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PREPIDIL

 * Generic Name: dinoprostone cervical gel
 * Brand Name: Prepidil
 * Drug Class: Abortifacient, Vaginal Preparations, Other

Medical Author: John P. Cunha, DO, FACOEP Last updated on RxList: 12/12/2022

home drugs a-z list prepidil (dinoprostone cervical gel) drug

   
   
 * Related Drugs
   Cervidil Prostin E2
   
   


DRUG SUMMARY

WHAT IS PREPIDIL?

Prepidil (dinoprostone) Cervical Gel is a prostaglandin, a hormone-like
substance, 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.

WHAT ARE SIDE EFFECTS OF PREPIDIL?

Prepidil may cause serious side effects including:

 * hives,
 * difficulty breathing,
 * swelling of your face, lips, tongue, or throat,
 * severe dizziness,
 * intense pain between contractions,
 * sudden vaginal bleeding,
 * unexpected stomach pain,
 * chest pain,
 * easy bruising,
 * unusual bleeding,
 * bleeding from a wound, surgical incision, or vein where an IV was placed, and
 * any bleeding that will not stop

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Prepidil Cervical Gel include:

 * nausea,
 * vomiting,
 * stomach or abdominal pain,
 * diarrhea,
 * back pain, or
 * feeling of warmth in the vaginal area.

Side effects of Prepidil Cervical Gel in the fetus include fetal heart rate
abnormality, and slow heart rate. Tell your doctor if your contractions slow
down or become uneven, or if you have serious side effects of Prepidil Cervical
Gel including:

 * fever,
 * sudden vaginal bleeding,
 * cough,
 * wheezing,
 * chest tightness,
 * trouble breathing,
 * pale skin, or
 * blue colored lips.

Seek medical care or call 911 at once if you have the following serious side
effects:

 * Serious eye symptoms such as sudden vision loss, blurred vision, tunnel
   vision, eye pain or swelling, or seeing halos around lights;
 * Serious heart symptoms such as fast, irregular, or pounding heartbeats;
   fluttering in your chest; shortness of breath; and sudden dizziness,
   lightheadedness, or passing out;
 * Severe headache, confusion, slurred speech, arm or leg weakness, trouble
   walking, loss of coordination, feeling unsteady, very stiff muscles, high
   fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur.
Check with your physician for additional information about side effects.

DOSAGE FOR PREPIDIL

Prepidil should be used only with strict adherence to recommended dosages and
administered by physicians in a hospital that can provide immediate intensive
care and acute surgical facilities.

WHAT DRUGS, SUBSTANCES, OR SUPPLEMENTS INTERACT WITH PREPIDIL?

Other drugs may interact with Prepidil. Tell your doctor all medications and
supplements you use.

PREPIDIL DURING PREGNANCY OR BREASTFEEDING

Prepidil is used in pregnant women. Consult your doctor before breastfeeding.

ADDITIONAL INFORMATION

Our Prepidil Gel (dinoprostone) Side Effects Drug Center provides a
comprehensive view of available drug information on the potential side effects
when taking this medication.


FDA DRUG INFORMATION

 * Drug Description
 * Indications & Dosage
 * Side Effects & Drug Interactions
 * Warnings
 * Precautions
 * Overdose & Contraindications
 * Clinical Pharmacology
 * Medication Guide


DESCRIPTION FOR PREPIDIL

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:










USES FOR PREPIDIL

PREPIDIL Gel is indicated for ripening an unfavorable cervix in pregnant women
at or near term with a medical or obstetrical need for labor induction.


DOSAGE FOR PREPIDIL

NOTE: USE CAUTION IN HANDLING THIS PRODUCT TO PREVENT CONTACT WITH SKIN. WASH
HANDS THOROUGHLY WITH SOAP AND WATER AFTER ADMINISTRATION.

PREPIDIL Gel should be brought to room temperature (59° to 86°F; 15° to 30°C)
just prior to administration. Do not force the warming process by using a water
bath or other source of external heat (eg, microwave oven).

To prepare the product for use remove the protective end cap endocervical
catheter should be used if no effacement is present, and the 10 mm catheter
should be used if the cervix is 50% effaced. Firmly attach the catheter hub to
the syringe tip as evidenced by a distinct click. Fill the catheter with sterile
gel by pushing the plunger assembly to expel air from the catheter prior to
administration to the patient. Proper assembly of the dosing apparatus is shown
below.



(to serve as plunger extension) and insert the protective end cap into the
plunger stopper assembly in the barrel of syringe. Choose the appropriate length
shielded catheter (10 mm or 20 mm) and aseptically remove the sterile shielded
catheter from the package. Careful vaginal examination will reveal the degree of
effacement which will regulate the size of the shielded endocervical catheter to
be used. That is, the 20 mm





To properly administer the product, the patient should be in a dorsal position
with the cervix visualized using a speculum. Using sterile technique, introduce
the gel with the catheter provided into the cervical canal just below the level
of the internal os. Administer the contents of the syringe by gentle expulsion
and then remove the catheter. The gel is easily extrudable from the syringe. Use
the contents of one syringe for one patient only. No attempt should be made to
administer the small amount of gel remaining in the catheter. The syringe,
catheter, and any unused package contents should be discarded after use.
Following administration of PREPIDIL Gel, the patient should remain in the
supine position for at least 15–30 minutes to minimize leakage from the
cervical canal. If the desired response is obtained from PREPIDIL Gel, the
recommended interval before giving intravenous oxytocin is 6–12 hours. If
there is no cervical/uterine response to the initial dose of PREPIDIL Gel,
repeat dosing may be given. The recommended repeat dose is 0.5 mg dinoprostone
with a dosing interval of 6 hours. The need for additional dosing and the
interval must be determined by the attending physician based on the course of
clinical events. The maximum recommended cumulative dose for a 24-hour period is
1.5 mg of dinoprostone (7.5 mL PREPIDIL Gel).


HOW SUPPLIED

PREPIDIL Gel is available as a sterile semitranslucent viscous preparation for
endocervical application: 0.5 mg PGE2 per 3.0 g (2.5 mL) in syringe. In
addition, each package contains two shielded catheters (10 mm and 20 mm tip)
enclosed in sterile envelopes. The contents are not guaranteed sterile if
envelopes are not intact.

Each 3 gram syringe applicator contains: dinoprostone, 0.5 mg; colloidal silicon
dioxide, 240 mg; triacetin, 2760 mg.

1 × 3 gram syringe NDC 0009-3359-01
5 × 3 gram syringes NDC 0009-3359-02

PREPIDIL Gel needs to be stored under continuous refrigeration (36° to 46°F; 2°
to 8°C).

Distributed by: Pharmacia & Upjohn Co, Division of Pfizer Inc, NY, NY 10017.
Revised: Apr 2019


SIDE EFFECTS FOR PREPIDIL

PREPIDIL Gel is generally well-tolerated. In controlled trials, in which 1731
women were entered, the following events were reported at an occurrence of ≥ 1%:



Adverse Reaction PGE2
(N = 884) Control*
(N = 847) Maternal N (%) N (%) Uterine contractile abnormality 58 (6.6) 34 (4.0)
Any gastrointestinal effect 50 (5.7) 22 (2.6) Back pain 27 (3.1) 0 (0) Warm
feeling in vagina 13 (1.5) 0 (0) Fever 12 (1.4) 10 (1.2) Fetal Any fetal heart
rate abnormality 150 (17.0) 123 (14.5) Bradycardia 36 (4.1) 26 (3.1)
Deceleration Late 25 (2.8) 18 (2.1) Variable 38 (4.3) 29 (3.4) Unspecified 19
(2.1) 19 (2.2) *placebo gel or no treatment



In addition, in other trials amnionitis and intrauterine fetal sepsis have been
associated with extra-amniotic intrauterine administration of PGE2. Uterine
rupture has been reported in association with the use of PREPIDIL Gel
intracervically. Additional events reported in the literature, associated by the
authors with the use of PREPIDIL Gel, included premature rupture of membranes,
fetal depression (1 min Apgar < 7), and fetal acidosis (umbilical artery pH <
7.15).

POST-MARKETING SURVEILLANCE

BLOOD AND LYMPHATIC SYSTEM DISORDERS

An increased risk of post-partum disseminated intravascular coagulation has been
described in patients whose labor was induced by pharmacological means, either
with dinoprostone or oxytocin (see WARNINGS). The frequency of this adverse
event, however, appears to be rare (<1 per 1,000 labors).

IMMUNE SYSTEM DISORDERS

Hypersensitivity reactions (e.g., Anaphylactic reaction, Anaphylactic shock,
Anaphylactoid reaction).

DRUG ABUSE AND DEPENDENCE

No drug abuse or drug dependence has been seen with the use of PREPIDIL Gel.


DRUG INTERACTIONS FOR PREPIDIL

PREPIDIL Gel may augment the activity of other oxytocic agents and their
concomitant use is not recommended. For the sequential use of oxytocin following
PREPIDIL Gel administration, a dosing interval of 6-12 hours is recommended.


WARNINGS FOR PREPIDIL

FOR HOSPITAL USE ONLY

Dinoprostone, as with other potent oxytocic agents, should be used only with
strict adherence to recommended dosages. Dinoprostone should be administered by
physicians in a hospital that can provide immediate intensive care and acute
surgical facilities.

Women aged 30 years or older, those with complications during pregnancy and
those with a gestational age over 40 weeks have been shown to have an increased
risk of post-partum disseminated intravascular coagulation. In addition, these
factors may further increase the risk associated with labor induction (see
ADVERSE REACTIONS).

Therefore, in these women, use of dinoprostone should be undertaken with
caution. Measures should be applied to detect as soon as possible an evolving
fibrinolysis in the immediate post-partum phase.

The Clinician should be alert that the intracervical placement of dinoprostone
gel may result in inadvertent disruption and subsequent embolization of
antigenic tissue causing in rare circumstances the development of Anaphylactoid
Syndrome of Pregnancy (Amniotic Fluid Embolism).

There have been post-marketing reports of serious and life-threatening
hypersensitivity reactions including anaphylaxis and angioedema with PREPIDIL
Gel (dinoprostone). Onset of these reported reactions occurred within minutes to
hours after initiation with PREPIDIL Gel (dinoprostone). If a hypersensitivity
reaction is suspected, if possible remove PREPIDIL Gel (dinoprostone). Assess
for other potential causes of the event, and institute symptomatic and
supportive therapy, as needed.


PRECAUTIONS FOR PREPIDIL

GENERAL PRECAUTIONS

During use, uterine activity, fetal status, and character of the cervix
(dilation and effacement) should be carefully monitored either by auscultation
or electronic fetal monitoring to detect possible evidence of undesired
responses, e.g., hypertonus, sustained uterine contractility, or fetal distress.
In cases where there is a history of hypertonic uterine contractility or tetanic
uterine contractions, it is recommended that uterine activity and the state of
the fetus should be continuously monitored. The possibility of uterine rupture
should be borne in mind when high-tone myometrial contractions are sustained.
Feto-pelvic relationships should be carefully evaluated before use of PREPIDIL
Gel (see CONTRAINDICATIONS).

Caution should be exercised in administration of PREPIDIL Gel in patients with:

 * asthma or history of asthma
 * glaucoma or raised intraocular pressure

Caution should be taken so as not to administer PREPIDIL Gel above the level of
the internal os. Careful vaginal examination will reveal the degree of
effacement which will regulate the size of the shielded endocervical catheter to
be used. That is, the 20 mm endocervical catheter should be used if no
effacement is present, and the 10 mm catheter should be used if the cervix is
50% effaced. Placement of PREPIDIL Gel into the extra-amniotic space has been
associated with uterine hyperstimulation.

As PREPIDIL Gel is extensively metabolized in the lung, liver, and kidney, and
the major route of elimination is the kidney, PREPIDIL Gel should be used with
caution in patients with renal and hepatic dysfunction.

PATIENTS WITH RUPTURED MEMBRANES

Caution should be exercised in the administration of PREPIDIL Gel in patients
with ruptured membranes. The safety of use of PREPIDIL Gel in these patients has
not been determined.

NONCLINICAL TOXICOLOGY

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

Carcinogenic bioassay studies have not been conducted in animals with PREPIDIL
Gel due to the limited indications for use and short duration of administration.
No evidence of mutagenicity was observed in the Micronucleus Test or Ames Assay.

PREGNANCY, TERATOGENIC EFFECTS

Prostaglandin E2 produced an increase in skeletal anomalies in rats and rabbits.
No effect would be expected clinically, when used as indicated, since PREPIDIL
Gel is administered after the period of organogenesis. PREPIDIL Gel has been
shown to be embryotoxic in rats and rabbits, and any dose that produces
sustained increased uterine tone could put the embryo or fetus at risk. See
statements under General Precautions.

PEDIATRIC USE

Safety and effectiveness in pediatric patients have not been established.




OVERDOSE INFORMATION FOR PREPIDIL

Overdosage with PREPIDIL Gel may be expressed by uterine hypercontractility and
uterine hypertonus. Because of the transient nature of PGE2-induced myometrial
hyperstimulation, nonspecific, conservative management was found to be effective
in the vast majority of the cases; i.e., maternal position change and
administration of oxygen to the mother. β-adrenergic drugs may be used as a
treatment of hyperstimulation following the administration of PGE2 for cervical
ripening.


CONTRAINDICATIONS FOR PREPIDIL

Endocervically administered PREPIDIL Gel is not recommended for the following:

 a. Patients in whom oxytocic drugs are generally contraindicated or where
    prolonged contractions of the uterus are considered inappropriate, such as:
    * cases with a history of cesarean section or major uterine surgery
    * cases in which cephalopelvic disproportion is present
    * cases in which there is a history of difficult labor and/or traumatic
      delivery
    * grand multiparae with six or more previous term pregnancies cases with
      non-vertex presentation
    * cases with hyperactive or hypertonic uterine patterns
    * cases of fetal distress where delivery is not imminent
    * in obstetric emergencies where the benefit-to-risk ratio for either the
      fetus or the mother favors surgical intervention
 b. Patients with hypersensitivity to prostaglandins or constituents of the gel
    (see WARNINGS and ADVERSE REACTIONS).
 c. Patients with placenta previa or unexplained vaginal bleeding during this
    pregnancy.
 d. Patients for whom vaginal delivery is not indicated, such as vasa previa or
    active herpes genitalia.


CLINICAL PHARMACOLOGY FOR PREPIDIL

PREPIDIL Gel (dinoprostone) administered endocervically may stimulate the
myometrium of the gravid uterus to contract in a manner similar to contractions
seen in the term uterus during labor. Whether or not this action results from a
direct effect of dinoprostone on the myometrium has not been determined.
Dinoprostone is also capable of stimulating smooth muscle of the
gastrointestinal tract in humans. This activity may be responsible for the
vomiting and/or diarrhea that is occasionally seen when dinoprostone is used for
preinduction cervical ripening.

In laboratory animals, and also in humans, large doses of dinoprostone can lower
blood pressure, probably as a result of its effect on smooth muscle of the
vascular system. With the doses of dinoprostone used for cervical ripening this
effect has not been seen. In laboratory animals, and also in humans,
dinoprostone can elevate body temperature; however, with the dosing used for
cervical ripening this effect has not been seen.

In addition to an oxytocic effect, there is evidence suggesting that this agent
has a local cervical effect in initiating softening, effacement, and dilation.
These changes, referred to as cervical ripening, occur spontaneously as the
normal pregnancy progresses toward term and allow evacuation of uterine contents
by decreasing cervical resistance at the same time that myometrial activity
increases. While not completely understood, biochemical changes within the
cervix during natural cervical ripening are similar to those following
PGE2-induced ripening. Further, it has been shown that these changes can take
place independent of myometrial activity; however, it is quite likely that PGE2
administered endocervically produces effacement and softening by combined
contraction-inducing and cervical-ripening properties. There is evidence to
suggest that the changes that take place within the cervix are due to collagen
degradation resulting from collagenase secretion as a response, at least in
part, to PGE2.

Using an unvalidated assay, the following information was determined. When
PREPIDIL Gel was administered endocervically to women undergoing preinduction
ripening, results from measurement of plasma levels of the metabolite
13,14-dihydro-15-keto-PGE2 (DHK-PGE2) showed that PGE2 was relatively rapidly
absorbed and the Tmax was 0.5 to 0.75 hours. Plasma mean Cmax for gel-treated
subjects was 433 ± 51 pg/mL versus 137 ± 24 pg/mL for untreated controls. In
those subjects in which a clinical response was observed, mean Cmax was 484 ± 57
pg/mL versus 213 ± 69 pg/mL in nonresponders and 219 ± 92 pg/mL in control
subjects who had positive clinical progression toward normal labor. These
elevated levels in gel-treated subjects appear to be largely a result of
absorption of PGE2 from the gel rather than from endogenous sources.

PGE2 is completely metabolized in humans. PGE2 is extensively metabolized in the
lungs, and the resulting metabolites are further metabolized in the liver and
kidney. The major route of elimination of the products of PGE2 metabolism is the
kidneys.


PATIENT INFORMATION FOR PREPIDIL

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.


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of content and ads and in your interaction with them.

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DELIVER AND PRESENT ADVERTISING AND CONTENT 41 PARTNERS CAN USE THIS PURPOSE

Always Active

Certain information (like an IP address or device capabilities) is used to
ensure the technical compatibility of the content or advertising, and to
facilitate the transmission of the content or ad to your device.

List of IAB Vendors‎ | View Illustrations 

MATCH AND COMBINE DATA FROM OTHER DATA SOURCES 39 PARTNERS CAN USE THIS PURPOSE

Always Active

Information about your activity on this service may be matched and combined with
other information relating to you and originating from various sources (for
instance your activity on a separate online service, your use of a loyalty card
in-store, or your answers to a survey), in support of the purposes explained in
this notice.

List of IAB Vendors‎

LINK DIFFERENT DEVICES 35 PARTNERS CAN USE THIS PURPOSE

Always Active

In support of the purposes explained in this notice, your device might be
considered as likely linked to other devices that belong to you or your
household (for instance because you are logged in to the same service on both
your phone and your computer, or because you may use the same Internet
connection on both devices).

List of IAB Vendors‎

IDENTIFY DEVICES BASED ON INFORMATION TRANSMITTED AUTOMATICALLY 36 PARTNERS CAN
USE THIS PURPOSE

Always Active

Your device might be distinguished from other devices based on information it
automatically sends when accessing the Internet (for instance, the IP address of
your Internet connection or the type of browser you are using) in support of the
purposes exposed in this notice.

List of IAB Vendors‎
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