Dinoprostone

CERVIDIL

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Pronunciation: dye-noe-PROST-oen

Dinoprostone ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Dinoprostone ballicule

What it isProstaglandin E2 analog; cervical ripening and labor induction.

Why this oneIt ripens an unfavorable cervix, which oxytocin alone does not do.

What limits itUterine tachysystole with fetal heart rate changes — the insert is removable, which is why it is preferred over misoprostol when reversal may be needed.

Dinoprostone molecular structure (skeletal formula) — Molecular structure: Dinoprostone

FDA label

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FDA dosing	Population	Start	Target	Max
Cervical ripening (initiation/continuation) at or near term with indication for labor induction	Pregnant women at/near term	One 10 mg insert intravaginally, once (releases ~0.3 mg/h)	Leave in up to 12 h	1 insert; remove at 12 h

Renal Undefined

Hepatic Undefined

Instructions

Hospital use only, by trained obstetrical personnel
Keep frozen until use; do not warm; tear foil (no scissors); do not use unless retrieval system intact
Insert transversely in posterior fornix; minimal water-miscible lubricant only
Recumbent during insertion and for 2 h after
Remove at 12 h, onset of active labor, before amniotomy/after ROM, or with tachysystole, hypertonicity, or fetal distress
Remove ≥30 min before starting an oxytocic agent; inspect to confirm slab removed

Available strengths

insert 10 mg
gel 0.5 mg/3 g

Contraindications

Known hypersensitivity to prostaglandins
Fetal distress where delivery is not imminent
Unexplained vaginal bleeding in current pregnancy
Marked cephalopelvic disproportion
Conditions where induction of labor or oxytocic drugs are contraindicated
Previous cesarean section or uterine surgery affecting uterine integrity (e.g., myomectomy)
Conditions where prolonged uterine contraction may harm fetal safety
Concurrent IV oxytocic agents
Six or more previous term pregnancies

Cautions

For hospital use only
Disseminated intravascular coagulation (postpartum)
Amniotic fluid embolism syndrome
Uterine tachysystole and hypersystole/hypertonicity — remove insert
Glaucoma (raised IOP)

Adverse reactions

Uterine tachysystole without fetal distress (4.7%)
Fetal distress without tachysystole (3.8%)
Uterine tachysystole with fetal distress (2.8%)

Pregnancy Indicated in pregnancy; limited data show no clear association with adverse developmental outcomes; no relevant animal data.

Lactation Not indicated in breastfeeding women; no data on breastfed child or milk production.

Cost

Dinoprostone (CERVIDIL)

Strength		#/mo	generic $/unit	CostPlus
10 mg	insert	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Dinoprostone is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

NO BOXED WARNINGS

Principal riskUterine tachysystole with fetal heart rate changes

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger3 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk3 / 4

Legacy pregnancy categoryC

Defining liabilityUterine tachysystole, fetal compromise and uterine rupture

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