Active substanceOxytocinOxytocin
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  • Dosage form: & nbspinjection
    Composition:

    1 ml of solution (1 ampoule) contains:

    active substance: oxytocin 5 ME;

    Excipients: chlorobutanol hemihydrate 5 mg, 1 M solution of acetic acid to pH 3.5-4.5, water for injection up to 1 ml.

    Description:

    Colorless transparent liquid with a characteristic odor.

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

    H.01.B.B.02   Oxytocin

    Pharmacodynamics:

    Oxytocin - a synthetic analogue of the peptide hormone of the posterior lobe of the pituitary gland - stimulates the contraction of the smooth muscles of the uterus (especially at the end of pregnancy,during labor and at the time of delivery) and myoepithelial cells of the breast. Oxytocin has a weak antidiuretic effect and in therapeutic doses does not significantly affect blood pressure. The effect occurs in 1-2 minutes with n / k and / m introduction, lasts 20-30 minutes; when in / in the introduction - after 0.5-1 minutes.

    Pharmacokinetics:

    Half-life (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 and in the placenta, the concentration of oxytocinase inactivating the endogenous and exogenous oxytocin. Excretion, mainly by the kidneys in unchanged form.

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

    Contraindications:

    Hypersensitivity, hypertension, renal insufficiency, predisposition to rupture of the uterus, mismatch in the pelvis of the mother and fetus (narrow pelvis anatomical and clinical), transverse or oblique fetal position, premature birth, threatening rupture of the uterus, scars on the uterus (after a previous cesarean section, surgery on the uterus), excessive stretching of the uterus, uterus after multiple births, uterine sepsis, invasive cervical carcinoma, uterine hypertension (not arisen during labor), fetal compression, parts Noah placenta previa, fetal presentation facial.

    Pregnancy and lactation:

    In the first trimester of pregnancy oxytocin apply only to spontaneous or induced abortions.

    The effect of oxytocin on the fetus has been poorly studied, and no cases of teratogenic effects have been described.

    Oxytocin is excreted in small amounts with the mother's milk.

    Dosing and Administration:

    Oxytocin is administered intravenously, intramuscularly, into the wall or vaginal part of the cervix.

    For excitation of childbirth: 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 dextrose. 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. During the infusion, constant monitoring of uterine activity and fetal heart rate is necessary.

    Treatment of unavoidable or incomplete abortion: intravenously, 10 IU of oxytocin per 500 ml of 5% dextrose solution at a rate of 20-40 cap / min.

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

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

    In cesarean section (after removal of the afterbirth): Oxytocin Grindeks is injected into the wall of the uterus at a dose of 3-5 ME.

    Side effects:

    Possible arrhythmia and bradycardia (in the mother and fetus), a decrease or increase in blood pressure, shock, subarachnoidal bleeding, nausea, vomiting, neonatal jaundice, reduced fibrinogen concentration in the fetus, allergic reactions, bronchospasm, water retention. If symptoms of these complications appear, discontinue the drug immediately.

    Overdose:

    Symptoms: hyperstimulation of the uterus, which can lead to hypertension and tetanic contractions of the uterus, which in turn can lead to rupture of the uterus, postpartum hemorrhage, various changes in cardiac fetal activity, hypoxia and fetal death; contraction of the fetus, fetal asphyxia, fetal bradycardia, utero-placental hypoperfusion, hypercapnia, birth injuries of the fetus, water intoxication, convulsions.

    Treatment: should immediately stop the introduction of oxytocin, reduce the introduction of fluid, force diuresis, enter symptomatic drugs and hypertensive saline solutions (to normalize the electrolyte balance), barbiturates (with caution). Careful observation is necessary for the patient.

    Interaction:

    Use with caution oxytocin in combination with sympathomimetics (potentiates pressor action 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 under the control of the contractile activity of the uterus, the condition of the fetus, blood pressure and the general condition of the woman.

    Effect on the ability to drive transp. cf. and fur:

    Oxytocin does not affect the ability to manage vehicles and mechanisms, work on which is associated with an increased risk of injury.

    Form release / dosage:

    Solution for injection, 5 IU / ml.

    Packaging:

    1 ml in an ampoule of colorless glass I of hydrolytic class with a line or break point, as well as a single marking ring of blue-green color (for the manufacturer HBM Pharma sr.o.).

    5 ampoules per cell pack of PVC film without coating (pallet).

    2 cell packs (pallet) with instructions for use are placed in a pack of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N016106 / 01
    Date of registration:01.04.2011 / 21.02.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:GRINDEX, JSC GRINDEX, JSC Latvia
    Manufacturer: & nbsp
    Santonika, UAB Lithuania
    HBM PHARMA, s.r.o. The Slovak Republic
    Representation: & nbspGrindeks Rus, Open CompanyGrindeks Rus, Open CompanyRussia
    Information update date: & nbsp25.05.2017
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