dinoprostone

ROUTE	ONSET	PEAK	DURATION
Cervical ripening (gel)	rapid	30–45 min	unknown
Cervical ripening (insert)	rapid	unknown	12 hr

Contraindicated in:

Hypersensitivity to prostaglandins or additives in the gel or suppository;
Should be avoided in situations in which prolonged uterine contractions should be avoided, including:
- Previous cesarean section or uterine surgery;
- Cephalopelvic disproportion;
- Traumatic delivery or difficult labor;
- Multiparity (≥6 term pregnancies);
- Hyperactive or hypertonic uterus;
- Fetal distress (if delivery is not imminent);
- Unexplained vaginal bleeding;
- Placenta previa;
- Vasa previa;
- Active herpes genitalis;
- Obstetric emergency requiring surgical intervention;
- Situations in which vaginal delivery is contraindicated;
Presence of acute pelvic inflammatory disease or ruptured membranes;
Concurrent oxytocic therapy (wait for 30 min after removing insert before using oxytocin).

Use Cautiously in:

Uterine scarring;
Asthma;
Hypotension;
Cardiac disease;
Adrenal disorders;
Anemia;
Jaundice;
Diabetes mellitus;
Seizure disorders;
Glaucoma;
Renal impairment;
Hepatic impairment;
Pulmonary disease;
Multiparity (up to five previous term pregnancies);
Women >30 yr, those with complications during pregnancy, and those with a gestational age >40 wk (↑ risk of disseminated intravascular coagulation).

Adv. Reactions/Side Effects ⬆ ⬇

GU: uterine contractile abnormalities, warm feeling in vagina

MS: back pain

Misc: AMNIOTIC FLUID EMBOLISM, fever

Interactions ⬆ ⬇

Drug-drug:

Augments the effects of other oxytocics.

Route/Dosage ⬆ ⬇

Vag (Adults , Cervical): Endocervical gel: 0.5 mg; if response is unfavorable, may repeat in 6 hr (not to exceed 1.5 mg/24 hr). Vaginal insert: One 10-mg insert.

Availability ⬆ ⬇

Endocervical gel (Prepidil): 0.5 mg dinoprostone in 3 g of gel vehicle in a prefilled syringe with catheters
Vaginal insert (Cervidil): 10 mg

Assessment ⬆ ⬇

Monitor uterine activity, fetal status, and cervical dilation and effacement continuously throughout therapy. Assess for hypertonus, sustained uterine contractility, and fetal distress throughout treatment and after removal for ≥15 min. Insert should be removed at the onset of active labor. Discontinue use if uterine tachysystole or uterine hypersystole/hypertonicity with or without fetal HR changes occurs.
Monitor for signs and symptoms of amniotic fluid embolism syndrome (rare but fatal) (dyspnea, tachypnea, rales, rhonchi, chills, hypotension, mental status changes, abnormal bleeding, fetal distress) during treatment; notify health care provider immediately and provide supportive care.
Women ≥30 yr who had complications during pregnancy and with a gestational age >40 wk have an ↑ risk of postpartum disseminated intravascular coagulation; Monitor for evolving fibrinolysis during the immediate postpartum period.

Implementation ⬆ ⬇

Dinoprostone is a potent oxytocic agent and should be used with strict adherence to recommended dosages and only by medically trained personnel in a hospital setting that can provide immediate intensive care and acute surgical facilities.
Vaginal Insert: Place vaginal insert transversely in the posterior vaginal fornix immediately after removing from foil package. Warming of insert and sterile conditions are not required. Use vaginal insert only with a retrieval system. Use minimal amount of water-soluble lubricant during insertion; avoid excess because it may hamper release of dinoprostone from insert. Patient should remain supine for 2 hr after insertion; then may ambulate. Store vaginal inserts in freezer.
- Vaginal insert delivers dinoprostone 0.3 mg/hr over 12 hr. Remove insert at the onset of active labor, before amniotomy, or after 12 hr.
- Oxytocin should not be used during or <30 min after removal of insert.
Endocervical Gel: Determine degree of effacement before insertion of the endocervical catheter. Do not administer above the level of the internal os. Use a 20-mm endocervical catheter if no effacement is present and a 10-mm catheter if the cervix is 50% effaced.
- Use caution to prevent contact of dinoprostone gel with skin. Wash hands thoroughly with soap and water after administration.
- Bring gel to room temperature just before administration. Do not force warming with external sources (e.g., water bath, microwave). Remove peel-off seal from end of syringe; then remove the protective end cap and insert end cap into plunger stopper assembly in barrel of syringe. Aseptically remove catheter from package. Firmly attach catheter hub to syringe tip; click is evidence of attachment. Fill catheter with sterile gel by pushing plunger to expel air from catheter before administration to patient. Gel is stable for 24 mo if refrigerated.
- Patient should be in dorsal position with cervix visualized using a speculum. Introduce gel with catheter into cervical canal using sterile technique. Administer gel by gentle expulsion from syringe and then remove catheter. Do not attempt to administer small amount of gel remaining in syringe. Use syringe for only one patient; discard syringe, catheter, and unused package contents after using.
- Patient should remain supine for 15–30 min after administration to minimize leakage from cervical canal.
- Oxytocin may be administered 6–12 hr after desired response from dinoprostone gel. If no cervical/uterine response to initial dose of dinoprostone is obtained, repeat dose may be administered in 6 hr.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication and vaginal exams. Advise patient to read Medication Guide before starting and periodically during therapy in case of changes.
Cervical Ripening: Inform patient they may experience a warm feeling in their vagina during administration.
- Advise patient to notify health care professional if contractions become prolonged.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.

Evaluation/Desired Outcomes ⬆ ⬇

Cervical ripening and induction of labor.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

0009- Pharmacia and Upjohn Company LLC
- 0009-0058-
  - 0009-0058-01- 1 BAG in 1 DRUM (0009-0058-01) / 6 kg in 1 BAG

0009- Pharmacia & Upjohn Company LLC
- 0009-3359- Prepidil
  - 0009-3359-01- 1 SYRINGE in 1 CARTON (0009-3359-01) / 3 g in 1 SYRINGE

12079- Kyowa Pharma Chemical Co., Ltd.
- 12079-0485-
  - 12079-0485-1- 500 g in 1 BOTTLE (12079-0485-1)

40016- YS Life Science Co., Ltd.
- 40016-012-
  - 40016-012-01- 15 g in 1 VIAL, GLASS (40016-012-01)

55566- Ferring Pharmaceuticals Inc.
- 55566-2800- CERVIDIL
  55566-2800-1- 1 POUCH in 1 CARTON (55566-2800-1) / 10 mg in 1 POUCH (55566-2800-0)

68245- Chirogate International Inc.
- 68245-0015-
  - 68245-0015-1- 1 g in 1 BAG (68245-0015-1)

68245- Chirogate International Inc.
- 68245-0015-
  68245-0015-2- 10 g in 1 BAG (68245-0015-2)

68245- Chirogate International Inc.
- 68245-0015-
  68245-0015-3- 20 g in 1 BAG (68245-0015-3)

68245- Chirogate International Inc.
- 68245-0015-
  68245-0015-4- 50 g in 1 BAG (68245-0015-4)

68245- Chirogate International Inc.
- 68245-0015-
  68245-0015-5- 100 g in 1 BAG (68245-0015-5)

82231- EUROAPI Hungary Ltd.
- 82231-104-
  82231-104-01- 100 g in 1 BOTTLE (82231-104-01)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇