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 right away.
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 right away 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 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.
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.
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.
This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. 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.
Use under direct medical supervision.
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 July 2016. Copyright(c) 2016 First Databank, Inc.
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