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dinoprostone topical

Generic Name: dinoprostone topical (DYE no PROS tone TOP ik al)
Brand Name: Cervidil, Prepidil, Prostin E2

What is dinoprostone topical?

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 is the most important information I should know about dinoprostone topical?

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.

What should I discuss with my health care provider before receiving dinoprostone topical?

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 (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.

To make sure you can safely use dinoprostone topical, tell your doctor if you have any of these other conditions:

  • kidney disease;

  • liver disease;

  • glaucoma;

  • a history of asthma;

  • if you are 30 years or older; or

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

How is dinoprostone topical given?

Dinoprostone is a gel that is placed directly onto the cervix through the vagina using a special applicator. Your doctor, nurse, or other healthcare professional will give you this medication.

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.

After you are given this medication, you will need to remain lying down for at least 15 minutes unless your doctor tells you otherwise.

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

If your uterus responds to the medication, 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.

What happens if I miss a dose?

Since dinoprostone topical is given by a healthcare professional, you are not likely to miss a dose.

What happens if I overdose?

Tell your caregivers right away if you think you have received too much of this medicine.

Overdose symptoms may include increased contractions or more intense labor pains.

What should I avoid after receiving dinoprostone topical?

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

Dinoprostone topical side effects

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:

  • fever;

  • 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.

See also: Side effects (in more detail)

Dinoprostone topical dosing information

Usual Adult Dose for Labor Induction:

Cervical gel:
Careful vaginal examination will reveal the degree of effacement which will regulate the size of the shielded endocervical catheter to be used. The 20 mm endocervical catheter should be used if no effacement is present, and the 10 mm catheter should be used if the cervix is 50% effaced. Dinoprostone cervical gel should not be administered above the level of the internal os.

Following administration of dinoprostone cervical gel, the patient should remain in the supine position for at least 15 to 30 minutes to minimize leakage from the cervical canal. If the desired response is obtained, the recommended interval before giving IV oxytocin is 6 to 12 hours. If there is no cervical/uterine response to the initial dose of the cervical gel, repeat dosing may be given. The recommended repeat dose is 0.5 mg dinoprostone with a dosing interval of 6 hours. The need for additional dosing and the interval must be determined by the attending physician based on the course of clinical events. The maximum recommended cumulative dose for a 24 hour period is 1.5 mg of dinoprostone (7.5 mL Prepidil (R) Gel).

Vaginal insert:
The dosage of dinoprostone in the vaginal insert is 10 mg designed to be released at approximately 0.3 mg/hour over a 12 hour period. The dinoprostone vaginal insert should be removed upon onset of active labor or 12 hours after insertion.

One dinoprostone vaginal insert is placed transversely in the posterior fornix of the vagina immediately after removal from its foil package. The insertion of the vaginal insert does not require sterile conditions. The vaginal insert must not be used without its retrieval system. There is no need for previous warming of the product. A minimal amount of water-miscible lubricant may be used to assist insertion of dinoprostone vaginal insert. Care should be taken not to permit excess contact or coating with the lubricant and thus prevent optimal swelling and release of dinoprostone from the vaginal insert. Patients should remain in the recumbent position for 2 hours following insertion, but thereafter may be ambulatory. Care should be taken to ensure the vaginal insert remains in place if the patient is ambulatory.

Upon removal of dinoprostone vaginal insert, it is essential to ensure that the slab has been removed, as it will continue delivering the active ingredient. The knitted polyester retrieval system should be visualized to confirm that it contains the slab. If the slab is not contained within the polyester retrieval system, a vaginal exam is recommended to remove the slab.

Usual Adult Dose for Abortion:

Vaginal suppository:
A suppository containing 20 mg of dinoprostone should be inserted high into the vagina. The patient should remain in the supine position for 10 minutes following insertion.

Additional intravaginal administration of each subsequent suppository should be at 3 to 5 hour intervals until abortion occurs. Within the above recommended intervals administration time should be determined by abortifacient progress, uterine contractility response, and by patient tolerance.

Continuous administration of the drug for more than 2 days is not recommended.

Usual Adult Dose for Trophoblastic Disease:

Vaginal suppository:
A suppository containing 20 mg of dinoprostone should be inserted high into the vagina. The patient should remain in the supine position for 10 minutes following insertion.

Additional intravaginal administration of each subsequent suppository should be at 3 to 5 hour intervals until abortion occurs. Within the above recommended intervals administration time should be determined by abortifacient progress, uterine contractility response, and by patient tolerance.

Continuous administration of the drug for more than 2 days is not recommended.

What other drugs will affect dinoprostone topical?

There may be other drugs that can interact with dinoprostone topical. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about dinoprostone topical
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.02. Revision Date: 2010-12-15, 5:01:39 PM.

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