Active substanceMifepristoneMifepristone Similar drugsTo uncover Agesta pills inwards Promomed Rus, Open Company Russia Gynepristone® pills inwards Nizhny Novgorod Chemical and Pharmaceutical Plant, OJSC Gynestril® pills inwards NIZHFARM, JSC Russia Genale® pills inwards IZVARINO PHARMA, LLC Russia Miropristone® pills inwards NIZHFARM, JSC Russia Mifegin pills inwards Exceleljin France Mifyprex pills inwards MOSCOW PHARMACEUTICAL FACTORY, CJSC Russia Mifepristone pills inwards China Resource Zizhu Pharmaceutical Co., Ltd China Mifepristone pills inwards IZVARINO PHARMA, LLC Russia Mythophianus pills inwards Shanghai New Hualian Pharmaceutical Co., Ltd. China Pencroft® pills inwards FARMSINTEZ, PAO Russia Dosage form: & nbspPills. Composition:For one tabletActive substance: Mifepristone - 200 mgExcipients: Povidone is a medium molecular weight (polyvinylpyrrolidone, an average molecular weight medical) - 12 mgSilicon dioxide colloid -3 mgCorn starch -102 mg Microcrystalline cellulose - 30 mg Magnesium stearate - 3 mg Description:Tablets of light yellow color, flat-cylindrical form with a facet and a risk. Pharmacotherapeutic group:Antigestagen. ATX: & nbspG.03.X.B.01 Mifepristone Pharmacodynamics:Mifeprex ® - a synthetic steroid anti-gestagenic agent (blocks the action of progesterone at the level of receptors), does not possess gestagenic activity. Antagonism with glucocorticosteroids was noted (due to competition at the level of communication with receptors).Increases the contractile ability of the myometrium, stimulating the release of interleukin-8 in choroid-epidural cells and increasing the sensitivity of the myometrium to prostaglandins. 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 dose of the drug inside at a dose of 600 mg, the maximum concentration of 2 mg / l is reached after 1.35 hours. Absolute bioavailability is 69%.In the blood plasma mifepristone on 98% is associated with proteins: albumin and acid alpha-1-glycoprotein.After the distribution phase, the elimination is first slowed down, the concentration is halved after 12-72 hours, then faster; the elimination half-life is 18 hours. Indications:- Medication interruption of uterine pregnancy at early stages (up to 42 days amenorrhea).- Preparation for childbirth and induction of labor in term of full term pregnancy. Contraindications:Hypersensitivity to mifepristone, adrenal insufficiency, long-term use of glucocorticosteroids, acute or chronic renal and / or hepatic insufficiency, anemia, porphyria, uterine fibroids, scarring of the uterus, hemostasis disorder (including previous anticoagulant treatment), inflammatory diseases of the genital organs, severe extragastital pathology.Do not use smoking women older than 35 years without first consulting a therapist.With drug abortion: suspicion of ectopic pregnancy; pregnancy, not confirmed by clinical studies; pregnancy exceeding 42 days of amenorrhea; a pregnancy that occurs when intrauterine contraception is used, or after the abolition of hormonal contraception.When preparing for childbirth and induction of labor: severe preeclampsia, preeclampsia, eclampsia, preterm or premature pregnancy, placenta previa, mismatch in femoral head and pelvis size, abnormal fetal position, spotting from the genital tract of unclear etiology. Carefully:Assign for chronic obstructive pulmonary diseases (including bronchial asthma), severe arterial hypertension, heart rhythm disorders and heart failure. Pregnancy and lactation:Breastfeeding should be discontinued for a period of 14 days after taking Mifeprex®. Dosing and Administration:The drug should be used in obstetric and gynecological medical facilities that have the appropriate license, trained medical personnel and the necessary equipment.For medical termination of early pregnancy.600 mg Mifeprex® (3 tablets 200 mg) is taken orally once in the presence of a doctor, 1-1.5 hours after a meal (light breakfast), with half a glass of boiled water. The patient should be under the supervision of medical personnel, at least within 2 hours after application.After 36-48 hours after taking mifepristone, the patient is given an ultrasound (ultrasound) and, if necessary, 400 μg of misoprostol are administered. After 8-14 days, a repeat clinical examination and ultrasound can be performed, as well as a determination of the level of beta-chorionic gonadotropin to confirm that the miscarriage has occurred.In the absence of effect of the drug on day 14 (incomplete abortion or ongoing pregnancy) is carried out, followed by vacuum aspiration of aspirate histological examination.For the preparation and induction of labor in a full-term pregnancy: once 200 mg of mifepristone in the presence of a doctor. After 24 hours, a second dose of 200 mg. After 48-72 hours assesses the state of the birth canal, and, if necessary, prostaglandins or appointed oxytocin. Side effects:Menstrual disorders, amenorrhea, metrorrhagia, lohiometra, uterine subinvoljutcija, discomfort and pain in the abdomen; exacerbation of inflammatory processes of the uterus, appendages, urinary tract; weakness, headache, nausea, vomiting, diarrhea, dizziness, hyperthermia, chills, urticaria, by combination therapy with misoprostol (optional): vaginitis, indigestion, insomnia, fatigue, leg pain, anxiety, anemia, decrease in Hb (over at 2 g / dl), fainting. Overdose:In cases of drug overdose, symptoms of adrenal insufficiency may appear. Interaction:It is necessary to avoid the simultaneous use of non-steroidal anti-inflammatory drugs (NSAIDs) and for 8-12 days after the administration of mifepristone. Special instructions:Patients should be necessarily informed that, in the absence of effect by 10-14 days from the use of the drug (incomplete abortion or continuing pregnancy), pregnancy should be discontinued in another way because of the high risk of congenital malformations in the fetus.The use of the drug requires the prevention of rhesus-alloimmunization and other general activities associated with abortion.Patients with artificial heart valves or infective endocarditis with mifepristone should be given prophylactic antibiotic treatment. Form release / dosage:Tablets 200 mg. Packaging:3 tablets in a planar cell package. One contour mesh package together with the instruction for use is placed in a pack of cardboard. Storage conditions:In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children. Shelf life:4 years. Do not use the drug after the expiration date. Terms of leave from pharmacies:For hospitals Registration number:P N002741 / 01 Date of registration:08.04.2009 Expiration Date:Unlimited The owner of the registration certificate:MOSCOW PHARMACEUTICAL FACTORY, CJSC MOSCOW PHARMACEUTICAL FACTORY, CJSC Russia Manufacturer: & nbspMOSCOW PHARMACEUTICAL FACTORY, CJSC Russia Information update date: & nbsp2016-09-19 Illustrated instructions × Illustrated instructions Instructions