dinoprostone

General

Pronunciation
dye-noe-PROST-one [Pronunciation]

Trade Name(s)

• Cervidil Vaginal Insert

• Prepidil Endocervical Gel

• Prostin E Vaginal Suppository

Pregnancy Category
Category C

Ther. class.
cervical ripening agent

Pharm. class.
oxytocics
prostaglandins

Indications

• Endocervical Gel, Vaginal Insert:

» Used to "ripen" the cervix in pregnancy at or near term when induction of labor is indicated.

• Vaginal Suppository:

» Induction of midtrimester abortion,

» Management of missed abortion up to 28 wk,

» Management of nonmetastatic gestational trophoblastic disease (benign hydatidiform mole).

Action

• Produces contractions similar to those occurring during labor at term by stimulating the myometrium (oxytocic effect).

• Initiates softening, effacement, and dilation of the cervix ("ripening").

• Also stimulates GI smooth muscle.

Therapeutic Effect(s):

• Initiation of labor.

• Expulsion of fetus.

Pharmacokinetics

Absorption: Rapidly absorbed.

Distribution: Unknown. Action is mostly local.

Metabolism and Excretion: Metabolized by enzymes in lung, kidneys, spleen, and liver tissue.

Half-life: Unknown.

TIME/ACTION PROFILE

ROUTE	ONSET	PEAK	DURATION
Cervical ripening (gel)	rapid	30–45 min	unknown
Cervical ripening (insert)	rapid	unknown	12 hr
Abortion time (suppository)	10 min	12–24 hr	2–3 hr

Contraindication/Precautions

Contraindicated in:

• Hypersensitivity to prostaglandins or additives in the gel or suppository;

• The gel/insert should be avoided in situations in which prolonged uterine contractions should be avoided, including;

• 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;

• Epilepsy;

• Glaucoma;

• Pulmonary, renal, or hepatic disease;

• Multiparity (up to 5 previous term pregnancies);

• Women >30 yr, those with complications during pregnancy, and those with a gestational age >40 wk (↑ risk of disseminated intravascular coagulation).

Adverse Reactions/Side Effects

Endocervical Gel, Vaginal Insert

GU: uterine contractile abnormalities, warm feeling in vagina.

MS: back pain.

Misc: AMNIOTIC FLUID EMBOLISM, fever.

Suppository

CNS: headache, drowsiness, syncope.

Resp: coughing, dyspnea, wheezing.

CV: hypotension, hypertension.

GI: diarrhea, nausea, vomiting.

GU: UTERINE RUPTURE, urinary tract infection, uterine hyperstimulation, vaginal/uterine pain.

Misc: ALLERGIC REACTIONS INCLUDING ANAPHYLAXIS , chills, fever.

*CAPITALS indicates life-threatening.
*italic indicates most frequent.

Interactions

Drug-Drug
Augments the effects of other oxytocics .

Route/Dosage

Cervical Ripening

• 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..

Abortifacient

• Vag (Adults): One 20-mg suppository, repeat q 3–5 hr (not to exceed 240 mg total or longer than 48 hr)..

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

• Vaginal suppository (Prostin E Vaginal): 20 mg

Assessment

Abortifacient

• Monitor frequency, duration, and force of contractions and uterine resting tone. Opioid analgesics may be administered for uterine pain.

» Monitor temperature, pulse, and BP periodically throughout therapy. Dinoprostone-induced fever (elevation >1.1°C or 2°F) usually occurs within 15–45 min after insertion of suppository. This returns to normal 2–6 hr after discontinuation or removal of suppository from vagina.

» Auscultate breath sounds. Wheezing and sensation of chest tightness may indicate hypersensitivity reaction.

» Assess for nausea, vomiting, and diarrhea in patients receiving suppository. Vomiting and diarrhea occur frequently. Patient should be premedicated with antiemetic and antidiarrheal.

» Monitor amount and type of vaginal discharge. Notify health care professional immediately if symptoms of hemorrhage (increased bleeding, hypotension, pallor, tachycardia) occur.

Cervical Ripening

• Monitor uterine activity, fetal status, and dilation and effacement of cervix continuously throughout therapy. Assess for hypertonus, sustained uterine contractility, and fetal distress. Insert should be removed at the onset of active labor.

Potential Nursing Diagnoses

• Deficient knowledge , related to medication regimen (Patient/Family Teaching)

Implementation

• Abortifacient: Warm the suppository to room temperature just before use.

» Wear gloves when handling unwrapped suppository to prevent absorption through skin.

» Patient should remain supine for 10 min after insertion of suppository; then she may be ambulatory.

• 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.

» 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 less than 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 (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 1 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 of medication and vaginal exams.

• Abortifacient: Instruct patient to notify health care professional immediately if fever and chills, foul-smelling vaginal discharge, lower abdominal pain, or increased bleeding occurs.

» Provide emotional support throughout therapy.

• Cervical Ripening: Inform patient that she may experience a warm feeling in her vagina during administration.

» Advise patient to notify health care professional if contractions become prolonged.

Evaluation/Desired Outcomes

• Complete abortion. Continuous administration for more than 2 days is not usually recommended.

• Cervical ripening and induction of labor.