Atosiban is indicated to delay imminent pre-term birth in pregnant women with:
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
6.75 - 270 mg
From 2.25 To 90 mg 3 time(s) per day every day
Treatment with atosiban should be initiated and maintained by a physician experienced in the treatment of pre-term labour.
Atosiban is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with atosiban 6.75 mg/0.9 ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/min) of atosiban 37.5 mg/5 ml concentrate for solution for infusion during three hours, followed by a lower dose of atosiban 37.5 mg/5 ml concentrate for solution for infusion (subsequent infusion 100 micrograms/min) up to 45 hours. The duration of the treatment should not exceed 48 hours. The total dose given during a full course of atosiban therapy should preferably not exceed 330.75 mg of atosiban.
Intravenous therapy using the initial bolus injection should be started as soon as possible after diagnosis of pre-term labour. Once the bolus has been injected, proceed with the infusion. In the case of persistence of uterine contractions during treatment with atosiban, alternative therapy should be considered.
The following table shows the full posology of the bolus injection followed by the infusion:
| Step | Regimen | Infusion rate | Atosiban dose |
|---|---|---|---|
| 1 | 0.9 ml intravenous bolus injection given over 1 minute | Not applicable | 6.75 mg |
| 2 | 3 hours intravenous loading infusion | 24 ml/hour (300 µg/min) | 54 mg |
| 3 | Up to 45 hours subsequent intravenous infusion | 8 ml/hour (100 µg/min) | Up to 270 mg |
In case a re-treatment with atosiban is needed, it should also commence with a bolus injection of atosiban 6.75 mg/0.9 ml, solution for injection followed by infusion with atosiban 37.5 mg/5 ml, concentrate for solution for infusion.