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

    1 ml of the drug (1 ampoule) contains

    active substance: oxytocin - 5 ME;

    Excipients: chlorobutanol hydrate - 5 mg, 1 M Acetic acid acid solution - up to pH 3.0-4.5, water for injection - up to 1 ml.

    Description:A clear, colorless liquid with a characteristic odor.
    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).

    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 (manifests them only in high doses), does not cause contraction of the muscles of the bladder and intestines. The effect occurs after 1-2 minutes with intramuscular injection, lasts 20-30 minutes; at intravenous - in 0,5-1 minutes.

    Pharmacokinetics:

    The elimination half-life is 1-6 min (decreased on late terms 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 content 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 (including during 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).

    Hypolactation in the postpartum period.

    Contraindications:

    Hypersensitivity; narrow basin (anatomical and clinical), transverse and oblique fetal position, facial presentation of the fetus, premature birth, menacing 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.

    Pregnancy and lactation:

    In the first trimester of pregnancy oxytocin apply only with spontaneous or induced abortion. Numerous data on the use of oxytocin, its chemical structure and pharmacological properties indicate that, while observing the prescriptions for use, oxytocin does not affect the formation of malformations of the fetus.

    In small amounts penetrates into breast milk. When using the drug to stop uterine bleeding, breastfeeding can be started only after the completion of the course of treatment with oxytocin.

    Dosing and Administration:

    Intravenous, intramuscularly, into the wall of the uterus.

    For excitation of labor: intramuscularly at 0.5-2 ME; if necessary, repeat the injection every 30-60 minutes.

    Induction of labor: intravenously drip 10 ME oxytocin on 1 liter of a 5% dextrose solution, with the development of excessive uterine contractions, slowing 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, constant monitoring of uterine activity and fetal heart rate is necessary.

    Treatment of unavoidable or incomplete abortion: intravenously drip 10 ME oxytocin per 500 ml of a 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 daily for 2-3 days, intramuscular injection is acceptable 10 ME immediately after the removal of the placenta. For the treatment of hypotonic uterine bleeding, 5-8 ME 2-3 times a day for 3 days. If necessary, drip intravenously 10-40 ME oxytocin, dissolved in 100 ml of donor blood.

    Strengthening the separation of milk (to prevent mastitis due to milk stagnation): intramuscularly 2 ME.

    To stimulate lactation in the puerperium: intramuscularly 0.5 ME for 5 minutes before feeding.

    When giving birth in a pelvic presentation: 2-5 ME.

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

    Side effects:Bradycardia (in the mother and fetus), lowering of blood pressure, shock or increased blood pressure and subarachnoidal bleeding, violation of the rhythm of the heart (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 symptomatic 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 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:

    Not applicable, given indications for use.

    Form release / dosage:

    A solution for intravenous and intramuscular administration, 5 IU / ml.

    Packaging:

    1 ml per ampoule of neutral glass.

    5 ampoules per contour pack of PVC film.

    5 ampoules per contour mesh package made of PVC film and foil of aluminum or flexible packaging on the basis of aluminum foil or packaging material.

    1 or 2 contour packs with instructions for use and a knife for opening ampoules or a scarifier are placed in a pack of cardboard. When using ampoules with a notch, a point or a fracture ring, the ampoule knife or scarifier is not inserted.

    Packing for hospitals

    10, 20, 25, 50, 75, 100, 200, 230, 360, 420 contour cell packs with ampoules, together with an equal number of instructions for use, are placed in a cardboard box.

    Storage conditions:

    In the dark place at a temperature of 8 to 20 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use the product after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001899
    Date of registration:13.03.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:BRYNTSALOV-A, CJSC BRYNTSALOV-A, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspBRYNTSALOV-A, CJSCBRYNTSALOV-A, CJSC
    Information update date: & nbsp12.08.2015
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