dinoprostone (Rx)

Brand and Other Names:Cervidil, Prepidil, more...Prostaglandin E2, Prostin E2
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Dosing & Uses

AdultPediatric

Dosage Forms & 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

Not applicable

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Interactions

Interaction Checker

and dinoprostone

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (1)

                • oxytocin

                  dinoprostone increases effects of oxytocin by pharmacodynamic synergism. Use Caution/Monitor.

                Minor (0)

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                  Adverse 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

                  Postmarketing Reports

                  Hypersensitivity reactions (e.g., Anaphylactic reaction, anaphylactic shock)

                  Cardiovascular disorders: Myocardial Infarction in women with a history of myocardial infarction

                  Nervous system disorders: Headache

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                  Warnings

                  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 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

                  Cautions

                  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

                  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 source of procoagulant material, replacement of depleted clotting factors and, in some cases, anti-coagulation 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 and 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 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 prior to amniotomy or following rupture of membranes because the higher vaginal pH that occurs with rupture of membranes may result in 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
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                  Pregnancy & Lactation

                  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

                  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.

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                  Pharmacology

                  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)

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                  Images

                  BRAND FORM. UNIT PRICE PILL IMAGE
                  Cervidil vaginal
                  -
                  10 mg insert
                  Cervidil vaginal
                  -
                  10 mg insert
                  Prepidil vaginal
                  -
                  0.5 mg/3 g gel

                  Copyright © 2010 First DataBank, Inc.

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                  Patient Handout

                  Patient Education
                  dinoprostone vaginal

                  DINOPROSTONE GEL - VAGINAL

                  (DYE-noe-PROS-tone)

                  COMMON BRAND NAME(S): Prepidil

                  USES: This medication is used to help prepare your cervix (the lower opening of the womb) for labor and delivery. It is used by women who are having a normal pregnancy and who are at or near their delivery due date. Dinoprostone is a natural substance that your body makes in preparation for labor. It relaxes and softens your cervix (cervical ripening) to allow the baby to pass through the birth canal during delivery.

                  HOW TO USE: This drug is inserted high in your vagina next to the cervix by a health care professional. You will be lying on your back with your knees bent outward while the medication is placed, and you will usually need to continue lying down for at least 15 to 30 minutes to prevent the gel from leaking out. The health care professional will tell you when you can get up and walk around.This medication should only be used in a hospital setting with trained medical care available. You will be monitored for changes in your cervix, for signs of active labor (such as water breaking, strong sustained contractions), and for your baby's condition. If you do not have signs of active labor after 6 hours, your doctor may give you another dose. The dosage is based on your medical condition and response to treatment.

                  SIDE EFFECTS: Side effects such as fever, nausea, vomiting, diarrhea, or abdominal pain are uncommon and usually mild. If any of these effects last or get worse, tell your doctor or midwife right away.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: strong contractions that are very close together (uterine overstimulation).Get medical help right away if you have any very serious side effects, including: easy bruising/bleeding, shortness of breath, chest pain, confusion.This drug has rarely caused injury to the womb (uterine rupture), which may require emergency surgery. Symptoms include severe pain in your womb and an abnormal heart rate in your baby. Careful monitoring by your doctor or midwife may decrease your risk.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                  PRECAUTIONS: Before using dinoprostone, tell your doctor, midwife, or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this drug, tell your doctor your medical history, especially of: asthma, full-term births including previous cesarean section (c-section) births, glaucoma, infections in the vaginal area (such as genital herpes), vaginal bleeding during pregnancy, surgery on the cervix/womb, womb scarring.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This drug should not be used if you are carrying more than one baby, if your labor has already started, or if your water has broken.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

                  DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: other prostaglandins (such as misoprostol), oxytocin.

                  OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                  NOTES: Use under direct medical supervision.

                  MISSED DOSE: Not applicable.

                  STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

                  Information last revised September 2020. Copyright(c) 2021 First Databank, Inc.

                  IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                  Formulary

                  FormularyPatient Discounts

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                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.