Instruction for use: Miropristone

Active substance Mifepristone

ATX code G03XB01 Mifepristone

Pharmacological groups

Estrogens, gestagens; Their homologues and antagonists

Nosological classification (ICD-10)

O06 Abortion, unspecified

Abortion, Incomplete abortion, Abortion

O62.2 Other uterine inertia

metroparalysis; The weakness of labor activity; Decreased uterine tone; Induction of labor; Induction of labor at term; Induction of labor at term or near term; Activation of labor

O83.9 Obstetrical allowance for single-childbirth, unspecified

Induction of labor, Childbirth

Composition

Tablets 1 table.

active substance:

Mifepristone 200 mg

Auxiliary substances: MCC - 264.4 mg; Sodium carboxymethyl starch - 54 mg; Calcium stearate - 5.4 mg; Talc - 16.2 mg

Description of dosage form

Tablets, 200 mg: light yellow or light yellow with a greenish tint of a flat-cylindrical tablet form with a risk and a facet.

pharmachologic effect

Pharmacological action is anti-gestagenic.

Pharmacodynamics

Mifepristone is a synthetic steroid anti-gestagenic agent (blocks the action of progesterone at the level of receptors), does not possess gestagenic activity. Antagonism with GCS (glucocorticosteroids) was noted (due to competition at the level of communication with receptors). Increases the contractility of the myometrium, stimulating the release of IL (interleukin) -8 in choroidectid cells and increasing the sensitivity of the myometrium to PG (prostaglandins). As a result of the action of the drug desquamation of the decidual membrane occurs and excretion of the fetal egg.

Pharmacokinetics

After a single oral dose of 600 mg Cmax, 1.98 mg / l is achieved after 1.3 hours. Absolute bioavailability is 69%. In plasma, mifepristone binds 98% 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. T1 / 2 is 18 hours.

Indications

Interruption of uterine pregnancy in early periods (up to 42 days amenorrhea) in combination with misoprostol;

Preparation and induction of labor.

Contraindications

The presence in the anamnesis of hypersensitivity to mifepristone and / or to any of the components of the drug;

Adrenal insufficiency and long-term GCS-therapy;

Acute or chronic renal and / or liver failure;

Hereditary porphyria;

Uterine myoma in large sizes (for a given dosage form);

Anemia (Hb level less than 100 g / l);

Violations of hemostasis (including the previous treatment with anticoagulants);

Acute inflammatory diseases of female genital organs;

Presence of severe extragenital pathology;

Bronchial asthma, severe form;

Cachexia;

Smoking women older than 35 years, without first consulting a therapist.

For drug abortion:

Suspicion of ectopic pregnancy;

Pregnancy, not confirmed by clinical studies; Exceeding the duration of 42 days amenorrhea;

Pregnancy caused by the use of intrauterine contraception or after the abolition of hormonal contraception;

Contraindications

For the preparation and induction of labor:

Severe gestosis;

Pre-eclampsia;

eclampsia;

Premature or premature pregnancy;

Mismatch of the pelvis of the mother and the head of the fetus;

Abnormal position of the fetus;

Bloody discharge during pregnancy from the genital tract, unspecified etiology;

Severe forms of hemolytic disease of the fetus;

Presentation or detachment of the placenta.

With caution: chronic obstructive pulmonary disease, bronchial asthma, arterial hypertension, heart rhythm disturbances, heart failure.

Side effects

Associated with taking Miropristone ®. Feeling of discomfort in the lower abdomen, general weakness, headache, nausea and vomiting, dizziness, hyperthermia, urticaria.

Related to the procedure of medical abortion. Bloody discharge from the genital tract. Pain in the lower abdomen. Exacerbation of inflammatory processes of the uterus and appendages.

Interaction

Use of NSAIDs should be avoided. With the simultaneous administration of Miropristone® and GCS, it is necessary to increase the dose of the latter.

Dosing and Administration

Inside. The drug should be used only in medical institutions that have appropriately trained medical personnel and the necessary equipment.

For medical termination of pregnancy in the early stages: 600 mg Miropristone ® (3 tablets of 200 mg) taken single-time in the presence of a doctor, 1-1.5 h after meals (light breakfast), with half cup (100 ml) of boiled water. After 36-48 hours after taking Miropristone®, the patient should report to the medical institution for taking misoprostol 400 μg. After taking misoprostol, you need a dynamic observation of the doctor within 2 hours. After 10-14 days, the clinical examination and ultrasound are re-performed, if necessary, determine the level of CG to confirm that the miscarriage has occurred.

In the absence of the effect of using the drug on day 14 (incomplete abortion or continuing pregnancy), a vacuummask is performed followed by a histological examination of the aspirate.

For the preparation and induction of labor: inside 200 mg Miropristone ® (1 table) once 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, PG or oxytocin are prescribed.

Overdose

Taking Miropristone ® in doses up to 2 g does not cause undesirable reactions. In cases of drug overdose, adrenal insufficiency may occur.

special instructions

Patients using Miropristone® for early termination of pregnancy 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 necessarily be discontinued in another way, since it is possible to form congenital malformations Development of the fetus.

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

Breastfeeding should be discontinued for 3 days after taking Mifepristone® in case of medical abortion.

The use of the preparation Mifepristone for the preparation of the cervix for delivery does not affect subsequent lactation.

Form of issue

Tablets, 200 mg. In banks of polymer 2, 3 or 6 pcs. In the outline cell packing 2 or 3 pcs. 1 or 2 contour squares in a cardboard bundle.

Terms of leave from pharmacies

The drug can be supplied only to medical obstetric and gynecological institutions related to the public health system, as well as to municipal and private property agencies that have licenses for this type of activity.

storage conditions

In a dry, the dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life

5 years.

Do not use after the expiry date printed on the package.