CERVIDIL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CERVIDIL (CERVIDIL).
Prostaglandin E2 (PGE2) receptor agonist; induces cervical ripening and uterine contractions via binding to EP receptors, increasing intracellular calcium and promoting gap junction formation.
| Metabolism | Rapidly metabolized via 15-hydroxydehydrogenase in the lungs, liver, and kidney; primary metabolite is 15-keto-PGE2, which is further reduced and oxidized. |
| Excretion | Primarily hepatic metabolism via 15-hydroxyprostaglandin dehydrogenase; metabolites are excreted renally (approximately 60% over 24 hours) and fecally (approximately 40%). |
| Half-life | Terminal elimination half-life of dinoprostone is 2.5 to 5 minutes; clinical effects persist due to sustained release formulation (e.g., vaginal insert). |
| Protein binding | Approximately 90% bound to albumin. |
| Volume of Distribution | Approximately 0.3 L/kg; indicates moderate distribution into tissues. |
| Bioavailability | Vaginal administration: systemic bioavailability is approximately 50% due to first-pass uterine extraction and local metabolism. |
| Onset of Action | Vaginal insert: Cervical ripening begins within 6-8 hours; vaginal gel: onset of uterine activity within 30 minutes. |
| Duration of Action | Vaginal insert: 12-24 hours (removal after 12 hours or onset of active labor); vaginal gel: 2-3 hours of uterine activity. |
10 mg vaginal insert (dinoprostone) placed high in the posterior vaginal fornix; may be removed after 12 hours or onset of active labor; one insert per 24 hours.
| Dosage form | INSERT, EXTENDED RELEASE |
| Renal impairment | No dose adjustment required; cervidil is not systemically absorbed to a significant extent. |
| Liver impairment | No dose adjustment required; cervidil is not systemically absorbed to a significant extent. |
| Pediatric use | Not indicated for pediatric use; cervidil is used for cervical ripening in term pregnancies. |
| Geriatric use | Not indicated for geriatric use; cervidil is used exclusively in obstetric patients for cervical ripening. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CERVIDIL (CERVIDIL).
| Breastfeeding | Not recommended during breastfeeding. Dinoprostone is rapidly metabolized; M/P ratio unknown. Potential for adverse effects in infant (diarrhea). Avoid use in nursing mothers. |
| Teratogenic Risk | FDA Pregnancy Category C. In first trimester, risk cannot be ruled out; no adequate studies. Second and third trimesters: used for cervical ripening; potential for uterine hyperstimulation and fetal distress. No evidence of structural teratogenicity. |
| Fetal Monitoring |
■ FDA Black Box Warning
Cervidil should be used only by trained personnel in a hospital setting with immediate access to facilities for maternal and fetal resuscitation. Improper use may lead to uterine hyperstimulation and fetal distress.
| Serious Effects |
["Hypersensitivity to prostaglandins or any component of the formulation","Evidence of fetal distress or undiagnosed vaginal bleeding","Known placenta previa or vasa previa","History of cesarean section or major uterine surgery","Grand multiparity (≥6 previous term pregnancies)","Acute pelvic inflammatory disease","Non-vertex fetal presentation","Cephalopelvic disproportion or conditions contraindicating vaginal delivery"]
| Precautions | ["Uterine hyperstimulation may occur, requiring removal of the insert and tocolytic therapy.","Fetal distress may result from hyperstimulation; continuous fetal monitoring is essential.","Avoid in patients with ruptured membranes, history of cesarean section, or grand multiparity.","Should not be used for prolonged duration (maximum 12 hours).","May cause nausea, vomiting, diarrhea, and fever in the mother."] |
| Food/Dietary |
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| Continuous fetal heart rate monitoring and uterine activity monitoring required. Assess maternal vital signs, signs of uterine hyperstimulation, and fetal distress. Monitor cervical status. |
| Fertility Effects | No known direct effect on fertility. Use for cervical ripening in term pregnancy may facilitate labor; no evidence of long-term reproductive impairment. |
| No significant food interactions. Fasting is not required, but food intake may be restricted during active labor per institutional protocol. |
| Clinical Pearls | Cervidil (dinoprostone) is a prostaglandin E2 vaginal insert used for cervical ripening in term pregnancies. It should be removed prior to amniotomy or if active labor begins. Monitor uterine activity and fetal heart rate continuously. Do not use in women with prior cesarean section or major uterine surgery. Insert transversely in posterior fornix; if placed too high, removal may be difficult. Remove insert at onset of active labor or after 12 hours. Oxytocin should be delayed at least 30 minutes after removal. |
| Patient Advice | This medication is inserted vaginally to help prepare your cervix for labor. · You will need to remain lying down for at least 2 hours after insertion. · Report any strong or frequent contractions, unusual pain, or vaginal bleeding to your nurse immediately. · The insert will be removed after 12 hours or when labor begins. · You may experience mild cramping or nausea. |