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Drugs reference index «Dinoprostone (PGE2; Prostaglandin E2)»

Dinoprostone

( PGE2 ; Prostaglandin E2 ) Pronunciation: (DIE-no-PROSTE-ohn)Class: Prostaglandin, Agent for cervical ripening

Trade Names:Cervidil- Vaginal insert 10 mg

Trade Names:Prepidil- Gel 0.5 mg

Trade Names:Prostin E2- Vaginal suppository 20 mg

Pharmacology

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

Pharmacokinetics

Absorption

T max is 0.5 to 0.75 h (gel). C max 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

t ½ is 2.5 to 5 min. Metabolites excreted in the urine.

Indications and Usage

Gel

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

Vaginal suppositories

Termination of pregnancy from 12 to 20 wk.

Contraindications

Hypersensitivity to prostaglandins; 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.

Dosage and Administration

Cervical RipeningAdults

Intravaginal Gel 0.5 mg (contents of one syringe); may repeat dose 6 h later if necessary (max dose 1.5 mg (3 syringes/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 PregnancyAdults

Intravaginal 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 days.

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.
  • 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 and insert in freezer. Store gel in refrigerator. Bring both to room temperature just prior to use, do not use external sources of heat (eg, hot water bath, microwave oven) to decrease warming time.

Drug Interactions

Oxytocic agents

May augment effect of other oxytocic agents; avoid concomitant use.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Transient fall in BP; syncope; dizziness; arrhythmias.

CNS

Headache; flushing; anxiety; tension; hot flashes; paresthesia; weakness.

EENT

Blurred vision; eye pain.

GI

Anorexia; nausea; vomiting; diarrhea.

Genitourinary

Uterine contractile abnormality; endometritis; uterine rupture; uterine pain; amnionitis; premature rupture of membranes; vaginal pain; warm feeling in vagina.

Respiratory

Bronchospasm; coughing; dyspnea; wheezing.

Miscellaneous

Back pain; muscular cramps; fever; chills; joint inflammation; breast tenderness; diaphoresis; rash; leg cramps; dehydration. Fetal effects: Fetal heart rate abnormalities; bradycardia; deceleration; sepsis; depression (1 min Apgar less than 7); acidosis.

Precautions

Warnings

Experienced physician/equipped facility

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

Monitor

Perform physical assessment to determine baseline vital signs and fetopelvic relationships. Perform careful uterine and fetal monitoring throughout use of dinoprostone. 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. Monitor patient closely for adverse reactions including nausea, vomiting, or diarrhea. 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, cardiovascular or renal or hepatic function impairment, anemia, jaundice, diabetes, epilepsy, compromised uterus, infected endocervical lesions; acute vaginitis.

Overdosage

Symptoms

Uterine hypercontractility, uterine hypertonus.

Patient Information

  • Inform patient that uterine contractions are expected and that if pain from contractions becomes severe, health care provider will be notified to obtain order for analgesic.
  • Instruct patient to report these symptoms to health care provider immediately: nausea, vomiting, difficulty breathing, chest pain, headache.

Copyright © 2009 Wolters Kluwer Health.

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