Prostin E2

DRUG DESCRIPTION

PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2).

Its chemical name is (5Z,11?,13E,15S)-11,15-Dihydroxy-9-oxo-prosta-5,13-dien-1-oic acid and the structural formula is represented below:

Prostin E2 
  (dinoprostone) Structural Formula Illustration

The molecular formula is C20H32O5. The molecular weight of dinoprostone is 352.5.

Dinoprostone occurs as a white crystalline powder. It has a melting point within the range of 64 to 71C. Dinoprostone is soluble in ethanol and in 25% ethanol in water. It is soluble in water to the extent of 130 mg/100 mL.

Each suppository contains 20 mg of dinoprostone in a mixture of glycerides of fatty acids.

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 Prostin E2

What are the precautions when taking dinoprostone vaginal suppository (Prostin E2)?

Before using this medication, tell your doctor 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problem (e.g., uncontrolled asthma), current pelvic problem (active pelvic inflammatory disease), current heart disease (e.g., uncontrolled angina, recent heart attack), liver disease, kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: anemia, asthma, high or low blood pressure,...

Read All Potential Precautions of Prostin E2


Prostin E2 Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, fever, chills, abdominal pain, flushing, and dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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.

Most women will experience a fever 15-45 minutes after the suppository is inserted. Sponge baths and drinking lots of fluids may help lower the fever. Aspirin will not usually lower the fever. The fever usually goes away within 6 hours after the last dose. Seek immediate medical attention if you have a high fever (e.g., higher than 101 degrees F or 38 degrees C) after the abortion. Fever may be a sign of a serious infection.

Tell your doctor immediately if any of these rare but very serious side effects occur: fainting, strong contractions that are very close together (uterine overstimulation), severe abdominal pain.

Seek immediate medical attention if this rare but very serious side effect occurs: chest pain.

This drug has rarely caused injury to the womb (uterine rupture), which may require emergency surgery. Your doctor will be monitoring you for signs of uterine overstimulation.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 this medication, tell your doctor 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problem (e.g., uncontrolled asthma), current pelvic problem (active pelvic inflammatory disease), current heart disease (e.g., uncontrolled angina, recent heart attack), liver disease, kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: anemia, asthma, high or low blood pressure, diabetes, glaucoma, heart disease (e.g., angina, heart attack), infections in the vaginal/pelvic area (e.g., cervicitis, vaginal infection, genital herpes, pelvic inflammatory disease), seizure disorder, uterine surgery including previous cesarean section (c-section) birth, pelvic problems (e.g., womb scarring, fibroids, cervical stenosis).

This medication should not be used if the unborn baby is mature enough to survive outside the womb. 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.


Prostin E2 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 (Prostin E2)?
  • What are the possible side effects of dinoprostone topical (Prostin E2)?
  • What is the most important information I should know about dinoprostone topical (Prostin E2)?
  • What should I discuss with my health care provider before receiving dinoprostone topical (Prostin E2)?
  • How is dinoprostone topical given (Prostin E2)?
  • What happens if I miss a dose (Prostin E2)?
  • What happens if I overdose (Prostin E2)?
  • What should I avoid after receiving dinoprostone topical (Prostin E2)?
  • What other drugs will affect dinoprostone topical (Prostin E2)?
  • Where can I get more information?

What is dinoprostone topical (Prostin E2)?

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 (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 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 (Prostin E2)?

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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