Prostaglandin E2

What is Prostaglandin E2?

• Prostaglandin E2, is also known as dinoprostone (Cervidil; Prepidil; Prostin E2) is a prostaglandin analog used to prepare the cervix for the induction of labor in pregnant women who are at or near term.

Other uses:

• Dinoprostone is used in bleeding after delivery, termination of pregnancy, and in newborn babies to keep the ductus arteriosus open.
• In babies it is used in those with congenital heart defects until surgery can be carried out.
• It is also used to manage gestational trophoblastic disease.
• It may be used within the vagina or by injection into a vein.

What are the uses of this medicine?

• Dinoprostone is used for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor.

How does this medicine work?

• Dinoprostone is found in low concentrations in most tissues of the body and functions as a local hormone.
• In pregnancy, dinoprostone is secreted continuously by the fetal membranes and placenta and plays an important role in the final events leading to the initiation of labor including cervical ripening.
• Dinoprostone stimulates the production of prostaglandin F2α (PGF2α), which sensitizes the myometrium to endogenous or exogenously administered oxytocin.
• Available evidence indicates that dinoprostone, in the concentrations found during the early part of labor, plays an important role in cervical ripening without affecting uterine contractions.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Known hypersensitivity to prostaglandins
• Evidence or clinical suspicion of fetal distress where delivery is not imminent
• Unexplained vaginal bleeding in the current pregnancy
• Evidence or clinical suspicion of marked cephalopelvic disproportion
• Conditions for which induction of labor is contraindicated
• Conditions for which oxytocic drugs are contraindicated
• Previous cesarean section or other uterine surgery expected to affect uterine integrity (such as myomectomy)
• Conditions under which prolonged contraction of the uterus may be detrimental to fetal safety
• Concurrent use with intravenous oxytocic agents
• Six or more previous term pregnancies

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• oxytocic agents

• A dosing interval of at least 30 minutes is recommended for the sequential use of an oxytocic agent following the removal of Cervidil.

Is this medicine FDA approved?

• Prostaglandin E2 was first synthesized in 1970 and approved for medical use by the FDA in the United States in 1977.
• It is on the World Health Organization's List of Essential Medicines.

How should this medicine be used?

Recommended dosage:

• Administer a single vaginal insert (10 mg) for up to 12 hours of use (approximately 0.3 mg of dinoprostone is released per hour).
• Remove upon onset of active labor or 12 hours after insertion.

Administration:

• Dinoprostone comes as a vaginal insert and as a gel that is inserted high into the vagina.
• It is administered using a syringe, by a health professional in a hospital or clinic setting.
• After the dose has been administered you should remain lying down for up to 2 hours as directed by your physician.
• A second dose of the gel may be administered in 6 hours if the first dose does not produce the desired response.
• Carefully monitor for uterine activity, fetal status and the progression of cervical dilatation and effacement.
• Cervidil should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a vaginal insert and as a gel

This medicine is available in fallowing brand namesː

• Cervidil; Prepidil; Prostin E2

What side effects can this medication cause?

The most common side effects of this medicine include:

• uterine tachysystole without fetal distress, uterine tachysystole with fetal distress, and fetal distress without uterine tachysystole.

Less common side effects may include:

• Drug related fever, nausea, vomiting, diarrhea, and abdominal pain

Dinoprostone may cause serious side effects which may include:

• Disseminated Intravascular Coagulation
• Amniotic Fluid Embolism
• Uterine Tachysytole and Uterine Hypersystole/Hypertonicity
• Myocardial Infarction
• Hypersensitivity
• uterine rupture
• Hypotension

What special precautions should I follow?

• Cervidil should be administered in a hospital setting with an obstetrical care facility.
• Advise the woman to remain in the recumbent position for 2 hours following Cervidil insertion and to inform her health care provider immediately if Cervidil does not remain in place.
• Cervidil is associated with an increased risk of disseminated intravascular coagulation (DIC) during the postpartum period. As soon as possible, assess for an evolving fibrinolysis in the immediate post-partum period. Therapy consisting of prompt removal of the source of procoagulant material, replacement of depleted clotting factors and, in some cases, anti-coagulation with heparin should be instituted promptly.
• Cervidil can result in inadvertent disruption and subsequent embolization of antigenic tissue causing the development of Amniotic Fluid Embolism Syndrome, a rare and often fatal obstetric condition. Carefully monitor patients for clinical signs of Amniotic Fluid Embolism Syndrome including hypotension, hypoxemia and respiratory failure, DIC, coma or seizures and provide supportive care as needed.
• Cervidil may cause frequent or prolonged contractions. This might result in disruption of blood flow through the placenta and to the fetus. Remove Cervidil prior to amniotomy or following rupture of membranes because the higher vaginal pH that occurs with rupture of membranes may result in higher release rate of dinoprostone.
• Cervidil can lead to raised intraocular pressure and constriction of pupils. Consider non-prostaglandin cervical ripening procedures.
• Concomitant administration of Cervidil is not indicated in breastfeeding women.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Cervidil is indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor.
• Limited available data with Cervidil use in pregnant women do not show a clear association with adverse developmental outcomes.

Can this medicine be used in children?

• The safety and effectiveness of Cervidil have not been established in pregnant girls.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• DINOPROSTONE

Inactive Ingredients:

• POLYETHYLENE GLYCOL, UNSPECIFIED

Who manufactures and distributes this medicine?

Manufactured for:

• Ferring Pharmaceuticals, Inc.
• Parsippany, NJ

What should I know about storage and disposal of this medication?

• Store in a freezer between -20°C and -10°C (-4°F and 14°F).
• Cervidil, enclosed in its aluminum/polyethylene pack, is stable when stored in a freezer for a period of three years.
• Vaginal inserts exposed to high humidity will absorb moisture from the air and thereby alter the release characteristics of dinoprostone.

• Dailymed label info on Prostaglandin E2
• FDA Prostaglandin E2

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