Mifegin

General characteristics. Structure:

Active ingredient: 20 mg of the mifepristone micronized.

Excipients: silicon dioxide colloid, starch corn, povidone, cellulose microcrystallic, magnesium stearate.

Pharmacological properties:

Pharmacodynamics. Synthetic steroid antigestagenny drug (blocks effect of progesterone at the level of receptors), has no gestagenny activity. Antagonism with 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 (apply to strengthening of effect in combination with a synthetic analog of prostaglandin). Effect of drug is resulted by desquamation of a decidua and an ekspulsiya of fetal egg.

Pharmacokinetics. After a single dose inside in a dose of 600 mg of Cmax of 1.98 mg/l it is reached in 1.3 h. Absolute bioavailability makes 69%.

In plasma mifepristone for 98% contacts proteins: albumine and acid alfa1-glycoprotein.

After a distribution phase removal at first happens slowly, concentration decreases twice between 12-72 h, then more quickly. T1/2 makes 18 h.

Indications to use:

— medicamentous interruption of a uterine pregnancy on early terms (up to 42 days of an amenorrhea);

— preparation and induction of childbirth at the full-term pregnancy.

Route of administration and doses:

Drug has to be used only in medical to an uchra zhdeniye under observation of the doctor.

For medicamentous abortion: 600 mg of mifepristone (3 таб. on 200 mg) accept inside once in the presence of the doctor. The patient has to be under observation of medical personnel, at least, during 2 h after use. In 36-48 h after administration of drug of Mifegin® the patient has to be on ultrasonography control. In 8-14 days clinical examination and ultrasonography control is repeatedly conducted, and also determine the level of beta and chorionic hormone for confirmation that the abortion occurred. In the absence of effect of use of drug for the 14th day (incomplete abortion or the continuing pregnancy) carry out a vakuumaspiration with the subsequent histologic research of aspirate.

For preparation and induction of childbirth: once 200 mg of mifepristone (1 таб.) / days inside in the presence of the doctor. In 24 h repeated reception of 200 mg. In 48-72 h assessment of a condition of patrimonial ways is carried out, and, as necessary, prostaglandins or oxytocin are appointed.

Features of use:

Use at pregnancy and feeding by a breast. Breastfeeding should be stopped for 14 days after mifepristone reception.

Special instructions. Patients, have to be informed that if for 10-14 day the effect of use of drug is absent (incomplete abortion or the continuing pregnancy), pregnancy should be interrupted surely with a different way as formation of inborn malformations at a fruit is possible.

Use of drug demands the prevention a Rhesus factor hallo of immunization and other general actions accompanying abortion.

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

Drug has to be used in the medical institutions of an obstetric and gynecologic profile having the corresponding license, the prepared medical shots and the necessary equipment.

Side effects:

Bloody allocations from a genital tract, discomfort and pain in the bottom of a stomach, an aggravation of inflammatory processes of a uterus and appendages, weakness, a headache, nausea, vomiting, diarrhea, dizziness, a hyperthermia, a small tortoiseshell.

Against the background of the combined treatment with mizoprostoly (in addition): a vaginitis, dyspepsia, sleeplessness, an adynamy, a scelalgia, concern, anemia, decrease in hemoglobin (more than on 2 g/dl), unconscious states, bleach.

Interaction with other medicines:

It is necessary to avoid use of non-steroidal anti-inflammatory drugs within 8-12 days after mifepristone use.

Contraindications:

— adrenal insufficiency;

— acute or chronic renal and/or liver failure;

— porphyria;

— long reception of glucocorticoids;

— anemia;

— disturbance of a hemostasis (including the previous treatment by anticoagulants);

— existence of heavy extragenital pathology;

— existence in the anamnesis of hypersensitivity to mifepristone and/or auxiliary components.

For medicamentous abortion:

— suspicion on an extrauterine pregnancy;

— the pregnancy which is not confirmed with clinical trials;

— pregnancy more than 42 days amenorrhea;

— the pregnancy which occurred against the background of use of intrauterine contraceptives or after cancellation of hormonal contraception;

— inflammatory diseases of generative organs;

— smoking at women is more senior than 35 years without preliminary consultation of the therapist.

For preparation and induction of childbirth:

— gestosis of heavy degree, preeclampsia, eclampsia;

— premature or postmature pregnancy;

— placental presentation;

— discrepancy of the sizes of a head of a fruit and woman's basin;

— abnormal provision of a fruit;

— bloody allocations from a genital tract of not clear etiology.

With care appoint at chronic obstructive pulmonary diseases (including bronchial asthma), arterial hypertension, arrhythmia, chronic heart failure.

Overdose:

Reception of mifepristone 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. To store in the unavailable to children, dry, protected from light place at a temperature not above 25 °C. A period of validity - 3 years.

Issue conditions:

According to the recipe

Packaging:

Tablets on 3 pieces in the blister and a cardboard pack. Drug can be delivered only in the medical obstetric and gynecologic institutions having the license for this kind of activity.