The dosage of dinoprostone in the vaginal insert is 10 mg designed to be released at approximately 0.3 mg/hour
over a 12 hour period. Cervidil® can be removed as needed by the healthcare provider in the setting of an acute
event during labor induction. Cervidil should be removed upon onset of active labor, 12 hours after insertion, or whichever comes first.
Cervidil is supplied in an individually wrapped aluminium/polyethylene package with a "tear mark" on one side
of the package. The package should only be opened by tearing the aluminium package along the tear mark. The package should never
be opened with scissors or other sharp objects which may compromise or cut the knitted polyester pouch that serves as the retrieval
system for the polymeric slab.
Cervidil must be kept frozen until use. It should be stored in a freezer between -20°C and -10°C (-4°F and 14°F).
Cervidil is packed in foil and is stable when stored in a freezer for a period of three years.
Cervidil should be administered only by trained obstetrical personnel in a hospital setting with appropriate
obstetrical care facilities. There is no need for previous warming of the product. A minimal amount of water-soluble lubricant may be
used to assist insertion of Cervidil. Care should be taken not to permit excess contact or coating with the lubricant which could prevent
optimal swelling and release of dinoprostone from the vaginal insert. (Figure 2)
Cervidil is administered by placing one unit transversely in the posterior fornix of the vagina immediately after
removal from its foil package. The insertion of the vaginal insert does not require sterile conditions. The vaginal insert must not be
used without its retrieval system. (Figure 3)
Patients should remain in the recumbent position for 2 hours following insertion, but thereafter may be ambulatory.
If the patient is ambulatory, care should be taken to ensure the vaginal insert remains in place. The insert should be removed:
- 12 hours after insertion or upon onset of active labor, or whichever comes first
- Prior to amniotomy
- With any evidence of:
- Uterine hyperstimulation
- Sustained uterine contractions
- Fetal distress
- Other fetal or maternal adverse reactions
Upon removal of Cervidil, it is essential to ensure that the slab has been removed, as it will continue
delivering the active ingredient. This is accomplished by visualizing the knitted polyester retrieval system and confirming that it
contains the slab. In the rare instance that the slab is not contained within the polyester retrieval system, a vaginal exam should
be performed to remove the slab.
Cervidil is contraindicated in patients already receiving intravenous oxytocic drugs. Since prostaglandins potentiate
the effect of oxytocin, Cervidil must be removed before oxytocin administration is initiated and the patient’s uterine activity carefully
monitored for uterine hyperstimulation. A dosing interval of at least 30 minutes is recommended for the sequential use of oxytocin
following the removal of the dinoprostone vaginal insert.
Cervidil Vaginal Insert (dinoprostone, 10 mg) is indicated for the initiation and/or
continuation of cervical ripening in patients at or near term in whom there is a
medical or obstetrical indication for the induction of labor.
Cervidil is for hospital use only and should be administered only by trained obstetrical
personnel in a hospital setting with appropriate obstetrical care facilities.
Cervidil is designed to be released at approximately 0.3 mg/hour over a 12-hour
period. Cervidil should be removed upon onset of active labor or 12 hours after
Upon removal of Cervidil, it is essential to ensure that the slab has been removed
as it may have separated from the knitted polyester retrieval system and will continue
delivering the active ingredient.