Prepidil

DRUG 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:

Prepidil® Gel
  (dinoprostone) Structural Formula Illustration

What are the possible side effects of dinoprostone topical (Cervidil, Prepidil, Prostin E2)?

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, if you feel like you have a fever, or if you have any sudden vaginal bleeding.

Less serious side effects may include:

  • nausea, stomach pain;
  • back pain; or
  • feeling of warmth in the vaginal area.

This is not a...

Read All Potential Side Effects and See Pictures of Prepidil »


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 other 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, if you feel like you have a fever, or if you have any sudden vaginal bleeding.

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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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, or a history of asthma.

After you have received dinoprostone topical, tell your caregivers at once if your contractions slow down or become uneven, if you feel like you have a fever, or if you have any sudden vaginal bleeding.

Related Drug Centers
  • Cervidil
  • Prepidil
  • Prostin E2


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