Dinoprostone


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Pregnancy termination in the 2nd trimester 2.5 mcg/min via infusion over 30 min, then maintain or increase to 5 mcg/min. Maintain for ≥4 hr before increasing further. Extra-amniotic Pregnancy termination in the 2nd trimester Instill 1 mL via foley catheter followed by 1-2 mL at 2 hr intervals according to response. Endocervical Cervical priming, induction and augmentation of labour As cervical gel: Insert 0.5 mg into the cervical canal, may repeat at 6 hr interval, if needed. Max: 1.5 mg/24 hr. Vaginal Cervical priming, induction and augmentation of labour As vag device or insert delivering 0.3 mg/hr: Administer 1 vag device/insert (10 mg) high into posterior fornix; remove when cervical ripening is complete, or after 12-24 hr (depending on product) if cervical ripening is insufficient. Labour induction As vag gel: 1 mg (or 2 mg in primigravid patient w/ unfavourable induction features) inserted into the posterior fornix, then 1-2 mg after 6 hr, if needed. Max: 3 mg (or 4 mg in unfavourable primigravid patient) per course. As vag tab: 3 mg inserted high into the posterior fornix, followed by a further 3 mg after 6-8 hr, if necessary. Max: 6 mg per course. Pregnancy termination in the 2nd trimester As vag supp: Insert 1 supp (20 mg) high into the posterior fornix, repeat at 3-5 hr interval until abortion occurs, for up to 2 days.
Dosage Details
Extra-amniotic
Pregnancy termination in the 2nd trimester
Adult: Instill 1 mL via suitable foley catheter followed by 1-2 mL at 2 hr intervals according to patient's response.

Intracervical
Cervical priming, induction and augmentation of labour
Adult: As cervical gel: Insert 0.5 mg into the cervical canal, may be repeated at 6 hr interval, if needed. Max: 1.5 mg/24 hr.

Intravenous
Pregnancy termination in the 2nd trimester
Adult: 2.5 mcg/min via infusion over 30 min, then maintain or increase to 5 mcg/min. Maintain for at least 4 hr before increasing further.

Vaginal
Labour induction
Adult: As vag gel: 1 mg (or 2 mg in primigravid patient w/ unfavourable induction features) inserted into the posterior fornix, followed by 1-2 mg after 6 hr, if needed. Max: 3 mg (or 4 mg in unfavourable primigravid patient) per course. As vag tab: 3 mg inserted high into the posterior fornix, followed by a further 3 mg after 6-8 hr, if necessary. Max: 6 mg per course.

Vaginal
Pregnancy termination in the 2nd trimester
Adult: As vag supp: Insert 1 supp (20 mg) high into the posterior fornix, repeat at 3-5 hr interval until abortion occurs, for up to 2 days.

Vaginal
Cervical priming, induction and augmentation of labour
Adult: As vag device or insert delivering 0.3 mg/hr: Administer 1 vag device/insert (10 mg) high into posterior fornix and remove when cervical ripening is complete, or after 12-24 hr (depending on product) if cervical ripening is insufficient.
Reconstitution
IV: Dilute w/ appropriate volume of NaCl 0.9% or dextrose 5% to prepare a soln containing 5 mcg/mL. Extra-amniotic:Dilute w/ 50 mL of the diluent provided to prepare a soln containing 100 mcg/mL.
Contraindications
Acute or history of pelvic inflammatory disease, vag infections or cervicitis, placenta praevia or unexplained vag bleeding, history of major uterine surgery or caesarean section, cephalopelvic disproportion, foetal malpresentation, foetal distress, grand multiparae, history of traumatic delivery, ruptured membranes. Active cardiac, pulmonary, renal or hepatic disease.
Special Precautions
Patient w/ compromised uteri, asthma, glaucoma, raised intraocular pressure, HTN or CV disease, epilepsy, gestational diabetes, hypothyroidism. Compromised cardiac, hepatic, or renal function.
Adverse Reactions
Significant: Rarely, disseminated intravascular coagulation (DIC).
CV: HTN.
GI: Diarrhoea, nausea, vomiting.
Resp: Asthma, bronchospasm.
Genitourinary: Uterine hypertonus, uterine rupture, abruptio placenta, pulmonary amniotic fluid embolism, rapid cervical dilatation, vag warmth, irritation, and pain.
Musculoskeletal: Back pain.
Dermatologic: Rash.
Immunologic: Anaphylactoid reactions including shock.
Others: Fever.
Potentially Fatal: Cardiac arrest.
MonitoringParameters
Monitor foetal heart rate, uterine activity, progression of cervical dilation and effacement (gel, insert); confirmation of foetal death (supp).
Overdosage
Symptoms: Uterine hypercontractility, uterine hypertonus. Management: Conservative treatment (including change in maternal position or admin of oxygen); if not effective, β-adrenergic agents may be given.
Drug Interactions
Potentiates the uterotonic effect of oxytocic drugs.
Action
Description: Dinoprostone, a prostaglandin E2, stimulates uterine smooth muscle, thereby inducing uterine contractions similar to those produced by the body during spontaneous labour. It also promotes cervical ripening through activation of the collagenase enzyme which is responsible for digestion of some of the structural collagen network in the cervix. This results in cervical smooth muscle relaxation, allowing dilation and passage of the foetus through the birth canal.
Onset: W/in 10 min (vag supp).
Duration: 2-3 hr (vag supp); 0.3 mg/hr over 12 hr (vag insert).
Pharmacokinetics:
Absorption: Slowly absorbed (vag supp). Time to peak plasma concentration: 30-45 min (cervical gel).
Distribution: Rapidly distributed (IV). Diffuses into the maternal blood. Enters breast milk.
Metabolism: Extensively metabolised in the lungs, forming metabolites which are further metabolised in the liver and kidney.
Excretion: Mainly via urine; faeces (small amounts). Elimination half-life: 2.5-5 min.
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Database. Dinoprostone, CID=5280360, https://pubchem.ncbi.nlm.nih.gov/compound/Dinoprostone (accessed on Jan. 21, 2020)

Storage
Soln: Store at 4°C. Gel: Store between 2-8°C. Vag supp: Store below -20°C. Vag insert: Store between -20 to -10°C.
ATC Classification
G02AD02 - dinoprostone ; Belongs to the class of prostaglandins. Used to induce abortion or augment labour and to minimize blood loss from the placental site.
References
Anon. Dinoprostone. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/11/2016.

Buckingham R (ed). Dinoprostone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/11/2016.

Cervidil Insert (Ferring Pharmaceuticals Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/11/2016.

Joint Formulary Committee. Dinoprostone. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/11/2016.

McEvoy GK, Snow EK, Miller J et al (eds). Dinoprostone. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 03/11/2016.

Prepidil Gel (Pharmacia and Upjohn Company). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/11/2016.

Prostin E2 Suppository (Pharmacia and Upjohn Company). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/11/2016.

Disclaimer: This information is independently developed by MIMS based on Dinoprostone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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