Inhibition of premature labor in pregnant women, if: during 30 min there are at least 4 regular, at least 30 s contractions of the uterus; the opening of the cervix is 1-3 cm (in the firstborn 0-3 cm) and the shortening of the cervix is ≥50%; gestational age is 24 to 33 full weeks; fetal heart rate is normal.
Composition:
1 vial (0.9 ml) solution for injection contains 6.75 mg of atosiban. One vial (5 ml) of concentrate for solution for infusion contains 37.5 mg of atosiban.
Action:
A competitive antagonist of human oxytocin at the receptor level, reducing the frequency of contractions and muscle tone of the uterus. In the case of threatening early delivery, at the recommended doses, it counteracts uterine contractions and induces its resting state. After application of atosiban, the number of uterine contractions decreases significantly within 10 min, and the rest state achieved (≤ 4 contractions / h) lasts for 12 hours. After intravenous infusion at 300 μg / min for 6-12 h, the drug concentration in blood was found within 1 hour of the onset of the infusion. The drug binds to plasma proteins at 46-48%. It is metabolized in the liver. It passes through the placenta barrier and into breast milk.
Contraindications:
Hypersensitivity to atosiban or other components of the preparation. A gestational age less than 24 weeks or more than 33 full weeks Premature rupture of membranes in pregnancy over 30 weeks. Fetal pulse disturbances. Uterine macrovascular hemorrhage requiring immediate delivery. Throat or severe preeclampsia requiring delivery. Intrauterine death of the fetus. Suspicion of intrauterine infection. The leading bearing. Premature separation of the placenta. Any other condition of the mother or fetus in which sustaining pregnancy is dangerous.
Precautions:
Due to lack of experience or limited experience, the drug should be used with extreme caution if premature rupture of the membranes, liver or kidney dysfunction, multiple pregnancy or gestational age from 24 to 27 weeks, repeat therapy (up to 3 repetitions) can not be excluded, and intrauterine fetal growth retardation. As an oxytocin antagonist, atosiban may facilitate uterine prolapse and postpartum bleeding, and therefore the degree of blood loss after delivery should be controlled.
Pregnancy and lactation:
It should only be used for preterm delivery in pregnant women between 24 and 33 weeks of age. If a woman is breast-feeding a previously born child, breast-feeding should be discontinued during treatment with atosiban, since oxytocin release during breastfeeding may increase uterine contractility and can neutralize the effect of tocolytic treatment.
Side effects:
Very often: nausea. Common: hyperglycemia, headache and dizziness, tachycardia, hypotension, hot flushes, vomiting, reaction at the injection site. Uncommon: insomnia, pruritus, rash, fever. Rare: hypersensitivity reactions, uterine haemorrhage, uterine atony.
Dosage:
Treatment with the preparation should be started and maintained by a physician experienced in the treatment of preterm delivery. The preparation is administered intravenously in 3 consecutive phases: the starting dose of 6.75 mg (solution for injection) is given in a direct, at least one minute intravenous injection (bolus); immediately afterwards a continuous intravenous infusion (concentrate for solution for infusion) at a dose of 300 μg / min (loading dose) for 3 hours is used; followed by an infusion of this formulation at a dose of 100 μg / min (maintenance dose) up to 45 h. Treatment should not last longer than 48 h, and the total dose should not exceed 330.75 mg. It is not recommended to use more than 3 repeated treatment cycles during pregnancy. The IV infusion should be prepared by dissolving the concentrate for solution for infusion in 0.9% NaCl solution, lactated Ringer's solution or 5% Glucose solution.
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