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

Cervidil 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.

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

You should not be treated with Cervidil 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 had a baby born in a breech position, or if you have had a difficult labor or delivery of a previous child.

Dinoprostone is a gel or suppository that is placed directly onto the cervix through the vagina using a special applicator. A healthcare provider will insert Cervidil at the correct time best prepare your cervix.

Dinoprostone is usually given while you are lying on your back. Your doctor may use a vaginal speculum to view your cervix. This will help your doctor determine how much of this medication to use.

You will need to remain lying down for 15 to 30 minutes, and possibly for up to 2 hours, unless your doctor tells you otherwise.

Your contractions and your baby's heartbeat will be constantly monitored after you are treated with dinoprostone. Your doctor will also check your cervix frequently to determine how much it has dilated.

Cervidil can cause contractions to occur more often and they may also last longer.

If your uterus responds to dinoprostone, you may begin having regular uterine contractions within a few hours. You may also be given other medications to help stimulate your uterine contractions and make them more regular.

If your uterus does not respond to dinoprostone within 6 hours, your doctor may apply a second dose.

A Cervidil suppository is usually removed once you begin labor, or 12 hours after the medicine was inserted.

You should not be treated with this medicine if you are allergic to prostaglandins, or if you have:

• active genital herpes with a vaginal lesion;

• placenta previa (the placenta is below the fetus in your uterus); 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 (not head-first); or

• if you have ever had a difficult labor or delivery of a previous child.

Tell your doctor if you have ever had:

• liver or kidney disease;

• glaucoma;

• asthma;

• if you are 30 years or older; or

• if your pregnancy is at full term (40 weeks).

Dinoprostone is not expected to be harmful to the unborn baby when used to induce labor.

You should not breastfeed while you are being treated with Cervidil.

Since dinoprostone is used when needed in a clinical setting, it does not have a daily dosing schedule.

Since Cervidil is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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

Get emergency medical help if you have 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:

• a light-headed feeling, like you might pass out;

• weak or shallow breathing;

• intense pain between contractions;

• sudden vaginal bleeding;

• unexpected stomach pain;

• chest pain;

• easy bruising, unusual bleeding;

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

• any bleeding that will not stop.

Common side effects of Cervidil may include:

• contractions that are more frequent;

• slow heartbeats in the baby;

• nausea, stomach pain;

• feeling of warmth in the vaginal area;

• back pain; or

• fever.

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.

Other drugs may affect dinoprostone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.