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STRUCTURE

active substance: carbetocin


1 ml carbetocin 100 mcg


excipients: sodium chloride, glacial acetic acid, water for injection.


DOSAGE FORM

Injection.


MAIN PHYSICAL AND CHEMICAL PROPERTIES:

colorless transparent solution free of visible particles.


PHARMACOLOGICAL GROUP

Pituitary, hypothalamic hormones and their analogues. Hormones of the posterior lobe of the pituitary gland. Oxytocin and analogues.


ATX code H01B B03.


PHARMACOLOGICAL PROPERTIES

Pharmacological.


Carbetocin is a long-acting oxytocin agonist.


Like oxytocin, carbetocin selectively binds to oxytocin receptors of smooth muscle cells of the myometrium, stimulates rhythmic contractions of the uterus, increases the frequency of contractions, has already begun, and increases the tone of the muscles of the uterus.


In the postnatal period, carbetocin is able to increase the frequency and strength of spontaneous uterine contractions. After the introduction of carbetocin, an intensive onset of contractile action with powerful contractions is achieved within 2 minutes.


A single intravenous injection of 100 mcg of carbetocin intravenously after childbirth is sufficient to maintain adequate uterine contractility, preventing uterine atony and excessive blood loss compared to an oxytocin infusion for several hours.


Pharmacokinetics.


Carbetocin has a biphasic nature of elimination after administration with linear pharmacokinetics in the dose range from 400 to 800 μg. The half-life is approximately 40 minutes. The renal clearance of the unchanged form is low, less than 1% of the administered dose is excreted unchanged by the kidneys.



INDICATIONS

For the prevention of uterine atony in the case of a cesarean section, which was carried out using spinal or epidural anesthesia.


CONTRAINDICATIONS

Hypersensitivity to carbetocin or oxytocin.

The period of pregnancy and childbirth before the birth of the child.

Should not be used to stimulate labor.

Diseases of the liver and kidneys.

Episodes of preeclampsia and eclampsia.

Severe diseases of the cardiovascular system.

Epilepsy.


SPECIAL PRECAUTIONS

Carbetocin should only be used in well-equipped obstetric hospitals with the constant availability of trained and appropriately qualified personnel.


Carbetocin is for intravenous administration only. Use only a clear solution that does not contain mechanical impurities.


Unused product should be disposed of in accordance with local disposal requirements.


INTERACTION WITH OTHER DRUGS AND OTHER INTERACTIONS

When using carbetocin in conjunction with various analgesics, antispasmodics, drugs for spinal and epidural anesthesia, no signs of any drug interaction were detected.


Since the chemical structure of carbetocin is close to oxytocin, the possibility of interactions inherent in oxytocin cannot be excluded.


Severe hypertension was observed after oxytocin was administered 3–4:00 after prophylactic administration of vasoconstrictors for spinal anesthesia.


Oxytocin and carbetocin, when used together with ergot alkaloids such as methylergometrine, can increase blood pressure, potentiating the effects of these drugs. The risk of cumulative exposure increases if oxytocin or methylergometrine is given after carbetocin.


Since it has been established that prostaglandins potentiate the effect of oxytocin, it can be assumed that a similar effect is possible when used with carbetocin. In this regard, the combined use of prostaglandins and carbetocin is undesirable. If drugs are administered at the same time, the patient must be closely monitored.


Some inhaled anesthetics, such as halothane and cyclopropane, can increase the hypotensive effect and weaken the effect of carbetocin on the uterus. Cases of arrhythmias with concurrent administration with oxytocin have been described.


FEATURES OF APPLICATION

The use of carbetocin at any stage of labor is unacceptable because its hysterotonic effect lasts several hours after a single bolus. This property is a significant difference compared to the rapid cessation of the effect after interruption of the oxytocin infusion.


If uterine bleeding continues after the administration of carbetocin, the cause should be clarified. Possible reasons include incomplete separation of the placenta, inadequate cleaning or suturing of the uterus, coagulopathy.


With the development of persistent hypotension or atony of the uterus and, as a result, with prolonged bleeding, the possibility of additional administration of oxytocin and / or ergometrine should be considered.


There are still no data on the repeated administration of carbetocin, as well as on its use after oxytocin for persistent uterine atony.