Cervidil

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 11?, 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, 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...

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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...

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Cervidil Consumer (continued)

SIDE EFFECTS: Side effects such as fever, nausea, vomiting, diarrhea or abdominal pain are uncommon and usually mild. If these persist or worsen, notify your doctor or midwife immediately.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if this uncommon but serious side effect occurs: strong contractions that are very close together (uterine overstimulation).

This drug has rarely caused injury to the womb (uterine rupture), which may require emergency surgery. Symptoms include severe pain in your womb and an abnormal heart rate in your baby. Your doctor or midwife will be monitoring for this and for signs of uterine overstimulation.

A very serious allergic reaction to this drug is unlikely, but immediate medical attention is required if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Cervidil 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 (Cervidil)?
  • What are the possible side effects of dinoprostone topical (Cervidil)?
  • What is the most important information I should know about dinoprostone topical (Cervidil)?
  • What should I discuss with my health care provider before receiving dinoprostone topical (Cervidil)?
  • How is dinoprostone topical given (Cervidil)?
  • What happens if I miss a dose (Cervidil)?
  • What happens if I overdose (Cervidil)?
  • What should I avoid after receiving dinoprostone topical (Cervidil)?
  • What other drugs will affect dinoprostone topical (Cervidil)?
  • Where can I get more information?

What is dinoprostone topical (Cervidil)?

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 (Cervidil)?

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 (Cervidil)?

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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