Expiration date: 01/2025

Structure and Composition:

Tablets. 1 tablet contains 200 mg of mifepristone

Excipients: MCC Sodium carboxymethylstarch calcium stearate, talc

in blisters 2 or 3 pieces. a stack of cardboard packaging 1 or 2 or a polymeric banks 2, 3 or 6 pieces. In the paper cartons 1 bank.

Description pharmaceutical form:

Tablets are light yellow or light yellow with greenish hue color, Valium forms, with Valium and a facet.

Pharmacokinetics:

After receiving a single dose of 600 mg Cmax 1,98 mg / l is reached in 1.3 hours. The absolute bioavailability is 69%.

In plasma mifepristone is 98% bound to proteins - albumin and alpha 1-acid glycoprotein. After removing first phase distribution is slow, decreases the concentration of 2-fold between 12-72 hours, and then more quickly. T1 / 2 is 18 h.

Description of the pharmacological actions:

Mifepristone - synthetic steroid antigestagens means (blocks the action of progesterone at the receptor level) progestogenic activity is not. Marked antagonism with GCS (due to competition on the level of communication with the receptors).

Increases contractility of the myometrium, stimulating the release of IL-8 in horiodetsidualnyh cells, increasing the sensitivity of the myometrium to the PG. As a result of the drug takes place decidua desquamation and removal of the ovum.

Testimony:

• interruption of early intrauterine pregnancy (up to 42 days of amenorrhea) in combination with misoprostol
  
• training and induction of labor.
  

Contraindications:

• a history of hypersensitivity to mifepristone
  
• adrenal insufficiency and long-term GCS therapy
  
• acute or chronic renal and / or hepatic impairment
  
• porphyria
  
• Uterine fibroids (for a given dosage form)
  
• Severe anemia (hemoglobin level of less than 100 g / l)
  
• hemostatic disorders (including previous treatment with anticoagulants)
  
• acute pelvic inflammatory disease
  
• presence of severe extragenital pathology
  
• smoking women older than 35 years (without prior consultation of the therapist).
  

For the medical termination of pregnancy (optional):

• suspicion of ectopic pregnancy
  
• pregnancy not confirmed by clinical studies, as well as exceeding the deadline by 42 days of amenorrhea
  
• pregnancy, appeared at the background of intrauterine contraception, or after the cancellation of hormonal contraception.
  

For the training and induction of labor (optional):

• preeclampsia, severe preeclampsia-eclampsia
  
• preterm or post-term pregnancy
  
• size mismatch pelvis maternal and the fetal head,
  
• abnormal fetal position
  
• spotting during pregnancy from the genital tract, unspecified etiology.
  

Carefully:

• chronic obstructive pulmonary disease
  
• bronchial asthma
  
• arterial hypertension
  
• cardiac arrhythmias
  
• heart failure.
  

Application of pregnancy and breastfeeding:

Breast-feeding should be discontinued 3 days after receiving Miropristona in the case of medical abortion.

Using Miropristona for preparing for childbirth cervix does not affect the subsequent lactation.

Side effect:

Related mifepristone: a sense of discomfort in the abdomen, weakness, headache, nausea and vomiting, dizziness, pyrexia, rash.

Related to the procedure of medical abortion: bleeding from the genital tract, abdominal pain exacerbation of inflammatory processes of the uterus and appendages.

Drug Interactions:

NSAIDs should be avoided. At simultaneous reception Valium and Miropristona need to increase the dose of the latter.

Dosage and administration:

Inside. The drug should be used only in hospitals that have a properly trained medical personnel and necessary equipment.

For the medical termination of early pregnancy: 600 mg Miropristona (. 3 Table 200 mg) taken once in the presence of a doctor, after 1-1.5 hours after a meal (continental breakfast), we washed down with a half cup of boiled water. Within 36-48 hours after receiving Miropristona patient should come to the hospital to receive 400 mcg misoprostol. After administration of misoprostol must be dynamic medical supervision for 2 hours. After 10-14 days to re-conducted clinical examination and ultrasound control, if necessary, to determine the level of human chorionic gonadotropin to confirm that there was a miscarriage.

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

For the training and induction of labor: inside 200 mg Miropristona (. Table 1) once in the presence of a doctor. After 24 h - 200 mg repeated reception. After 48-72 hours, assesses the state of the birth canal and, if necessary, prescribe oxytocin or PG.

Overdose:

Symptoms mifepristone at doses up to 2 g does not cause unwanted reactions. In cases of overdose adrenal insufficiency may occur.

Special instructions:

Patients using Miropriston for abortion in early pregnancy should be informed that if the effect on the 10-14 day of the drug is not available (incomplete abortion or ongoing pregnancy), pregnancy, be sure to interrupt the other way, because it is possible the formation of congenital malformations in the fetus .

Use of the drug requires prevention of Rh-alloimmunization and conduct other common measures related to abortion.