Universal reference book for medicines
Product name: AGESTA (AGESTA)

Active substance: mifepristone

Type: Anti-gestagenic drug

Manufacturer: BIOCHEMIK (Russia)
Description of the active substance :.
This information is a reference and it is not enough that the drug was prescribed by a doctor.
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PHARMACHOLOGIC EFFECT
Synthetic steroidal anti-gestagenic agent.
Blocks the action of progesterone at the level of gestagen receptors. Gestagenic activity does not possess, antagonism with GCS is noted (due to competition at the level of communication with receptors).
Depending on the phase of the menstrual cycle, it causes an increase in the contractility of the myometrium, stimulating the release of interleukin-8 in choroidectid cells, increasing the sensitivity of the myometrium to the prostaglandins (to enhance the effect used in conjunction with the synthetic analogue of prostaglandin), resulting in desquamation of the decidua and excretion of the fetal egg .
It causes inhibition of ovulation, changes in the endometrium and prevents the implantation of a fertilized egg.
A key role in the pathogenesis of uterine leiomyoma is played by sex hormones, especially progesterone.
The blockade of progesterone receptors can contribute both to inhibition of tumor growth, and to a decrease in the size of the myomatous nodes and uterus.
INDICATIONS
Interruption of uterine pregnancy in early periods (up to 42 days amenorrhea);
induction of labor in term of pregnancy; emergency postcoital contraception (after unprotected intercourse or if the contraceptive method used can not be considered reliable); uterine leiomyoma (up to 12 weeks gestation).
DOSING MODE
For medical abortion: inside, in the presence of a doctor, once 600 mg (1-1.5 hours after eating, drinking 100 ml of water).
In order to increase the effect of mifepristone, a synthetic analogue of prostaglandin E1-misoprostol is prescribed at a dose of 400 mg. The patient should be supervised by the medical personnel for at least 2 hours after use.After 36-48 hours after taking mifepristone, the patient should undergo ultrasound testing. After 8-14 days, a clinical examination and ultrasound are repeated, and the level of chorionic gonadotropin is determined to confirm the abortion. In the absence of the effect of mifepristone on day 14 (incomplete abortion or continuing pregnancy), vacuum aspiration is performed followed by histological examination of the aspirate.
For the preparation and induction of labor: inside, in the presence of a doctor, once 200 mg of mifepristone.
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 are administered.
Postcoital contraception: inside at a dose of 10 mg (regardless of the phase of the menstrual cycle), 2 hours before or 2 hours after ingestion (the next 72 hours after unprotected sexual intercourse).

Leiomyoma of the uterus: inside the dose of 50 mg 1 time / day, the duration of treatment - 3 months.

SIDE EFFECT
From the digestive system: nausea, vomiting, diarrhea.

From the side of the central nervous system: dizziness, headache.

On the part of the reproductive system: bloody discharge from the genital tract, menstrual irregularities, amenorrhea, exacerbation of the inflammatory processes of the uterus and appendages, the lychiometer, the subinvolution of the uterus.

Allergic reactions: urticaria.

Other: a feeling of discomfort and pain in the lower abdomen, weakness, hyperthermia.

CONTRAINDICATIONS
General contraindications: adrenal insufficiency, long-term use of SCS, acute or chronic renal failure, acute or chronic hepatic insufficiency, porphyria, uterine myoma, severe anemia, hemostasis disorders (including previous anticoagulant therapy), inflammatory diseases of female genital organs, severe extragenital pathology (without the advice of a therapist), smokers of women over 35 years of age, hypersensitivity to mifepristone (in the anamnesis).

With medical abortion: a suspicion of ectopic pregnancy, pregnancy, not confirmed by clinical studies, pregnancy for more than 42 days of amenorrhea, pregnancy that occurs with the use of intrauterine contraception or after the abolition of hormonal contraception.

In the preparation and induction of labor: severe 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.

With leiomyoma: submucous location of myomatous nodes, the size of uterine leiomyoma, exceeding in the sizes of 12 weeks of pregnancy, ovarian tumors, endometrial hyperplasia.

With caution should be prescribed for chronic obstructive pulmonary diseases, bronchial asthma, arterial hypertension, arrhythmias, chronic heart failure, heart rhythm disturbances.

PREGNANCY AND LACTATION
If it is necessary to administer mifepristone, breastfeeding should be stopped for 14 days.

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

APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in acute or chronic renal failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in acute or chronic hepatic insufficiency.

SPECIAL INSTRUCTIONS
Patients using mifepristone for early termination of pregnancy should be informed that if on the 10-14th day the effect from the application is absent (incomplete abortion or continuing pregnancy), pregnancy should necessarily be discontinued in another way because of the risk of congenital malformations in the fetus.

The use of mifepristone requires the prevention of rhesus-alloimmunization and other common activities associated with abortion.

Patients with artificial heart valves or infective endocarditis with mifepristone should be given prophylactic antibacterial therapy.

Simultaneous administration of mifepristone with NSAIDs should be avoided.

The use of mifepristone for postcoital contraception does not protect against sexually transmitted diseases and AIDS.

It is not recommended for regular use as a planned continuous contraceptive.

DRUG INTERACTION
With the simultaneous use of mifepristone and GCS, it is necessary to increase the dose of the latter.


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