Mifepristone

Mifepristone – the antigestagenny means increasing sokratitelny activity and a tone of a myometrium.

Form of release and structure

Dosage form – tablets of light yellow color, sometimes with a greenish shade (on 3 or 6 pieces in banks polymeric, in a pack of cardboard 1 bank; on 3 or 6 pieces in packaging planimetric cell, in a pack cardboard 1 or 2 packagings).

Active agent – mifepristone, in 1 tablet – 200 mg.

Excipients: carboxymethylstarch, potato starch, cellulose microcrystallic, magnesium stearate, polyvinylpirrolidone, lactose.

Indications to use

• Interruption of a uterine pregnancy on terms up to 42 days of an amenorrhea;
• Stimulation of patrimonial activity (an indispensable condition the full-term pregnancy is).

Contraindications

General contraindications:

• Hysteromyoma;
• Inflammatory diseases of female generative organs;
• Heavy extragenital pathology (without consultation of the therapist);
• Renal/liver failure (acute or chronic);
• Disturbances of a hemostasis or the previous treatment using anticoagulants;
• Porphyria;
• Adrenal insufficiency;
• Heavy anemia;
• Prolonged use of glucocorticosteroids;
• Smoking is aged more senior than 35 years;
• Hypersensitivity to drug components.

Additional contraindications to carrying out medicamentous abortion:

• Pregnancy on term more than 42 days of an amenorrhea;
• The pregnancy which is not confirmed with clinical trials;
• Suspicion on existence of an extrauterine pregnancy;
• The pregnancy which arose during use of intrauterine contraceptives or after cancellation of hormonal contraception.

Additional contraindications by preparation and induction of childbirth:

• Eclampsia;
• Preeclampsia;
• Gestosis of heavy degree;
• Wrong provision of a fruit;
• Discrepancy of the sizes of a basin of the woman and head of a fruit;
• Postmature/premature pregnancy;
• Bloody allocations from a genital tract of an unknown origin during pregnancy.

With care Mifepristone should be applied in the following cases:

• Chronic heart failure;
• Chronic obstructive pulmonary diseases;
• Arterial hypertension;
• Arrhythmias;
• Bronchial asthma.

Route of administration and dosage

Mifepristone can be applied only in the specialized medical institutions equipped with the special equipment.

For the purpose of medicamentous abortion drug appoint in a dose 600 mg once. 1-1,5 hours later after a light breakfast the patient in the presence of the doctor has to accept drug, washing down tablets ½ of a glass of boiled water; within 2 hours after reception – to be under observation of the doctor; in 36-48 hours – to be in medical institution for ultrasonic control. In certain cases repeated reception of Mifepristone can be required.

10-14 days later carrying out repeated clinical inspection and ultrasonography, sometimes – determination of level of a chorionic gonadotrophin for confirmation of abortion is shown.

In case of lack of effect of administration of drug for the 14th day (if pregnancy remained, or there was an incomplete abortion) carrying out vacuum aspiration and the subsequent histologic research of aspirate is necessary.

For induction of childbirth at the full-term pregnancy Mifepristone appoint 200 mg in a dose. The woman has to accept drug in the presence of the doctor. In 24 hours reception of a repeated dose of 200 mg, and 48-72 hours later – assessment of a condition of patrimonial ways and if necessary purpose of oxytocin or prostaglandins is shown.

Side effects

• Owing to Mifepristone reception: a lohia serosa, a hyperthermia, nausea and vomiting, feeling of discomfort in the bottom of a stomach, dizziness, a headache, the general weakness, uterus subinvolution;
• Owing to the procedure of medicamentous abortion: pains in the bottom of a stomach, bloody allocations from a genital tract, an aggravation of inflammatory processes of a uterus and its appendages.

Special instructions

In case of performing medicamentous abortion during a lactation breastfeeding should be interrupted for 3 days after reception of tablets.

Use of drug for preparation of a neck of uterus for delivery does not influence the subsequent lactation.

Use of Mifepristone demands the prevention a Rhesus factor-alloimmunizatsii and other the general, accompanying abortion, actions.

Medicinal interaction

In need of simultaneous use of glucocorticosteroids it is necessary to increase their dose.

It is necessary to avoid simultaneous use with Mifepristone of non-steroidal anti-inflammatory drugs.

Terms and storage conditions

To store in the place unavailable to children protected from light and moisture.

Period of validity – 2 years.