Oxytocin 5Me/ml solution for injection ampoules, 10pcs

Composition

Auxiliary substances:  

glacial acetic acid,

chlorobutanol hemihydrate,

ethanol 96%,

d/i water.

Pharmacological action

Synthetic hormonal agent, similar in pharmacological and clinical properties to endogenous oxytocin of the posterior pituitary gland. It interacts with oxytocin-specific uterine myometrial receptors belonging to the G-protein superfamily. The number of receptors and response to the action of oxytocin increases as pregnancy progresses and reaches a maximum by the end of it.

It stimulates uterine labor by increasing the permeability of cell membranes for calcium and increasing its intracellular concentration, as well as by subsequently reducing the resting potential of the membrane and increasing its excitability. Causes contractions similar to normal spontaneous labor, temporarily impairing the blood supply to the uterus. With an increase in the amplitude and duration of muscle contractions, the uterine pharynx expands and smoothes. In appropriate amounts, it is able to increase the contractility of the uterus from moderate in strength and frequency, characteristic of spontaneous motor activity, to the level of prolonged tetanic contractions.

Causes contraction of myoepithelial cells adjacent to the alveoli of the breast, improving the release of breast milk.

Acting on the smooth muscles of blood vessels, it causes vasodilation and increases blood flow in the kidneys, coronary vessels and brain vessels. Usually, blood pressure (BP) remains unchanged, but with intravenous use of large doses or a concentrated solution of oxytocin, blood pressure may temporarily decrease with the development of reflex tachycardia and a reflex increase in cardiac output. The initial decrease in blood pressure is followed by a prolonged, albeit small, increase in blood pressure.

Unlike vasopressin, oxytocin has a minimal antidiuretic effect, but hyperhydration is possible when oxytocin is administered with large amounts of electrolyte solutions and/or when they are administered too quickly. It does not cause contraction of the bladder and bowel muscles.

Indications

Oxytocin is intended for labor stimulation and labor stimulation.

– labor stimulation at late and close to them terms of pregnancy, if early delivery is necessary due to gestosis, rhesus conflict, early or premature rupture of fetal membranes and discharge of amniotic fluid, as well as with a postponed pregnancy (more than 42 weeks), intrauterine fetal development delay, intrauterine fetal death.

– stimulation of labor activity in case of primary or secondary weakness of labor activity in the first and second periods of labor.

Oxytocin is also used to prevent and treat hypotonic bleeding after childbirth and abortion, during caesarean section (after the birth of a child and separation of the afterbirth), to accelerate postpartum involution, and as an adjunct therapy for incomplete or unavitable abortion.

Contraindications

the contraindications to vaginal birth (e. g., presentation or prolapse of the umbilical cord, full or partial placenta previa, narrow pelvis (the disparity in size of the fetal head and pelvis of the mother), transverse or oblique position of the fetus, preventing spontaneous delivery, emergency requiring surgical intervention the situation caused by the condition of the mother or fetus, the status of fetal distress long before the terminal stages of pregnancy, long-term use when the inertia of the uterus, severe preeclampsia (high blood pressure, impaired renal function), hypertonicity of the uterus (caused during birth), sepsis, heart disease, arterial hypertension, impaired renal function, pictorial presentation of the fetus; excessive stretching of the uterus, the compression of the fetus).

– hypersensitivity to oxytocin.

Side effects

For women in labor

From the side of the reproductive system:  at high doses or hypersensitivity – uterine hypertension, spasm, tetany, uterine rupture; increased bleeding in the postpartum period as a result of oxytocin-induced thrombocytopenia, afibrinogenemia and hypoprothrombinemia, sometimes pelvic hemorrhage. With careful medical monitoring of childbirth, the risk of bleeding in the postpartum period is reduced.

From the cardiovascular system: at high doses – arrhythmia, ventricular extrasystole, severe hypertension (in the case of vasopressors), hypotension (when used simultaneously with the anesthetic cyclopropane), reflex tachycardia, shock, if administered too quickly – bradycardia, subarachnoid hemorrhage.

From the digestive system: nausea, vomiting.

From the side of water-electrolyte metabolism: severe hyperhydration with prolonged intravenous use (usually at a rate of 40-50 mED / min) with a large amount of fluid (antidiuretic effect of oxytocin), with a 24-hour slow infusion of oxytocin, hyperhydration can be accompanied by convulsions and coma; rarely-fatal outcome.

From the immune system: anaphylaxis and other allergic reactions, with too rapid use of bronchospasm; rarely-fatal outcome.

In the fetus or newborn

As a consequence of the introduction of oxytocin to the mother – a low Apgar score at the 1st and 5th minutes, hyperbilirubinemia of newborns, with too rapid introduction – a decrease in the level of fibrinogen in the blood, retinal hemorrhage; as a consequence of the contractile activity of the uterus – sinus bradycardia, tachycardia, ventricular extrasystole and other arrhythmias, changes in the central nervous system, fetal death as a result of asphyxia.

Interaction

When oxytocin is administered 3-4 hours after the use of vasoconstrictors together with caudal anesthesia, severe arterial hypertension is possible.

During anesthesia with cyclopropane, halothane, a change in the cardiovascular effect of oxytocin is possible with the unexpected development of arterial hypotension, sinus bradycardia and rhythm from the atrioventricular node in a parturient woman during anesthesia.

How to take, course of use and dosage

In/in or in/m.

In order to stimulate and enhance labor, oxytocin is used exclusively intravenously, in a hospital equipped with appropriate medical equipment. Concomitant use of the drug intravenously and intramuscularly is contraindicated. The dose is selected taking into account the individual sensitivity of the woman in labor and the fetus.

Oxytocin is used exclusively as an intravenous drip infusion to stimulate labor and stimulate labor. Strict monitoring of the prescribed infusion rate is mandatory. For safe use of oxytocin during stimulation and enhancement of labor, it is necessary to use an infusion pump or other similar device, as well as monitoring the strength of uterine contractions and fetal heart activity. If there is an excessive increase in uterine contractility, the infusion should be stopped immediately, as a result of which the excess muscle activity of the uterus quickly decreases.

1. Before starting to administer the drug, you should start injecting a saline solution that does not contain oxytocin.

2. To prepare a standard oxytocin infusion, dissolve 1 ml (5 IU) of oxytocin in 1000 ml of non-hydrating liquid and mix thoroughly by rotating the bottle. 1 ml of the infusion prepared in this way contains 5% oxytocin. For accurate dosing of the infusion solution, an infusion pump or other similar device should be used.

3. The rate of use of the initial dose should not exceed 0.5-4 mEU / min, which corresponds to 2-16 drops/min, since 1 drop of infusion contains 0.25 MEU of oxytocin). Every 20-40 minutes, it can be increased by 1-2 mED / min, until the desired degree of contractile activity of the uterus is reached. When the desired uterine contraction rate corresponding to spontaneous labor is reached, and when the uterine pharynx is opened up to 4-6 cm in the absence of signs of fetal distress, the infusion rate can be gradually reduced at a rate similar to its acceleration.

In the later stages of pregnancy, the infusion should be administered at a higher rate, and only in rare cases, a rate exceeding 8-9 IU/min may be required. In the case of preterm labor, a high speed may be required, which in some cases may exceed 20 mED / min (80 cap / min).

1. Fetal heartbeat, resting uterine tone, frequency, duration, and strength of uterine contractions should be monitored.

2. In case of uterine hyperactivity or fetal distress, oxytocin should be stopped immediately and oxygen therapy should be provided to the woman in labor. The condition of the woman in labor and the fetus should be re-checked by a specialist doctor.

Prevention and treatment of hypotonic bleeding in the postpartum period:

1. Intravenous drip infusion: dissolve 10-40 IU of oxytocin in 1000 ml of non-hydrating liquid; 20-40 IU/min of oxytocin is usually needed to prevent uterine atony.

2. I / M introduction: 5 IU / ml of oxytocin after placental separation.

Incomplete or failed abortion:

Add 10 IU / ml of oxytocin to 500 ml of saline solution or a mixture of 5% glucose and saline solution. The rate of intravenous infusion is 20-40 drops / min.

Overdose

Symptoms depend mainly on the degree of hyperactivity of the uterus, regardless of the presence of hypersensitivity to the drug. Hyperstimulation with hypertonic and tetanic contractions or with basal tone ≥15-20 mm wt.between two contractions leads to discoordination of labor, rupture of the body or cervix, vagina, bleeding in the postpartum period, uteroplacental insufficiency, fetal bradycardia, hypoxia, hypercapnia, compression, birth injuries or death. Hyperhydration with seizures as a result of the antidiuretic effect of oxytocin is a serious complication and develops with prolonged use of large doses (40-50 ml / min).

Treatment of hyperhydration: withdrawal of oxytocin, restriction of fluid intake, use of diuretics to force diuresis, intravenous use of hypertensive saline solution, correction of electrolyte imbalance, relief of seizures with appropriate doses of barbiturates and ensuring careful care for the patient in a coma.

Special instructions

Before starting the use of oxytocin, it is necessary to compare the expected benefit of therapy with the possibility, although small, of developing hypertension and uterine tetany.

Oxytocin should not be used to stimulate labor until the fetal head is inserted into the pelvic entrance.

Every patient receiving intravenous oxytocin should be kept in the hospital under the constant supervision of experienced specialists with experience in using the drug and recognizing complications. If necessary, immediate assistance from a specialist doctor should be provided. To avoid complications during the use of the drug, uterine contractions, cardiac activity of the woman in labor and the fetus, and blood pressure of the woman in labor should be constantly monitored. If signs of uterine hyperactivity occur, oxytocin use should be stopped immediately, as a result of which uterine contractions caused by the drug usually subside soon.

When used appropriately, oxytocin causes uterine contractions similar to spontaneous labor. Excessive stimulation of the uterus with improper use of the drug is dangerous for both the woman in labor and the fetus. Even with adequate use of the drug and appropriate monitoring, hypertonic uterine contractions occur with increased sensitivity of the uterus to oxytocin.

The risk of afibrinogenemia and increased blood loss should be considered.

There are cases of death of a woman in labor as a result of hypersensitivity reactions, subarachnoid hemorrhage, uterine rupture and fetal death for various reasons associated with parenteral use of the drug to induce labor and stimulate labor in the first and second periods of labor.

As a result of the antidiuretic effect of oxytocin, hyperhydration may develop, especially with the use of a constant infusion of oxytocin and the use of liquid inside.

The drug can be diluted in solutions of sodium lactate, sodium chlorate and glucose. The finished solution should be used in the first 8 hours after its preparation. Compatibility studies were conducted with infusions of 500 ml.

Effect of the drug on the ability to drive a car and mechanisms that are associated with an increased risk of injury

Oxytocin does not affect the ability to drive a car and mechanisms that are associated with an increased risk of injury.

Storage conditions

Store at a temperature of 2-15 °C, protected from light, out of the reach of children.

Shelf

life is 3 years. Do not use the product after the expiration date indicated on the package.

Active ingredient

Oxytocin

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection and infusion