Prostin E2

Prostin E2 Special Precautions

dinoprostone

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Full Prescribing Info
Special Precautions
This product is only available to hospitals and clinics with specialised obstetric units and should only be used where 24-hour resident medical cover is provided.
Use caution in handling this product to prevent contact with skin. Wash hands thoroughly with soap and water after administration.
As with any oxytocic agent, the risk of uterine rupture should be considered. Concomitant medication, maternal and foetal status should be taken into consideration in order to minimise the risk of uterine hyperstimulation, uterine rupture, uterine haemorrhage, foetal and neonatal death. Continuous electronic monitoring of uterine activity and foetal heart rate should be conducted during use of dinoprostone. Patients who develop uterine hypertonus or hypercontractility, or in whom unusual foetal heart rate patterns develop, should be managed in a manner that addresses the welfare of the fetus and mother.
Caution should be exercised in the administration of dinoprostone for the induction of labour in patients with: asthma or a history of asthma; epilepsy or a history of epilepsy; glaucoma or raised intra-ocular pressure; compromised cardiovascular, hepatic, or renal function; hypertension; ruptured chorioamniotic membranes.
Dinoprostone should be used with caution in patients with multiple pregnancy.
In labour induction, cephalopelvic relationships should be carefully evaluated before use of dinoprostone. During use, uterine activity, foetal status and the progression of cervical dilation should be carefully monitored to detect possible evidence of undesired responses, e.g. hypertonus, sustained uterine contractions, or foetal distress.
In cases where there is a known history of hypertonic uterine contractility or tetanic uterine contractions, it is recommended that uterine activity and the state of the foetus (where applicable) should be continuously monitored throughout labour. The possibility of uterine rupture should be borne in mind where high-tone uterine contractions are sustained.
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 labor induction (see Adverse Reactions). 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. The clinician should be alert that the intracervical placement of dinoprostone may result in inadvertent disruption and subsequent embolization of antigenic tissue, causing in rare circumstances the development of Anaphylactoid Syndrome of Pregnancy (Amniotic Fluid Embolism).
Effects on ability to drive and use machines: Not applicable.
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