Drugs List

Therapeutic Indications

Uses

Premature labour : prevention

Suppression of uterine contractions in uncomplicated preterm labour in patients between 24 and 33 completed weeks of gestation.

Treatment should not be initiated until patients have:
Regular uterine contractions which last at least 30 seconds, and occur at a rate of four or more every 30 minutes.
Cervical dilation of 1cm to 3cm (0 to 3 for nulliparas) with effacement of 50% or more.

Administration

Intravenous bolus injection (using the 6.75mg/0.9ml solution for injection) followed by intravenous infusions (using the 37.5mg/5ml concentrate for solution for infusion).

Contraindications

Abnormal foetal heart rate
Children under 18 years
Suspected intra-uterine infection
Antepartum haemorrhage
Eclampsia
Gestational age below 24 weeks
Gestational age over 33 weeks
Intra-uterine foetal death
Intra-uterine infection
Placenta abruptio
Placenta praevia
Premature rupture of membranes at greater than 30 weeks gestation
Severe pre-eclampsia

Precautions and Warnings

Gestational age between 24 and 27 weeks
Hepatic impairment
Intra-uterine growth retardation
Multiple pregnancy

Treatment to be initiated and supervised by a specialist
Do not mix with other injections or infusions prior to administration
Monitor blood loss after delivery
Monitor uterine contractions and foetal heart rate

If premature rupture of the membranes cannot be excluded, consider the benefits of delaying delivery versus the potential risk of chorioamnionitis.

In cases of intrauterine growth retardation, the decision to use atosiban should be based on assessment of foetal maturity.

In patients with multiple pregnancies or at gestational ages between 24 and 27 weeks, use atosiban with caution. Due to limited clinical experience in these patient groups, benefits are uncertain. Multiple pregnancy is also associated with an increased risk of pulmonary oedema which can be further intensified by use of medicines with tocolytic activity (e.g. beta agonists, calcium channel blockers).

Pregnancy and Lactation

Pregnancy

Atosiban should only be used between 24 and 33 completed weeks of gestation.

Early embryonic studies have not been performed. Embryo-foetal toxicity studies did not identify any toxic effects.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Patients treated with atosiban during pregnancy may breastfeed the neonate/infant following birth.

Atosiban is expressed in breast milk in small amounts. No effects on breastfeeding were identified during clinical trials.

Patients requiring treatment with atosiban during pregnancy who are currently breastfeeding another child should discontinue breastfeeding for the duration of atosiban treatment. Breastfeeding causes a release of oxytocin which may augment uterine contractility. As such, continuing to breastfeed during atosiban treatment may counteract the clinical effects of atosiban.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Allergic reaction
Dizziness
Dyspnoea
Headache
Hot flushes
Hyperglycaemia
Hypotension
Injection site reactions
Insomnia
Nausea
Pruritus
Pulmonary oedema
Pyrexia
Rash
Tachycardia
Uterine atony
Uterine haemorrhage
Vomiting

Presentation

Injections of atosiban.

Drugs List

Therapeutic Indications

Uses

Premature labour : prevention

Suppression of uterine contractions in uncomplicated preterm labour in patients between 24 and 33 completed weeks of gestation.

Treatment should not be initiated until patients have:
Regular uterine contractions which last at least 30 seconds, and occur at a rate of four or more every 30 minutes.
Cervical dilation of 1cm to 3cm (0 to 3 for nulliparas) with effacement of 50% or more.

Dosage

Initiate treatment as soon as possible following diagnosis of preterm labour.

Adults

Additional Dosage Information

Administration

Intravenous bolus injection (using the 6.75mg/0.9ml solution for injection) followed by intravenous infusions (using the 37.5mg/5ml concentrate for solution for infusion).

Contraindications

Abnormal foetal heart rate
Children under 18 years
Suspected intra-uterine infection
Antepartum haemorrhage
Eclampsia
Gestational age below 24 weeks
Gestational age over 33 weeks
Intra-uterine foetal death
Intra-uterine infection
Placenta abruptio
Placenta praevia
Premature rupture of membranes at greater than 30 weeks gestation
Severe pre-eclampsia

Precautions and Warnings

Gestational age between 24 and 27 weeks
Hepatic impairment
Intra-uterine growth retardation
Multiple pregnancy

Treatment to be initiated and supervised by a specialist
Do not mix with other injections or infusions prior to administration
Monitor blood loss after delivery
Monitor uterine contractions and foetal heart rate

If premature rupture of the membranes cannot be excluded, consider the benefits of delaying delivery versus the potential risk of chorioamnionitis.

In cases of intrauterine growth retardation, the decision to use atosiban should be based on assessment of foetal maturity.

In patients with multiple pregnancies or at gestational ages between 24 and 27 weeks, use atosiban with caution. Due to limited clinical experience in these patient groups, benefits are uncertain. Multiple pregnancy is also associated with an increased risk of pulmonary oedema which can be further intensified by use of medicines with tocolytic activity (e.g. beta agonists, calcium channel blockers).

Pregnancy and Lactation

Pregnancy

Atosiban should only be used between 24 and 33 completed weeks of gestation.

Early embryonic studies have not been performed. Embryo-foetal toxicity studies did not identify any toxic effects.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Patients treated with atosiban during pregnancy may breastfeed the neonate/infant following birth.

Atosiban is expressed in breast milk in small amounts. No effects on breastfeeding were identified during clinical trials.

Patients requiring treatment with atosiban during pregnancy who are currently breastfeeding another child should discontinue breastfeeding for the duration of atosiban treatment. Breastfeeding causes a release of oxytocin which may augment uterine contractility. As such, continuing to breastfeed during atosiban treatment may counteract the clinical effects of atosiban.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Allergic reaction
Dizziness
Dyspnoea
Headache
Hot flushes
Hyperglycaemia
Hypotension
Injection site reactions
Insomnia
Nausea
Pruritus
Pulmonary oedema
Pyrexia
Rash
Tachycardia
Uterine atony
Uterine haemorrhage
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: October 2018

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Summary of Product Characteristics: Atosiban 37.5mg/5ml Concentrate for Solution for Infusion. Accord Healthcare Ltd. Revised August 2015.
Summary of Product Characteristics: Atosiban 6.75mg/0.9ml Solution for Injection. Bowmed Ibisqus. Revised February 2018.
Summary of Product Characteristics: Atosiban 37.5mg/5ml Concentrate for Solution for Infusion. Bowmed Ibisqus. Revised February 2018.
Summary of Product Characteristics: Tractocile 7.5mg/ml Solution for Injection. Ferring Pharmaceuticals Ltd. Revised February 2013.
Summary of Product Characteristics: Tractocile 7.5mg/ml Concentrate for Solution for Infusion. Ferring Pharmaceuticals Ltd. Revised February 2013.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 17 October 2018