Oxytocin injection 5IU / ml, 1ml No. 5 Richter

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Окситоцин раствор для инъекций 5МЕ/мл, 1мл №5 Рихтер

Oxytocin injection 5IU / ml, 1ml No. 5 Richter

  • for labor induction and stimulation of labor (primary and secondary weakness of labor; the need for early delivery due to gestosis, Rh-conflict, intrauterine fetal death; post-term pregnancy; premature discharge of amniotic fluid, management of labor in breech presentation);

  • for the prevention and treatment of hypotonic uterine bleeding after abortion (including with long periods of pregnancy);

  • in the early postpartum period to accelerate the postpartum involution of the uterus;

  • for contraction of the uterus during cesarean section (after removal of the placenta).

In / in or in / m.

In order to induce and enhance labor activity, oxytocin is used exclusively in / in, in a hospital setting, under appropriate medical supervision. The simultaneous use of the drug in / in and in / m is contraindicated. The dose is selected taking into account the individual sensitivity of the pregnant woman and the fetus.

For labor induction and stimulation of labor activity, oxytocin is used exclusively in the form of intravenous drip infusion. Strict control of the prescribed infusion rate is imperative. For the 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 monitor the strength of uterine contractions and fetal cardiac activity. In the event of an excessive increase in the contractile activity of the uterus, the infusion should be stopped immediately, as a result, the excessive muscle activity of the uterus rapidly decreases.

1. Before starting the administration of the drug, you should begin to inject saline that does not contain oxytocin.

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

3. The rate of administration of the initial dose should not exceed 0.5-4 IU / min, which corresponds to 2-16 drops / min, because 1 drop of infusion contains 0.25 IU of oxytocin). Every 20-40 minutes, it can be increased by 1-2 honey / min, until the desired degree of uterine contractile activity is achieved. Upon reaching the desired frequency of uterine contractions, corresponding to spontaneous labor, and with the opening of the pharynx of the uterus to 4-6 cm in the absence of signs of fetal distress, you can gradually reduce the rate of infusion at a rate similar to its acceleration.

In late pregnancy, infusion at a higher rate requires caution, only in rare cases may a rate in excess of 8-9 IU / min be required. In the case of premature birth, a high speed may be required, which in isolated cases may exceed 20 IU / min (80 drops / min).

1. It is necessary to control the fetal heartbeat, the tone of the uterus at rest, the frequency, duration and strength of its contractions.

2. In case of uterine overactiveness or fetal distress, the administration of oxytocin should be stopped immediately and the woman in labor should be given oxygen therapy. The condition of the woman in labor and the fetus should be re-monitored 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; for the prevention of uterine atony, 20-40 IU / min of oxytocin is usually needed.

2. In / m introduction: 5 IU / ml of oxytocin after placenta separation.

Incomplete or failed abortion

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

Active ingredient: oxytocin - 5 IU

Excipients : glacial acetic acid - 2.0 mg, chlorobutanol hemihydrate - 3 mg, ethanol 96% - 40 mg, water d / i - up to 1 ml.

  • narrow pelvis (anatomical and clinical);

  • transverse or oblique position of the fetus;

  • facial presentation of the fetus;

  • premature birth;

  • threatening rupture of the uterus;

  • scars on the uterus (after a previously postponed cesarean section, operations on the uterus);

  • excessive stretching of the uterus;

  • uterus after multiple births;

  • partial placenta previa;

  • uterine sepsis;

  • invasive carcinoma of the cervix;

  • hypertonicity of the uterus (not occurring during childbirth);

  • compression of the fetus;

  • arterial hypertension;

  • chronic renal failure;

  • hypersensitivity to the components of the drug.

Clinical and pharmacological group: A drug that increases the tone and contractile activity of the myometrium

Pharmaco-therapeutic group: Labor activity stimulant - oxytocin drug

pharmachologic effect

Synthetic hormonal drug. In terms of pharmacological and clinical properties, it is similar to endogenous oxytocin of the posterior lobe of the pituitary gland. Interacts with oxytocin-specific receptors of the myometrium of the uterus, belonging to the superfamily of G-proteins. The number of receptors and the response to the action of oxytocin increase as pregnancy progresses and reach a maximum towards the end of pregnancy. Stimulates the labor activity of the uterus by increasing the permeability of cell membranes for calcium ions and increasing its intracellular concentration, a subsequent decrease in 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 expansion and smoothing of the uterine pharynx occurs.In appropriate quantities, it is able to enhance the contractile ability of the uterus from moderate in strength and frequency, characteristic of spontaneous motor activity, to the level of prolonged tetanic contractions.

It causes a contraction of myoepithelial cells adjacent to the alveoli of the mammary gland, improving the secretion of breast milk.

By acting on vascular smooth muscle, it causes vasodilation and increases blood flow in the kidneys, coronary vessels and cerebral vessels. Usually, blood pressure remains unchanged, however, with intravenous administration in high 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. An initial decrease in blood pressure is followed by a prolonged, albeit slight increase.

Unlike vasopressin, oxytocin has a minimal antidiuretic effect, however, overhydration is possible when oxytocin is administered with large amounts of electrolyte-free solutions and / or when they are administered too quickly. Does not cause contraction of the muscles of the bladder and intestines.

Pharmacokinetics

With intravenous administration, the effect of oxytocin on the uterus manifests itself almost instantly and lasts for 1 hour. With intramuscular administration, the myotonic effect occurs in the first 3-7 minutes and lasts for 2-3 hours.

Like vasopressin, oxytocin is distributed throughout the extracellular space. Small amounts of oxytocin appear to enter the fetal circulatory system. T1 / 2 is 1-6 minutes and becomes shorter in late pregnancy and lactation. Most of the drug is rapidly metabolized in the liver and kidneys. In the process of enzymatic hydrolysis, it is inactivated, first of all, by the action of tissue oxytokinase (oxytokinase is also found in the placenta and plasma). Only a small amount of oxytocin is excreted unchanged by the kidneys.

Indications

  • for labor induction and stimulation of labor (primary and secondary weakness of labor; the need for early delivery due to gestosis, Rh-conflict, intrauterine fetal death; post-term pregnancy; premature discharge of amniotic fluid, management of labor in breech presentation);

  • for the prevention and treatment of hypotonic uterine bleeding after abortion (including with long periods of pregnancy);

  • in the early postpartum period to accelerate the postpartum involution of the uterus;

  • for contraction of the uterus during cesarean section (after removal of the placenta).

Dosage regimen

In / in or in / m.

In order to induce and enhance labor activity, oxytocin is used exclusively in / in, in a hospital setting, under appropriate medical supervision. The simultaneous use of the drug in / in and in / m is contraindicated. The dose is selected taking into account the individual sensitivity of the pregnant woman and the fetus.

For labor induction and stimulation of labor activity, oxytocin is used exclusively in the form of intravenous drip infusion. Strict control of the prescribed infusion rate is imperative. For the 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 monitor the strength of uterine contractions and fetal cardiac activity. In the event of an excessive increase in the contractile activity of the uterus, the infusion should be stopped immediately, as a result, the excessive muscle activity of the uterus rapidly decreases.

1. Before starting the administration of the drug, you should begin to inject saline that does not contain oxytocin.

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

3. The rate of administration of the initial dose should not exceed 0.5-4 IU / min, which corresponds to 2-16 drops / min, because 1 drop of infusion contains 0.25 IU of oxytocin). Every 20-40 minutes, it can be increased by 1-2 honey / min, until the desired degree of uterine contractile activity is achieved. Upon reaching the desired frequency of uterine contractions, corresponding to spontaneous labor, and with the opening of the pharynx of the uterus to 4-6 cm in the absence of signs of fetal distress, you can gradually reduce the rate of infusion at a rate similar to its acceleration.

In late pregnancy, infusion at a higher rate requires caution, only in rare cases may a rate in excess of 8-9 IU / min be required. In the case of premature birth, a high speed may be required, which in isolated cases may exceed 20 IU / min (80 drops / min).

1. It is necessary to control the fetal heartbeat, the tone of the uterus at rest, the frequency, duration and strength of its contractions.

2. In case of uterine overactiveness or fetal distress, the administration of oxytocin should be stopped immediately and the woman in labor should be given oxygen therapy. The condition of the woman in labor and the fetus should be re-monitored 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; for the prevention of uterine atony, 20-40 IU / min of oxytocin is usually needed.

2. In / m introduction: 5 IU / ml of oxytocin after placenta separation.

Incomplete or failed abortion

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

Side effect

Women in labor

From the reproductive system: at high doses or increased sensitivity - uterine hypertonicity, spasm, tetany, rupture of the uterus; increased bleeding in the postpartum period as a result of oxytocin-induced thrombocytopenia, afibrinogenemia and hypoprothrombinemia, sometimes hemorrhage in the pelvic organs. With close medical supervision of childbirth, the risk of bleeding in the postpartum period is reduced.

From the side of the cardiovascular system: when used in high doses - arrhythmia, ventricular extrasystole, severe arterial hypertension (in the case of using vasopressor drugs), arterial hypotension (when used simultaneously with the anesthetic cyclopropane), reflex tachycardia, shock, with too rapid administration - bradycardia, subarachnoid hemorrhage.

From the digestive system: nausea, vomiting.

On the part of water and electrolyte metabolism: severe overhydration with prolonged intravenous administration (usually at a rate of 40-50 IU / min) with a large amount of fluid (antidiuretic effect of oxytocin), can also occur with a 24-hour slow infusion of oxytocin, accompanied by convulsions and coma; rarely - death.

Allergic reactions: anaphylaxis and other allergic reactions, with too rapid administration of bronchospasm; rarely - death.

In a fetus or newborn

As a result of the introduction of oxytocin to the mother - within 5 minutes a low score on the Apgar scale, jaundice of newborns, with too rapid administration - a decrease in the level of fibrinogen in the blood, hemorrhage in the retina; as a result of increased contractile activity of the uterus - sinus bradycardia, tachycardia, ventricular premature beats and other arrhythmias, changes in the central nervous system, fetal death as a result of asphyxia.

Contraindications for use

  • narrow pelvis (anatomical and clinical);

  • transverse or oblique position of the fetus;

  • facial presentation of the fetus;

  • premature birth;

  • threatening rupture of the uterus;

  • scars on the uterus (after a previously postponed cesarean section, operations on the uterus);

  • excessive stretching of the uterus;

  • uterus after multiple births;

  • partial placenta previa;

  • uterine sepsis;

  • invasive carcinoma of the cervix;

  • hypertonicity of the uterus (not occurring during childbirth);

  • compression of the fetus;

  • arterial hypertension;

  • chronic renal failure;

  • hypersensitivity to the components of the drug.

Application during pregnancy and lactation

In the first trimester of pregnancy, oxytocin is used only for spontaneous or induced abortion. Numerous data on the use of oxytocin, its chemical structure and pharmacological properties indicate that, if the recommendations are followed, the likelihood of the effect of oxytocin on an increase in the frequency of fetal malformations is small.

In small amounts excreted in breast milk.

When using the drug to stop uterine bleeding, breastfeeding can be started only after the end of the course of treatment with oxytocin.

Application for impaired renal function

Contraindicated in chronic renal failure.

special instructions

Until the moment of insertion of the fetal head into the entrance of the pelvis, it is impossible to use oxytocin to stimulate labor.

Before proceeding with the use of oxytocin, it is necessary to compare the alleged benefits of therapy with the possibility, albeit small, of the development of hypertension and tetany of the uterus.

Each patient receiving IV oxytocin should be in the hospital under the constant supervision of experienced specialists who have experience in using the drug and recognizing complications. If necessary, immediate medical attention should be provided. In order to avoid complications during the use of the drug, the uterine contractions, the cardiac activity of the woman in labor and the fetus, and the blood pressure of the woman in labor should be constantly monitored. If there are signs of uterine hyperactivity, the administration of oxytocin should be stopped immediately, as a result of which the uterine contractions caused by the drug usually subside soon.

When used appropriately, oxytocin induces 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 observation, hypertensive contractions of the uterus occur with increased sensitivity of the uterus to oxytocin.

The risk of developing 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, rupture of the uterus and fetal death for various reasons associated with parenteral administration of the drug for induction of labor and stimulation of labor in the first and second stages of labor.

As a result of the antidiuretic effect of oxytocin, the development of overhydration is possible, 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 chloride and glucose. The ready-made solution should be used in the first 8 hours after its preparation. Compatibility studies were performed with 500 ml infusions.

Influence on the ability to drive vehicles and mechanisms

Oxytocin does not affect the ability to drive and operate machinery that is associated with an increased risk of injury.

Overdose

—имптомы завис¤т, главным образом, от степени гиперактивности матки, независимо от наличи¤ повышенной чувствительности к препарату. vиперстимул¤ци¤ с гипертоническими и тетаническими сокращени¤ми либо с базальным тонусом ?15-20 мм водн. ст. между двум¤ сокращени¤ми ведет к дискоординации родовой де¤тельности, разрыву тела или шейки матки, влагалища, кровотечению в послеродовом периоде, маточно-плацентарной недостаточности, брадикардии плода, его гипоксии, гиперкапнии, сдавлению, родовым травмам или гибели. vипергидратаци¤ с судорогами в результате антидиуретического эффекта окситоцина ¤вл¤етс¤ серьезным осложнением и развиваетс¤ при продолжительном введении препарата в высоких дозах (40-50 мл/мин).

Ћечение гипергидратации: отмена окситоцина, ограничение употреблени¤ жидкости, применение диуретиков дл¤ форсировани¤ диуреза, в/в введение гипертонического солевого раствора, коррекци¤ электролитного дисбаланса, купирование судорог соответствующими дозами барбитуратов и обеспечение тщательного ухода за пациенткой в состо¤нии комы.

Ћекарственное взаимодействие

ѕри введении окситоцина через 3-4 ч после применени¤ вазоконстрикторов совместно с каудальной анестезией возможна т¤жела¤ артериальна¤ гипертензи¤.

ѕри анестезии циклопропаном, галотаном возможно изменение кардиоваскул¤рного действи¤ окситоцина с непредвиденным развитием артериальной гипотензии, синусовой брадикардии и AV-ритма у роженицы во врем¤ анестезии.

”слови¤ хранени¤

The drug should be stored out of the reach of children, protected from light, at a temperature of 2 ? to 15 ? C.

Shelf life

Shelf life is 3 years. Do not use the drug after the expiration date.

Terms of sale

The drug is available with a prescription.

Contacts for inquiries

GEDEON RICHTER JSC (Hungary)

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