Gynepristone® (Gynepriston)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceMifepristoneMifepristone
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    • Dosage form: & nbsppills
    Composition:
    One tablet contains:
    Active substance: mifepristone - 0.01 g.
    Excipients: cellulose microcrystalline - 0.0774 g, carboxymethyl starch sodium - 0.0045 g, calcium stearate - 0.0009 g.
    Description:Tablets are flat-cylindrical from light yellow to light yellow with a greenish tinge.
    Pharmacotherapeutic group:Antigestagen
    ATX: & nbsp

    G.03.X.B.01   Mifepristone

    Pharmacodynamics:
    Ginepriston® is a synthetic steroid anti-gestagenic agent (blocks the action of progesterone at the receptor level), does not possess gestational activity.Antagonism with glucocorticosteroids (GCS) was noted (due to competition at the level of communication with receptors).
    Increases the contractility of the myometrium, stimulating the release of interleukin-8 in choroidectid cells, increasing the sensitivity of the myometrium to prostaglandins. Depending on the phase of the menstrual cycle, inhibition of ovulation, changes in the endometrium and prevents the implantation of a fertilized egg.
    Pharmacokinetics:
    After a single dose of 600 mg, the maximum concentration in the blood serum of 1.98 mg / l is reached after 1.30 hours. Absolute bioavailability is 69%.
    The connection with blood plasma proteins (albumin and acid alpha 1 - glycoprotein) is 98%.
    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:Emergency (postcoital) contraception (after unprotected intercourse or if the method of contraception used can not be considered reliable).
    Contraindications:The presence in the anamnesis of hypersensitivity to mifepristone,adrenal insufficiency and long-term glucocorticosteroid therapy, acute and chronic renal and / or hepatic insufficiency, the presence of severe extragenital pathology.
    Carefully:Violation of hemostasis (including the previous treatment with anticoagulants), chronic obstructive pulmonary disease (including bronchial asthma), severe arterial hypertension, cardiac arrhythmias, heart failure.
    Pregnancy and lactation:The drug should not be used during pregnancy. Breastfeeding should be discontinued for 14 days after taking ginepriston®.
    Dosing and Administration:Inside, for 72 hours after unprotected sexual intercourse, 1 tablet of Ginepristone ® 10 mg. To maintain the contraceptive effect, you should refrain from eating 2 hours before the drug and 2 hours after it. Gynepristone can be used in any phase of the menstrual cycle.
    Side effects:Feeling of discomfort in the abdomen, weakness, headache, nausea, vomiting, dizziness, urticaria, hyperthermia, spotting from the genital tract, menstrual cycle disorders.
    Overdose:Taking ginepristone ® in doses up to 2 g does not cause undesirable reactions. In cases of drug overdose, adrenal insufficiency may occur.
    Interaction:Use of non-steroidal anti-inflammatory drugs should be avoided.
    Special instructions:Gyneprisgona® is not recommended for regular use as a planned, continuous contraception. Gineprisgona® does not protect against sexually transmitted diseases and AIDS.
    Effect on the ability to drive transp. cf. and fur:Currently, there is no evidence that the drug can affect the ability to drive and other mechanisms.
    Form release / dosage:Pills.
    Packaging:For 1 or 2 tablets in a contour mesh package and 1 or 2 tablets per can of polymer, 1 contour pack or jar along with instructions for use are placed in a pack of cardboard.
    Storage conditions:
    In a dry place protected from light. 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 indicated on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-000604
    Date of registration:21.06.2010 / 02.07.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:Nizhny Novgorod Chemical and Pharmaceutical Plant, OJSCNizhny Novgorod Chemical and Pharmaceutical Plant, OJSC
    Manufacturer: & nbsp
    Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia
    Information update date: & nbsp2016-09-19
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