Oxytocin-Vial - instructions for use, dose, side effects, contraindications

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 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.

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:

The half-life period is 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.

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 (intravenously) (intramuscularly and slowly), intramuscularly (intramuscularly), subcutaneously (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, a constant monitoring of uterine activity and the number of fetal heartbeats is necessary.

Treatment of unavoidable or incomplete abortion: 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 on 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, 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 - ME (0.4 mL).

To stimulate lactation in the puerperium: w / m or intranasal 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 cesarean section (after removing the afterburn) 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: cancellation of the drug, reduction of fluid administration, forced diuresis, administration of Hypertonic sodium chloride solution, normalization of electrolyte balance, barbiturates (with caution), 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, 5 IU / ml.

Packaging:

1 ml per ampoule of neutral colorless glass with a dot to indicate the location of the fracture. Each label is labeled or labeled with a quick-fixing paint.

10 ampoules per contour cell package. One contour mesh package together with instructions for use in a cardboard box.

Storage conditions:

In the dark place at a temperature of 2 to 8 ° C.

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:LP-001582

Date of registration:15.03.2012 / 03.04.2017

Expiration Date:Unlimited

The owner of the registration certificate:VIAL, LLC VIAL, LLC Russia

Manufacturer: & nbsp

CSPC OUYI PHARMACEUTICAL, Co.Ltd. China

Information update date: & nbsp12.08.2015

Illustrated instructions

Instructions

Oxytocin-Vial (Oxytocin-VIAL)