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The description is actual on 03.06.2016
- Latin name: Mifepristone
- ATH code: G03XB01
- Active ingredient: Mifepristone (Mifepristone)
- Producer: Xianju Green Leaf Pharmaceutical Factory, Hubei Gedian Humanwell Pharmaceutical Co. (China), Obninsk chemical and pharmaceutical company, Izvarino of LLC Farm, Farmsintez of closed joint stock company (Russia)
Tablets contain active component in structure mifepristone, and also a number of additional components: microcrystallic cellulose, potato starch, lactose, polyvinylpirrolidone, magnesium stearate, carboxymethylstarch.
Mifepristone is made in tablets which have light yellow color, can possess a greenish shade also. Tablets contain in packagings or in polymeric banks on 3 or 6 pieces.
Means Mifepristone is steroid synthetic antigestagenny drug. Under its influence the tone and sokratitelny activity of a myometrium increases. Getting to an organism, active agent blocks influence of progesterone at the level of receptors. Does not show gestagenny activity, the antagonism of substance with GKS in view of the competition at the level of communication with receptors is noted.
Sokratitelny ability of a myometrium under the influence of medicine increases due to release stimulation interleykina-8 in horiodetsidualny cells, and also increases in level of sensitivity of a myometrium to prostaglandins. As a result, under the influence of drug there pass desquamation of a decidua and fetal egg is removed.
Pharmacokinetics and pharmacodynamics
After drug was accepted inside in a dose of 600 mg, the maximum concentration of active agent is noted 1.3 hours later, making at the same time 1.98 mg/l. Level of absolute bioavailability is equal to 69%.
Mifepristone contacts blood proteins for 98%.
The elimination half-life is equal to 18 hours. Substance is removed from an organism in two phases: at first there is its slow removal for from 12 to 72 hours then the level of concentration of a component in plasma decreases twice. Further the phase of fast removal of mifepristone follows.
Indications to use
Means is applied in such cases:
- for the purpose of interruption of a uterine pregnancy on term about nine weeks (lack of periods till 63 days) a medicamentous method, combining with synthetic analogs of prostaglandins;
- for conservative expansion of a neck of uterus before abortion for up to 12 weeks by a surgical method;
- for potentiation of influence of prostaglandins in the course of abortion, which term — 13-22 weeks (it is carried out on social and medical indications);
- for a rodovozbuzhdeniye at death of a fruit in the second and third trimesters of pregnancy.
There is a number of the general contraindications for reception of the tablets Mifepristone:
- long treatment of GKS;
- adrenal insufficiency;
- renal or liver failure in an acute or chronic form;
- anemia in a severe form;
- diseases of female generative organs of inflammatory character;
- disturbances of a hemostasis (also at the treatment by anticoagulants preceding drug intake);
- heavy extragenital pathology (it is impossible to accept without preliminary consultation with the specialist);
- high sensitivity to medicine components;
- provided that the patient aged after 35 flyings regularly smokes.
Contraindications at medicamentous abortion:
- existence of suspicion on an extrauterine pregnancy;
- in the absence of clinical confirmation of pregnancy;
- duration of gestation is more than 42 days of amenorrhea;
- at pregnancy which arose at use of intrauterine contraceptives or after cancellation of hormonal contraceptives.
Contraindications in case of preparation and induction of childbirth:
- gestosis in a severe form;
- postmature or premature pregnancy;
- abnormal provision of a fruit;
- discrepancy of a head of a fruit and sizes of a basin of the woman in labor;
- existence of bloody allocations from generative organs during pregnancy which origin is not established.
Carefully the patients having obstructive diseases of lungs in a chronic form, bronchial asthma, arrhythmia, arterial hypertension, heart failure in a chronic form should accept Mifepristone.
Side effects which arise at reception of the tablets Mifepristone:
- sensation of discomfort in the lower part of a stomach;
- feeling of the general weakness;
- dizziness, headache;
- vomiting, nausea;
- uterus subinvolution.
Side effects which are connected with carrying out medicamentous abortion:
- bloody allocations from generative organs;
- feeling of pain in the lower part of a stomach;
- aggravations of an inflammation of a uterus, appendages.
Tablets Mifepristone, application instruction (Way and dosage)
It is necessary to consider that the application instruction of Mifepristone provides use of tablets only in the conditions of medical institutions in which there are a necessary equipment and control of specialists.
For the purpose of abortion in early terms the single dose in a dose of 600 mg of medicine (three tablets) is appointed. It is necessary to take a pill in the presence of the doctor, it is necessary to do it 1-1.5 hours later after easy meal. Tablets are washed down with a half of a glass of water.
The doctor has to watch the patient for, at least, two hours. 36-48 hours later after the pill was taken, the woman needs to visit medical institution and to carry out ultrasonic control. If necessary appoint Mizoprostol.
It is important to conduct 10-14 days later repeated research and control of ultrasonography. If there is a need, the doctor appoints to the patient determination of level of a chorionic gonadotrophin to confirm carrying out a misbirth.
If the effect of use of medicine is absent for the 14th day (that is there was an incomplete abortion or pregnancy continues), the gynecologist conducts vacuum aspiration and the subsequent histologic research of aspirate.
Mifepristone for an odynagogue at the full-term pregnancy it is necessary to accept in a dose 200 mg, that is one tablet once a day. 24 hours later appoint repeatedly similar dose. On the expiration from 48 to 72 hours estimate a condition of patrimonial ways. If there is a need, to the patient appoint reception of Oxytocin or prostaglandins.
When this scheme of treatment begins to work, depends on a condition of the woman. As a rule, the expulsion of the fetus happens over less than 10 hours after use of the scheme of treatment.
Mifepristone in/in is not applied.
Mizoprostol and Mifepristone
For process of abortion on early terms Mizoprostol and Mifepristone together is often used. The medicine Mifepristone promotes a softening of a neck of uterus and its reductions, Mizoprostol induces uterine reductions.
In spite of the fact that there is an instruction how to accept Mifepristone and Mizoprostol, the exact scheme of reception is defined by the doctor. Tablets can be drunk only under control of the specialist and in specialized institutions. It is possible to buy these drugs directly in medical institutions. The price of mifepristone and a mizoprostol depends on under what trademark these drugs are implemented. Responses of women demonstrate that such combination of drugs is effective for abortion on early terms.
Mifepristone and Mirolyut
When carrying out medicamentous abortions also combine the drugs Mifepristone and Миролют which active agent is mizoprostol. It is necessary to use these means also only under supervision of the doctor who defines how to take a pill. In house conditions of it it is impossible to do. As a rule, Mirolyut appoint in a dose 400 mg 36-48 hours later after reception of Mifepristone in a dose of 600 mg.
At use of drug in a dose to 2 g negative manifestations do not develop. If there is an overdose of medicine, at the patient adrenal insufficiency can be shown.
At use at the same time of Mifepristone and GKS the dose of the last should be increased.
It is recommended not to resort to reception of non-steroidal anti-inflammatory drugs, including acetylsalicylic acid to avoid decrease in efficiency of treatment.
Terms of sale
Mifepristone is delivered in specialized medical institutions.
Means belongs to the list A. It needs to be stored in the dark and dry place, to protect from access for children.
Period of validity
It is possible to store 2 years. After expiry date it is impossible to use.
It is necessary to inform women that if they do not celebrate effect of use of medicine for 10-14 day after its reception, it is necessary to interrupt surely pregnancy with different way as there is a probability of development of inborn defects in a fruit without fail.
At use of medicine it is necessary to warn a Rhesus factor-alloimmunizatsiyu and to hold other general events which practice at abortion.
Use is carried out only in the conditions of a hospital. It is necessary to consider that at development of plentiful bleeding immediate carrying out a surgery can be required.
Women at whom the artificial heart valve is established or patients with an infectious endocarditis have to complete a course of preventive treatment by antibiotics at Mifepristone reception.
Natural feeding needs to be stopped for two weeks after reception of tablets.
It is recommended to apply this medicine to regular use as a contraception method. Means does not protect from infection with AIDS and venereal diseases.
Analogs of Mifepristone
Coincidence on the ATH code of the 4th level:
Mifepristone or Mifegin?
Mifegin is medicine analog which contains in structure active component mifepristone. This drug has similar action and is applied according to the similar scheme. What of drugs to choose, depends on recommendations of the doctor. Both drugs have the extensive list of contraindications and can be applied only in a hospital under control of the specialist.
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