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

Mifepristone is a synthetic steroidal antigestagenic agent (it 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 excretion 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:

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

- Preparation and induction of labor.

Contraindications:

For all indications:

Presence in the anamnesis of hypersensitivity to mifepristone and / or to any of the components of the drug;
Adrenal insufficiency;
Long-term glucocorticosteroid therapy;
Acute or chronic renal and / or liver failure;
Hereditary porphyria;
Myoma of the uterus of large size (for this dosage form);
Anemia (hemoglobin level less than 100 g / l);
Violation of hemostasis (including previous treatment with anticoagulants);
Acute inflammatory diseases of female genital organs;
The presence of severe extragenital pathology;
Smoking in women over 35 years old without prior consultation of a therapist;
Bronchial asthma, severe form;
Cachexia.

For drug abortion:

suspicion of ectopic pregnancy,
pregnancy, not confirmed clinico-laboratory, pregnancy for more than 42 days amenorrhea,
a pregnancy that occurs when intrauterine contraceptives are used or after the abolition of hormonal contraceptives,
contraindications to the use of misoprostol.

For the preparation and induction of labor in term of full-term pregnancy:

heavy gestosis, preeclampsia, eclampsia, premature or delayed pregnancy, mismatch of the pelvis of the mother and fetal head, abnormal fetal position,bloody discharge during pregnancy from the genital tract, unspecified etiology, severe forms of hemolytic disease of the fetus, presentation or detachment of the placenta.

Carefully:

With chronic obstructive pulmonary diseases, bronchial asthma, arterial hypertension, heart rhythm disorders, heart failure.

Pregnancy and lactation:

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

The use of mifepristone to prepare the cervix for delivery does not affect subsequent lactation.

Dosing and Administration:

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

For medical termination of early pregnancy.

600 mg of mifepristone (3 tablets of 200 mg) are taken orally once in the presence of a doctor, 1-1.5 hours after ingestion (light breakfast), with 100 ml of boiled water. After 36-48 hours after taking mifepristone, the patient should report to the medical institution for taking misoprostol 400 mcg. After taking misoprostol, dynamic observation of the doctor within 2 hours. After 10-14 days, a clinical examination and ultrasound examination is repeated, if necessary, determine the level of the chorionic gonadotropin to confirm that the miscarriage has occurred.

In the absence of the effect of the drug on the 14th day (incomplete abortion or continuing pregnancy), vacuum aspiration is carried out followed by a histological examination of the aspirate.

For the preparation and induction of labor:

Once inside 200 mg of mifepristone (1 tablet) 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:

Associated with the administration of mifepristone.

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.

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 (NSAIDs) should be avoided. With the simultaneous administration of mifepristone and glucocorticosteroid drugs, it is necessary to increase the dose of the latter.

Special instructions:

Patients using mifepristone for the termination of early pregnancy, should be informed that if on the 10-14th day the effect from the use of the drug is absent (incomplete abortion or continuing pregnancy), pregnancy should necessarily be interrupted in another 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.

The drug can be delivered 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.

Form release / dosage:Tablets 200 mg.

Packaging:

By 2, 3 or 6 tablets in cans of polymeric. 2 or 3 tablets per contour cell pack.For 1 or 2 contour packs or a jar with instructions for use are placed in a cardboard box.

Storage conditions:

In a dry, protected from light 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 expiry date.

Terms of leave from pharmacies:For hospitals

Registration number:P N002340 / 01

Date of registration:21.07.2008 / 18.05.2010

Expiration Date:Unlimited

The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia

Manufacturer: & nbsp

OBNINSKAYA CHEMICAL - PHARMACEUTICAL COMPANY, CJSC Russia

Information update date: & nbsp09.06.2018

Illustrated instructions

Instructions

Miropristone® (Miropristone®)