Lipantil of 200 M

General characteristics. Structure:

Active agent: фенофибрат micronized 200 mg

Excipients: sodium lauryl sulfate; lactose; starch prezhelatinizirovanny; кросповидон; magnesium stearate; titanium dioxide; ferrous oxide; gelatin.

Pharmacological properties:

Pharmacodynamics. Lowers the level of triglycerides and, to a lesser extent — cholesterol in blood. Promotes reduction of maintenance of LPONP, to a lesser extent — LPNP, to increase in maintenance of anti-atherogenous LPVP. Activates lipoproteinlipase and, thereby, influences exchange of triglycerides; breaks synthesis of fatty acids and cholesterol, promotes increase in number of LPNP-receptors in a liver. Fenofibrat reduces aggregation of thrombocytes, reduces the increased fibrinogen level in plasma, can lower several glucose level in blood at patients with a diabetes mellitus, reduces the level of uric acid in blood.

Pharmacokinetics. The main metabolite is fenofibroyevy acid. After administration of drug in Cmax in plasma it is reached in 5 h. At reception in a dose of 200 mg average concentration in plasma makes 15 mkg/ml. Level of concentration of drug in plasma is steady. T1/2 of fenofibroyevy acid is about 20 h. It is removed generally with urine (fenofibroyevy acid and its glucuronide) in 6 days. Does not kumulirut at reception of a single dose and long use. Fenofibroyevy acid is not removed at a hemodialysis.

Clinical pharmacology. Lowers the general cholesterol of blood by 20–25%, blood triglycerides — for 40–45% and a lithemia — for 25%. At long effective therapy extravascular deposits of cholesterol decrease.

Indications to use:

Hypercholesterolemia (IIA type), endogenous gipertriglitseridemiya (types: IIb, III (isolated and mixed), IV), not giving in corrections by a diet at adults.

Route of administration and doses:

Inside, together with food. The recommended dosage (if the doctor did not appoint differently) — on 1 капс. in day. The course of treatment is defined by the doctor.

Features of use:

There are messages on influence of fibrat on muscular tissue, including exceptional cases of their necrosis. These processes happen at the reduced level of albumine of a blood plasma more often. The specified influence needs to be considered at all patients with a diffusion mialgiya, with morbidity of muscles and at substantial increase of level of a kreatinfosfokinaza (norms are 5 times higher). In these cases treatment should be stopped.

Besides, the risk of injury of muscles can be increased if drug is appointed with GMG-KOA-reduktazy inhibitors.

Because of availability of lactose drug is contraindicated at an inborn galactosemia, at a sprue of glucose and a galactose or at deficit of lactase.

If at use of drug within 3–6 months satisfactory decrease in lipids in blood serum was not received, other therapeutic approach has to be provided.

Systematic control of level of hepatic transaminases in blood serum within the first 12 months of treatment is necessary each 3 months. If the level of nuclear heating plant and ALT is increased more than by 3 times in comparison with VGN, it is necessary to stop treatment.

At a combination to indirect anticoagulants careful control of indicators of coagulant system of blood is necessary.

Side effects:

Diffusion mialgiya, morbidity of muscles, weakness, and also (in rare instances) — рабдомиолиз, sometimes — heavy. At the treatment termination these phenomena are, as a rule, reversible.

From a GIT: dyspepsia. The increased level of activity of hepatic transaminases in blood serum.

Allergic reactions: seldom — skin rashes, an itch, urticaria, a photosensitization. In certain cases (after several months of use) development of reaction of photosensitivity in the form of an erythema, papules, bubbles or eczematic rashes is possible.

Interaction with other medicines:

Combinations which are contraindicated: with other fibrata — the increased risk of side effects (damage of muscles).

Undesirable combinations: with GMG-KOA-reduktazy inhibitors — the increased risk of side effects (damage of muscles).

Combinations which should be used with care — with indirect anticoagulants (risk of development of bleeding). More frequent control of PV during selection of a dose of indirect anticoagulant is necessary during treatment of a fibratama and within 8 days after their cancellation.

Fenofibrat is not applied along with MAO inhibitors.

Contraindications:

The expressed abnormal liver functions and kidneys, existence in the anamnesis of phototoxic or photoallergic reactions at treatment of a fenofibratama or other drugs, especially ketoprofen, similar on structure, a combination to other fibrata, children's age up to 18 years, pregnancy, the lactation period, an inborn galactosemia, deficit of lactase.

Use at pregnancy and feeding by a breast
Contraindicated at pregnancy. For the period of treatment it is necessary to stop breastfeeding.

Overdose:

Treatment: symptomatic therapy.

Storage conditions:

In the dry place, at a temperature of 15-25 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

In the blister of 10 pieces; in a pack cardboard 3 blisters.