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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PREPIDIL®(dinoprostone)
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PREPIDIL® Quick Finder
Dosage and Administration
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
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 and Precautions
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
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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
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
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
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
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/Storage and Handling
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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