Dinoprostone (Cervical Ripening / Induction of Labour)

Fetched label is 'Dinoprostone 10 mg Vaginal delivery system' (PROPESS, UK SPC) — indication matches this page. Should only be administered by qualified healthcare personnel in hospitals and clinics with specialised obstetric units with facilities for continuous fetal and uterine monitoring; after insertion, uterine activity and fetal condition must be carefully and regularly monitored. ADMINISTRATION: remove from the freezer just prior to insertion — no thawing required; open the sachet along the tear mark (do not use scissors or sharp objects which may cut the retrieval system); after insertion the withdrawal tape may be cut with scissors, always leaving sufficient tape outside the vagina to allow removal, and no attempt should be made to tuck the end of the tape into the vagina. The patient should be recumbent for 20 to 30 minutes after insertion. The vaginal delivery system should NEVER be removed from its retrieval device. On removal it will have swollen to 2-3 times its original size and be pliable. REMOVE the delivery system for any of the following: (1) onset of labour — defined for induction purposes as regular painful uterine contractions occurring every 3 minutes irrespective of any cervical change (once regular painful contractions are established the device should be removed irrespective of cervical state, to avoid uterine hyperstimulation); (2) spontaneous rupture of membranes or amniotomy; (3) any suggestion of uterine hyperstimulation or hypertonic uterine contractions; (4) evidence of fetal distress; (5) evidence of maternal systemic adverse dinoprostone effects such as nausea, vomiting, hypotension or tachycardia; (6) at least 30 minutes prior to starting an intravenous infusion of oxytocin, as there is a much greater risk of hyperstimulation if the dinoprostone source is not removed first. A dosing interval of at least 30 minutes is recommended for the sequential use of oxytocin following removal. SEPARATE US PRODUCT (different formulation — do not merge with the regimen above): the fetched openFDA label is PREPIDIL endocervical gel, given intracervically just below the level of the internal os with the patient supine for 15-30 minutes afterwards; if there is no cervical/uterine response to the initial dose, the recommended repeat dose is 0.5 mg dinoprostone at a dosing interval of 6 hours, the maximum recommended cumulative dose in a 24-hour period is 1.5 mg dinoprostone (7.5 mL gel), and the recommended interval before giving intravenous oxytocin is 6-12 hours. Paediatric (non per-kg, so not expressed as a mg/kg dose): the safety and efficacy of PROPESS in pregnant women aged less than 18 years has not been established and no data are available. Verify any under-18 use against a children's formulary.