Prepidil (Dinoprostone Vaginal) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

4. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenic bioassay studies have not been conducted in animals with PREPIDIL Gel due to the limited indications for use and short duration of administration. No evidence of mutagenicity was observed in the Micronucleus Test or Ames Assay.

5. Pregnancy

Teratogenic Effects

PREGNANCY CATEGORY C

Prostaglandin E₂ produced an increase in skeletal anomalies in rats and rabbits. No effect would be expected clinically, when used as indicated, since PREPIDIL Gel is administered after the period of organogenesis. PREPIDIL Gel has been shown to be embryotoxic in rats and rabbits, and any dose that produces sustained increased uterine tone could put the embryo or fetus at risk. See statements under General Precautions.

OVERDOSAGE

Overdosage with PREPIDIL Gel may be expressed by uterine hypercontractility and uterine hypertonus. Because of the transient nature of PGE₂-induced myometrial hyperstimulation, nonspecific, conservative management was found to be effective in the vast majority of the cases; i.e., maternal position change and administration of oxygen to the mother. β-adrenergic drugs may be used as a treatment of hyperstimulation following the administration of PGE₂ for cervical ripening.

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

DRUG ABUSE AND DEPENDENCE

No drug abuse or drug dependence has been seen with the use of PREPIDIL Gel.