Presentation and Status in Health Basket
4 X 3 mg
One tablet (3 mg) to be inserted high into the posterior fornix. A second tablet may be inserted after six to eight hours if labour is not established. Maximum dose 6 mg.
Induction of labor, especially in patients with favorable induction features, when there are no fetal or maternal contra-indications
Hypersensitivity to the active substance(s) or to any of the excipients.
Prostin E2 Vaginal Tablets should not be used where the patient is sensitive to prostaglandins or other constituents of the tablet.
Prostin E2 Vaginal Tablets are 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 cephalopelvic disproportion.
– Cases in which fetal malpresentation is present.
– Cases where there is clinical suspicion or definite evidence of pre-existing fetal distress.
– Cases in which there is a history of difficult labour and/or traumatic delivery.
– Grand multiparae with over five previous term pregnancies.
• Patients with ruptured membranes.
• In patients with a past history of, or existing, pelvic inflammatory disease, unless adequate prior treatment has been instituted.
• In patients where there is clinical suspicion or definite evidence of placenta praevia or unexplained vaginal bleeding during this pregnancy.
• 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.
Caution should be exercised in the administration of Prostin E2 Vaginal Tablets 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
As with any oxytocic agent, Prostin E2 Vaginal Tablets should be used with caution in patients with compromised (scarred) uteri.
In labour induction, cephalopelvic relationships should be carefully evaluated before use of Prostin E2 Vaginal Tablets. During use, uterine activity, fetal 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 fetal 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 fetus (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 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.
Cardiac disorders: Cardiac arrest
Vascular disorders: Hypertension
Gastrointestinal disorders: Diarrhoea, nausea, vomiting
General disorders and administration site conditions: Fever
Immune system disorders: Hypersensitivity reactions such as anaphylactoid reactions and anaphylactic reactions including anaphylactic shock.
Musculoskeletal and connective tissue disorders: Back pain
Pregnancy, puerperium and perinatal conditions:
Maternal-related conditions: Uterine hypertonus, uterine rupture, abruptio placenta, pulmonary amniotic fluid embolism, rapid cervical dilatation.
Fetus-related conditions: Uterine hypercontractility with/without fetal bradycardia fetal distress/altered fetal heart rate (FHR).
Neonatal conditions: Neonatal distress, neonatal death, stillbirths, low Apgar score.
Reproductive system and breast disorders: Warm feeling in vagina, irritation, pain.
Respiratory, thoracic and mediastinal disorders: Asthma, bronchospasm
Skin and subcutaneous tissue disorders: Rash
Blood and lymphatic system disorders: An increased risk of post-partum disseminated intravascular coagulation has been described in patients whose labour was induced by pharmacological means, either with dinoprostone or oxytocin. The frequency of this adverse event, however, appears to be rare (<1 per 1,000 labours).
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 and Lactation
Pregnancy: Prostin E2 Vaginal Tablets are only used during pregnancy, to induce labour.
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, fetal 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 fetal distress. Because of the transient nature of prostaglandin E2 (PGE2)-induced myometrial hyperstimulation, non-specific, conservative management was found to be effective in the vast majority of cases: i.e. maternal position change and administration of oxygen to the mother. If conservative management is not effective, ß-adrenergic drugs may be used as a treatment of hyperstimulation following administration of PGE2 for cervical ripening, in appropriate patients.