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

Excipients: chlorobutanol hemihydrate (chlorobutanol hydrate) equivalent to 5.00 mg of chlorobutanol, acetic acid to pH 3.0-4.5, water for injection up to 1 ml.

Description:Transparent colorless liquid with the smell of chlorobutanol hydrate.

Pharmacotherapeutic group:Generic activity stimulant - oxytocin preparation

ATX: & nbsp

H.01.B.B.02 Oxytocin

Pharmacodynamics:

Hormonal remedy. Synthetic polypeptide analogue of the hormone of the posterior lobe of the pituitary gland. Has uterotonizing, stimulating labor and lactotropic action. Has a stimulating effect on the myometrium (especially at the end of pregnancy, during labor and immediately during delivery).

Under the influence of oxytocin, the permeability of membranes for calcium increases, the resting potential decreases and their excitability increases (the decrease in the membrane potential leads to an increase in the frequency, intensity, and duration of contractions).

Oxytocin stimulates the secretion of breast milk, enhancing the production of prolactin by 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 (only in high doses), does not cause contraction of the muscles of the bladder and intestines.

The effect occurs in 1-2 minutes with subcutaneous and intramuscular injection, lasts for 20-30 minutes; at intravenous - in 0,5-1 minutes,intranasally - for several minutes.

Pharmacokinetics:

The association with plasma proteins is low (30%). 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 in an unchanged form. The half-life is 1-6 minutes (it decreases in late pregnancy and lactation).

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 for 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).

Contraindications:

Hypersensitivity, narrow pelvis (anatomical and clinical), transverse or oblique position of the fetus,facial presentation of the fetus, premature birth, predisposition to rupture of the uterus, scars on the uterus (after a previous cesarean section or other operations on the uterus), excessive uterine stretching, uterus after multiple births, partial placenta previa, uterine sepsis, invasive cervical carcinoma, hypertonia the uterus (which did not arise during labor), fetal compression, arterial hypertension, chronic renal failure, suspicion of premature placental abruption, intrauterine hypoxia of the fetus.

Dosing and Administration:

Oxytocin is administered intravenously or intramuscularly.

For excitation of childbirth injected intramuscularly 0,5-2 ME oxytocin; if necessary, repeat the injection every 30-60 minutes.

For intravenous drip injection, dilute 1 ml of synthetic oxytocin 5 ME in 500 ml of a 5% solution of dextrose (glucose). The introduction begins with 5-8 drops per minute, with a subsequent increase in speed, depending on the nature of labor activity (every 5-10 minutes for 5 drops, but not more than 40 drops per minute).

For the treatment of unavoidable or incomplete abortion: intravenously drip, 10 ME oxytocin on 500 ml of a 5% dextrose solution at a rate of 20-40 drops per minute.

For the prevention of hypotonic uterine bleeding oxytocin administered intramuscularly for 3-5 ME 2-3 times a day daily for 2-3 days, and for the treatment of hypotonic uterine bleeding, 5-8 ME 2-3 times a day for 3 days.

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, as well as overly active labor that can cause fetal hypoxia, premature detachment of the normally located placenta, rupture of the uterus.

If symptoms of these complications appear, discontinue the drug immediately.

Overdose:

Hyperstimulation of the uterus, which can lead to hypertonia and tetanic contractions of the uterus, which in turn can lead to uterine rupture, postpartum hemorrhage, various changes in cardiac fetal activity, hypoxia and fetal death.With long-term use of oxytocin in large doses by infusion (40-50 ml / min), symptoms associated with the antidiuretic effect of oxytocin may appear.

When an overdose should immediately stop the introduction of oxytocin, force diuresis, enter symptomatic drugs and hypertensive saline solutions (in order to normalize the electrolyte balance).

Interaction:

Use with caution oxytocin in combination with sympathomimetics (potentiates pressor action of sympathomimetics).

Halothane and cyclopropane increase the risk of developing arterial hypotension.

Special instructions:

Oxytocin is used under the control of the contractile activity of the uterus, the condition of the fetus, blood pressure and the general condition of the woman.

Form release / dosage:

Solution for intravenous and intramuscular injection, 5 IU / ml.

Packaging:

For 1 ml of the drug in ampoules of neutral glass grade HC-1 or imported.

5 ampoules per circuit cell packaging made of polyvinylchloride film and foil of aluminum printed lacquered or flexible packaging on the basis of aluminum foil, or without foil.

For 1 or 2 contour mesh packages (with foil or without foil) with instruction on the use of the preparation, with a knife or scapegrator ampoule in a pack of cardboard.

For 20, 50 or 100 contour cell packs (with foil) with 20, 50 or 100 instructions for the use of the preparation, respectively, with knives or scarifiers ampoule into boxes of cardboard or in boxes of corrugated cardboard (for inpatient).

When packing ampoules with notches, rings and break points, knives or scarifier ampoules do not.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:

3 of the year. Do not use at the expiration date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N000370 / 01

Date of registration:09.04.2007 / 21.04.2014

Expiration Date:Unlimited

The owner of the registration certificate:MOSCOW ENDOCRINE FACTORY, FSUE MOSCOW ENDOCRINE FACTORY, FSUE Russia

Manufacturer: & nbsp

MOSCOW ENDOCRINE FACTORY, FSUE Russia

Representation: & nbspMOSCOW ENDOCRINE FACTORY FGUP MOSCOW ENDOCRINE FACTORY FGUP Russia

Information update date: & nbsp25.05.2017

Illustrated instructions

Instructions

Oxytocin-MEZ (Oxytocinum-MEZ)