AdultPediatricDosage 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 administrationNot applicableInteraction CheckerEnter a drug name and dinoprostoneNo Results No Interactions Found Interactions FoundContraindicatedSerious - Use AlternativeSignificant - Monitor CloselyMinorAll Interactions Sort By: SeverityName Contraindicated (0)Serious - Use Alternative (0)Monitor Closely (1)oxytocindinoprostone increases effects of oxytocin by pharmacodynamic synergism. Use Caution/Monitor.Minor (0)oxytocinMonitor Closely (1)dinoprostone increases effects of oxytocin by pharmacodynamic synergism. Use Caution/Monitor. 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 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 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 productionPregnancy 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. 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) BRAND FORM. UNIT PRICE PILL IMAGE Cervidil vaginal- 10 mg insertCervidil vaginal- 10 mg insertCopyright © 2010 First DataBank, Inc.Print Patient Educationdinoprostone vaginal DINOPROSTONE SUPPOSITORY - VAGINAL (DYE-noe-PROST-one) COMMON BRAND NAME(S): Prostin E2 USES: This medication is used to cause an abortion during weeks 12-20 of pregnancy. It is also used up to week 28 of pregnancy to help vaginally remove any remaining material in the womb from a miscarriage/missed abortion. This medication causes the womb to contract and push out its contents, including the placenta and the fetus/unborn baby, whether living or not. Dinoprostone is a natural substance (prostaglandin) that your body makes in preparation for labor. It softens and widens the opening of the womb and increases contractions.It is also used to treat a certain type of womb problem (benign hydatiform mole). This medication should not be used for cervical ripening or any other use in a pregnancy that is near the time of delivery. HOW TO USE: This drug is used vaginally. Allow the suppository to warm to room temperature and remove the foil before use. The suppository is inserted high in the vagina by a health care professional, and you must remain in a reclined or lying-down position for at least 10 minutes after insertion. More doses may be used every 3-5 hours until the desired effect occurs. Do not use for more than 48 hours.This medication should only be used in a hospital setting with trained medical care available. You will be monitored for changes in your womb (such as water breaking, strong/long-lasting contractions). If the desired result has not occurred in 48 hours, or if the abortion is not complete, other treatment (such as surgical removal) may be needed. This medication may be used with a medication given by vein (oxytocin) to help strengthen the contractions. It is very important that all of the products of pregnancy (such as fetal/unborn baby tissue, placenta) are removed to prevent serious, rarely fatal problems such as severe infection and bleeding. SIDE EFFECTS: Nausea, vomiting, diarrhea, fever, chills, abdominal pain, flushing, and dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor 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.Most women will experience a fever 15-45 minutes after the suppository is inserted. Sponge baths and drinking lots of fluids may help lower the fever. Aspirin will not usually lower the fever. The fever usually goes away within 6 hours after the last dose. Get medical help right away if you have a high fever (for example, higher than 101 degrees F or 38 degrees C) after the abortion. Fever may be a sign of a serious infection.Tell your doctor right away if you have any serious side effects, including: fainting, strong contractions that are very close together (uterine overstimulation), severe abdominal pain.Get medical help right away if you have any very serious side effects, including: chest pain.This drug has rarely caused injury to the womb (uterine rupture), which may require emergency surgery. Your doctor will be monitoring you for signs of uterine overstimulation.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 this medication, tell your doctor 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 medication, tell your doctor or pharmacist your medical history, especially of: anemia, asthma, high or low blood pressure, diabetes, glaucoma, heart disease (such as angina, heart attack), kidney disease, liver disease, infections in the vaginal/pelvic area (such as cervicitis, vaginal infection, genital herpes, pelvic inflammatory disease), seizure disorder, uterine surgery including previous cesarean section (c-section) birth, pelvic problems (such as womb scarring, fibroids, cervical stenosis).This medication should not be used if the unborn baby is mature enough to survive outside the womb. 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