Гинестрил®

General characteristics. Structure:

Active agent: Mifepristone of 50 mg. Excipients Cellulose microcrystallic, sodium carboxymethylstarch, talc, calcium stearate.

Pharmacological properties:

Pharmacodynamics. Гинестрил® - synthetic steroid antigestagenny means (blocks effect of progesterone at the level of receptors), has no gestagenny activity. Antagonism with glucocorticosteroids is noted (due to the competition at the level of communication with receptors). A key role in a pathogeny of a leiomyoma of a uterus is played by sex hormones, especially progesterone. Progesterone use as blocker of progesteronovy receptors can promote both to growth inhibition of a tumor, and reduction of the sizes of myomatous nodes and a uterus.

Pharmacokinetics. After intake the maximum concentration is reached in 1,3 hours. Absolute bioavailability makes 69%. In Ginestril® plasma for 98% contacts proteins: albumine and acid alfa1-glycoprotein. 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:

Treatment of a leiomyoma of a uterus (pregnancy up to 12 weeks in size).

Route of administration and doses:

Inside, in a single dose of 50 mg of Ginestrila® (1 tablet), once. A course of treatment – 3 months.

Features of use:

Patients with artificial heart valves or an infectious endocarditis at use of Ginestrila® should carry out preventive treatment by antibiotics.

Side effects:

Disturbances of a menstrual cycle, an amenorrhea, discomfort and pain in the bottom of a stomach, a headache, nausea, vomiting, diarrhea, dizziness, a hyperthermia, weakness, a small tortoiseshell.

Interaction with other medicines:

It is necessary to avoid use of non-steroidal anti-inflammatory drugs. At a concomitant use with glucocorticosteroids it is necessary to increase a dose of the last.

Contraindications:

Pregnancy, lactation period. Existence in the anamnesis of hypersensitivity to mifepristone, adrenal insufficiency and long glucocorticosteroid therapy, an acute and chronic renal and/or liver failure, a porphyria, anemia, disturbances of a hemostasis (including the previous treatment by anticoagulants), inflammatory diseases of female generative organs, existence of heavy extragenital pathology. Submucous arrangement of myomatous nodes. The uterus leiomyoma size exceeding in sizes of 12 weeks of pregnancy. Tumors of ovaries and/or hyperplasia of an endometria.

With care drug is appointed at chronic obstructive diseases of lungs (including bronchial asthma), heavy arterial hypertension, disturbances of a heart rhythm and heart failure.

Overdose:

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

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 10 tablets on 50 mg in a blister strip packaging or on 10, 20 or 30 tablets in bank of polymeric. On 1,2,3,4 either 6 blister strip packagings or to bank together with the application instruction place in a pack from a cardboard.