Mifegin

Active material: Myfepryston
When ATH: G03XB01
CCF: Antigestagens drug
When CSF: 15.13.02
Manufacturer: Exelgyn Laboratories (France)

Pharmaceutical form, composition and packaging

Pills light yellow colors, lenticular, with an identification code “167B” one side.

Excipients: corn starch, colloidal silicon dioxide, povidone, microcrystalline cellulose, magnesium stearate.

3 PC. – blisters (1) – cardboard boxes.

Pharmacological action

A synthetic steroid drug antigestagens (blocks the action of progesterone at the receptor level), progestin activity is not. Marked antagonism with GCS (through competition at an receptors).

Increases contractility of the myometrium, stimulating the release of IL-8 in cells horiodetsidualnyh, increasing the sensitivity of the myometrium to prostaglandins (for enhancing the effect used in combination with a synthetic prostaglandin analog). As a result of the drug takes place decidua desquamation and expulsion of the ovum.

Pharmacokinetics

After a single oral dose 600 mг Cmax 1.98 mg / l is achieved in 1.3 no. The absolute bioavailability of 69%.

In plasma mifepristone on 98% It binds to proteins: albumin and alpha 1-acid glycoprotein.

After the first phase of the distribution of elimination is slow, the concentration decreases 2 between times 12-72 no, then more rapidly. T1 / 2 is 18 no.

Indications for use of the drug

• medical termination of intrauterine pregnancy in the early stages (to 42 days of amenorrhea);
• training and induction of labor at term.

Dosage regimen

The drug should only be used in facilities encounter under the supervision of a physician.

For the medical termination of pregnancy: 600 mg of mifepristone (3 for tablets 200 mg) taken orally once in the presence of a doctor. The patient should be under medical supervision, at least, during 2 h after application. Through 36-48 h after dosing Mifegin® patient should come to the US control. Through 8-14 days to re-performed clinical examination and ultrasound control, as well as determine the level of beta-human chorionic hormone to confirm, that the miscarriage occurred. In the absence of effect of the drug on 14 day (incomplete abortion or ongoing pregnancy) vakuumaspiratsiyu conducted with subsequent histological examination of aspirate.

For the preparation and induction of labor: single 200 mg of mifepristone ( 1 tablets)/ inside in the presence of a doctor. Through 24 h readmission 200 mg. Through 48-72 h assesses the state of the birth canal, and, of necessity, prostaglandins or oxytocin appointed.

Side effect

Bleeding from the genital tract, discomfort and pain in the abdomen, acute inflammation of the uterus and appendages, weakness, headache, nausea, vomiting, diarrhea, dizziness, hyperthermia, hives.

Against the background of combined treatment with misoprostol (additionally): vaginitis, dyspepsia, insomnia, asthenia, scelalgia, anxiety, anemia, decrease in hemoglobin (more than 2 g / dl), fainting, white.

Contraindications

• adrenal insufficiency;
• acute or chronic renal and / or hepatic insufficiency;
• porphyria;
• long-term use of glucocorticoids;
• anemia;
• violation of hemostasis (incl. previous treatment with anticoagulants);
• the presence of severe extragenital;
• a history of hypersensitivity to mifepristone and / or auxiliary components.

For the medical termination of pregnancy:

• Suspected ectopic pregnancy;
• pregnancy, not confirmed by clinical studies;
• pregnancies beyond 42 days of amenorrhea;
• pregnancy, stepping on the background of an intrauterine contraceptive or after cancellation of hormonal contraception;
• inflammatory diseases of the genital organs;
• Smoking in women over 35 years without consulting a therapist.

For the preparation and induction of labor:

• severe preeclampsia, preэklampsiya, eclampsia;
• preterm or post-term pregnancy;
• placenta previa;
• size mismatch of the fetal head and pelvis woman;
• abnormal fetal position;
• bleeding from the genital tract of unknown etiology.

With caution is prescribed for chronic obstructive pulmonary disease (incl. asthma), hypertension, Arrhythmia, chronic heart failure.

Pregnancy and lactation

Breast-feeding should be discontinued at 14 days after mifepristone.

Cautions

Patients, They must be informed, that if 10-14 Day effect of the drug is absent (incomplete abortion or ongoing pregnancy), Be sure to interrupt the pregnancy in any other way, since it is possible the formation of congenital malformations in the fetus.

Use of the drug requires a warning rhesus allo immunization and other general activities, concomitant abortion.

Patients with artificial heart valves, or infective endocarditis with mifepristone should be carried out preventive treatment with antibiotics.

The drug should be used in hospitals obstetrical and gynecological, having the appropriate license, trained medical staff and the necessary equipment.

Overdose

Mifepristone at doses up to 2 g does not cause unwanted reactions. In cases of overdose can occur adrenal insufficiency.

Drug Interactions

Avoid the use of non-steroidal anti-inflammatory drugs for 8-12 days after mifepristone.

Conditions of supply of pharmacies

The drug can be delivered only in the medical obstetric and gynecological institutions, have a license for this kind of activity.

Conditions and terms

A List. Keep out of reach of children, dry, dark place at a temperature no higher than 25 ° C. Shelf life – 3 year.