Dinoprostone

DAE Class; Rx

Common Brand Names; Cervidil, Prepidil, Prostaglandin E2, Prostin E2

• Prostaglandins, Endocrine; 
• Vaginal Preparations, Other; 
• Abortifacient

Synthetic form of prostaglandin E2; has oxytocic actions; use requires specialized care facilities and monitoring
Vaginal suppositories used clinically to induce abortion or to evacuate uterine contents following intrauterine fetal death, missed abortion, or benign hydatidiform mole
Endocervical gel or vaginal inserts are used for cervical ripening during labor in term pregnancies

Gel

• Hypersensitivity to the drug or components
• Patients for whom oxytocic drugs are contraindicated
• History of cesarean section or major uterine surgery
• Cephalopelvic disproportion present
• Cases of fetal distress where delivery not imminent
• History of difficult labor or traumatic delivery
• 6 or more previous term pregnancies (grand multiparae)
• Cases with hyperactive or hypertonic uterine patterns
• Unexplained vaginal bleeding during pregnancy
• Cases where vaginal delivery not indicated
• Cases with nonvertex presentation

Insert

• Hypersensitivity to prostaglandins
• Cases of fetal distress where delivery not imminent
• Unexplained vaginal bleeding during pregnancy
• Cephalopelvic disproportion present
• Patients currently receiving IV oxytocic drugs
• 6 or more previous term pregnancies (grand multiparae)
• Conditions for which induction of labor contraindicated
• Patients for whom oxytocic drugs are contraindicated
• Previous cesarean section or other uterine surgery expected to affect uterine integrity (eg, myomectomy)
• When prolonged contraction of the uterus may negatively affect fetal safety or uterine integrity
• Uterine rupture or other associated obstetrical complications

Suppository

• Hypersensitivity to dinoprostone, acute pelvic inflammatory disease
• Active pulmonary, cardiac, hepatic, renal disease or acute pelvic inflammatory disease

Gel

• Fever/temperature elevations (1%)
• GI upset (6%)
• Abnormal uterine contractions (7%)
• Warm feeling in vagina (2%)
• Back pain (3%)

Insert

• Hypertonic uterine dysfunction with fetal distress (3%)
• Hypertonic uterine dysfunction without fetal distress (2-5%)

<1%

Gel

• Amnionitis
• Premature rupture of membranes
• Uterine rupture
• Postpartum disseminated intravascular coagulation

Insert

• Hypotention
• Uterine rupture
• Postpartum disseminated intravascular coagulation

Frequency Not Defined

Suppository

• Chest pain
• Arrhythmia
• Syncope
• Chest tightness
• Skin discoloration
• Endometritis
• Dehydration
• Hot flashes
• Vaginitis
• Vulvitis
• Paresthesia
• Hearing impairment
• Eye pain
• Blurred vision
• Diaphoresis

Administer in hospital setting with obstetric care facility

Use caution in patients with epilepsy, glaucoma, hepatic/renal impairment, pulmonary disease

Wait 30 min following removal of insert, or 6-12 hr following gel application, before administering other oxytocic drugs

Do not administer gel above level of internal os

Remove insert before amniotomy

Patients with cervical laceration with resultant retention of placenta and severe hemorrhage may require blood transfusions

Closely monitor with acute vaginitis, anemia, cardiovascular disease, cervical stenosis, cervicitis, diabetes mellitus, endocervical lesions, glaucoma, hypertension, hypotension, jaundice, mild pre-eclampsia, multiparity, severe pre-eclampsia, seizures with epilepsy, surgery of uterus or cervix, uterine fibroids

Increased risk of postpartum disseminated intravascular coagulation in women aged 30 years or older, those with complications during pregnancy, and those with gestational age >40 weeks; assess for evolving fibrinolysis in the immediate postpartum period; promptly institute therapy consisting of prompt removal of the source of procoagulant material, replacement of depleted clotting factors and, in some cases, anticoagulation with heparin

Inadvertent disruption and subsequent embolization of antigenic tissue causing in rare circumstances the development of anaphylactoid syndrome of pregnancy

Life-threatening hypersensitivity reactions including anaphylaxis and angioedema reported; onset occurred within minutes to hours after initiation with therapy; If a hypersensitivity reaction is suspected, remove (dinoprostone gel application, if possible; assess for other potential causes of event, and institute symptomatic and supportive therapy, as needed

Pregnancy

Indicated for initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for induction of labor

Limited available data with use in pregnant women do not show a clear association with adverse developmental outcomes; relevant animal reproduction data with dinoprostone is not available

When therapy was removed for fetal distress, there was a return to normal rhythm and there were no neonatal sequelae; remove therapy in the event of persistent tachysystole with or without fetal heart rate changes, and follow established institutional protocols in management of patients

Lactation

Concomitant administration of is not indicated in breastfeeding women; there is no information on effects of maternal administration on breastfed child

Insufficient information is available on effects of maternal administration on milk production

Adults

Dependent on indication for use and dosage formulation selected for therapy.

Elderly

Safety and efficacy have not been established.

Adolescents

Dependent on indication for use and dosage formulation selected for therapy.

Children

Safety and efficacy have not been established.

Dinoprostone