Active substanceMifepristoneMifepristone
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  • Dosage form: & nbsppills
    Composition:One tablet contains:
    Active substance - mifepristone - 10 mg.
    Excipients: sugar milk (lactose), corn starch, aerosil (silicon dioxide colloid), microcrystalline cellulose for medical purposes, calcium stearate (calcium stearic acid).
    Description:Tablets of light yellow color with a greenish shade of color, a flat-cylindrical shape with a bevel. "Marble" is allowed.
    Pharmacotherapeutic group:Antigestagen
    ATX: & nbsp

    G.03.X.B.01   Mifepristone

    Pharmacodynamics:Mifepristone - a synthetic steroid anti-gestagenic agent, does not possess gestagenic activity. Antagonism with glucocorticosteroids was noted (due to competition at the level of communication with receptors). The effect of mifepristone is due to the blocking of the action of progesterone at the receptor level. 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 oral dose of 600 mg, the maximum concentration 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. It is used within 72 hours after sexual intercourse without the use of contraceptives or methods, or in case of their unsuccessful application (for example, an error with the use of the calendar method, unsuccessful interruption of the sexual intercourse, rupture or slipping of the condom).
    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, anemia, the presence of severe extragenital pathology, pregnancy; the period of breastfeeding.
    Carefully:Violation of hemostasis (including the previous treatment with anticoagulants), chronic obstructive pulmonary disease (including bronchial asthma), severe arterial hypertension, cardiac arrhythmias, heart failure.
    Dosing and Administration:Inside, for 72 hours after unprotected sexual intercourse, 1 tablet of AGESTA. To maintain the contraceptive effect, you should refrain from eating 2 hours before the drug and 2 hours after it. AGHESTA can be used by a woman in any phase of the menstrual cycle.
    Side effects:Feeling of discomfort in the lower abdomen, weakness, headache, dizziness, nausea, vomiting, diarrhea, hyperthermia, spotting from the genital tract, menstrual irregularities.
    Overdose:The intake of mifepristone in doses up to 2 g does not cause undesirable reactions. In case of an overdose of the drug, acute adrenal insufficiency
    Interaction:Use of non-steroidal anti-inflammatory drugs should be avoided. they can reduce the contraceptive effect.
    Special instructions:It is not recommended to regularly use AGESTA as a planned, permanent contraception after each sexual intercourse, and it is not recommended to apply the drug on a monthly basis.
    It is recommended to use Agesta after the completion of the complete menstrual cycle preceding the one during which the method of emergency contraception is applied.
    After applying the drug to the end of this menstrual cycle it is desirable to refrain from subsequent sexual acts or use barrier methods of contraception.
    The dose of 10 mg is not enough to cause abortion, so before using it, a highly sensitive pregnancy test should be conducted, ensuring that only women who do not become pregnant use this drug to prevent pregnancy.
    In the absence of effect from the use of the drug, it is recommended to interrupt the pregnancy with a medication or surgical method. If the patient decides to keep the pregnancy, it is impossible to completely exclude the risk to the health of the unborn child.
    AGESTA does not protect against sexually transmitted diseases and AIDS.
    Form release / dosage:Tablets 10 mg.
    Packaging:1 or 2 tablets per contour cell packaging made of polyvinylchloride film EP-73 and aluminum foil printed lacquered.
    For 1 or 2 tablets in a polymer can with a screw or barrier type of locking in a volume of 10 ml. 20 ml or 25 ml.
    Storage conditions:In a dry, protected from light place at a temperature of no higher than 25 ° C. In a place inaccessible to children.
    Shelf life:3 years.

    Do not use after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-005269/07
    Date of registration:25.12.2007/13.10.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Promomed Rus, Open CompanyPromomed Rus, Open Company Russia
    Manufacturer: & nbsp
    Information update date: & nbsp21.01.2017
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