Healthcare Provider Information

Introduction to Cervidil^®

Cervidil is indicated for the initiation and/or continuation of cervical ripening in patients at or near term in whom there is a medical or obstetrical indication for the induction of labor. Cervidil is the only FDA-approved prostaglandin insert in the United States, and more than 3 million inserts have been dispensed in U.S. hospitals since 1995.

In the United States, approximately 22% of gravid women undergo induction of labor. The goal of induction is to achieve vaginal delivery by dilating the cervix and stimulating uterine contractions before the spontaneous onset of labor. If a physician decides that induction is necessary and the status of the cervix is unfavorable, agents for cervical ripening may be used. If cervical ripening is used, monitoring of fetal heart rate (FHR) and uterine contractions is recommended, as for any high-risk patient in active labor. About half of women who are induced require a cervical ripener to assist with labor.

Cervidil and Prepidil^® (dinoprostone cervical gel) are the only two synthetic prostaglandins (PGE₂) approved by the FDA for cervical ripening. Cervidil is the only FDA-approved retrievable pessary insert in the United States. Cervidil provides safe and efficacious cervical ripening in women with an unfavorable cervix.

Cervidil may augment the activity of oxytocic agents and their concomitant use is not recommended. A dosing interval of at least 30 minutes is recommended for the sequential use of oxytocin following the removal of the Cervidil insert. No other drug interactions have been identified.

Product Description

Cervidil is a thin, flat, polymeric slab which is rectangular in shape with rounded corners contained within the pouch of an off-white knitted polyester retrieval system. An integral part of the retrieval system is the long tape designed to aid retrieval. Each Cervidil insert contains 10 mg of dinoprostone in a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3mg/hr.

Cervidil Vaginal Insert (dinoprostone, 10 mg) is indicated for the initiation and/or continuation of cervical ripening in patients at or near term in whom there is a medical or obstetrical indication for the induction of labor.

Cervidil is for hospital use only and should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.

Cervidil is designed to be released at approximately 0.3 mg/hour over a 12-hour period. Cervidil should be removed upon onset of active labor or 12 hours after insertion.

Upon removal of Cervidil, it is essential to ensure that the slab has been removed as it may have separated from the knitted polyester retrieval system and will continue delivering the active ingredient.