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|Prepidil Gel

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Prepidil Gel

Generic Name: Dinoprostone Cervical Gel (DIE-no-PROSTE-ohn)
Brand Name: Prepidil

Prepidil Gel is used for:

Inducing labor in pregnant women at term or near term.

Prepidil Gel is a prostaglandin. It works by causing softening and dilation of the cervix.

Do NOT use Prepidil Gel if:

you are allergic to any ingredient in Prepidil 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.

Before using Prepidil Gel:

Some medical conditions may interact with Prepidil 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 Prepidil Gel. However, no specific interactions with Prepidil 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 Prepidil 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 Prepidil Gel:

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

Prepidil 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 Prepidil Gel, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Prepidil Gel.

Important safety information:

Prepidil 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 Prepidil Gel, discuss with your doctor the benefits and risks of using Prepidil Gel during pregnancy. It is unknown if Prepidil Gel is excreted in breast milk. If you are or will be breast-feeding while you are using Prepidil Gel, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Prepidil 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 or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Prepidil Gel:

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

General information:

If you have any questions about Prepidil Gel, please talk with your doctor, pharmacist, or other health care provider.
Prepidil 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.

This information is a summary only. It does not contain all information about Prepidil Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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