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Cervidil

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Cervidil

CERVIDIL®
(dinoprostone) Vaginal Insert

DRUG DESCRIPTION

Dinoprostone vaginal insert is a thin, flat, polymeric slab which is rectangular in shape with rounded corners contained within the pouch of an off-white knitted polyester retrieval system. Each slab is buff colored, semitransparent and contains 10 mg of dinoprostone in a hydrogel insert. An integral part of the knitted polyester retrieval system is a long tape designed to aid retrieval at the end of the dosing interval or earlier if clinically indicated. The finished product is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.

The chemical name for dinoprostone (commonly known as prostaglandin E2 or PGE2) is 11α, 15S-dihydroxy-9-oxo-prosta-5Z,13E-dien-1-oic acid and the structural formula is represented below:

CERVIDIL®
(dinoprostone) Structural Formula Illustration

The molecular formula is C20H32O5 and its molecular weight is 352.5. Dinoprostone occurs as a white to off-white crystalline powder. It has a melting point within the range of 65° to 69°C. Dinoprostone is soluble in ethanol and in 25% ethanol in water. Each insert contains 10 mg of dinoprostone in 241 mg of a cross-linked polyethylene oxide/urethane polymer which is a semi-opaque, beige colored, flat rectangular slab measuring 29 mm by 9.5 mm and 0.8 mm in thickness. The insert and its retrieval system, made of polyester yarn, are non-toxic and when placed in a moist environment, absorb water, swell, and release dinoprostone.

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, 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...

Read All Potential Side Effects and See Pictures of Cervidil »

What are the precautions when taking dinoprostone (Cervidil)?

Before using dinoprostone, tell your doctor, midwife, or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this drug, tell your doctor your medical history, including: asthma, full term births including previous cesarean section (c-section) births, glaucoma, infections in the vaginal area (e.g., genital herpes), surgery on the cervix, surgery on the womb (uterus), vaginal bleeding during pregnancy, womb scarring.

This drug should not be used if you are carrying more than one baby, if your labor has already started, or if your water has broken.

This medication should be used only when...

Read All Potential Precautions of Cervidil »

Last reviewed on RxList: 6/17/2010
This monograph has been modified to include the generic and brand name in many instances.

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Cervidil - User Reviews

Cervidil User Reviews

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Here is a collection of user reviews for the medication Cervidil sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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