Drugs List

Therapeutic Indications

Uses

For the initiation of cervical ripening in patients at term (from 37 completed weeks of gestation).

Administration

Pessary for vaginal administration

Handling

After insertion the withdrawal tape may be cut ensuring there is enough tape left outside the vagina for easy removal should it be required.

Contraindications

The pessary should not be used or left in place when labour has started or when oxytocic drugs are being given.

Do not use in conditions where prolonged uterine contractions are inappropriate such as:
Previous Caesarean section
History of uterine surgery e.g. myomectomy
History of cervical surgery
History of cervical rupture
Foetal malpresentation
Foetal distress
Cephalopelvic disproportion

Uncontrolled pelvic inflammatory disease
Acute cardiac disease
Acute pulmonary disease
Acute hepatic disease
Acute renal failure
Placenta praevia
Undiagnosed vaginal bleeding during pregnancy
History of difficult or traumatic delivery

Precautions and Warnings

Assess condition of cervix before commencing treatment.

Women with the following conditions have an increased risk of developing disseminated intravascular coagulation (DIC), monitor for early signs in the immediate post partum phase:
Women aged 35 and over
Gestational diabetes
Arterial hypertension
Hypothyroidism
Gestational age above 40 weeks

Caution is required in patients with the following;
Ruptured amniotic membranes
History of uterine hypertonia
Asthma or history of asthma
Ruptured membranes
Glaucoma
Raised intra-ocular pressure
Cardiac disorders
Hepatic impairment
Renal impairment
Pulmonary disease
Hypertension
Epileptic disorder
Uterine scarring
Multiple pregnancy

Caution should be exercised in multiparae patients with over three previous term pregnancies.

After insertion uterine activity and the foetal condition should be monitored regularly. Any suggestion of maternal or foetal complications including adverse reactions requires the removal of the pessary.

Uterine rupture has been reported in association with dinoprostone - mainly in patients in whom its use was contraindicated (previous Caesarean section or uterine surgery).

Remove dinoprostone vaginal delivery system to terminate drug deliver when cervical ripening is judged to be complete or for the following reasons:
Evidence of maternal systemic adverse effects - nausea, vomiting, hypotension or tachycardia
Evidence of uterine hyperstimulation or hypertonic uterine contractions (with or without foetal distress), there may be a possibility of hypertonus or rupture.
Evidence of foetal distress
Onset of labour which is defined as the presence of regular painful contractions occurring every 3 minutes irrespective of cervical change. Contractions will not reduce in frequency or intensity as long as the pessary remains in situ.
Spontaneous or artificial rupture of the membranes or amniotomy

Pregnancy and Lactation

Pregnancy

Dinoprostone should not be used during pregnancy prior to 37 completed weeks of gestation.

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

Dinoprostone may be excreted in colostrum and breast milk. The level and duration of dinoprostone is expected to be very limited and it is not considered necessary to hinder breastfeeding. Clinical studies have not shown any adverse effects on the breastfed new-born.

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

Nausea
Vomiting
Diarrhoea
Uterine hypertonus
Uterine contractions (severe)
Irritation (localised)
Vaginal warmth
Vaginal pain
Amniotic fluid embolism
Pulmonary embolism
Abruptio placentae
Foetal heart rate disorder
Foetal distress
Maternal hypertension
Bronchospasm
Rapid cervical dilation
Fever
Backache
Uterine hyper contractility with foetal bradycardia
Uterine hyper contractility without foetal bradycardia
Low Apgar score in newborn
Cardiac arrest
Uterine rupture
Stillbirth
Neonatal death
Disseminated intravascular coagulation
Anaphylactic reaction
Genital oedema
Uterine hyperstimulation
Hypersensitivity reactions
Headache
Altered foetal heart rate patterns
Hypotension
Neonatal respiratory distress syndrome
Abdominal pain
Pruritus
Abnormal labour affecting foetus
Altered uterine contractions
Meconium in amniotic fluid
Uterine atony
Vulvovaginal burning
Febrile reactions

Presentation

Vaginal pessary containing 10mg of dinoprostone.

Drugs List

Therapeutic Indications

Uses

For the initiation of cervical ripening in patients at term (from 37 completed weeks of gestation).

Dosage

For the purposes of induction of labour with dinoprostone, the onset of labour is defined as the presence of regular painful uterine contractions occurring every 3 minutes irrespective of any cervical changes.

Adults

Elderly

Children

Additional Dosage Information

Administration

Pessary for vaginal administration

Handling

After insertion the withdrawal tape may be cut ensuring there is enough tape left outside the vagina for easy removal should it be required.

Contraindications

The pessary should not be used or left in place when labour has started or when oxytocic drugs are being given.

Do not use in conditions where prolonged uterine contractions are inappropriate such as:
Previous Caesarean section
History of uterine surgery e.g. myomectomy
History of cervical surgery
History of cervical rupture
Foetal malpresentation
Foetal distress
Cephalopelvic disproportion

Uncontrolled pelvic inflammatory disease
Acute cardiac disease
Acute pulmonary disease
Acute hepatic disease
Acute renal failure
Placenta praevia
Undiagnosed vaginal bleeding during pregnancy
History of difficult or traumatic delivery

Precautions and Warnings

Assess condition of cervix before commencing treatment.

Women with the following conditions have an increased risk of developing disseminated intravascular coagulation (DIC), monitor for early signs in the immediate post partum phase:
Women aged 35 and over
Gestational diabetes
Arterial hypertension
Hypothyroidism
Gestational age above 40 weeks

Caution is required in patients with the following;
Ruptured amniotic membranes
History of uterine hypertonia
Asthma or history of asthma
Ruptured membranes
Glaucoma
Raised intra-ocular pressure
Cardiac disorders
Hepatic impairment
Renal impairment
Pulmonary disease
Hypertension
Epileptic disorder
Uterine scarring
Multiple pregnancy

Caution should be exercised in multiparae patients with over three previous term pregnancies.

After insertion uterine activity and the foetal condition should be monitored regularly. Any suggestion of maternal or foetal complications including adverse reactions requires the removal of the pessary.

Uterine rupture has been reported in association with dinoprostone - mainly in patients in whom its use was contraindicated (previous Caesarean section or uterine surgery).

Remove dinoprostone vaginal delivery system to terminate drug deliver when cervical ripening is judged to be complete or for the following reasons:
Evidence of maternal systemic adverse effects - nausea, vomiting, hypotension or tachycardia
Evidence of uterine hyperstimulation or hypertonic uterine contractions (with or without foetal distress), there may be a possibility of hypertonus or rupture.
Evidence of foetal distress
Onset of labour which is defined as the presence of regular painful contractions occurring every 3 minutes irrespective of cervical change. Contractions will not reduce in frequency or intensity as long as the pessary remains in situ.
Spontaneous or artificial rupture of the membranes or amniotomy

Pregnancy and Lactation

Pregnancy

Dinoprostone should not be used during pregnancy prior to 37 completed weeks of gestation.

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

Dinoprostone may be excreted in colostrum and breast milk. The level and duration of dinoprostone is expected to be very limited and it is not considered necessary to hinder breastfeeding. Clinical studies have not shown any adverse effects on the breastfed new-born.

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

Effects on Ability to Drive and Operate Machinery

Not applicable

Side Effects

Nausea
Vomiting
Diarrhoea
Uterine hypertonus
Uterine contractions (severe)
Irritation (localised)
Vaginal warmth
Vaginal pain
Amniotic fluid embolism
Pulmonary embolism
Abruptio placentae
Foetal heart rate disorder
Foetal distress
Maternal hypertension
Bronchospasm
Rapid cervical dilation
Fever
Backache
Uterine hyper contractility with foetal bradycardia
Uterine hyper contractility without foetal bradycardia
Low Apgar score in newborn
Cardiac arrest
Uterine rupture
Stillbirth
Neonatal death
Disseminated intravascular coagulation
Anaphylactic reaction
Genital oedema
Uterine hyperstimulation
Hypersensitivity reactions
Headache
Altered foetal heart rate patterns
Hypotension
Neonatal respiratory distress syndrome
Abdominal pain
Pruritus
Abnormal labour affecting foetus
Altered uterine contractions
Meconium in amniotic fluid
Uterine atony
Vulvovaginal burning
Febrile reactions

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 ).

Shelf Life and Storage

Store at minus 10 to 20 degrees C
Store in original container in order to protect from moisture.
Keep in storage until immediately before use.

Further Information

Last Full Review Date: March 2012

Reference Sources

British National Formulary, 63rd Edition (2012) Pharmaceutical Press, London.

Summary of Product Characteristics: Propess 10mg vaginal delivery system. Ferring Pharmaceuticals Ltd. Revised January 2017.