Mifolian

Mifolian – the synthetic steroid antiprogestogenny medicine (a progesterone blocker at the level of receptors) which does not have gestagenny activity.

Form of release and structure

Dosage form of Mifolian – a tablet: light yellow, round (on 1 or 3 pieces in blisters, in a cardboard pack 1 blister).

Structure of 1 tablet:

• Active agent: mifepristone – 0,2 g;
• Auxiliary components: gipromelloza, lactose, sodium carboxymethylstarch, starch, magnesium stearate.

Indications to use

• Pharmabort on early terms of a uterine pregnancy (up to 42 days of an amenorrhea);
• Childbirth at the full-term pregnancy: for preparation for delivery and induction of patrimonial activity.

Contraindications

Absolute:

• Anemia;
• Inflammatory diseases of reproductive organs;
• Long therapy by glucocorticosteroids;
• Adrenal insufficiency;
• Hysteromyoma;
• Disturbance of a hemostasis (including the previous therapy by anticoagulants);
• Porphyria;
• Hem on a uterus;
• Heavy extragenital pathology;
• Chronic or acute liver and/or renal failure;
• Data in the anamnesis on hypersensitivity to mifepristone.

In addition for medicamentous abortion a contraindication are:

• Pregnancy on terms is more than 42 days of amenorrhea;
• The pregnancy which arose after cancellation of hormonal contraceptives or against the background of use of an intrauterine spiral;
• The pregnancy which is not confirmed with clinical trials;
• Ectopic pregnancy (including assumed).

Additional contraindications to Mifolian's use for preparation and induction of childbirth:

• Eclampsia, preeclampsia, gestosis of heavy degree;
• Postmature or premature pregnancy.

Relative (drug is used with care in a type of high probability of side effects): chronic obstructive diseases of lungs (including bronchial asthma), heavy arterial hypertension, disturbances of a heart rhythm and heart failure.

To the smoking women 35 years aged are more senior it is impossible to use drug without preliminary consultation of the therapist.

Route of administration and dosage

Mifolian it is necessary to use only in specialized institutions, in the presence of the necessary equipment and appropriately prepared medical personnel.

Tablets are intended for oral administration.

The recommended dosing mode for medicamentous abortion: in the presence of the doctor take 3 pill of Mifolian on 0,2 g (0,6 g of mifepristone) once. At least 2 hours after reception it is necessary to be under observation of medical personnel. 36-48 hours later after mifepristone use the patient needs to undergo ultrasonography control. In 1-2 weeks ultrasonography control and clinical inspection are carried out repeatedly, besides the level of β-chorionic hormone is defined to receive confirmation of lack of pregnancy. If the effect of use of drug is not observed 2 weeks (the continuing pregnancy or incomplete abortion) later do vacuum aspiration, and then a histologic research of aspirate.

The recommended dosing mode for preparation and induction of childbirth: 1 tablet of Mifolian (0,2 g of mifepristone) a day, once, in the presence of the doctor. In a day – repeated reception of 0,2 g of drug. 48-72 hours later conditions of patrimonial ways carry out assessment, further, if necessary, appoint oxytocin or prostaglandins.

Side effects

• Investigation of the therapeutic procedure: painful feelings in the bottom of a stomach, menstrualnopodobny bloody allocations from a genital tract, an exacerbation of inflammatory diseases of appendages and a uterus;
• Consequence of use of mifepristone: dizziness, a headache, weakness, nausea, vomiting, a hyperthermia, a sensation of discomfort in the bottom of a stomach;
• Result of overdose: adrenal insufficiency.

Special instructions

In case of lack of the expected effect of Mifolian's use for 10-14 day from reception (the continuing pregnancy or incomplete abortion), it is required to interrupt pregnancy in any other way as owing to reception of abortal substances at a fruit malformations can form.

Mifepristone in a dose to 2 g of undesirable side reactions does not cause in the patient.

Before use of mifepristone the Rhesus factor-alloimmunizatsii is required to hold the general events accompanying abortion, including actions for decrease.

In the period of a lactation for 2 weeks after Mifolian's use it is required to stop breastfeeding.

Medicinal interaction

It is necessary to avoid simultaneous use with mifepristone of nonsteroid antiinflammatory medicines.

Terms and storage conditions

To store in the unavailable to children, protected from light and moisture place, at a temperature up to 25 °C.

Period of validity – 2 years.