Гинепристон®

General characteristics. Structure:

Active agent: Mifepristone - 10 mg; Excipients Cellulose microcrystallic, were karboksimetolkrakhmat sodium, calcium by stearate.

Pharmacological properties:

Pharmacodynamics. Гинепристон® - synthetic steroid antigestagenny means (blocks effect of progesterone at the level of receptors), has no gestagenny activity. Antagonism with glucocorticosteroids (GKS) is noted (due to the competition at the level of communication with receptors). Increases sokratitelny ability of a myometrium, stimulating release interleykina-8 in horiodetsidualny cells, increasing sensitivity of a myometrium to prostaglandins. Depending on a phase of a menstrual cycle causes braking of an ovulation, change of an endometria and interferes with implantation of an oospore.

Pharmacokinetics. After a single dose in a dose of 600 mg the maximum concentration in blood serum of 1,98 mg/l is reached in 1:30 hours. Absolute bioavailability makes 69%. Communication with proteins of a blood plasma (albumine and acid alfa1 - a glycoprotein) makes 98%. After a distribution phase removal at first happens slowly, concentration decreases twice between 12-72 hours, then more quickly. The elimination half-life makes the 18th hour.

Indications to use:

The emergency (post-coital) contraception (after the unprotected sexual intercourse or if the applied way of contraception cannot be considered as reliable).

Route of administration and doses:

Inside, within 72 hours after the sexual intercourse unprotected by contraception, on 1 tablet Гинепристона® 10 of mg. For preservation of contraceptive effect it is necessary to refrain from meal in 2 hours prior to use of drug also 2 hours after it. Гинепристон® it can be applied in any phase of a menstrual cycle.

Features of use:

Гинепристон® it is not recommended for regular use as planned, continuous contraception. Гинепристон® does not protect from diseases, sexually transmitted and AIDS.

Side effects:

Feeling of discomfort in the bottom of a stomach, weakness, a headache, nausea, vomiting, dizziness, urticaria, a hyperthermia, bloody allocations from a genital tract, disturbance of a menstrual cycle.

Interaction with other medicines:

It is necessary to avoid use of non-steroidal anti-inflammatory drugs.

Contraindications:

Existence in the anamnesis of hypersensitivity to mifepristone, adrenal insufficiency and long glucocorticosteroid therapy, an acute and chronic renal and/or liver failure, existence of heavy extragenital pathology. With care: disturbance of a hemostasis (including the previous treatment by anticoagulants), chronic obstructive diseases of lungs (including bronchial asthma), heavy arterial hypertension, disturbances of a heart rhythm, heart failure.

Overdose:

Reception of Ginepristona® in doses to 2 g does not cause undesirable reactions. In cases of overdose of drug adrenal insufficiency can be observed.

Storage conditions:

List A. In dry, protected from light and the place, unavailable to children, at a temperature not above 30 °C.

Issue conditions:

According to the recipe

Packaging:

On 1 or 2 tablets in a blister strip packaging and on 1 or 2 tablets in bank polymeric. On 1 blister strip packaging or bank together with the application instruction place in a pack from a cardboard.