Abbreviated Prescribing Information of CERVIDIL 10mg
Indications: Initiation of cervical ripening in patients, at or near term.
Dosage & Administration: One pessary is administered high into the posterior vaginal fornix. If there has been insufficient cervical ripening in 24 hours, the pessary should be removed. A dosing interval of at least 30 minutes is recommended for the sequential use of uterotonic drugs following the removal of the pessary. Administration: CERVIDIL should be removed from the freezer just prior to the insertion. The pessary should be inserted high into the posterior vaginal fornix using only small amounts of water soluble lubricants to aid insertion. The patient should be recumbent for 30 minutes after insertion. Removal: The pessary can be removed quickly and easily by gentle traction of the retrieval tape. It is necessary to remove the pessary to terminate drug administration when cervical ripening is judged to be complete or: onset of labour; spontaneous rupture of the membranes or amniotomy; any suggestion of uterine hyperstimulation or hypertonic uterine contractions; evidence of fetal distress; evidence of maternal systemic adverse dinoprostone effects such as nausea, vomiting, hypotension or tachycardia; at least 30 minutes prior to starting an intravenous infusion of uterotonic drugs.
Contra-indications: CERVIDIL should not be used or left in place when: labour has started; uterotonic drugs or other labour induction agents are being given; strong prolonged uterine contractions would be inappropriate; there is current pelvic inflammation disease, unless adequate prior treatment has been instituted; there is hypersensitivity to dinoprostone or to any of the excipients; there is placenta previa or active herpes genitalis or unexplained vaginal bleeding during the current pregnancy; the patient is carrying more than one fetus or the fetus is in a non-vertex presentation; there is abnormal cardiotocography or suspected fetal compromise; any suggestion of uterine hyperstimulation or hypertonic uterine contractions.
Special Warning or Precautions: CERVIDIL must only be used in hospitals and clinics with obstetric units with facilities for continuous fetal and uterine monitoring. Uterine activity and fetal condition must be monitored regularly by qualified healthcare personnel; should be used cautiously in patients with history of uterine hypertony, glaucoma or asthma; medication with non-steroidal anti-inflammatory drugs should be stopped before administration of dinoprostone; multiple pregnancy; patients with lung, liver or renal disease; women aged 35 and over; complications during pregnancy; gestational age > 40 weeks.
Undesirable Effects: Common (≥ 1/100 and < 1/10): Fetal heart rate disorder, abnormal uterine contractions, abnormal labor affecting fetus and meconium in amniotic fluid. Uncommon (≥ 1/1000 and ≤ 1/100): Headache, hypotension, neonatal respiratory distress related conditions, neonatal hyperbilirubinaemia, pruritus, postpartum haemorrhage, premature separation of placenta, Apgar score low, arrested labour, chorioamnionitis, uterine atony, vulvovaginal burning sensation, and febrile disorders.
Full prescribing information is available upon request.