Sinestrol (Synoestrol)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceHexestrolHexestrol
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  • Sinestrol
    solution w / m 
    DALHIMFARM, OJSC     Russia
    • Dosage form: & nbspsolution for intramuscular administration [oily].
    Composition:Synestrol - 1g or 20g;
    olive oil or peach oil - up to 1L.
    Description:Transparent oily liquid of light yellow or golden yellow color. Crystalline precipitation or crystallization of the entire contents of the ampoule is allowed. In the case of crystal precipitation or crystallization of the entire contents of the ampoule, the ampoule should be heated in a boiling water bath with shaking. If the crystals disappear and the solution becomes transparent, and upon cooling to 36-38 ° C the crystals do not fall again, the solution is usable.
    Pharmacotherapeutic group:Estrogen
    ATX: & nbsp

    G.03.C.A   Natural and semi-synthetic estrogens

    Pharmacodynamics:Sinestrol is a hormonal drug, in chemical structure differs from steroid estrogenic hormones, but on biological and medical properties is close to them.

    The therapeutic effect of synestrol is identical to the action of follicular hormone preparations, both with respect to the effect on the uterus and mammary glands, and on the effects on the cardiovascular, nervous systems and on the general condition of the female body.

    Under the influence of synestrol, the blood supply to the genital organs is increased,Endometrial proliferation processes are activated. Sinestrol can cause engorgement and enlargement of the mammary glands due to the proliferation of glandular tissue.

    The drug has the property to eliminate vegetative-vascular disorders that occur in women on the basis of depletion of ovarian function (menopause, condition after castration).
    Pharmacokinetics:Absorption is high, has the effect of "first passage" through the liver. Excretion by the kidneys; depending on the physiological state (individual phases of the menstrual cycle), age and other conditions, the rate of excretion is different.
    Indications:
    - conditions associated with insufficient function of the ovaries (primary and secondary amenorrhea, oligomenorrhea, dysmenorrhea);
    -hypoplasia of the genitals;
    - menopausal and post-stroke disorders;
    infertility; weakness of labor, miscarriage;
    - prostate cancer, breast cancer.

    Contraindications:Hypersensitivity to the components of the drug; pregnancy; liver and kidney disease; mastopathy, endometriosis, uterine bleeding of unclear etiology, as well as with various forms of hyperestrogenia; diseases,associated with the increase of the blood coagulability, malignant and benign neoplasms of the genital and other organs in women (under the age of 60 years).
    Inflammatory diseases of female genital organs (salpingoophoritis, endometritis), hyperphilicular stage of climacteric period, propensity to uterine bleeding.
    Dosing and Administration:The drug is administered as an oil solution intramuscularly.
    Before use, the ampoule should be heated to 30-40 ° C.
    - With hypogenitalism, primary amenorrhea and uterine underdevelopment I apply t 1-2 mg intramuscularly daily for 4-6 weeks or more. If there is an effect, then the progesterone or pregnin for 6-8 days. In secondary amenorrhea, 1 to 2 mg of Sinestrol is prescribed for 15-20 days, then for 6-8 days, progesterone or pregnin at the indicated dose;
    - With oligomenorrhea - intramuscularly 1 mg every day or every other day during the first half of the menstrual period;
    - Infertility due to uterine underdevelopment - 1 mg intramuscularly in the first 7-8 days after menstruation;
    - With menopausal disorders, appoint 0.5-1 mg.The duration of treatment is individualized;
    - For prostate adenoma, 2 ml of a solution of 20 mg / ml of Synestrol (0.04 g) are administered daily for 30 days. During the year, 2-3 more courses are held for 20 days at intervals of 2-3 months;
    - In prostate cancer, intramuscularly daily, 3-4 ml of a solution of 20 mg / ml of Synestrol (0.06-0.08 g) for 2 months, then 0.5-1 ml of a solution of 20 mg / ml per day intramuscularly. The total dose and duration of treatment depend on changes in the prostate gland, the presence or absence of metastases, the general condition and degree of feminization;
    - In breast cancer in women older than 60 years, use a solution of 20 mg / ml Sinestrol. Enter daily, starting with 1 ml per day, then the daily dose is gradually increased to 5 ml. By careful observation, an optimal dose is set, which is administered for a long time. Higher doses of Sioestrol for adults (intramuscular): one-time - 0,002 g (2 ml of solution 1 mg / ml); daily - 0.003 g.
    In the treatment of malignant neoplasms: the highest single dose - 0.06 g (3 ml of solution 20 mg / ml), the highest daily dose - 0.1 g (5 ml of solution 20 mg / ml).
    Side effects:Nausea, vomiting, dizziness, rash, edema of the eyelids, erythropenia.With prolonged use: in men - feminization (decrease in sexual function, swelling and pigmentation of the nipples, a decrease in the size of the testicles); in women - sclerosis of the ovaries, violation of sodium exchange (peripheral edema), metrorrhagia.
    Overdose:When taking large doses, toxic liver damage is possible; excessive proliferation of endometrium and uterine bleeding, peripheral edema, increased coagulability of blood. Expressed feminization in men (decreased sexual function, swelling and pigmentation of the nipples, a decrease in the size of the testicles).
    Interaction:
    Antiestrogenic agents (clomiphen citrate, etc.), used to treat infertility, are able to block estrogen receptors and weaken the action of estrogens.

    Folic acid and thyroid drugs intensify the action of synestrol.

    Side effects of synestrol are reduced under the influence of progestins (gestagens), which serves as the basis for the joint use of synestrol with gestagenic preparations (pregnin, progesterone and etc.). Synestrol enhances the action of lipid-lowering agents, diuretic, antiarrhythmic, antihypertensive drugs, indirect anticoagulants.
    Special instructions:The administration of the drug should be carried out only by the attending physician, under his supervision after an accurate diagnosis.
    Effect on the ability to drive transp. cf. and fur:Care should be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, since the drug may cause side effects that may affect these abilities.
    Form release / dosage:Solution for intramuscular administration [oily] 1 mg / ml and 20 mg / ml.
    Packaging:1 ml per ampoule of neutral glass.
    For 10 ampoules, together with the instruction for use and the ampoule opening opener or ampoule scarifier, is placed in a cardboard box.
    5 ampoules per contour cell pack of polyvinylchloride braids and aluminum foil lacquered or foil-free. 2 contour mesh packs together with instructions for use are placed in a pack of cardboard. When using ampoules with notches, rings and break points, the ampoule opener opener or ampoule scarifier is allowed not to be inserted.
    Storage conditions:In the dark place at a temperature of 5 to 30 ° C.
    Keep out of the reach of children.
    Shelf life:5 years. Do not use the product after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:P N002087 / 01
    Date of registration:05.02.2009/15.07.2014
    The owner of the registration certificate:DALHIMFARM, OJSC DALHIMFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp19.04.2016
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