This medication is used to help prepare your cervix (the lower opening of the womb) for labor and delivery. It is used in women who are having a normal pregnancy and who are at or near their delivery due date. Dinoprostone is a natural substance that your body makes in preparation for labor. It relaxes and softens your cervix (cervical ripening) to allow the baby to pass through the birth canal during delivery.

This drug is inserted high in your vagina next to the cervix by a health care professional. You will be lying down while the medication is placed, and you will usually need to continue lying down for 2 hours after insertion. The health care professional will tell you when you can get up and walk around.

This medication should only be used in a hospital setting with trained medical care available. You will be monitored for changes in your cervix, for signs of active labor (e.g., water breaking, strong sustained contractions), and for your baby's condition. The health care professional will remove the insert if there are side effects, after 12 hours, or when it is no longer needed. The drug's effects wear off quickly after the insert is removed.

Side effects such as fever, nausea, vomiting, diarrhea or abdominal pain are uncommon and usually mild. If these persist or worsen, notify your doctor or midwife immediately.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if this uncommon but serious side effect occurs: strong contractions that are very close together (uterine overstimulation).

This drug has rarely caused injury to the womb (uterine rupture), which may require emergency surgery. Symptoms include severe pain in your womb and an abnormal heart rate in your baby. Your doctor or midwife will be monitoring for this and for signs of uterine overstimulation.

A very serious allergic reaction to this drug is unlikely, but immediate medical attention is required if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using dinoprostone, tell your doctor, midwife, or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this drug, tell your doctor your medical history, including: asthma, full term births including previous cesarean section (c-section) births, glaucoma, infections in the vaginal area (e.g., genital herpes), surgery on the cervix, surgery on the womb (uterus), vaginal bleeding during pregnancy, womb scarring.

This drug should not be used if you are carrying more than one baby, if your labor has already started, or if your water has broken.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Your healthcare professionals (e.g., doctor, midwife, or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: other prostaglandins (e.g., misoprostol), oxytocin.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before you receive dinoprostone.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Use under direct medical supervision.

Not applicable.

Store in a freezer between -4 and 14 degrees F (-20 to -10 degrees C) away from light and moisture.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.