PREPIDIL® Indications and Usage (dinoprostone) | Pfizer Medical Information - US

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INDICATIONS AND USAGE

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.

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INDICATIONS AND USAGE

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.

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DOSAGE AND ADMINISTRATION

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...

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CONTRAINDICATIONS

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...

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WARNINGS

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...

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ADVERSE REACTIONS

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%:

...

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DRUG ABUSE AND DEPENDENCE

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

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OVERDOSAGE

Overdosage with PREPIDIL Gel may be expressed by uterine hypercontractility and uterine hypertonus. Because of the transient nature of PGE2-induced myometrial hyperstimulation, nonspecific...

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DESCRIPTION

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...

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CLINICAL PHARMACOLOGY

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...

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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...

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For Endocervical Use

This product's labeling may have been updated. For current full...

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Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.