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Prepidil Generic Name & Formulations
Legal Class
Rx
General Description
Dinoprostone 0.5mg/3g; endocervical gel.
Pharmacological Class
PGE2 oxytocic.
How Supplied
Prefilled-syringe applicator (w. catheters)—5
Manufacturer
Prepidil Indications
Indications
Ripening an unfavorable cervix in pregnant women at or near term.
Prepidil Dosage and Administration
Adult
See full labeling.
Children
Not applicable.
Prepidil Contraindications
Contraindications
Where oxytocics or prolonged uterine contractions are inappropriate, including: history of cesarean section, major uterine surgery, presence of cephalopelvic disproportion, difficult labor, traumatic delivery, 6 or more previous term pregnancies, nonvertex presentation, hyperactive or hypertonic uterine patterns, fetal distress where delivery is not imminent. Ruptured membranes. Placenta previa or unexplained vaginal bleeding. When vaginal delivery is not indicated. Concomitant oxytocics.
Prepidil Boxed Warnings
Not Applicable
Prepidil Warnings/Precautions
Warnings/Precautions
For hospital use only when immediate intensive care and acute surgical facilities can be provided. Avoid contact with skin. Monitor uterine activity, fetal status, cervix. History of/or asthma. Glaucoma or increased intraocular pressure. If hypersensitivity reaction is suspected, remove Prepidil gel if possible. Renal or hepatic dysfunction. Pregnancy (Cat.C).
Prepidil Pharmacokinetics
See Literature
Prepidil Interactions
Interactions
Potentiates oxytocics. Oxytocin: a dosing interval of 6–12hrs is needed, if used following Prepidil administration.
Prepidil Adverse Reactions
Adverse Reactions
Maternal: Uterine rupture, uterine contraction abnormality, GI upset, back pain, warm feeling in vagina, fever, premature rupture of membranes. Fetal: Heart rate abnormality, fetal depression, fetal acidosis. Amnionitis and intrauterine fetal sepsis associated with extra-intrauterine administration.
Prepidil Clinical Trials
See Literature
Prepidil Note
Not Applicable
Prepidil Patient Counseling
See Literature
