Active substanceOxytocinOxytocin
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  • Dosage form: & nbspsolution for injection and topical application
    Composition:

    1 ml of the preparation contains:

    active substance: Oxytocin synthetic 5 ME;

    Excipients: chlorobutanol hemihydrate (chlorobutanol hydrate) 5 mg, acetic acid to pH 3.0-4.5, water for injection up to 1 ml.

    Description:

    Transparent colorless or slightly colored liquid.

    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. It has a stimulating effect on the smooth muscles of the uterus, increases the contractile activity of the myometrium and to a lesser degree the tone (especially at the end of pregnancy, during labor and immediately during delivery). Under the influence of oxytocin, the permeability of cell membranes for calcium ions 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). In small doses oxytocin increases the frequency and amplitude of uterine contractions, in large doses or with repeated administration contributes to an increase in the tone of the uterus, the increase and intensification of its contractions (up to the tetanic).

    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 the strengthening of the milk compartment.

    Virtually devoid of vasoconstrictor and antidiuretic action (manifests them only in high doses), does not cause contraction of the muscles of the bladder and intestines.With intramuscular and subcutaneous injection of the drug, the effect occurs after 1-2 minutes and lasts for 20-30 minutes; when administered intravenously, the effect occurs 0.5-1 minutes; with intranasal administration, the effect occurs within a few minutes.

    Pharmacokinetics:

    Half-life -1-6 min (decreased in late pregnancy and lactation). The connection with plasma proteins is low (30%). Well absorbed through the nasal mucosa.

    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:

    For the initiation and stimulation of labor (primary and secondary weakness of labor, the need for early delivery in connection with gestosis, rhesus-conflict, intrauterine fetal death, delayed pregnancy, premature discharge of amniotic fluid, management of births in pelvic presentation).

    For prophylaxis and treatment of hypotonic uterine bleeding after abortion (including for long periods of pregnancy),in the early postpartum period and to accelerate postpartum involution of the uterus; to enhance the contractile capacity of the uterus in cesarean section (after removal of the afterbirth).

    Hypolactation in the postpartum period.

    Painful premenstrual syndrome, accompanied by edema, weight gain.

    Contraindications:

    Hypersensitivity; a narrow basin (anatomical and clinical), a transverse and oblique position of the fetus, facial presentation of the fetus, premature birth, threatening rupture of the uterus, scars on the uterus (after a previous cesarean section, operations on the uterus), excessive uterine stretching, uterus after multiple births, partial placenta previa, uterine sepsis, invasive cervical carcinoma; hypertension of the uterus (which did not occur during labor), fetal compression, arterial hypertension, chronic renal failure.

    Dosing and Administration:

    Intravenously (slowly and driply), intramuscularly, subcutaneously, into the wall or vaginal part of the cervix, intranasally (using a pipette).

    A single dose for the / m administration, depending on the clinical situation, usually varies from 2 to 10 ME (0.4 to 2 ml); for intravenous administration (jet slowly or drip) a single dose is usually 5-10 ME (1-2 ml).

    For excitation of childbirth: in / m, at 0.5-2 ME (0.1-0.4 ml of the preparation); if necessary, repeat the injection every 30-60 minutes.

    Induction of labor: in / in the drip, 10 ME oxytocin (2 ml of drug) per 1 L of 5% dextrose (glucose) solution, with the development of excessive uterine contractions, slowing of the infusion quickly leads to a decrease in myometrium activity. Introduction begins with 5-8 cap / min, with the subsequent increase in speed depending on the nature of labor activity, but not more than 40 cap / min. During the infusion, continuous monitoring of uterine activity and the number of fetal heartbeats are necessary.

    Abortion in the course: in / in the drip, 10 ME (2 ml) of oxytocin per 500 ml of a 5% solution of dextrose (glucose) at a rate of 20-40 cap / min.

    For the prevention of hypotonic uterine bleeding: oxytocin Enter in / m, for 3-5 ME (0.6-1 ml) 2-3 times a day daily for 2-3 days, admissible in / m administration 10 ME (2 ml) immediately after removal of the placenta.

    For the treatment of hypotonic uterine bleeding: Introduce 5-8 ME (1-1.6 ml) 2-3 times a day for 3 days. If necessary, inject / drip 10-40 ME (2-8 ml) of oxytocin dissolved in 100 ml of donor blood.

    Strengthening the separation of milk (to prevent mastitis due to milk stagnation): in / m - 2 ME (0.4 mL).

    To stimulate lactation in the puerperium: intramuscularly or intranasally, 0.5 ME (0.1 ml) 5 minutes before feeding.

    When giving birth in a pelvic presentation: 2-5 ME (0.4-1 ml).

    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 (0.6-1 ml).

    Side effects:

    Bradycardia (in the mother and fetus), lowering of arterial pressure, shock or increased blood pressure and subarachnoidal hemorrhage, heart rhythm disturbances (including the fetus); bronchospasm; nausea, vomiting, water retention; neonatal jaundice, decreased fibrinogen concentration in the fetus, allergic reactions.

    Overdose:

    Symptoms: contraction of the fetus, fetal asphyxia, fetal bradycardia, postpartum hemorrhage, tetanus of the uterus, uterine rupture, utero-placental hypoperfusion, hypoxia, hypercapnia, fetal death, fetal birth injuries, water intoxication, convulsions.

    Treatment: drug withdrawal, reduction of fluid administration, forced diuresis, hypertonic sodium chloride solution, normalization of electrolyte balance, barbiturates (with caution), careful observation.

    Interaction:

    Oxytocin enhances the pressor effect of sympathomimetic amines.

    In combination with monoamine oxidase 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, fetus, blood pressure (BP) and the general condition of the woman.

    Form release / dosage:

    Solution for injection and topical application, 5 IU / ml.

    Packaging:

    1 ml per ampoule of neutral glass.

    For 10 ampoules with instructions for use and scarifier ampoule in a box of cardboard.

    5 or 10 ampoules per contour cell pack of a polyvinyl chloride film.

    1 contour cell package with 10 ampoules, or 1, 2 contour packs with 5 ampoules with instructions for use and a scapegrator ampoule in a pack of cardboard.

    Scarifier ampoule in boxes and packs do not invest in case of use of ampoules with a ring of fracture or with an incision and a point.

    Storage conditions:

    In the dark place at a temperature of 8 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-003483/10
    Date of registration:27.04.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspSYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products SYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products Russia
    Information update date: & nbsp24.05.2017
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