Atosiban
РастворTocolytic agent – oxytocin receptor blocking agent
Indications
Atosiban is indicated for use in case of threat of premature birth in pregnant women in the presence of the following criteria:
• regular uterine contractions lasting at least 30 seconds and with a frequency of 4 or more for 30 minutes
• dilation of the cervix from 1 to 3 cm (0-3 cm for unborn women) and smoothing of the cervix by more than 50 %
• gestation period from 24 to 33 full weeks
• normal fetal heart rate
Contraindications
- Hypersensitivity to atosiban and / or to any excipient in the composition of the drug
- The gestation period is less than 24 or more than 33 full weeks
- Premature rupture of the amniotic sac during pregnancy for more than 30 weeks
- Fetal heart rhythm disorders
- Prenatal uterine bleeding requiring immediate delivery
- Eclampsia and severe preeclampsia requiring immediate delivery
- Intrauterine fetal death
- Suspected intrauterine infection
- Placenta previa
- Placental abruption
- Any conditions of the mother and fetus in which prolongation of pregnancy is dangerous
- Breastfeeding period
- Under the age of 18 (due to the lack of clinical data on the efficacy and safety of atosiban in pregnant women under the age of 18)
With caution
- in patients with impaired liver function
- in case of multiple pregnancies and / or concomitant use of other tocolytics
Usage
Atosiban 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 atosiban at a dose of 300 µg/min for 3 h (infusion rate - 24 ml/h, atosiban dose - 18 mg/h);
3) this is followed by a prolonged (up to 45 h) infusion of atosiban at a dose of 100 µg/min (infusion rate - 8 ml/h, atosiban dose - 6 mg/h).
The total duration of treatment should not exceed 48 h. The maximum dose of atosiban for the whole course should not exceed 330.75 mg.
If there is a need for repeated administration of atosiban, it should also be started with Step 1 followed by infusion of atosiban (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 atosiban 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.
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Drugs in the category obstetrics and gynecology
Has contraindications. Needs specialist overview.