Dinoprostone

FDA label

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Renal Undefined

Hepatic Undefined

Repeat-dose spacing 6 h; need for additional dosing determined by attending physician; 6–12 h interval before sequential oxytocin

Instructions

• Bring gel to room temperature just before use; do not force warming (no water bath/microwave)
• Choose shielded endocervical catheter by effacement: 20 mm if no effacement, 10 mm if cervix ≥50% effaced
• Administer with patient dorsal, cervix visualized by speculum; sterile technique; introduce just below internal os
• Patient remains supine 15–30 min after administration to minimize leakage
• One syringe per patient; do not administer gel remaining in catheter; discard unused contents
• Avoid skin contact when handling; wash hands thoroughly after administration
• If desired response obtained, wait 6–12 h before giving IV oxytocin

Contraindications

• Patients in whom oxytocic drugs are generally contraindicated or prolonged uterine contractions inappropriate
• History of cesarean section or major uterine surgery
• Cephalopelvic disproportion
• History of difficult labor and/or traumatic delivery
• Grand multiparae (≥6 previous term pregnancies)
• Non-vertex presentation
• Hyperactive or hypertonic uterine patterns
• Fetal distress where delivery is not imminent
• Obstetric emergencies where benefit-to-risk favors surgical intervention
• Placenta previa or unexplained vaginal bleeding during this pregnancy
• Vaginal delivery not indicated (e.g., vasa previa, active genital herpes)

Cautions

• Uterine rupture reported with intracervical use
• Increased risk of postpartum disseminated intravascular coagulation with pharmacologically induced labor (rare, <1/1,000 labors)
• May augment other oxytocic agents — concomitant use not recommended; wait 6–12 h before sequential oxytocin
• Handle with care to prevent skin contact; wash hands after administration

Adverse reactions

• Maternal (≥1% vs control): uterine contractile abnormality 6.6%, GI effects 5.7%, back pain 3.1%, warm feeling in vagina 1.5%, fever 1.4%
• Fetal: any FHR abnormality 17%, bradycardia 4.1%, late/variable decelerations
• Uterine rupture; amnionitis/intrauterine fetal sepsis (extra-amniotic PGE2); premature rupture of membranes; fetal depression/acidosis
• Postmarketing: hypersensitivity incl. anaphylaxis/anaphylactic shock; postpartum DIC

Pregnancy Administered at/near term (after organogenesis) for cervical ripening; embryotoxic in rats/rabbits — any dose producing sustained uterine tone can put fetus at risk

Lactation Undefined