PREPIDIL Gel is indicated for ripening an unfavorable cervix in pregnant women at or near term with a medical or obstetrical need for labor induction.

NOTE: USE CAUTION IN HANDLING THIS PRODUCT TO PREVENT CONTACT WITH SKIN. WASH HANDS THOROUGHLY WITH SOAP AND WATER AFTER ADMINISTRATION. PREPIDIL Gel should be brought to room temperature (59º to 86ºF; 15º to 30ºC) just prior to administration. Do not force the warming process by using a water bath or other source of external heat (eg, microwave oven).

To prepare the product for use, remove the peel-off seal from the end of the syringe. Then remove the protective end cap (to serve as plunger extension) and insert the protective end cap into the plunger stopper assembly in the barrel of syringe. Choose the appropriate length shielded catheter (10mm or 20mm) and aseptically remove the sterile shielded catheter from the package. Careful vaginal examination will reveal the degree of effacement which will regulate the size of the shielded endocervical catheter to be used. That is, the 20mm endocervical catheter should be used if no effacement is present, and the 10mm catheter should be used if the cervix is 50% effaced. Firmly attach the catheter hub to the syringe tip as evidenced by a distinct click. Fill the catheter with sterile gel by pushing the plunger assembly to expel air from the catheter prior to administration to the patient. Proper assembly of the dosing apparatus is shown below.

To properly administer the product, the patient should be in a dorsal position with the cervix visualized using a speculum. Using sterile technique, introduce the gel with the catheter provided into the cervical canal just below the level of the internal os. Administer the contents of the syringe by gentle expulsion and then remove the catheter. The gel is easily extrudable from the syringe. Use the contents of one syringe for one patient only. No attempt should be made to administer the small amount of gel remaining in the catheter. The syringe, catheter, and any unused package contents should be discarded after use. Following administration of PREPIDIL Gel, the patient should remain in the supine position for at least 15 - 30 minutes to minimize leakage from the cervical canal. If the desired response is obtained from PREPIDIL Gel, the recommended interval before giving intravenous oxytocin is 6-12hours. If there is no cervical/uterine response to the initial dose of PREPIDIL Gel, repeat dosing may be given. The recommended repeat dose is 0.5mg dinoprostone with a dosing interval of 6hours. The need for additional dosing and the interval must be determined by the attending physician based on the course of clinical events. The maximum recommended cumulative dose for a 24-hour period is 1.5mg of dinoprostone (7.5mL PREPIDIL Gel).

PREPIDIL Gel is available as a sterile semitranslucent viscous preparation for endocervical application: 0.5mg PGE₂ per 3.0g (2.5mL) in syringe. In addition, each package contains two shielded catheters (10mm and 20mm tip) enclosed in sterile envelopes. The contents are not guaranteed sterile if envelopes are not intact.

Each 3gram syringe applicator contains: dinoprostone, 0.5mg; colloidal silicon dioxide, 240mg; triacetin, 2760mg.

5 x 3gram syringes NDC 0009-3359-02 PREPIDIL Gel has a shelf life of 24 months when stored under continuous refrigeration (36º to 46ºF; 2º to 8ºC).

Manufactured by Pharmacia & Upjohn N.V. / S.A., Puurs-Belgium for Pharmacia & Upjohn Company Kalamazoo, MI 49001, USA, Revised April 1999 815 040 206

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