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Pronunciation |
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(dye
noe PROST
one) |
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U.S. Brand
Names |
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Cervidil® Vaginal Insert;
Prepidil® Vaginal Gel; Prostin E2® Vaginal
Suppository |
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Generic
Available |
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No |
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Synonyms |
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PGE2; Prostaglandin E2 |
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Pharmacological Index |
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Abortifacient; Prostaglandin |
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Use |
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Gel: Promote cervical ripening prior to labor induction; usage for gel
include any patient undergoing induction of labor with an unripe cervix, most
commonly for pre-eclampsia, eclampsia, postdates, diabetes, intrauterine growth
retardation, and chronic hypertension
Suppositories: Terminate pregnancy from 12th through 28th week of gestation;
evacuate uterus in cases of missed abortion or intrauterine fetal death; manage
benign hydatidiform mole
Vaginal insert: Initiation and/or cervical ripening in patients at or near
term in whom there is a medical or obstetrical indication for the induction of
labor |
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Pregnancy Risk
Factor |
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C |
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Contraindications |
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Vaginal insert: Known hypersensitivity to prostaglandins; fetal distress
(suspicion or clinical evidence unless delivery is imminent); unexplained
vaginal bleeding during this pregnancy; strong suspicion of marked cephalopelvic
disproportion; patients in whom oxytoxic drugs are contraindicated or when
prolonged contraction of the uterus may be detrimental to fetal safety or
uterine integrity (including previous cesarean section or major uterine
surgery); greater than 6 previous term pregnancies; patients already receiving
oxytoxic drugs
Gel: Hypersensitivity to prostaglandins or any constituents of the cervical
gel, history of asthma, contracted pelvis, malpresentation of the fetus
Gel: The following are "relative" contraindications and should only be
considered by the physician under these circumstances: Patients in whom vaginal
delivery is not indicated (ie, herpes genitalia with a lesion at the time of
delivery), prior uterine surgery, breech presentation, multiple gestation,
polyhydramnios, premature rupture of membranes
Suppository: Known hypersensitivity to dinoprostone, acute pelvic
inflammatory disease, uterine fibroids, cervical stenosis |
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Warnings/Precautions |
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Dinoprostone should be used only by medically trained personnel in a
hospital; caution in patients with cervicitis, infected endocervical lesions,
acute vaginitis, compromised (scarred) uterus or history of asthma, hypertension
or hypotension, epilepsy, diabetes mellitus, anemia, jaundice, or
cardiovascular, renal, or hepatic disease. Oxytocin should not be used
simultaneously with Prepidil® (>6 hours of the last
dose of Prepidil®). |
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Adverse
Reactions |
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>10%:
Central nervous system: Headache
Gastrointestinal: Vomiting, diarrhea, nausea
1% to 10%:
Cardiovascular: Bradycardia
Central nervous system: Fever
Neuromuscular & skeletal: Back pain
<1%: Hypotension, cardiac arrhythmias, syncope, flushing, tightness of the
chest, vasomotor and vasovagal reactions, dizziness, chills, pain, hot flashes,
wheezing, dyspnea, coughing, bronchospasm, shivering |
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Overdosage/Toxicology |
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Symptoms of overdose include vomiting, bronchospasm, hypotension, chest pain,
abdominal cramps, uterine contractions
Treatment is symptomatic |
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Drug
Interactions |
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Increased effect of oxytocics |
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Stability |
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Suppositories must be kept frozen, store in freezer not above
-20°F (-4°C); bring to room
temperature just prior to use; cervical gel should be stored under refrigeration
2°C to 8°C
(36°F to 46°F) |
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Mechanism of
Action |
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A synthetic prostaglandin E2 abortifacient that stimulates uterine
contractions similar to those seen during natural labor |
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Pharmacodynamics/Kinetics |
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Onset of effect (uterine contractions): Within 10 minutes
Duration: Up to 2-3 hours
Absorption: Vaginal: Slow following administration
Metabolism: In many tissues including the kidney, lungs, and spleen
Elimination: Primarily in urine with small amounts excreted in feces
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Usual Dosage |
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Abortifacient: Insert 1 suppository high in vagina, repeat at 3- to 5-hour
intervals until abortion occurs up to 240 mg (maximum dose); continued
administration for longer than 2 days is not advisable
Cervical ripening:
Gel:
Intracervical: 0.25-1 mg
Intravaginal: 2.5 mg
Suppositories: Intracervical: 2-3 mg
Vaginal Insert (Cervidil®): 10 mg (to be removed at the
onset of active labor or after 12 hours) |
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Administration |
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Vaginal insert: One vaginal insert is placed transversely in the posterior
fornix of the vaginal immediately after removal from its foil package. Patients
should remain in the recumbent position for 2 hours after insertion, but
thereafter may be ambulatory |
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Mental Health: Effects
on Mental Status |
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May cause dizziness |
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Mental Health:
Effects on Psychiatric
Treatment |
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None reported |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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No effects or complications reported |
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Patient
Information |
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Nausea and vomiting, cramping or uterine pain, or fever may occur. Report
acute pain, respiratory difficulty, or skin rash. Closely monitor for vaginal
discharge for several days. Report vaginal bleeding, itching, malodorous or
bloody discharge, or severe cramping. |
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Nursing
Implications |
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Bring suppository to room temperature just prior to use; patient should
remain recumbent for 2 hours following insertion; commercially available
suppositories should not be used for extemporaneous preparation of any other
dosage form of drug |
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Dosage Forms |
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Insert, vaginal (Cervidil®): 10 mg
Gel, endocervical: 0.5 mg in 3 g syringes [each package contains a 10-mm and
20-mm shielded catheter]
Suppository, vaginal: 20 mg |
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References |
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Novakov A, Segedi D, Milasinovic L, et al,
"Induction of Labor by Endocervical Application of Prostaglandins and Intravenous Infusion of Oxytocin in Post-term Pregnancy,"
Med Pregl, 1998, 51(9-10):419-26.
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