Uses

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.

How To Use

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 (such as 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

Side effects such as fever, nausea, vomiting, diarrhea, or abdominal pain are uncommon and usually mild. If any of these effects last or get worse, tell your doctor or midwife right away.

Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including:

• strong contractions that are very close together (uterine overstimulation)

Get medical help right away if you have any very serious side effects, including:

• easy bruising/bleeding
• shortness of breath
• chest pain
• confusion

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. Careful monitoring by your doctor or midwife may decrease your risk.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• 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 or at www.fda.gov/medwatch.

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

Precautions

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 (such as 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.

During pregnancy, this medication should be used only when clearly needed. 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.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• other prostaglandins (such as misoprostol)
• oxytocin

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Use under direct medical supervision.

Missed Dose

Not applicable.

Storage

Store in a freezer 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.