Dinoprostone Cervical Gel

PREPIDIL Gel is generally well-tolerated. In controlled trials, in which 1731 women were entered, the following events were reported at an occurrence of ≥ 1%:

In addition, in other trials amnionitis and intrauterine fetal sepsis have been associated with extraamniotic intrauterine administration of PGE2 . Uterine rupture has been reported in association with the use of PREPIDIL Gel intracervically. Additional events reported in the literature, associated by the authors with the use of PREPIDIL Gel, included premature rupture of membranes, fetal depression (1 min Apgar < 7), and fetal acidosis (umbilical artery pH < 7.15).

Post-Marketing Surveillance

An increased risk of post-partum disseminated intravascular coagulation has been described in patients whose labor was induced by pharmacological means, either with dinoprostone or oxytocin (see WARNINGS). The frequency of this adverse event, however, appears to be rare (<1 per 1,000 labors).

Hypersensitivity reactions (e.g., Anaphylactic reaction, Anaphylactic shock, Anaphylactoid reaction).

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

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.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

• If you have an allergy to dinoprostone or any other part of dinoprostone cervical gel.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Heart disease, kidney disease, liver disease, lung disease, or pelvic inflammatory disease.
• If you have had any of these health problems: A C-section (cesarean section), uterine surgery, unexplained vaginal bleeding during this pregnancy, hard labor, tough delivery, or more than 6 pregnancies that have gone full term or the baby's head did not deliver first.
• If you have genital herpes.
• If you are using another drug like this one.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take dinoprostone cervical gel with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• This medicine will be given to you by a doctor.
• It is given into the vagina or cervix.
• After the gel is put in, lie down for 15 to 30 minutes.

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.

• If you need to store dinoprostone cervical gel at home, talk with your doctor, nurse, or pharmacist about how to store it.