Active substanceOxytocinOxytocin
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  • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:

    1 ampoule contains:

    active substance: oxytocin synthetic 5 ME;

    Excipients: chlorobutanol hydrate, water for injection, acetic acid 1 M solution to pH 3.0-4.5.

    Description:

    Transparent colorless liquid with the smell of chlorobutanol hydrate.

    Pharmacotherapeutic group:Generic activity stimulant - oxytocin preparation
    ATX: & nbsp

    H.01.B.B.02   Oxytocin

    Pharmacodynamics:

    Hormonal agent, polypeptide analogue of the hormone of the posterior lobe of the pituitary gland. Has uterotonizing, stimulating labor and lactotropic action.Has a stimulating effect on the myometrium (especially at the end of pregnancy, during labor and immediately during delivery). Under the influence of oxytocin, the permeability of cell membranes for Ca2+, the resting potential decreases and their excitability increases (a decrease in the membrane potential leads to an increase in the frequency, intensity, and duration of contractions). Stimulates the secretion of breast milk, increasing the production of prolactin in the anterior pituitary gland. Reduces myoepithelial cells around the alveoli of the breast, stimulates the flow of milk into large ducts or sinuses, contributing to increased separation of milk.

    Virtually devoid of vasoconstrictor and antidiuretic action (only in high doses), does not cause contraction of the muscles of the bladder and intestines.

    Pharmacokinetics:T1/2 - 1-6 min (decreased in late pregnancy and lactation). The connection with plasma proteins is low (30%). Metabolised in the liver and kidneys. During pregnancy in plasma, target organs, placenta, the concentration of oxytocinase inactivating the endogenous and exogenous oxytocin. Excretion in the main kidneys unchanged.
    Indications:

    To stimulate and stimulate labor; for the prevention and treatment of hypotonic uterine bleeding in the early postpartum period and for the acceleration of the postpartum involution of the uterus.

    Contraindications:

    Increased individual sensitivity to the drug, hypertension, renal failure, predisposition to rupture of the uterus, excessive uterine stretching, uterus after multiple births, the presence of scars after a cesarean section or other operations on the uterus, narrow pelvis (anatomical and clinical), transverse or oblique fetus, facial presentation of the fetus, suspicion of premature detachment of the placenta, placenta previa; intrauterine fetal hypoxia, premature birth, hypertension of the uterus (which did not occur during delivery), fetal compression, uterine sepsis, invasive cervical carcinoma.

    Dosing and Administration:

    Oxytocin is administered intravenously or intramuscularly.

    To excite the delivery of intramuscularly administered 0.5-2.0 ME oxytocin; if necessary, repeat the injection every 30-60 minutes.

    For intravenous drip injection, dilute 1 ml of oxytocin (5 ME) in 500 ml of a 5% solution of glucose. Introduction begins with 5-8 drops per minute, followed by an increase in speed, depending on the nature of labor, but not more than 40 drops per minute.

    For the prevention of hypotonic uterine bleeding oxytocin administered intramuscularly for 3-5 ME 2-3 times a day daily for 2-3 days, and for the treatment of hypotonic uterine bleeding, 5-8 ME 2-3 times a day for 3 days.

    In the operation of cesarean section (after removal of the afterbirth) oxytocin injected into the wall of the uterus at a dose of 3-5 ME.

    Side effects:

    Nausea, vomiting, arrhythmia and bradycardia (in the mother and fetus), allergic reactions, bronchospasm, water retention and increased blood pressure (BP), subarachnoid bleeding, decreased blood pressure, shock, neonatal jaundice, decreased fibrinogen concentration in the fetus, and excessive active labor that can cause acute fetal hypoxia, premature detachment of the normally located placenta, rupture of the uterus. If such symptoms appear, stop the injection immediately.

    Overdose:

    Hyperstimulation of the uterus, which can lead to hypertonia and tetanic contractions of the uterus, which in turn can lead to rupture of the uterus, postpartum hemorrhage,various changes in the fetal heart activity, hypoxia, asphyxia, birth trauma and fetal death. With prolonged use of oxytocin in large doses by infusion (40-50 ml / min), symptoms associated with the antidiuretic effect of oxytocin (water intoxication, convulsions) may appear.

    In case of an overdose, immediately stop the injection of oxytocin, force diuresis, start symptomatic therapy and introduce hypertonic saline solutions (to normalize the electrolyte balance).
    Interaction:

    Use with caution oxytocin in combination with sympathomimetics (enhances the pressor effect of sympathomimetics). In combination with MAO inhibitors, the risk of increasing blood pressure increases.

    Halothane and cyclopropane increase the risk of developing arterial hypotension.

    Special instructions:

    Apply only under the supervision of a doctor in a hospital environment under the control of the contractile activity of the uterus, fetal condition, blood pressure and the general condition of the woman.

    Form release / dosage:

    Solution for intravenous and intramuscular injection, 5 IU / ml.

    Packaging:

    Into ampoules of 1 ml.

    10 ampoules per pack (carton) of cardboard.

    5 ampoules in the outline of the cell.

    2 contour squares in a pack of cardboard.

    In each pack you put the instructions for use, the ampoule knife or the ampoule scarifier.

    When you pack the ampoules with a worn knife and scarifier ampoule do not invest.

    Storage conditions:

    Store in a dark place at a temperature of 8 to 20 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N001193 / 01
    Date of registration:05.03.2009 / 19.07.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Information update date: & nbsp25.05.2017
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