Atosiban injection for adults

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Who can administer

Who can administer: May be administered by competent doctor or nurse/midwife

Important information

  • Atosiban must be initiated and maintained by a physician experienced in the treatment of pre-term labour

Available preparations

  • Tractocile 6.75mg in 0.9ml vial
  • Tractocile 37.5mg in 5ml vial

Reconstitution

Tractocile 6.75mg in 0.9ml vial

  • Already in solution ready for administration

Tractocile 37.5mg in 5ml vial

  • Dilute further prior to infusion

Infusion fluids

Sodium chloride 0.9% or Glucose 5%

Methods of intravenous administration

Bolus intravenous injection (initial dose only)

  • Draw up 0.9ml from vial containing 6.75mg/0.9ml and administer as a bolus injection over one minute, followed by intravenous infusion as outlined below

Intermittent intravenous infusion

  • Remove and discard 10ml fluid from 100ml infusion solution
  • Add contents of two vials of 37.5mg/5ml (total 75mg in 10ml) to the bag to give a solution of approximately 75mg per 100ml (0.75mg/ml)
  • Prepare new 100ml bags in the same way to allow the infusion to be continued

Dose in adults

Initial bolus dose

  • Give 6.75mg (using the 6.75mg/0.9ml vial)
  • Followed immediately by an infusion as described below

Intravenous infusion

  • Using a solution as outlined above (75mg in 100ml)
  • Give 24ml per hour for three hours (equivalent to 18mg per hour)
  • Followed by 8ml per hour for up to a further 45 hours (equivalent to 6mg per hour)
  • The duration of treatment should not exceed 48 hours (total dose during a full course of treatment should not exceed 330.75mg atosiban)

Retreatment

  • In case a re-treatment with atosiban is needed, it should also commence with a bolus injection of 6.75mg, followed by an infusion as outlined above
  • There is only limited clinical experience available with multiple re-treatments (up to 3 re-treatments)

Renal impairment

  • Dosage adjustment is unlikely to be needed

Hepatic impairment

  • Use atosiban with caution

Monitoring

  • Specialist monitoring required- see local guidelines

Storage

Store between 2 and 80C

References

SPC March 2022

Therapeutic classification

Oxytocin receptor antagonist