Dinoprostone
- Drugs List
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Vaginal gel containing 1mg dinoprostone per single dose unit
Vaginal gel containing 2mg dinoprostone per single dose unit
Vaginal tablets containing 3mg dinoprostone
Drugs List
Dosage
Adults
All products should be used only in specialised obstetric units with resident medical cover.
Vaginal gel
Initial dose of 1mg
A second dose after 6 hours of 1mg should be administered where uterine activity is insufficient for satisfactory progress of labour.
OR
A second dose after 6 hours of 2mg may be used where the response to the initial dose is minimal.
Maximum total dose of 3mg
Patients who are pregnant for the first time with unfavourable induction features (Bishop score of 4 or less)
Initial dose of 2mg
A second dose after 6 hours of 1mg should be administered where uterine activity is insufficient for satisfactory progress of labour.
OR
A second dose after 6 hours of 2mg may be used where the response to the initial dose is minimal.
Maximum total dose of 4mg
Vaginal tablets
Initial dose of 3mg
A second dose of 3mg may be inserted after 6 to 8 hours if labour is not established.
Maximum total dose of 6mg
Elderly
Children
Patients with Renal Impairment
Use with caution in patients with renal impairment.
Contraindicated in patients with acute renal disease.
Patients with Hepatic Impairment
Use with caution in patients with hepatic impairment.
Contraindicated in patients with acute hepatic disease.
Administration
For vaginal administration
Vaginal gel
The gel should be inserted high into the posterior fornix. Administration in to the cervical canal should be avoided.
After administration, the patient should remain recumbent for at least 30 minutes.
Vaginal tablets
The tablets should be inserted high into the posterior fornix.
Handling
Handle with caution and avoid contact with skin. Hands must be washed thoroughly with soap and water after administration.Contraindications
Conditions where prolonged uterine contractions are inappropriate such as:
History of Caesarean section
History of major uterine surgery
Cephalopelvic disproportion
Foetal malpresentation
Foetal distress (known or suspected)
History of difficult or traumatic labour
Grand multipara (5 or more previous pregnancies)
Multiple pregnancy
Untreated pelvic infection
Untreated pelvic inflammatory disease
Placenta praevia (known or suspected)
Unexplained vaginal bleeding during the pregnancy
Ruptured membranes
Acute cardiac disorder
Acute pulmonary disorder
Acute renal disease
Acute hepatic disease
Precautions and Warnings
The preparations should only be used in hospitals or clinics with specialised obstetric units.
The vaginal gel and vaginal tablets are not bioequivalent.
Before use, evaluate cephalopelvic relationships and do not use in cases of cephalopelvic disproportion.
During use, uterine activity, foetal status and the progression of cervical dilation should be monitored in order to detect possible adverse effects such as hypertonus, sustained uterine contractions or foetal distress. In patients with a history of hypertonic uterine contractility or tetanic uterine contractions, uterine activity and foetal state should be monitored throughout labour. When high-tone uterine contractions are sustained, the possibility of uterine rupture should be considered.
Women aged 35 years or older, those with complications during pregnancy and those with a gestational age over 40 weeks have been shown to have an increased risk of post-partum disseminated intravascular coagulation. In addition, these factors may further increase the risk associated with labour induction. Therefore, in these women, use of dinoprostone should be undertaken with caution. Measures should be applied to detect as soon as possible an evolving fibrinolysis in the immediate post-partum phase.
If dinoprostone is used in sequence with oxytocin, the uterine activity of the patient should be closely monitored.
Handle with caution and avoid contact with skin. Hands must be washed thoroughly with soap and water after administration.
Use with caution in patients with the following conditions:
Asthma
History of asthma
Epilepsy
History of epilepsy
Glaucoma
Raised intraocular pressure
Cardiovascular impairment
Renal impairment
Hepatic impairment
Hypertension
Compromised (scarred) uterus
Pregnancy and Lactation
Pregnancy
Not applicable. For use during pregnancy to induce labour.
Lactation
Prostaglandins are excreted in breast milk but this is irrelevant to the indication.Side Effects
Vomiting
Nausea
Diarrhoea
Hypersensitivity reactions
Uterine rupture
Cardiac arrest
Pulmonary embolism
Amniotic fluid embolism
Abruptio placenta
Uterine hypercontractility or hypertonus
Hypertension
Bronchospasm
Asthma
Rapid cervical dilation
Fever
Backache
Rash
Vaginal warmth
Vaginal irritation
Vaginal pain
Disseminated intravascular coagulation
Anaphylaxis
Effects on the foetus/neonate
Stillbirth
Neonatal death
Foetal distress
Bradycardia
Low Apgar score
Altered foetal heart rate patterns
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 2-8 degrees C
Reference Sources
British National Formulary, 63rd Edition (2012) Pharmaceutical Press, London.
Summary of Product Characteristics: Prostin E2 vaginal gel. Pharmacia Ltd. Revised March 2012.
Summary of Product Characteristics: Prostin E2 vaginal tablets. Pharmacia Ltd. Revised March 2012.
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