Ginestril - instructions for use, dose, side effects, contraindications

One tablet contains: active substance: mifepristone - 0.05 g, Excipients: cellulose microcrystalline - 0.0661 g, carboxymethyl starch sodium - 0.0135 g, talc - 0.00405 g, calcium stearate - 0.00135 g.

Description:Tablets from light yellow to light yellow with a greenish tinge of flat-cylindrical shape with a bevel.

Pharmacotherapeutic group:Antigestagen

ATX: & nbsp

G.03.X.B.01 Mifepristone

Pharmacodynamics:

Ginestril® is a synthetic steroid anti-gestagenic agent (blocks the action of progesterone at the receptor level), does not possess gestational activity.Antagonism with glucocorticosteroids was noted (due to competition at the level of communication with receptors).

Sexual hormones play a key role in the pathogenesis of uterine leiomyoma, especially progesterone. The use of mifepristone as a blocker of progesterone receptors can contribute both to inhibition of tumor growth, and to a decrease in the size of the myomatous nodes and uterus.

Pharmacokinetics:

After oral administration, the maximum concentration is achieved after 1.3 hours. Absolute bioavailability is 69%.

In plasma, Ginestryl® binds 98% to proteins: albumin and acid alpha-1 glycoprotein.

After the distribution phase, the excretion first occurs slowly, the concentration decreases 2 times between 12-72 hours, then more rapidly.

The half-life is 18 hours.

Indications:Treatment of uterine leiomyoma (up to 12 weeks gestation).

Contraindications:

Pregnancy, lactation. The presence in the anamnesis of hypersensitivity to mifepristone, adrenal insufficiency and long-term glucocorticosteroid therapy, acute or chronic renal and / or hepatic insufficiency, porphyria, anemia,violations of hemostasis (including the previous treatment with anticoagulants), inflammatory diseases of female genital organs, the presence of severe extragenital pathology. Submucous location of myomatous nodes. The size of the uterus leiomyoma, exceeding in the sizes of 12 weeks of pregnancy. Ovarian tumors and / or endometrial hyperplasia.

Carefully:

Carefully apply for chronic obstructive pulmonary diseases (including bronchial asthma), severe arterial hypertension, heart rhythm disorders and heart failure.

Pregnancy and lactation:

Pregnancy and lactation are contraindications to the use of the drug.

Dosing and Administration:

Inside, in a single dose of 50 mg Ginestril ® (1 tablet), once. The course of treatment is 3 months.

Side effects:

Violations of the menstrual cycle, amenorrhea, discomfort and pain in the lower abdomen, headache, nausea, vomiting, diarrhea, dizziness, hyperthermia, weakness, urticaria.

Overdose:

Ginestryla® intake in doses up to 2 g does not cause undesirable reactions. In cases of drug overdose, adrenal insufficiency may occur. Treatment is symptomatic.

Interaction:

Use of non-steroidal anti-inflammatory drugs should be avoided. With simultaneous admission with glucocorticosteroids it is necessary to increase the dose of the latter.

Special instructions:

Patients with artificial heart valves or infective endocarditis with Ginestrol® should be preventive treatment with antibiotics.

Form release / dosage:Tablets 50 mg.

Packaging:

For 10 tablets of 50 mg in a planar cell package or 10, 20 or 30 tablets in a polymer can. For 1, 2, 3, 4 or 6 contour mesh packages or a jar along with the instructions for use are placed in a pack of cardboard.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N002340 / 02

Date of registration:14.03.2008

Expiration Date:Unlimited

The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia

Manufacturer: & nbsp

OBNINSKAYA CHEMICAL - PHARMACEUTICAL COMPANY, CJSC Russia

Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia

Information update date: & nbsp16.04.2017

Illustrated instructions

Instructions

Gynestril® (Gynestril®)