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dinoprostone (Cervidil, Prepidil, Prostaglandin E2, Prostin E2)

 

Classes: Prostaglandins, Endocrine; Vaginal Preparations, Other; Abortifacient

Dosing and uses of Cervidil, Prepidil (dinoprostone)

 

Adult dosage forms and strengths

vaginal insert

  • 10mg

endocervical geL

  • 0.5mg/3g (3g)

vaginal suppository

  • 20mg

 

Cervical Ripening

Cervidil: One insert in posterior fornix; remove at the onset of active labor or after 12 hr

Prepidil gel: 2.5 mL (0.5 mg) in cervical canal using syringe and catheter; may repeat after 6 hr, maximum cumulative dose 1.5 mg/24 hr

 

Pregnancy Termination

Prostin E2: One suppository (20 mg) intravaginal (high in vagina) q3-5hr until abortion occurs; do not exceed more than 2 days of continuous administration

 

Pediatric dosage forms and strengths

Not applicable

 

Cervidil, Prepidil (dinoprostone) adverse (side) effects

1-10%

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

 

Warnings

Black box warnings

Should be used only with strict adherence to recommended dosages by medically trained personnel who can provide immediate intensive care in acute surgical facilities

 

Contraindications

GeL

  • Hypersensitivity to the drug or components
  • Patients for whom oxytocic drugs are contraindicated
  • History of cesarea 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 pregnancie (grand multiparae)
  • Cases with hyperactive or hypertonic uterine patterns
  • 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 pregnancie (grand multiparae)
  • Patients for whom oxytocic drugs are contraindicated
  • 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

 

Cautions

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 tranfusions

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

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

 

Pregnancy and lactation

Pregnancy category: C

Lactation: Excretion in milk unknown

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Cervidil, Prepidil (dinoprostone)

Mechanism of action

Relaxes cervical smooth muscle; stimulates uterine contractions similar to those observed during labor

 

Pharmacokinetics

Peak plasma time: 0.5-0.75 hr

Onset: In most first and second trimester pregnancies, slight uterine contractions begin within 10 min

Duration: Contractions continue for 2-3 hr following vaginal insertion of a dinoprostone suppository

Metabolism: Rapidly in the maternal lungs, kidneys, spleen, and other tissues, primarily by oxidation of side chains to at least 9 inactive metabolites

Half-life: 2.5-5 min

Excretion: Urine (principally); feces (small amount)