Atosiban
КонцентратTocolytic agent – oxytocin receptor blocking agent
Indications
Atoziban is used for threatened preterm labour in pregnant women over 18 years of age at 24 to 33 full weeks' gestation with normal fetal heart rate in the following cases:
regular uterine contractions of at least 30 s duration and frequency of more than 4 within 30 min;
cervical opening of 1 to 3 cm (03 cm for unborn women).
Contraindications
hypersensitivity to atosiban or any of the excipients of the drug in anamnesis;
gestational age less than 24 or more than 33 full weeks;
premature rupture of membranes in pregnancy of more than 30 weeks;
intrauterine foetal developmental delay;
abnormal fetal heart rate (FHR);
uterine haemorrhage requiring immediate delivery;
eclampsia and severe pre-eclampsia requiring immediate delivery;
intrauterine foetal death;
suspected chorioamnionitis;
placenta previa;
premature detachment of the placenta;
any maternal or foetal condition that poses a risk to the continuation of pregnancy;
period of breastfeeding.
Caution
If premature rupture of the fetal membranes is suspected, the use of atoziban for prolongation of pregnancy should be weighed against the potential risk of chorioamnionitis. Atoziban should be used with caution in hepatic and renal dysfunction, in multiple pregnancy, in gestation period of 24-27 weeks (due to lack of sufficient clinical experience), as well as when co-administered with other medicinal products with tocolytic effect.
Use in pregnancy and during breastfeeding
Atoziban should be used only in case of diagnosed preterm labour between 24 and 33 full weeks of pregnancy.
Atoziban is contraindicated during breastfeeding.
Usage
Atoziban is administered intravenously immediately after the diagnosis of preterm labour in 3 stages:
1) first, I vial of 0.9 ml of the drug without dilution is administered within 1 min (initial dose - 6.75 mg);
2) immediately followed by infusion of atoziban at a dose of 300 µg/min for 3 h (infusion rate - 24 ml/h, atoziban dose - 18 mg/h);
3) this is followed by a prolonged (up to 45 h) infusion of atoziban at a dose of 100 µg/min (infusion rate - 8 ml/h, atoziban dose - 6 mg/h).
The total duration of treatment should not exceed 48 h. The maximum dose of atoziban for the whole course should not exceed 330.75 mg.
If there is a need for repeated administration of atoziban, it should also be started with Step 1 followed by infusion of atoziban (Steps 2 and 3).
Re-administration can be started at any time after the first administration of the drug and can be repeated for up to 3 cycles.
If after 3 cycles of atoziban therapy the contractile activity of the uterus does not decrease, the use of another tocolytic drug should be considered.
Instructions for preparation of solution for infusion (step 2 and 3)
The concentrate is diluted in one of the following solutions:
0.9% sodium chloride solution;
Ringer's acetate solution;
5% glucose solution.
From the vial containing 100 ml of one of the above solutions for dilution, 10 ml is drained. Then 10 ml (2 vials) of the drug is injected into the vial to obtain a concentration of 75mg/100ml.
Shelf life of the prepared solution for infusion is 24 h. Do not use if undissolved particles are visible in the solution or the solution has changed colour.
Special categories of patients
Under 18 years of age
Atoziban should not be used in pregnant women under 18 years of age due to lack of efficacy and safety data in patients in this age group.
Renal dysfunction
There are no data on the use of Atoziban in patients with impaired renal function.
Liver dysfunction
There are no data on the use of Atoziban in patients with hepatic dysfunction.
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Drugs in the category obstetrics and gynecology
Has contraindications. Needs specialist overview.