"In a drug safety communication issued today, the US Food and Drug Administration (FDA) says it is aware of recent reports "questioning" the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy, but that it l"...
Prepidil Patient Information Including Side Effects
Brand Names: Cervidil, Prepidil, Prostin E2
Generic Name: dinoprostone topical (Pronunciation: DYE no PROS tone TOP ik al)
- What is dinoprostone topical (Prepidil)?
- What are the possible side effects of dinoprostone topical (Prepidil)?
- What is the most important information I should know about dinoprostone topical (Prepidil)?
- What should I discuss with my health care provider before receiving dinoprostone topical (Prepidil)?
- How is dinoprostone topical given (Prepidil)?
- What happens if I miss a dose (Prepidil)?
- What happens if I overdose (Prepidil)?
- What should I avoid after receiving dinoprostone topical (Prepidil)?
- What other drugs will affect dinoprostone topical (Prepidil)?
- Where can I get more information?
What is dinoprostone topical (Prepidil)?
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.
What are the possible side effects of dinoprostone topical (Prepidil)?
Get emergency medical help if you have any of these 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:
- sudden vaginal bleeding;
- cough, wheezing, chest tightness, trouble breathing; or
- pale skin, blue colored lips.
After your baby is born, seek emergency medical attention if you have any signs of excessive bleeding, such as:
- weakness or fainting;
- unusual bleeding from your nose, mouth, vagina, or rectum;
- bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- sudden numbness or weakness, especially on one side of the body;
- sudden severe headache, confusion, problems with vision, speech, or balance;
- unusual bruising, purple or red pinpoint spots under your skin;
- bleeding from a wound, surgical incision, or vein where an IV was placed;
- any bleeding that will not stop.
Less serious side effects may include:
- nausea, stomach pain;
- back pain; or
- feeling of warmth in the vaginal area.
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.
Read the Prepidil (dinoprostone cervical gel) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about dinoprostone topical (Prepidil)?
You should not be treated with this medication 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 ever had a baby born in a breech position, or if you have ever had a difficult labor or delivery of a previous child.
Also tell your doctor if you have kidney or liver disease, glaucoma, a history of asthma, if you are 30 years or older, or if your pregnancy is at full term (40 weeks).
After you have received dinoprostone topical, tell your caregivers at once if your contractions slow down or become uneven, or if you have a fever, sudden vaginal bleeding, cough, wheezing, chest tightness, trouble breathing, pale skin, or blue colored lips.
After your baby is born, seek emergency medical attention if you have any signs of excessive bleeding, including weakness or fainting, unusual bruising, bloody or tarry stools, coughing up blood, sudden weakness or numbness, sudden severe headache, or sudden problems with vision, speech, or balance.
Additional Prepidil Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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