Prostin E2 10 mg/ml

/ Pfizer

Adults: Ampoule contents must be diluted before use and full instructions on method of dilution and dosage are given on the package insert which should be consulted prior to initiation of therapy. The following is a guide to dosage:
Dilute with normal saline or 5% dextrose according to the package insert to produce a 5 micrograms/ml solution. The 5 micrograms/ml solution is infused at 2.5 micrograms/minute for 30 minutes and then maintained or increased to 5 micrograms/minute. The rate should be maintained for at least 4 hours before increasing further.
Elderly: Not applicable.
Children: Not applicable.
Usage is restricted to qualified health care professionals and to hospitals and clinics with specialised obstetric units with facilities for continuous monitoring.
The recommended dose should not be exceeded, and the dosing interval should not be shortened as this increases the risk of uterine hyperstimulation, uterine rupture and uterine haemorrhage.

Therapeutic termination of pregnancy, missed abortion.

Hypersensitivity to the active substance(s) or to any of the excipients.
The drug should not be used where the patient is sensitive to prostaglandins.
Prostin® E2 10 mg/ml is not recommended in the following circumstances:
• For patients in whom oxytocic drugs are generally contra-indicated or where prolonged contractions of the uterus are considered inappropriate such as:
– Cases with a history of Caesarean section or major uterine surgery;
– Cases where there is evidence of a potential for obstructed labour.
• In patients with a past history of, or existing, pelvic inflammatory disease, unless adequate prior treatment has been instituted.
• Patients with active cardiac, pulmonary, renal or hepatic disease.

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 and maternal status should be taken into consideration in order to minimise the risk of uterine hyperstimulation, uterine rupture and uterine haemorrhage. Careful and regular monitoring of uterine activity should be conducted during use of dinoprostone. Patients who develop uterine hypertonus or hypercontractility should be managed in a manner that addresses the welfare of the mother.
It is advised that Prostin® E2 10 mg/ml should not be administered by the intramyometrial route since there have been reports of a possible association between this route of administration and cardiac arrest in severely ill patients.
Caution should be exercised 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.
As with any oxytocic agent, Prostin® E2 10 mg/ml should be used with caution in patients with compromised (scarred) uteri.
Animal studies lasting several weeks at high doses have shown that prostaglandins of the E and F series can induce proliferation of bone. Such effects have also been noted in newborn infants who received prostaglandin E1 during prolonged treatment. There is no evidence that short-term administration of prostaglandin E2 can cause similar bone effects.
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 (see section 4.8). 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.
Ethanol (alcohol): Depending on the daily dose administered this medicinal product will deliver varying amounts of ethanol.
Harmful for those suffering from alcoholism. It should also be taken into account when considering using this medicine in children and high-risk groups such as patients with liver disease or epilepsy. The amount of alcohol in this medicinal product may alter the effects of other medicines.

Very common: diarrhoea, nausea, vomiting, injection site irritation, injection site erythema, apgar score low, foetal heart rate abnormal
Common: vasovagal symptoms (flushing, shivering, headache, dizziness), hypertension, foetal distress syndrome, uterine hypertonus, uterine contractions abnormal.
See prescribing information for full details.

Since it has been found that prostaglandins potentiate the effect of oxytocin, it is not recommended that these drugs are used together. If used in sequence, the patient’s uterine activity should be carefully monitored.

Pregnancy: Prostin® E2 10 mg/ml is only used during pregnancy for therapeutic termination of pregnancy, missed abortion and hydatidiform mole. There has been some evidence in animals of a low order of teratogenic activity; therefore, if abortion does not occur or is suspected to be incomplete as a result of prostaglandin therapy (as in spontaneous abortion, where the process is sometimes incomplete), the appropriate treatment for complete evacuation of the pregnant uterus should be instituted in all instances.
Lactation: Prostaglandins are excreted in breast milk. This is not expected to be a hazard given the circumstances in which the product is used.

Overdosage may be expressed by uterine hypercontractility and uterine hypertonus. During use, uterine activity and the progression of cervical dilation should be carefully monitored to detect possible evidence of undesired responses, e.g. hypertonus or sustained uterine contractions. Because of the transient nature of prostaglandin E2 (PGE2-)-induced myometrial hyperstimulation, non-specific, conservative management should be used (rate of infusion should be decreased or discontinued, maternal position change and administration of oxygen). If conservative management is not effective, a tocolytic agent may be used in appropriate patients as a treatment of hyperstimulation following administration of PGE2 or appropriate measures should be considered.

Storage: Store in a refrigerator at 2° – 8°C.