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Dinoprostone

( PGE 2 ; Prostaglandin E 2 )

Pronunciation: DYE-noe-PROST-one
Class: Prostaglandin, Agent for cervical ripening

Trade Names

Cervidil
- Insert, vaginal 10 mg

Prepidil
- Gel, cervical 0.5 mg

Prostin E2
- Suppository, vaginal 20 mg

Pharmacology

Stimulates gravid uterus to contract; also stimulates smooth muscle of GI tract.

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Pharmacokinetics

Absorption

T max is 0.5 to 0.75 h (gel). C max is approximately 484 pg/mL (gel).

Metabolism

Rapidly metabolized in the local tissue. Systemically absorbed drug is extensively metabolized in the lungs, liver, and kidney.

Elimination

Half-life is 2.5 to 5 min. Metabolites excreted in the urine.

Indications and Usage

Cervical gel and vaginal insert

Cervical ripening in pregnant women at or near term with need for labor induction.

Vaginal suppositories

Termination of pregnancy from 12 to 20 gestational wk; evacuation of uterine contents in management of missed abortion or intrauterine fetal death up to 28 wk of gestational age; management of nonmetastatic gestational trophoblastic disease (benign hydatidiform mole).

Contraindications

Hypersensitivity to dinoprostone, prostaglandins, or any components of the product; patients in whom oxytocic drugs are contraindicated or when prolonged contractions of uterus are considered inappropriate; ruptured membranes; placenta previa; unexplained vaginal bleeding during current pregnancy; when vaginal delivery is not indicated; acute pelvic inflammatory disease; active cardiac, pulmonary, renal, or hepatic disease (suppository only).

Dosage and Administration

Cervical Ripening
Adults

Cervical gel 0.5 mg (contents of 1 syringe); may repeat dose 6 h later if necessary (max dose, 1.5 mg [3 syringes per 24 h]).

Intravaginal insert 10 mg (1 insert). Releases approximately 0.3 mg/h over 12 h. Remove insert upon onset of active labor or 12 h after insertion.

Termination of Pregnancy, Evacuation of Uterine Content in Management of Missed Abortion or Intrauterine Fetal Death, Management of Nonmetastatic Gestational Trophoblastic Disease
Adults

Vaginal suppository 1 suppository (20 mg) high into vagina. Repeat at 3- to 5-h intervals until abortion occurs. Do not give continuously for longer than 2 d.

General Advice

  • Carefully examine vagina to determine degree of effacement and appropriate length of endocervical catheter to be used for application of gel (10 mm if 50% effaced, 20 mm if no effacement).
  • Patient should be in dorsal position for administration and remain supine for 15 to 30 min after administration of cervical gel.
  • Following administration of vaginal suppository, the patient should remain in the supine position for 10 min.
  • Following administration of the vaginal insert, the patient should remain in a recumbent position for 2 h.
  • Inserts do not require warming prior to administration.
  • Suppositories and gel must be brought to room temperature. Do not use external sources of heat (eg, hot water bath, microwave oven) to decrease warming time.
  • Wait at least 6 to 12 h after administration of gel before using IV oxytocin; a dosing interval of at least 30 min is recommended after removal of insert.
  • Do not use dinoprostone vaginal suppository for extemporaneous preparation of any other dosage forms or for cervical ripening or other indications in the patient with term pregnancy.
  • Prevent contact of this drug with skin. Use of latex gloves followed by thorough hand washing with soap and water are recommended.

Storage/Stability

Store suppository in a freezer not above −4°F. Store insert in freezer between −4° and −14°F. Inserts are stable for a period of 3 y when stored in a freezer. Store gel in a refrigerator at 36° to 46°F.

Drug Interactions

Oxytocic agents

May augment effect of other oxytocic agents; avoid concomitant use. For the sequential use of oxytocin following dinoprostone cervical gel administration, a dosing interval of 6 to 12 h is recommended. A dosing interval of at least 30 min is recommended for the sequential use of oxytocin following the removal of the dinoprostone vaginal insert.

Adverse Reactions

Cardiovascular

Arrhythmias; chest pain; syncope; tightness in chest; transient fall in BP.

CNS

Dizziness; headache; flushing; tension; hot flashes; paresthesia; tremor; weakness.

EENT

Blurred vision; eye pain; hearing impairment; laryngitis; pharyngitis.

GI

Nausea; vomiting; diarrhea.

Genitourinary

Uterine contractile abnormality (7%); uterine hyperstimulation without fetal distress (5%); uterine hyperstimulation with fetal distress (3%); warm feeling in vagina (2%); amnionitis; endometritis; premature rupture of membranes; urine retention; uterine rupture; vaginal pain; vaginismus; vaginitis or vulvitis; amniotic fluid embolism (postmarketing).

Hematologic

Postpartum disseminated intravascular coagulation (postmarketing).

Respiratory

Coughing; dyspnea; wheezing.

Miscellaneous

Back pain (3%); fever, muscular cramps or pain (1%); breast tenderness; chills; dehydration; diaphoresis; joint inflammation or pain; nocturnal leg cramps; rash; skin discoloration; stiff neck.

Fetal effects

Fetal heart rate abnormalities (17%); bradycardia, fetal distress without uterine hyperstimulation, shivering, variable deceleration (4%); late deceleration (3%); unspecified deceleration (2%); acidosis (umbilical artery pH < 7.15); depression (1 min Apgar < 7); sepsis.

Precautions

Warnings

Experienced health care providers/equipped facility

Use only with strict adherence to recommended dosages by medically trained personnel who can provide immediate intensive care in acute surgical facilities.


Monitor

When used for termination of pregnancy, evacuation of uterine contents, and management of nonmetastatic gestational trophoblastic disease, monitor for medication efficacy. When used for cervical ripening, perform physical assessment to determine baseline vital signs and fetopelvic relationships. Perform careful uterine and fetal monitoring throughout use of dinoprostone. Monitor patient closely for adverse reactions including nausea, vomiting, or diarrhea, uterine hyperstimulation, sustained uterine contractions, fetal distress, and uterine rupture. Monitor vital signs frequently during administration, noting especially any increase in temperature and hypertension or hypotension. Monitor for hypersensitivity reactions such as bronchospasms, cardiac arrhythmias, or seizures.


Pregnancy

Category C . Contraindicated if fetus in utero has reached viability stage except when cervical ripening is indicated.

Lactation

Undetermined.

Special Risk Patients

Use with caution in patients with asthma, glaucoma, or raised IOP, hypotension or hypertension, CV or renal or hepatic impairment, anemia, jaundice, diabetes, epilepsy, compromised uterus, infected endocervical lesions, acute vaginitis, in patients with cases of non-vertex or non-singleton presentation, and in patients with a history of previous uterine hypertony.

Anaphylactoid syndrome of pregnancy

Intracervical placement of dinoprostone may result in inadvertent disruption and subsequent embolization of antigenic tissue, and rarely leads to development of anaphylactoid syndrome of pregnancy (amniotic fluid embolism).

Incomplete pregnancy termination

If dinoprostone pregnancy termination is incomplete, take other measures to ensure complete abortion.

Postpartum disseminated intravascular coagulation

An increased risk has been described in patients whose labor was induced by physiologic means. Women who are 30 y and older, those with complications during pregnancy, and those with gestational age more than 40 wk are at risk.

Pyrexia

Transient pyrexia (temperature elevations in excess of 2°F), possibly due to the dinoprostone effect on hypothalamic regulation, was observed in 50% of patients receiving suppositories at the recommended dosage. Temperature returned to normal on discontinuation of therapy.

Ruptured membranes

Exercise caution when administering dinoprostone cervical gel or vaginal insert to patients with ruptured membranes.

Uterine hyperstimulation

Placement of dinoprostone cervical gel into the extra-amniotic space has been associated with uterine hyperstimulation. When using the vaginal insert, if uterine hyperstimulation is encountered or if labor starts, the vaginal insert should be removed.

Overdosage

Symptoms

Uterine hypercontractility, uterine hypertonus.

Patient Information

  • Inform patients that uterine contractions are expected and that if pain from contractions becomes severe to notify their health care provider.
  • Instruct patients to report these symptoms to their health care provider immediately: nausea, vomiting, difficulty breathing, chest pain, headache, heavy vaginal bleeding.

Copyright © 2009 Wolters Kluwer Health.

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