Cervidil Special Precautions

The condition of the cervix should be assessed carefully before CERVIDIL is used. After insertion, uterine activity and fetal condition must be monitored carefully and regularly by qualified healthcare personnel. CERVIDIL must only be used in hospital and clinics with obstetric units with facilities for continuous fetal and uterine monitoring. If there is any suggestion of maternal or fetal complications or if adverse effects occur, the vaginal delivery system should be removed from the vagina.
Uterine rupture has been reported in association with the use of CERVIDIL, mainly in patients with contraindicated conditions (see Contraindications). Therefore, CERVIDIL should not be administered to patients with a history of previous caesarean section or uterine surgery given the potential risk for uterine rupture and associated obstetrical complications.
If uterine contractions are prolonged or excessive, there is possibility of uterine hypertonus or rupture and the vaginal delivery system should be removed immediately.
A second dose of CERVIDIL is not recommended, as the effects of a second dose have not been studied.
CERVIDIL should be used with caution in patients with a previous history of uterine hypertonus, glaucoma or asthma.
The experience of CERVIDIL in patients with ruptured membranes is limited. Therefore, CERVIDIL should be used with caution in those patients. Since the release of dinoprostone from the insert can be affected in the presence of amniotic fluid, special attention should be given to uterine activity and fetal condition.
Women aged 35 and over, women with complications during pregnancy, such as gestational diabetes, arterial hypertension and hypothyroidism, and women at gestational age above 40 weeks have a higher post partum risk for developing disseminated intravascular coagulation (DIC). These factors may additionally enhance the risk of disseminated intravascular coagulation in women with pharmacologically induced labour (see Adverse Reactions). Therefore, dinoprostone should be used with caution in these women. In the immediate post‑partum phase the physician should look out carefully for early signs of a developing DIC (e.g fibrinolysis).
The Clinician should be alert that, as with other labour induction methods, use of dinoprostone may result in inadvertent abruption of placenta and subsequent embolization of antigenic tissue causing in rare circumstances the development of Anaphylactoid Syndrome of Pregnancy (Amniotic Fluid Embolism).
CERVIDIL should be used with caution when there is a multiple pregnancy. No studies in multiple pregnancy have been performed.
CERVIDIL should be used with caution when the woman has had more than three full term deliveries. No studies in woman with more than three full term deliveries have been performed.
The use of the product in patients with diseases which could affect the metabolism or excretion of dinoprostone, e.g. lung, liver or renal disease, has not been specifically studied. The use of the product in such patients is not recommended.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Not relevant.