Dinoprostone

Dinoprostone is a prescription medication used for the treatment of cervical ripening and for terminating the pregnancy.

• Dinoprostone is available under the following different brand names: Cervidil, Prepidil, Prostaglandin E2, Prostin E2

Adult dosage

Vaginal insert

• 10mg

Endocervical gel

• 0.5mg/3g (3g)

Vaginal suppository

• 20mg

Cervical Ripening

Adult dosage

• Cervidil: One insert in posterior fornix; remove at the onset of active labor or after 12 hours
• Prepidil gel: 2.5 mL (0.5 mg) in the cervical canal using syringe and catheter; may repeat after 6 hours, maximum cumulative dose 1.5 mg/24 hr

Pregnancy Termination

Adult dosage

• Prostin E2: One suppository (20 mg) intravaginal (high in the vagina) every 3-5 hours until abortion occurs; do not exceed more than 2 days of continuous administration

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Dinoprostone include:

• more frequent contractions,
• slow heartbeats in the baby,
• nausea, stomach pain,
• a feeling of warmth in the vaginal area,
• back pain, or
• fever.

Serious side effects of Dinoprostone include:

• signs of an allergic reaction: hives, itching; wheezing, difficult breathing; feeling light-headed, swelling of the face, lips, tongue, or throat, 
• a light-headed feeling,
• weak or shallow breathing;
• intense pain between contractions,
• sudden vaginal bleeding,
• unexpected stomach pain,
• chest pain
• easy bruising, 
• unusual bleeding,
• bleeding from a wound, surgical incision, or vein at the injection site, or
• any bleeding that will not stop.

Rare side effects of Dinoprostone include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Dinoprostone has severe interactions with no other drugs.
• Dinoprostone has serious interactions with no other drugs.
• Dinoprostone has moderate interactions with the following drug:
  • oxytocin
• Dinoprostone has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

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 is 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 is 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

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Dinoprostone?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Dinoprostone?”

Cautions

• Administer in the hospital setting with the 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 hours following gel application, before administering other oxytocic drugs
• Do not administer gel above the level of the internal os
• Remove insert before amniotomy
• Patients with cervical laceration with resultant retention of the 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 cause in rare circumstances the development of the 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 the event, and institute symptomatic and supportive therapy, as needed
• Disseminated intravascular coagulation
  • Use with caution in women at high risk of postpartum disseminated intravascular coagulation (DIC); physiologic or pharmacologic induction of labor, is associated with an increased risk of DIC during the 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
• Amniotic fluid embolism syndrome
  • Use of dinoprostone-containing products may result in inadvertent disruption and subsequent embolization of antigenic tissue causing the development of a rare syndrome known as the amniotic fluid embolism syndrome, which can be fatal
  • Monitor patients for clinical signs of amniotic fluid embolism syndrome including hypotension, hypoxemia, respiratory failure, DIC, coma, or seizures and provide supportive care as needed
• Uterine tachysystole and uterine hypersystole/ hypertonicity
  • Therapy may cause uterine tachysystole with or without fetal heart rate changes
  • While receiving therapy, carefully monitor uterine activity, fetal status, and progression of cervical dilatation and effacement
  • Discontinue therapy with any evidence of uterine tachysystole, uterine hypersystole/hypertonicity, fetal distress, or if labor commences
  • Therapy is contraindicated when prolonged contraction of the uterus is detrimental to fetal safety or uterine integrity, such as previous cesarean section or major uterine surgery, because of risk of uterine rupture and obstetrical complications (e.g., need for hysterectomy and occurrence of fetal or neonatal death)
  • Prostaglandins may potentiate the effect of oxytocin; stop administration at least 30 minutes before administration of an oxytocic agent is initiated and continue to carefully monitor uterine activity
  • Stop drug before amniotomy or following rupture of membranes because the higher vaginal pH that occurs with rupture of membranes may result in a higher release rate of dinoprostone
  • Prostaglandins can lead to raised intraocular pressure and constriction of pupils; consider non-prostaglandin cervical ripening procedures in patients with glaucoma

Pregnancy and Lactation

• 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 a 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 the management of patients
• Lactation
  • Concomitant administration is not indicated in breastfeeding women; there is no information on the effects of maternal administration on the breastfed child
  • Insufficient information is available on the effects of maternal administration on milk production