Prepidil

What is Prepidil used for?

Prepidil is a prescription medicine that is used to get your cervix ready for childbirth. Prepidil may be given to you for other reasons.

Description

PREPIDIL Gel contains dinoprostone as the naturally occurring form of prostaglandin E2 (PGE2) and is designated chemically as (5Z, 11a, 13E, 15S)-11,15-Dihydroxy-9-oxo-prosta-5,13-dien-1-oic acid. The molecular formula is C20H32O5 and the molecular weight is 352.5. Dinoprostone occurs as a white to off-white crystalline powder with a melting point within the range of 65° to 69°C. It is soluble in ethanol, in 25% ethanol in water, and in water to the extent of 130 mg/100 mL. The active constituent of PREPIDIL Gel is dinoprostone 0.5 mg/3 g (2.5 mL gel); other constituents are colloidal silicon dioxide NF (240 mg/3 g) and triacetin USP (2760 mg/3 g).

The structural formula is represented below:

Before taking Prepidil, tell your doctor:

• If you are allergic to Prepidil; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Heart disease, kidney disease, liver disease, lung disease, or pelvic inflammatory disease.
• If you have had any of these health problems: A C-section (cesarean section), uterine surgery, unexplained vaginal bleeding during this pregnancy, hard labor, tough delivery, or more than 6 pregnancies that have gone full term or the baby’s head did not deliver first.
• If you have genital herpes.
• If you are using another drug like this one. If you are not sure, ask your doctor or pharmacist.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Prepidil with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Prepidil?

• Tell all of your health care providers that you take Prepidil. This includes your doctors, nurses, pharmacists, and dentists.
• Allergic reactions have happened with Prepidil. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
• Uterine rupture has happened with some forms of Prepidil. Some people have needed to have their uterus removed. When Prepidil has been used to help with childbirth, uterine rupture has led to loss of the unborn baby or newborn. Talk with your doctor.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Prepidil best taken?

Use Prepidil as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given into the vagina or cervix.
• After the gel is put in, lie down for 15 to 30 minutes.

What do I do if I miss a dose?

• This medicine will be given on an as needed basis in a healthcare setting.

What are the side effects of Prepidil that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Very bad belly pain.

What are some other side effects of Prepidil?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Diarrhea.
• Headache.
• Fever or chills.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Prepidil?

• If you need to store Prepidil at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL – 3 G SYRINGE BUNDLE LABEL

• NDC 0009-3359-02
  Contains 5 of NDC 0009-3359-01
• Prepidil® Gel    0.5 mg
• dinoprostone cervical gel
• 5–3 gram syringes
• Distributed by
  Pharmacia & Upjohn Co
  Division of Pfizer Inc, NY, NY 10017
• Rx only
• PAA056624

 

SRC: NLM .