Dinoprostone gel

Generic Name: dinoprostone (DIE-no-PROSTE-ohn)
Brand Name: Prepidil

Dinoprostone gel is used for:

Inducing labor in pregnant women at term or near term.

Dinoprostone gel is a prostaglandin. It works by causing softening and dilation of the cervix.

Do NOT use dinoprostone gel if:

  • you are allergic to any ingredient in dinoprostone gel
  • you are in the first or second trimester of pregnancy
  • there is evidence of distress to the fetus when labor is not occurring naturally
  • you have unexplained vaginal bleeding
  • there is evidence that the fetus' head is too large to deliver through the vagina
  • there is an emergency and surgery is safer for the fetus or the mother
  • you have a history of difficult labor or delivery
  • you have an overactive uterus
  • you have had a cesarean section or major uterine surgery
  • you have had 6 or more previous term pregnancies in which the head did not deliver first
  • you have a condition, such as genital herpes, that might harm a fetus delivered through the vagina

Contact your doctor or health care provider right away if any of these apply to you.

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Before using dinoprostone gel:

Some medical conditions may interact with dinoprostone gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have asthma, genital herpes, increased pressure in the eye, vaginal bleeding, membrane rupture, cramped muscles in the uterus, cephalopelvic disproportion, grand multiparity, placenta previa, or vasa previa
  • if you have a history of difficult labor or uterine surgery
  • if you are having a cesarean section or traumatic delivery

Some MEDICINES MAY INTERACT with dinoprostone gel. However, no specific interactions with dinoprostone gel are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if dinoprostone gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use dinoprostone gel:

Use dinoprostone gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Dinoprostone gel is usually inserted vaginally at your doctor's office, hospital, or clinic.
  • Remain lying down for 30 minutes to keep the gel in place.
  • If you miss a dose of dinoprostone gel, contact your doctor right away.

Ask your health care provider any questions you may have about how to use dinoprostone gel.

Important safety information:

  • Dinoprostone gel is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking dinoprostone gel, discuss with your doctor the benefits and risks of using dinoprostone gel during pregnancy. It is unknown if dinoprostone gel is excreted in breast milk. If you are or will be breast-feeding while you are using dinoprostone gel, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of dinoprostone gel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; abnormal muscle action within the uterus; diarrhea; fever; nausea; stomach pain; vomiting; warm feeling in the vagina.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); slow or abnormal heartbeat in the developing fetus.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of dinoprostone gel:

Dinoprostone gel is usually handled and stored by a health care provider. Keep dinoprostone gel out of the reach of children and away from pets.

General information:

  • If you have any questions about dinoprostone gel, please talk with your doctor, pharmacist, or other health care provider.
  • Dinoprostone gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take dinoprostone gel or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about dinoprostone gel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to dinoprostone gel. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using dinoprostone gel.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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