Prepidil

Dinoprostone is used to prepare the cervix for the induction of labor in pregnant women who are at or near term. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

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.

You should not be treated with this medication if you are allergic to prostaglandins, or if you have active genital herpes with a vaginal lesion, placenta previa, or if your water has broken.

Be sure your doctor knows your entire pregnancy history, especially if you have ever had a C-section or major surgery on your uterus, if you have ever had a baby born in a breech position, or if you have ever had a difficult labor or delivery of a previous child.

Also tell your doctor if you have kidney or liver disease, glaucoma, a history of asthma, if you are 30 years or older, or if your pregnancy is at full term (40 weeks).

After you have received dinoprostone topical, tell your caregivers at once if your contractions slow down or become uneven, or if you have a fever, sudden vaginal bleeding, cough, wheezing, chest tightness, trouble breathing, pale skin, or blue colored lips.

After your baby is born, seek emergency medical attention if you have any signs of excessive bleeding, including weakness or fainting, unusual bruising, bloody or tarry stools, coughing up blood, sudden weakness or numbness, sudden severe headache, or sudden problems with vision, speech, or balance.

Dinoprostone is a prostaglandin, a hormone-like substance that is naturally produced by tissues in the body.

Dinoprostone topical is used in a pregnant woman to relax the muscles of the cervix (opening of the uterus) in preparation for inducing labor at the end of a pregnancy.

Dinoprostone topical may be used for purposes not listed in this medication guide.

You should not be treated with this medication if you are allergic to prostaglandins, or if you have active genital herpes with a vaginal lesion, placenta previa, or if your water has broken.

Be sure your doctor knows your entire pregnancy history, especially if you have ever had a C-section or major surgery on your uterus, if you have ever had a baby born in a breech position, or if you have ever had a difficult labor or delivery of a previous child.

Also tell your doctor if you have kidney or liver disease, glaucoma, a history of asthma, if you are 30 years or older, or if your pregnancy is at full term (40 weeks).

After you have received dinoprostone topical, tell your caregivers at once if your contractions slow down or become uneven, or if you have a fever, sudden vaginal bleeding, cough, wheezing, chest tightness, trouble breathing, pale skin, or blue colored lips.

After your baby is born, seek emergency medical attention if you have any signs of excessive bleeding, including weakness or fainting, unusual bruising, bloody or tarry stools, coughing up blood, sudden weakness or numbness, sudden severe headache, or sudden problems with vision, speech, or balance.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if your contractions slow down or become uneven, or if you have:

• fever;

• sudden vaginal bleeding;

• cough, wheezing, chest tightness, trouble breathing; or

• pale skin, blue colored lips.

After your baby is born, seek emergency medical attention if you have any signs of excessive bleeding, such as:

• weakness or fainting;

• unusual bleeding from your nose, mouth, vagina, or rectum;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• sudden numbness or weakness, especially on one side of the body;

• sudden severe headache, confusion, problems with vision, speech, or balance;

• unusual bruising, purple or red pinpoint spots under your skin;

• bleeding from a wound, surgical incision, or vein where an IV was placed;

• any bleeding that will not stop.

Less serious side effects may include:

• nausea, stomach pain;

• back pain; or

• feeling of warmth in the vaginal area.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In the U.S.

• Cervidil
• Prepidil
• Prostin E2

Available Dosage Forms:

• Tampon
• Suppository
• Gel/Jelly
• Insert, Extended Release

Therapeutic Class: Uterine Stimulant

Pharmacologic Class: Prostaglandin

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

1. General Precautions

During use, uterine activity, fetal status, and character of the cervix (dilation and effacement) should be carefully monitored either by auscultation or electronic fetal monitoring to detect possible evidence of undesired responses, e.g., hypertonus, sustained uterine contractility, or fetal distress. In cases where there is a history of hypertonic uterine contractility or tetanic uterine contractions, it is recommended that uterine activity and the state of the fetus should be continuously monitored. The possibility of uterine rupture should be borne in mind when high-tone myometrial contractions are sustained. Feto-pelvic relationships should be carefully evaluated before use of Prepidil Gel (see CONTRAINDICATIONS).

Caution should be exercised in administration of Prepidil Gel in patients with:

• asthma or history of asthma
• glaucoma or raised intraocular pressure

Caution should be taken so as not to administer Prepidil Gel above the level of the internal os. 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 20 mm endocervical catheter should be used if no effacement is present, and the 10 mm catheter should be used if the cervix is 50% effaced. Placement of Prepidil Gel into the extra-amniotic space has been associated with uterine hyperstimulation.

As Prepidil Gel is extensively metabolized in the lung, liver, and kidney, and the major route of elimination is the kidney, Prepidil Gel should be used with caution in patients with renal and hepatic dysfunction.

2. Patients With Ruptured Membranes

Caution should be exercised in the administration of Prepidil Gel in patients with ruptured membranes. The safety of use of Prepidil Gel in these patients has not been determined.

3. Drug Interactions

Prepidil Gel may augment the activity of other oxytocic agents and their concomitant use is not recommended. For the sequential use of oxytocin following Prepidil Gel administration, a dosing interval of 6–12 hours is recommended.

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,

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.

6. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

NDC 0009-3359-02
Contains 5 of NDC 0009-3359-01

Prepidil® Gel    0.5 mg

dinoprostone cervical gel

5–3 gram syringes

Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017

Rx only

PAA056624