CONTRAINDICATIONS

Endocervically administered PREPIDIL Gel is not recommended for the following:

a.

Patients in whom oxytocic drugs are generally contraindicated or where prolonged contractions of the uterus are considered inappropriate, such as:

•

cases with a history of cesarean section or major uterine surgery

•

cases in which cephalopelvic disproportion is present

•

cases in which there is a history of difficult labor and/or traumatic delivery

•

grand multiparae with six or more previous term pregnancies cases with non-vertex presentation

•

cases with hyperactive or hypertonic uterine patterns

•

cases of fetal distress where delivery is not imminent

•

in obstetric emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention

b.

Patients with hypersensitivity to prostaglandins or constituents of the gel (see WARNINGS and ADVERSE REACTIONS).

c.

Patients with placenta previa or unexplained vaginal bleeding during this pregnancy.

d.

Patients for whom vaginal delivery is not indicated, such as vasa previa or active herpes genitalia.