Mifegin - instructions for use, dose, side effects, contraindications

Mifepristone is a synthetic steroidal antiprogestagenic agent (it blocks the action of progesterone at the receptor level), does not possess gestagenic activity. Antagonism with glucocorticosteroids (GCS) was noted (due to competition at the level of communication with receptors).

Increases the contractility of the myometrium, stimulating the release of interleukin-8 in choroid-epidural cells, increasing the sensitivity of the myometrium to prostaglandins (to enhance the effect used in conjunction with the synthetic analogue of prostaglandin). As a result of the action of the drug desquamation of the decidual membrane occurs and the expulsion of the fetal egg.

Pharmacokinetics:

After a single oral dose of 600 mg, the maximum concentration of 1.98 mg / l is achieved after 1.3 hours. Absolute bioavailability is 69%.

In the plasma mifepristone 98% bound to proteins: albumin and acid alpha-1 glycoprotein.

After the distribution phase, the excretion first occurs slowly, the concentration decreases 2 times between 12-72 hours, then more rapidly. The half-life is 18 hours.

Indications:Drug interruption of uterine pregnancy in early periods (up to 42 days amenorrhea). Preparation and induction of labor in term pregnancy.

Contraindications:

Presence in the anamnesis of hypersensitivity to mifepristone and / or accessory components, adrenal insufficiency, acute or chronic renal and / or hepatic insufficiency, porphyria, long reception of glucocorticoids, anemia, hemostasis disorder (including prior anticoagulant treatment), severe extragenital pathology.

For drug abortion:

Suspicion of ectopic pregnancy. Pregnancy, not confirmed by clinical studies. Pregnancy for more than 42 days amenorrhea. Pregnancy caused by the use of intrauterine contraceptives or after the abolition of hormonal contraception, inflammatory diseases of the genitals, smoking in women older than 35 years without first consulting a therapist.

For the preparation and induction of labor: Severe gestosis, preeclampsia, eclampsia, premature or delayed pregnancy, placenta previa, mismatch in femoral head and pelvis size, abnormal fetal position, spotting from the genital tract of unclear etiology.

Carefully:Caution is prescribed for chronic obstructive pulmonary diseases (including bronchial asthma), arterial hypertension, arrhythmia, chronic heart failure.

Pregnancy and lactation:Breastfeeding should be discontinued for 14 days after taking mifepristone.

Dosing and Administration:

The drug should be used only in medical institutions under the supervision of a doctor.

For drug abortion: 600 mg of mifepristone (3 tablets of 200 mg) are taken orally once in the presence of a doctor. The patient should be under the supervision of medical personnel, at least within 2 hours after application. After 36-48 hours after taking Mifegin®, the patient should report for ultrasound. After 8-14 days, a clinical examination and ultrasound monitoring is repeated, and the level of beta-chorionic hormone is determined to confirm that the miscarriage has occurred. In the absence of the effect of the drug on day 14 (incomplete abortion or continuing pregnancy), a vacuum is performed followed by a histological examination of the aspirate.

For the preparation and induction of labor: once 200 mg of mifepristone (1 tablet) per day in the presence of a doctor. After 24 hours, a second dose of 200 mg. After 48-72 hours, the condition of the birth canals is evaluated, and, if necessary, prostaglandins or oxytocin.

Side effects:Bloody discharge from the genital tract, discomfort and pain in the abdomen, exacerbation of inflammatory processes of the uterus and appendages, weakness, headache, nausea, vomiting, diarrhea, dizziness, hyperthermia, urticaria; on the background of combined treatment with misoprostol (in addition): vaginitis, dyspepsia, insomnia, asthenia, pain in the leg, anxiety, anemia, decreased Hb (more than 2 g / dl), fainting, leucorrhoea.

Overdose:The intake of mifepristone in doses up to 2 g does not cause undesirable reactions. In cases of drug overdose, adrenal insufficiency may occur.

Interaction:Use of non-steroidal anti-inflammatory drugs should be avoided for 8-12 days after the administration of mifepristone.

Special instructions:

Patients should be informed that if on the 10-14th day the effect of the drug is not available (incomplete abortion or continuing pregnancy),Pregnancy should be interrupted in any other way, since it is possible to form congenital malformations in the fetus.

The use of the drug requires the prevention of rhesus alloimmunization and other common activities associated with abortion.

Patients with artificial heart valves or infective endocarditis with mifepristone should be given prophylactic antibiotic treatment.

The drug should be used in obstetric and gynecological medical facilities that have the appropriate license, trained medical personnel and the necessary equipment.

Form release / dosage:Tablets 200 mg.

Packaging:

3 tablets per blister of PVC / aluminum foil.

One blister along with instructions for use in a pack of cardboard.

Storage conditions:Keep out of the reach of children. In the dark place at a temperature of no higher than 25 ° C.

Shelf life:4 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:For hospitals

Registration number:П N015925 / 01

Date of registration:06.10.2009 / 26.02.2015

Expiration Date:Unlimited

The owner of the registration certificate:ExceleljinExceleljin France

Manufacturer: & nbsp

MACORS Laboratoires France

Representation: & nbspIZVARIN PHARMA LLC IZVARIN PHARMA LLC Russia

Information update date: & nbsp16.05.2018

Illustrated instructions

Instructions

Mifegin (Mifegyne)