with reference to Dinoprostone Class: Oxytocics ATC Class: G02AD02 VA Class: HS875 Chemical Name: (5Z, 11a, 13E, 15S)-11,15-Dihydroxy-9-oxo-prosta-5,13-dien-1-oic acid Molecular Formula: C 20 H 32 O 5 CAS Number: 363-24-6 Brands: Cervidil, Prepidil, Prostin E2 Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Support Group Q & A Introduction Stimulates uterine smooth muscle and also produces cervical dilation and softening; prostaglandin E 2 . a 200 213 214 Slideshow FDA-Approved Weight Loss Drugs: Can They Help You? Uses for Dinoprostone Termination of Pregnancy Termination of intrauterine pregnancy during the second trimester (12 20th week of gestation, dated from the first day of the last menstrual period). a e 200 For termination of pregnancy, has been used in conjunction with oxytocin to reduce the dinoprostone dose and number of adverse effects associated with dinoprostone. a e f Evacuation of uterine contents in cases of missed abortion, intrauterine fetal death up to 28 weeks of gestational age, or nonmetastatic gestational trophoblastic disease (benign hydatidiform mole). a e 200 Labor Induction (Cervical Ripening ) Treatment to improve cervical inducibility (cervical ripening ) in pregnant women at or near term with a medical or obstetrical need for labor induction. 212 213 216 217 218 219 220 h Postpartum Hemorrhage Has been used in the management of postpartum hemorrhage . g Dinoprostone Dosage and Administration Administration Vaginal Administration Administer intravaginally as a vaginal suppository (Prostin E2 ), cervical gel (Prepidil ), or vaginal insert (Cervidil ). 200 212 213 Vaginal Suppositories Allow suppository to reach room temperature just prior to administration. 200 Remove the foil wrapper and insert the suppository high into the posterior vaginal fornix. 200 a Patient should remain supine for 10 minutes following each insertion. 200 May require the use of a diaphragm to prevent displacement of the suppository from the paracervical area. a Cervical Gel Allow the gel to reach room temperature just prior to administration; do not use a water bath or other source of external heat (e.g., microwave oven) to facilitate the warming process. 212 Consult the manufacturer s instructions for proper assembly of the syringe and catheter. 212 Administer the cervical gel (supplied in a syringe) through a shielded catheter into the cervical canal. 212 Select the proper size catheter based on the degree of effacement; if no effacement is present, use the 20-mm catheter; for 50% effacement, use the 10-mm catheter. 212 Place patient in a dorsal position and visualize the cervix using a speculum. 212 Using sterile technique, introduce the gel via the catheter into the cervical canal, just below the level of the internal os. 212 Remove the catheter. 212 Patient should remain supine for at least 15 30 minutes to minimize leakage from the cervical canal. 212 Vaginal Insert Keep frozen until use. d After removal from the protective package (tear at designated mark), d place the vaginal insert transversely in the posterior fornix of the vagina. 213 May use a small amount of water-soluble lubricant to assist insertion; excess contact or coating with lubricant may prevent optimal swelling and release of dinoprostone from the insert. 213 Patient should remain supine for 2 hours following insertion. 213 If patient is ambulatory, ensure that the vaginal insert remains in place. d Use the knitted polyester retrieval system to aid in drug retrieval at the end of the dosing interval. 213 Upon removal of the insert, ensure that the slab is removed. d If the slab is not found in the retrieval system, perform a vaginal examination to remove the slab. d Formulation Considerations Dinoprostone vaginal suppositories and any preparation made extemporaneously from dinoprostone vaginal suppositories should not be used at term for cervical ripening ; 200 dinoprostone cervical gel and vaginal insert are used at or near term to improve cervical inducibility. 212 213 Dinoprostone vaginal suppositories should not be used for extemporaneous preparation of any other dosage form. 200 Dosage Adults Termination of Pregnancy Intravaginal Vaginal suppositories: 20 mg every 3 5 hours until abortion occurs; adjust the dosing intervals according to abortifacient progress, uterine contractility, and patient tolerance. a 200 Vaginal suppositories: Initial dose of 5 mg, repeated as needed, when used for intrauterine fetal death at >24 weeks gestational age. e (See Prescribing Limits.) Induction of Labor (Cervical Ripening ) Intravaginal Cervical gel: Initially, 0.5 mg (2.5 mL of gel). 212 If there is no cervical and/or uterine response to the initial dose, administer another 0.5-mg dose after 6 12 hours. 212 220 Clinician should determine the need for additional doses and the dosing intervals. 212 Vaginal insert: 1 insert delivering dinoprostone 0.3 mg/hour for 12 hours. 213 Remove after 12 hours, at the onset of active labor, or if uterine hyperstimulation develops. 213 d Postpartum Hemorrhage Intravaginal or Rectal Vaginal suppositories: 20 mg every 2 hours has been used. g Prescribing Limits Adults Termination of Pregnancy Intravaginal Vaginal suppositories Intravaginal Vaginal suppositories: Use for >2 days not recommended. 200 Vaginal suppositories: Initially 5 mg; repeat as needed when used for intrauterine fetal death at >24 weeks, gestational age. e Use of 20-mg dose may result in uterine rupture. e Intravaginal Cervical gel: Maximum cumulative dose is 1.5 mg (7.5 mL)/24 hours. 212 220 Cautions for Dinoprostone Contraindications Known hypersensitivity to prostaglandins or any ingredient in the formulation. 200 212 213 Dinoprostone vaginal suppositories are contraindicated in patients with acute pelvic inflammatory disease and in those with active cardiac, pulmonary, renal, or hepatic disease. 200 Dinoprostone cervical gel and vaginal inserts are contraindicated in patients with contraindications to oxytocic agents and when prolonged contractions of the uterus are inappropriate (e.g., previous cesarean section, previous major uterine surgery, history of difficult labor and/or traumatic delivery, marked cephalopelvic disproportion, unfavorable fetal position, 6 previous term pregnancies, fetal distress when delivery is not imminent, hyperactive or hypertonic uterus, obstetric emergencies where maternal or fetal risk-to-benefit ratio favors surgery). 212 213 Dinoprostone cervical gel and vaginal inserts are contraindicated in patients with placenta previa or unexplained vaginal bleeding during the current pregnancy. 212 213 Dinoprostone cervical gel is contraindicated when vaginal delivery is not indicated (e.g., vasa previa, active genital herpes infection). 212 The manufacturer of dinoprostone vaginal inserts states that this preparation is contraindicated in patients receiving IV oxytocic therapy. 213 Warnings/Precautions Warnings Administer by qualified professional personnel in a hospital where intensive care and surgical facilities are immediately available. a 200 212 Considerations in Patients Undergoing Termination of Pregnancy Dinoprostone does not affect the fetoplacental unit. 200 Possibility exists that a previable fetus could exhibit transient signs of life following dinoprostone-induced abortion; dinoprostone is not indicated if the fetus has reached the stage of viability. 200 If pregnancy is terminated because of late fetal intrauterine death, confirm fetal death prior to administration of dinoprostone. 200 If the pregnancy is not terminated with dinoprostone, complete abortion by another method. 200 Confirm pregnancy termination for pregnancy diagnosed as missed abortion. 200 Considerations in Patients Undergoing Induction of Labor (Cervical Ripening ) Monitor uterine contractions, fetal status (e.g., heart rate), and progression of cervical dilation and effacement of the cervix to avoid complications. 220 212 213 Use with caution in patients with ruptured membranes. c d Carefully select patients; evaluate both maternal and fetal condition before dinoprostone use. 212 213 220 (See Contraindications.) Consider removing dinoprostone vaginal insert if sustained uterine contractions, fetal distress, or other fetal or maternal adverse effects occur. 213 Remove the insert if uterine hyperstimulation develops or labor starts. 213 Remove the insert before amniotomy. 213 General Precautions Musculoskeletal Effects Proliferation of long bones reported in neonates receiving long-term therapy with alprostadil (prostaglandin E 1 ). 200 a i No evidence that short-term administration of dinoprostone has similar effects on bone. 200 a Concomitant Diseases Caution in patients with cervicitis, infected endocervical lesions, acute vaginitis, compromised (scarred) uterus, asthma or a history of asthma, hypertension or hypotension, seizure disorders, diabetes mellitus, glaucoma, increased IOP, anemia, jaundice, or cardiovascular, renal, or hepatic disease. 200 212 213 a b Fever Transient fever (i.e., temperature elevations >1.1 C) reported. 200 When used for termination of pregnancy, may be difficult to distinguish drug-induced temperature elevations from post-abortion endometritis. 200 Specific Populations Pregnancy Category C. 200 212 213 Pediatric Use Safety and efficacy not established in children. 200 212 213 Safety and efficacy in adolescents expected to be the same as in adults. 213 Hepatic Impairment Use with caution. 200 212 Dinoprostone vaginal suppositories are contraindicated in patients with active hepatic disease. 200 Renal Impairment Use with caution. 200 212 Dinoprostone vaginal suppositories are contraindicated in patients with active renal disease. 200 Common Adverse Effects Dinoprostone vaginal suppositories: Vomiting, transient fever, diarrhea, nausea, headache, chills, transient DBP decreases of >20 mm Hg. 200 Dinoprostone cervical gel or vaginal insert: Uterine hyperstimulation, fetal heart rate abnormality, adverse GI effects, back pain, fever. 212 213 Interactions for Dinoprostone Specific Drugs Drug Interaction Comments Oxytocic agents (e.g., oxytocin) May increase activity of other oxytocic agents 200 212 213 Concomitant use not recommended 200 212 213 Dinoprostone cervical gel: Allow an inteval of 6 12 hours between administration of the cervical gel and initiation of IV oxytocin 212 220 Dinoprostone vaginal insert: Wait 30 minutes between removal of dinoprostone vaginal insert and initiation of IV oxytocin 213 220 Dinoprostone Pharmacokinetics Absorption Bioavailability Absorbed systemically following vaginal administration as dinoprostone suppositories; a small amount of drug is absorbed directly by the uterus through the cervix or local lymphatic or vascular channels. a Dinoprostone cervical gel: Peak plasma concentrations achieved in 30 45 minutes. 212 Dinoprostone vaginal insert: A controlled-release preparation designed to release 0.3 mg of dinoprostone per hour for 12 hours. 213 Onset Dinoprostone vaginal suppositories: Slight uterine contractions begin within 10 minutes (first and second trimester pregnancies). a Duration Dinoprostone vaginal suppositories: Contractions continue for 2 3 hours (first and second trimester pregnancies). a Distribution Extent Widely distributed in the mother. a Elimination Metabolism Rapidly metabolized in the maternal lungs, kidneys, spleen, and other tissues, primarily by oxidation of the side chains to at least 9 inactive metabolites. a Elimination Route Drug and its metabolites excreted principally in urine; small amounts excreted in feces. a Half-life 2.5 5 minutes. 213 Stability Storage Vaginal Gel 2 8 C. 212 Insert -20 C to -10 C. 213 Protect from moisture and humidity. 213 Suppositories Do not exceed -20 C. 200 Actions Elicits pharmacologic responses usually produced by endogenous prostaglandin E 2 . 200 212 213 Increases the amplitude and frequency of uterine contractions throughout pregnancy; uterine response to the drug increases with the duration of pregnancy. a Produces local cervical effects including softening, effacement, and dilation. 212 213 214 Causes stimulation of the circular smooth muscle of the GI tract, increasing GI motility. a Advice to Patients Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses. 200 212 213 Importance of informing patients of other important precautionary information. 200 212 213 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Dinoprostone Routes Dosage Forms Strengths Brand Names Manufacturer Vaginal Gel 0.5 mg/3 g Prepidil Pfizer Insert 10 mg Cervidil Forest Suppositories 20 mg Prostin E2 Pfizer AHFS DI Essentials. Copyright 2017, Selected Revisions January 1, 2008. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. Use is not currently included in the labeling approved by the US Food and Drug Administration. References 200. Pharmacia & Upjohn Company. Prostin E2 (dinoprostone vaginal suppository) prescribing information (dated 1999 Aug). In: Physician s desk reference. 55th ed. Montvale, NJ: Medical Economics Company Inc; 2001:2638-9. 201. Rayburn W, Gosen R, Ramadei C et al. Outpatient cervical ripening with prostaglandin E 2 gel in uncomplicated postdate pregnancies. Am J Obstet Gynecol . 1988; 158:1417-23. [PubMed 3289398] 202. Nager CW, Key TC, Moore TR. Cervical ripening and labor outcome with preinduction intracervical prostaglandin E2 (Prepidil) gel. J Perinatol . 1987; 7:189-93. [PubMed 3504454] 203. Trofatter KF Jr, Bowers D, Gall SA et al. Preinduction cervical ripening with prostaglandin E 2 (Prepidil) gel. Am J Obstet Gynecol . 1985; 153:268-71. [PubMed 3901764] 204. Neilson DR Jr, Prins RP, Bolton RN et al. A comparison of prostaglandin E 2 gel and prostaglandin F 2α gel for preinduction cervical ripening. Am J Obstet Gynecol . 1983; 146:526-32. [PubMed 6344644] 205. Lorenz RP, Botti JJ, Chez RA et al. Variations of biologic activity of low-dose prostaglandin E 2 on cervical ripening. Obstet Gynecol . 1984; 64:123-7. [PubMed 6377145] 206. Prins RP, Bolton RN, Mark C III et al. Cervical ripening with intravaginal prostaglandin E2 gel. Obstet Gynecol . 1983; 61:459-62. [PubMed 6572335] 207. Ulmsten U, Wingerup L, Andersson KE. Comparison of prostaglandin E 2 and intravenous oxytocin for induction of labor. Obstet Gynecol . 1979; 54:581-4. [PubMed 503385] 208. Dingfelder JR, Brenner WE, Hendricks CH et al. Reduction of cervical resistance by prostaglandin suppositories prior to dilatation for induced abortion. Am J Obstet Gynecol . 1975; 122:25-30. [PubMed 1130444] 209. Jagani N, Schulman H, Fleischer A et al. Role of prostaglandin-induced cervical changes in labor induction. Obstet Gynecol . 1984; 63:225-9. [PubMed 6582419] 210. Buchanan D, Macer J, Yonekura ML. Cervical ripening with prostaglandin E 2 vaginal suppositories. Obstet Gynecol . 1984; 63:659-63. [PubMed 6585733] 211. Lagrew DC, Freeman RK. Management of postdate pregnancy. Am J Obstet Gynecol . 1986; 154:8-13. [PubMed 3946506] 212. Pharmacia & Upjohn Company. Prepidil Gel (dinoprostone cervical gel) prescribing information (dated 1999 Apr). In: Physician s desk reference. 55th ed. Montvale, NJ: Medical Economics Company Inc; 2001:2637-8. 213. Forest Pharmaceuticals. Cervidil (dinoprostone vaginal insert) prescribing information (dated 2000 Feb). In: Physician s desk reference. 55th ed. Montvale, NJ: Medical Economics Company Inc; 2001:1261-3. 214. Bryman I, Norstrom A, Lindblom B. Has cervical smooth muscle any physiological role in the human? Acta Physiol Hung . 1985; 65:327-30. 215. MacLennan AH, Katz M, Creasy R. The morphologic characteristics of cervical ripening induced by the hormones relaxin and prostaglandin F 2 alpha in a rabbit model. Am J Obstet Gynecol . 1985; 152(6 pt 1):691-6. [PubMed 3861093] 216. Sadaty A, Pagano M, Greer C et al. A randomized trial of vaginal prostaglandin E(2) gel and dinoprostone vaginal insert for induction of labor at term. Prim Care Update Ob Gyns . 1998; 5:183. [PubMed 10838343] 217. Warke HS, Saraogi RM, Sanjwalla SM. Prostaglandin E2 gel In ripening of cervix in induction of labour. J Postgrad Med . 1999; 45:105-9. [PubMed 10734347] 218. Wieland D, Friedman F Jr. Comparing two dinoprostone agents for preinduction cervical ripening at term: a randomized trial. J Reprod Med . 1999; 44:724-8. [PubMed 10483544] 219. McKenna DS, Costa SW, Samuels P. Prostaglandin E2 cervical ripening without subsequent induction of labor. Obstet Gynecol . 1999; 94:11-4. [PubMed 10389710] 220. American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins. Induction of labor. Practice Bulletin No. 10. Washington, DC: American College of Obstetricians and Gynecologists; 1999 Nov. a. AHFS Drug Information 2007. McEvoy GK, ed. Dinoprostone. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 3267-9. b. Pharmacia and UpJohn. Prostin E2 (dinoprostone) vaginal suppository prescribing information. New York, NY; 2006 Apr.. c. Pharmacia and UpJohn . Prepidil (dinoprostone) cervical gel prescribing information. New York, NY; 2006 Nov. d. Forest Pharmaceuticals, Inc. Cervidil (dinoprostone) vaginal insert prescribing information. St Louis, MO; 2006 May. e. Stubblefield PG, Carr-Ellis S, Borgatta L. Methods for induced abortion. Obstet Gynecol . 2004; 104:174-85. [PubMed 15229018] f. Ramsey PS, Savage K, Lincoln T, Owen J. Vaginal misoprostol versus concentrated oxytocin and vaginal PGE 2 for second-trimester labor induction. Obstet Gynecol . 2004; 104:138-45. [PubMed 15229013] g. American College of Obstetricians and Gynecologists (ACOG) Committee Practice Bulletin. Postpartum hemorrhage. Practice Bulletin No. 76. Washington, DC: American College of Obstetricians and Gynecologists; 2006 Oct. h. Briggs GG, Wan SR. Drug therapy during labor and delivery, part 2. Am J Health-Syst Pharm . 2006; 63:1131-9. [PubMed 16754739] i. Pharmacia. Prostin VR Pediatric (alprostadil) injection prescribing information. Kalamazoo, MI; 2002 Aug. Next Interactions Print this page Add to My Med List More about dinoprostone topical Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group En Español 6 Reviews Add your own review/rating Drug class: uterotonic agents Consumer resources Dinoprostone topical ... +4 more Professional resources Dinoprostone (FDA) Dinoprostone (Wolters Kluwer) Other brands: Cervidil , Prostin E2 , Prepidil Related treatment guides Labor Induction Abortion Trophoblastic Disease} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Uterotonic agents Related Drugs Abortion misoprostol , Cytotec , oxytocin , Pitocin , mifepristone , Hemabate , Cervidil , carboprost , More... Labor Induction misoprostol , Cytotec , oxytocin , Pitocin , Cervidil , Syntocinon , Prostin E2 , Prepidil , More... Trophoblastic Disease methotrexate , Trexall , Cervidil , Prostin E2 , Cosmegen , dactinomycin , More... Dinoprostone topical Rating 6 User Reviews 3.8 /10 6 User Reviews 3.8 Rate it!} } you haven't any
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