Active substanceProgesteroneProgesterone
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  • Dosage form: & nbspsolution for intramuscular administration [oily]
    Composition:

    1 ml of the preparation contains:

    active substance: progesterone 10 mg or 25 mg;

    Excipients: benzyl benzoate medical 0,2 ml, olive oil up to 1 ml.

    Description:Transparent oily liquid of light yellow or golden yellow color.
    Pharmacotherapeutic group:gestagen
    ATX: & nbsp

    G.03.D.A   Derivative derivatives

    G.03.D.A.04   Progesterone

    Pharmacodynamics:

    The hormone of the yellow body, has a gestagenic effect. By binding to receptors on the surface of cells of target organs, it penetrates into the nucleus, where, by activating deoxyribonucleic acid, it stimulates the synthesis of ribonucleic acid. Promotes the transition of the mucous membrane of the uterus from the proliferation phase, caused by the follicular hormone, into the secretory,and after fertilization creates the necessary conditions for the implantation and development of a fertilized egg. Reduces excitability and contractility of the muscles of the uterus and fallopian tubes, stimulates the development of the end elements of the breast.

    Stimulating proteinolipase, increases fat stores, increases the utilization of glucose, increases the concentration of basal and stimulated insulin, promotes the accumulation of glycogen in the liver, increases the production of aldosterone; in small doses accelerates, and in large - suppresses the production of gonadotropic hormones of the pituitary gland; reduces azotemia, increases the excretion of nitrogen in the urine. Activates the growth of the secretory department of the mammary glands and induces lactation. Promotes the development of normal endometrium.

    Pharmacokinetics:

    Quickly and almost completely absorbed after intramuscular injection. Metabolized in the liver with the formation of conjugates with glucuronic and sulfuric acids. Also, isozyme participates in the metabolism CYP2C19. Half-life is a few minutes. It is excreted by the kidneys - 50-60%, with bile - more than 10%. The amount of metabolites excreted by the kidneys varies depending on the phase of the yellow body.

    Indications:

    Amenorrhea, anovulatory metrorrhagia, endocrine infertility (including insufficiency of the yellow body), threat of abortion; oligomenorrhoea, algodismenorea (on the basis of hypogenitalism); diagnosis of the formation of endogenous estrogens.

    Contraindications:Hypersensitivity; breast and genital cancers (as monotherapy); liver failure; pregnancy (II-III trimesters); propensity to thrombosis, acute forms of phlebitis or thromboembolic diseases; vaginal bleeding of unknown origin; abortive miscarriage; porphyria.
    Carefully:

    Diseases of the cardiovascular system, arterial hypertension, chronic renal failure, diabetes mellitus, bronchial asthma, epilepsy, migraine, depression; hyperlipoproteinemia, ectopic pregnancy, lactation.

    Dosing and Administration:

    The drug is administered intramuscularly.

    With bleeding associated with ovarian dysfunction, appoint 5-15 mg daily, for 6-8 days; if the scraping of the mucous membrane of the uterine cavity is preliminary performed, the injections are started after 18-20 days (if the scraping is impossible, injected during bleeding).During the treatment, bleeding may temporarily increase (by 3-5 days); sharply asthenizirovannym patient must first carry out blood transfusion (200-250 ml). After stopping bleeding, therapy is continued for 6 days. If after 6-8 days of treatment the bleeding does not stop, further administration is impractical.

    With hypogenitalism and amenorrhea injected after the use of estrogenic drugs in the form of injections of 5 mg daily or 10 mg every other day, for 6-8 days.

    With algodismenorea treatment is started 6-8 days before menstruation at 5 or 10 mg daily, for 6-8 days.

    With algodismorrhoea caused by uterine underdevelopment, combined with estrogen at a rate of 10,000 units every other day for 2-3 weeks; then within 6 days introduce progesterone.

    For the prevention and treatment of a threatening and beginning miscarriage associated with a deficiency of the function of the yellow body, - 10-25 mg daily or every other day, until the symptoms of a possible miscarriage disappear completely.

    With habitual abortion introduce up to 4 months of pregnancy.

    When the yellow body is deficient - 12.5 mg / day for 2 weeks from the moment of ovulation (when necessary - up to 11 weeks of pregnancy).

    Diagnosis of the formation of endogenous estrogens: 100 mg once.

    Side effects:

    From the nervous system: drowsiness, headache, depression, apathy, dysphoria.

    From the digestive system: cholestatic hepatitis, nausea, vomiting, decreased appetite, calculous cholecystitis.

    From the genitourinary system: decreased libido, reduced menstrual cycle, intermediate bleeding.

    From the sense organs: impaired vision.

    From the side of the cardiovascular system: increased blood pressure, swelling, thromboembolism (including pulmonary arteries and cerebral vessels), thrombophlebitis, retinal vein thrombosis.

    From the endocrine system: galactorrhea, alopecia, weight gain, increase, pain and tension of the mammary glands; hirsutism.

    Allergic reactions.

    Local reactions: pain in the injection site.

    Overdose:

    When using higher doses of the drug, the side effects described in the corresponding section are more likely. If gestagen-dependent side effects occur, the drug should be discontinued and, after their disappearance, resumed at a reduced dosage.If necessary, perform symptomatic treatment.

    Interaction:

    Reduces the lactogenic effect of oxytocin.

    Reduces the intensity of action of drugs that stimulate the smooth muscles of the uterus, anabolic steroids, gonadotropic hormones of the anterior lobe of the pituitary gland.

    With simultaneous use with barbiturates, a decrease in the action of progesterone is noted.

    Special instructions:

    No data.

    Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
    Form release / dosage:

    Solution for intramuscular administration [oily], 10 mg / ml, 25 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 polyvinyl chloride film. 2 contour squeeze packs with instructions for use and a knife for opening ampoules or a scarifier ampullum are placed in a pack of cardboard.

    When using ampoules with break points or rings, the ampoule opener or ampoule scaper 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.

    After expiration date the drug should not be used.

    Terms of leave from pharmacies:On prescription
    Registration number:P N002804 / 01-2003
    Date of registration:26.05.2008
    The owner of the registration certificate:DALHIMFARM, OJSC DALHIMFARM, OJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspDALHIMFARM, OJSCDALHIMFARM, OJSC
    Information update date: & nbsp02.09.2015
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