Gynoestryl

Гинестрил Drug photo

The description is actual on 31.03.2015

  • Latin name: Gynestril
  • ATH code: G03XB01
  • Active ingredient: Mifepristone (Mifepristone)
  • Producer: LLC Mir-farma (Russia)

Structure

1 tablet includes 50 mg of mifepristone – active ingredient.

Minor ingredients: potato starch, lactose, microcrystallic cellulose, povidone, magnesium stearate, sodium carboxymethylstarch.

Release form

Drug Ginestril is issued in the form of tablets on 50 mg No. 30.

Pharmacological action

Antigestagennoye.

Pharmacodynamics and pharmacokinetics

Gynoestryl is steroid antigestagenny drug of a synthetic origin.

Mifepristone at the level of receptors blocks effects of progesterone, at the same time, without showing gestagenny activity.

Note antagonism of drug with glucocorticoids, because of the competition of binding at the receptor level.

The main role in development of a leiomyoma of a uterus is assigned to sex hormones, in particular progesterone in this connection, purpose of mifepristone for the purpose of blocking of progesteronovy receptors well influences both a growth inhibition of the tumor, and decrease in the sizes of a uterus and myomatous nodes.

At reception orally Cmax is observed in 80 minutes, bioavailability equals 69%.

Communication with plasma proteins is carried out for 98% (with acid alpha 1 - a glycoprotein and albumine).

Behind a phase of distribution there passes the slow phase of removal, with double reduction of concentration between 12-72 hours then removal proceeds more quickly, with an elimination half-life at the level of 18 hours.

Indications to use

Drug Ginestril is shown for:

  • therapies of a uterine leiomyoma (the size about 3 months of pregnancy);
  • induction (stimulation) of patrimonial activity at the full-term pregnancy;
  • abortions (uterine) on term till 42 days of an amenorrhea;
  • emergency contraception (post-coital), at unreliability of the used contraceptive means or during the period after completion of the unprotected sexual intercourse.

Contraindications

At a leiomyoma

  • tumors of ovaries;
  • submucous placement of myomatous nodes;
  • endometria hyperplasia;
  • the size of a leiomyoma of more admissible (the size about 3 months of pregnancy).

For stimulation of patrimonial activity

  • preeclampsia;
  • heavy gestosis;
  • eclampsia;
  • postmature or premature pregnancy;
  • abnormal presentation;
  • disproportion of the sizes of a basin of the woman in labor and head of a fruit;
  • not diagnosed bloody allocations from a genital tract during pregnancy.

For abortion

General contraindications

  • long therapy by glucocorticoids;
  • renal/liver failure (in any form);
  • porphyria;
  • heavy anemia;
  • disturbances of a hemostasis (also, treatment by anticoagulants in the past);
  • extragenital pathology of difficult character (without consultation of the doctor);
  • pathologies of a female reproductive system of inflammatory genesis;
  • hypersensitivity (also, in the anamnesis);
  • nicotinodependence after 35 years.

With care

Side effects

TSNS:

System of digestion:

  • the nausea passing into vomiting;
  • diarrhea.

Allergic manifestations:

Reproductive system:

  • bloody allocations;
  • amenorrhea;
  • frustration of a menstrual cycle;
  • lohia serosa;
  • deepening of inflammatory processes of appendages and uterus;
  • uterus subinvolution.

Others:

  • pains and discomfort in the bottom of a stomach;
  • hyperthermia;
  • weakness.

Application instruction of Ginestril

At a uterus leiomyoma

Usually appoint Ginestril in a single daily dose 50 mg. Drug is accepted orally for 3 months.

For stimulation of patrimonial activity

Once in a dose of 200 mg, in the presence of the gynecologist, with repeated reception of an unambiguous dose in 24 hours. After 48-72 carry out an assessment of expansion of patrimonial ways, with possible further use of prostaglandins or Oxytocin.

For abortion

Gynoestryl to abortion is also applied in the presence of the gynecologist, in the single dose of 600 mg accepted in 60-90 minutes after food and which is washed down with 100 ml of water. For increase in efficiency of mifepristone purpose of 400 mg of a mizoprostol is possible  (synthetic E1 prostaglandin).

The patient is obliged to be under supervision of doctors not less than 2 hours after reception of a dose. In 36-48 hours carry out ultrasonography control. 8-14 days later conduct repeated ultrasonography and clinical examination, and also establish the maintenance of a chorionic gonadotrophin for confirmation of an abortion.

In a case absence of the expected effect in 2 weeks (continuation of pregnancy or incomplete abortion), recommend carrying out vacuum aspiration with further histologic research of results of procedure.

At post-coital contraception

Recommend oral administration of 10 mg of mifepristone in the next 72 hours after sexual intercourse (it is not dependent on a menstrual phase), in 2 hours prior to or after food.

Overdose

Ginestril's use in dosages to 2 grams did not cause negative reactions.

At overdose forming of adrenal insufficiency which demands a symptomatic treatment is possible.

Interaction

Do not recommend parallel use of NPVS.

At the combined reception from glyukortikoida it is necessary to increase a dosage of the last.

Terms of sale

Gynoestryl is on sale upon presentation of the recipe.

Storage conditions

To 30 °C, in the dry and dark room.

Period of validity

Of date of production – 5 years.

Special instructions

Do not recommend as a constant contraceptive.

In case of use for abortion, the patient has to be informed on need of its obligatory interruption in a different way if for the 10-14th day after Ginestril's reception incomplete abortion is observed or pregnancy continues, in connection with high risk of development of inborn defects in a fruit.

At mifepristone reception, to patients with an infectious endocarditis or artificial heart valves, it is necessary to appoint preventive antibacterial treatment.

At Ginestril's appointment the prevention a Rhesus factor-alloimmunizatsii and carrying out the other general actions accompanying abortion procedure is necessary.

Analogs

Zdravzona

  • Gynoestryl (mifepristone) of 50 mg No. 30 tabletkimir-farm closed joint stock company
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Section: Gynecologic Hormonal Contraceptives
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Education: Graduated from the Vinnytsia national medical university of N. I. Pirogov, pharmaceutical faculty, the higher pharmaceutical education – the specialty "Pharmacist".

Experience: Work in Koneks and Bios-Media pharmacy chains as "Druggist". Work as "Pharmacist" in Avicenna pharmacy chain of the city of Vinnytsia.

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