Pre-term birth

Active Ingredient: Atosiban

Indication for Atosiban

Population group: women, only adults (18 - 65 years old)

Atosiban is indicated to delay imminent pre-term birth in pregnant women with:

  • regular uterine contractions of at least 30 seconds duration at a rate of ≥4 per 30 minutes
  • a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ≥50%
  • age ≥18 years
  • a gestational age from 24 until 33 completed weeks
  • a normal fetal heart rate.

For this indication, competent medicine agencies globally authorize below treatments:

6.75-270 mg in 3 doses

Route of admnistration


Defined daily dose

6.75 - 270 mg

Dosage regimen

From 2.25 To 90 mg 3 time(s) per day every day

Detailed description

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:

StepRegimenInfusion rateAtosiban dose
10.9 ml intravenous bolus injection given over 1 minuteNot applicable6.75 mg
23 hours intravenous loading infusion24 ml/hour (300 µg/min) 54 mg
3Up to 45 hours subsequent intravenous infusion8 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.

Active ingredient


Atosiban is a synthetic peptide which is a competitive antagonist of human oxytocin at receptor level. In human pre-term labour, atosiban at the recommended dosage antagonises uterine contractions and induces uterine quiescence.

Read more about Atosiban

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