicor is used for combination or monotherapy in patients who do not respond to non-drug measures (adherence to a special diet, increased physical activity):

• with hypercholesterolemia (high blood cholesterol);
• with hypertriglyceridemia (an increased level of triglycerides in the blood).

Contraindications

Traicor is contraindicated:

• with intolerance to the components of the drug;
• with severe liver dysfunction (Child-Pugh class C, including biliary cirrhosis, persistent liver dysfunction of unknown etiology);
• with severe / moderate impaired renal function (with a creatinine clearance rate below 60 ml / minute);
• with photosensitization, phototoxicity during treatment with fibrates and ketoprofen in history;
• with a history of gallbladder diseases;
• with chronic or acute pancreatitis, with the exception of cases of acute pancreatitis caused by severe
• hypertriglyceridemia;
• during breastfeeding;
• under 18 years old.

Carefully:

• with a predisposition to the development of myopathy and / or rhabdomyolysis, incl. age over 70;
• with a burdened history of hereditary muscle diseases;
• with hypothyroidism;
• with alcohol abuse;
• during pregnancy;
• while taking oral anticoagulants, HMG-CoA reductase inhibitors.

Application during pregnancy and lactation

Animal studies have not shown teratogenic effects. Embryotoxic effects have been observed with doses that are toxic to the mother. In this regard, the drug can be used in pregnant women only as directed by a doctor after assessing the benefits and risks.
The drug is not prescribed for nursing mothers.

Method of application and dosage

Tricor can be taken at any time during the day, regardless of meals. The tablets should be swallowed whole with a glass of water.

Diet therapy started before prescribing the drug should be continued.

In the treatment of hyperlipidemia, the effectiveness of treatment should be monitored by determining serum lipid levels. If after a few months (for example after 3 months) an adequate response to treatment is not achieved, additional or other therapeutic measures should be considered.

The recommended dose is 1 tablet containing 145 mg of fenofibrate, once a day. Patients taking 1 capsule containing 200 mg of fenofibrate or 1 tablet containing 160 mg of fenofibrate can be replaced by 1 tablet of Tricor without additional dose adjustment.

If a patient needs to use fenofibrate in two indications (hyperlipidemia and diabetic retinopathy), only one tablet of Tricor should be taken per day.

Overdose

Not described.
If an overdose is suspected, symptomatic and supportive treatment is prescribed.

Side effects:

• Cardiovascular disorders: venous thromboembolism (deep vein, pulmonary embolism).
• Respiratory disorders: the development of interstitial pneumonia.
• Neurological disorders: headache (cephalalgia).
• Gastrointestinal disorders: nausea, abdominal pain, vomiting, diarrhea, pancreatitis, bloating.
• Hematological disorders: a decrease in the level of leukocytes, hemoglobin.
• Dermatological disorders: exanthema, urticaria, alopecia, pruritus, photosensitivity, photosensitivity of the skin with erythema, the appearance of nodules, vesicles on the skin.
• Hepatobiliary disorders: increased levels of transaminases in the blood, the formation of stones in the gallbladder, hepatitis, jaundice.
• Musculoskeletal disorders: muscle cramps, diffuse myalgia, myositis, rhabdomyolysis, muscle weakness.
• Changes in laboratory tests: hypercreatininemia, increased blood urea levels.
• Others: sexual dysfunction.