Dinoprostone: Uses, Dosage, Side Effects and More

This information is not country-specific. Please refer to the Malaysia prescribing information.

Generic Medicine Info

Indications and Dosage

Intracervical
Cervical ripening

Adult: In patients at or near term with an obstetrical or medical indication for labour induction: As cervical gel: Insert 0.5 mg into the cervical canal; may repeat every 6 hours if necessary. Max cumulative dose: 1.5 mg in 24 hours.

Intravenous
Hydatidiform mole, Missed abortion, Termination of pregnancy

Adult: As 10 mg/mL ampoule diluted to 5 mcg/mL final concentration: Initially, 2.5 mcg/min via IV infusion over 30 minutes; maintain current dose or increase to 5 mcg/min as necessary. If satisfactory uterine activity is not achieved after 4 hours, may increase the rate up to 10 mcg/min as tolerated; maintain the rate until abortion occurs or treatment is considered a failure. If significant adverse effects occur, reduce the rate by 50% or discontinue infusion. Interrupt therapy in the event of uterine hypertonus until conditions return to normal. Upon re-assessment, and if needed, the infusion may be resumed at a dosage reduced by 50% from the previous dose. Continuous administration for more than 2 days is not recommended.

Intravenous
Labour induction

Adult: As 1 mg/mL ampoule diluted to 1.5 mcg/mL final concentration: 0.25 mcg/min via IV infusion over 30 minutes, then maintain or increase the dose based on response. In cases of intra-uterine fetal death: Initially, 0.5 mcg/min, then may increase the dose as necessary at intervals of not less than 1 hour. Interrupt therapy in the event of fetal distress or uterine hypertonus until conditions return to normal. Upon re-assessment, and if needed, the infusion may be resumed at a dosage reduced by 50% from the previous dose. Discontinue treatment if there is no response after 12-24 hours.

Vaginal
Labour induction

Adult: As vaginal gel: Initially, insert 1 mg (or 2 mg in primigravida patients with unfavourable induction features) high into the posterior fornix. May insert a 2nd dose after 6 hours, either 1 mg if uterine delivery is insufficient for satisfactory progress of labour or 2 mg if response to the initial dose is minimal. Max dose: 3 mg (or 4 mg in primigravida patients with unfavourable induction features). As 3 mg vaginal tab: Initially, insert 1 tab (3 mg) high into the posterior fornix; may insert a 2nd tab after 6-8 hours if necessary. Max dose: 6 mg in 24 hours.

Vaginal
Cervical ripening

Adult: For the initiation or continuation of cervical ripening in patients at or near term in whom there is an obstetrical or medical indication for labour induction: As 10 mg vaginal insert, releasing approx 0.3 mg/hour: Administer 1 insert high into the posterior fornix. Remove the insert when cervical ripening is complete, or after 12 or 24 hours (depending on specific product) if there has been insufficient cervical ripening. The insert must also be removed upon onset of active labour, before amniotomy or following rupture of membranes, occurrence of uterine hyperstimulation or hypertonic uterine contractions, evidence of fetal distress or maternal systemic adverse effects, and at least 30 minutes before administration of uterotonic agents (e.g. oxytocin).

What are the brands available for Dinoprostone in Malaysia?

Prostin E2

Other Known Brands

Cervidil

Reconstitution

IV infusion: When used for labour induction: Withdraw 0.75 mL from the ampoule labelled as containing 1 mg/mL, then add to 500 mL of NaCl 0.9% or dextrose 5% in water to make a final concentration of 1.5 mcg/mL. When used for termination of pregnancy, missed abortion, and hydatidiform mole: Withdraw 0.5 mL from the ampoule labelled as containing 10 mg/mL, then add to 1,000 mL of NaCl 0.9% or dextrose 5% in water to make a final concentration of 5 mcg/mL. Shake well to ensure uniformity.

Contraindications

History of caesarean section, major uterine surgery (e.g. myomectomy), history of difficult labour and/or traumatic delivery, cephalopelvic disproportion, suspected or clinically evident preexisting fetal distress, unexplained vaginal bleeding during current pregnancy, presence or suspicion of placenta praevia; fetal malpresentation, history of or current untreated pelvic inflammatory disease (IV solution, vaginal insert, gel or tab); active cardiac, pulmonary, renal, or hepatic disease (IV solution, vaginal gel or tab); previous major uterine cervix surgery or rupture of the uterine cervix (vaginal insert); hyperactive or hypertonic uterine patterns, obstetric emergencies when surgical intervention would be favourable (cervical gel). Contraindications may vary among countries and between individual products (refer to specific product guidelines).

Special Precautions

Patient with history of or current asthma, epilepsy; glaucoma, raised IOP; risk factors for disseminated intravascular coagulation (including patients ≥30 years of age, gestational age >40 weeks, or patients with pregnancy complications); hypertension, compromised CV function; ruptured chorioamniotic membranes, multiple pregnancy. Available products or preparations of dinoprostone are not bioequivalent due to pharmacokinetic differences; hence, individual products and certain formulations are not interchangeable (refer to specific product guidelines for detailed information). Concomitant use of other oxytocic agents is not recommended.

Adverse Reactions

Significant: Postpartum disseminated intravascular coagulation (when used for labour induction); increased risk of uterine rupture; raised IOP and constriction of pupils.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain.
General disorders and administration site conditions: Pyrexia; inj site irritation and erythema (IV).
Musculoskeletal and connective tissue disorders: Back pain.
Nervous system disorders: Headache.
Pregnancy, puerperium and perinatal conditions: Abnormal uterine contractions, uterine tachysystole and hyperstimulation, meconium in amniotic fluid.
Reproductive system and breast disorders: Vulvovaginal burning sensation.
Skin and subcutaneous tissue disorders: Pruritus.
Vascular disorders: Hypertension, hypotension.
Potentially Fatal: Serious hypersensitivity reactions (e.g. anaphylaxis and angioedema). Rarely, inadvertent disruption and embolisation of antigenic tissue leading to anaphylactoid syndrome of pregnancy or amniotic fluid embolism syndrome (intracervical placement of endocervical gel, vaginal gel or insert).

Monitoring Parameters

Carefully evaluate cephalopelvic relationships prior to use in labour induction. Monitor regularly the uterine activity, fetal condition or heart rate; progression of cervical dilation and effacement (vaginal gel and insert); excessive uterine activity defined as contractions >5 every 10 minutes and/or the internal tonus consistently >15 mmHg (vaginal tab). Assess for signs and symptoms of amniotic fluid embolism (e.g. disseminated intravascular coagulation, hypotension, hypoxaemia, respiratory failure, seizures, coma) when using endocervical or vaginal gel and vaginal insert.

Overdosage

Symptoms: Uterine hypercontractility and uterine hypertonus. Management: Symptomatic and supportive treatment. May perform non-specific, conservative treatment (e.g. maternal position change, oxygen administration). In case of hyperstimulation following administration for cervical ripening, β-adrenergic drugs may be used if conservative treatment is ineffective.

Drug Interactions

Potentiates the uterotonic effect of oxytocic drugs (e.g. oxytocin).

Action

Description:
Mechanism of Action: Dinoprostone is a prostaglandin E₂, an endogenous hormone that plays an important role in the complex set of structural and biochemical alterations in cervical ripening. It relaxes the cervical smooth muscle, leading to cervical softening and dilation, thereby allowing the passage of the fetus through the birth canal. Dinoprostone also stimulates uterine smooth muscle contractions similar to those produced by the body during spontaneous labour.
Synonym(s): Prostaglandin E₂.
Duration: 0.3 mg/hour over 12 hours (vaginal insert).
Pharmacokinetics:
Absorption: Rapidly absorbed (cervical gel). Time to peak plasma concentration: 30-45 minutes (cervical gel).
Distribution: Rapidly distributed (IV). Enters breast milk.
Metabolism: Rapidly metabolised in the lungs mainly via oxidation forming inactive metabolites, which are further metabolised in the liver and kidneys.
Excretion: Mainly via urine; faeces (small amounts). Elimination half-life: 2.5-5 minutes.

Chemical Structure

Storage

IV solution: Store the intact ampoules or the diluted solution between 2-8°C. Use the diluted solution within 24 hours of preparation. Vaginal insert: Store in the freezer (between -20°C and -10°C). Protect from moisture. Cervical gel/Vaginal gel or tab: Store between 2-8°C. Follow applicable procedures for receiving, handling, administration, and disposal. Storage recommendations may vary among countries and between individual products. Refer to specific product guidelines.

MIMS Class

Drugs Acting on the Uterus

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

Brayfield A, Cadart C (eds). Dinoprostone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/06/2025.

Cervidil 10 mg Controlled Release Vaginal Delivery System (Ferring Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 30/06/2025.

Cervidil Insert (Ferring Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 30/06/2025.

Dinoprostone. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 30/06/2025.

Dinoprostone. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 30/06/2025.

Joint Formulary Committee. Dinoprostone. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/06/2025.

Pfizer New Zealand Limited. Prostin E2 1 mg or 2 mg Vaginal Gel data sheet 19 January 2019. Medsafe. http://www.medsafe.govt.nz. Accessed 30/06/2025.

Prepidil Gel (Pharmacia & Upjohn Company LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 30/06/2025.

Propess 10 mg Vaginal Delivery System (Ferring Pharmaceuticals Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 30/06/2025.

Prostin E2 mg Vaginal Tablets (Pfizer [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 30/06/2025.

Prostin E2 Sterile Solution 1 mg/mL (Pfizer Limited). MHRA. https://products.mhra.gov.uk. Accessed 30/06/2025.

Prostin E2 Sterile Solution 10 mg/mL (Pfizer Limited). MHRA. https://products.mhra.gov.uk. Accessed 30/06/2025.

Prostin E2 Vaginal Gel 1 mg (Pfizer Limited). MHRA. https://products.mhra.gov.uk. Accessed 30/06/2025.

Prostin E2 Vaginal Tablets 3 mg (Pfizer Limited). MHRA. https://products.mhra.gov.uk. Accessed 30/06/2025.

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 © 2025 MIMS. All rights reserved. Powered by MIMS.com