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Prepidil

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Prepidil

Prepidil

WARNINGS

FOR HOSPITAL USE ONLY

Dinoprostone, as with other potent oxytocic agents, should be used only with strict adherence to recommended dosages. Dinoprostone should be administered by physicians in a hospital that can provide immediate intensive care and acute surgical facilities.

Women aged 30 years or older, those with complications during pregnancy and those with a gestational age over 40 weeks have been shown to have an increased risk of post partum disseminated intravascular coagulation. In addition, these factors may further increase the risk associated with labor induction (see ADVERSE REACTIONS, Postmarketing surveillance). Therefore, in these women, use of dinoprostone should be undertaken with caution. Measures should be applied to detect as soon as possible an evolving fibrinolysis in the immediate post-partum phase.

The Clinician should be alert that the intracervical placement of dinoprostone gel may result in inadvertent disruption and subsequent embolization of antigenic tissue causing in rare circumstances the development of Anaphylactoid Syndrome of Pregnancy (Amniotic Fluid Embolism).

PRECAUTIONS

General Precautions

During use, uterine activity, fetal status, and character of the cervix (dilation and effacement) should be carefully monitored either by auscultation or electronic fetal monitoring to detect possible evidence of undesired responses, e.g., hypertonus, sustained uterine contractility, or fetal distress. In cases where there is a history of hypertonic uterine contractility or tetanic uterine contractions, it is recommended that uterine activity and the state of the fetus should be continuously monitored. The possibility of uterine rupture should be borne in mind when high-tone myometrial contractions are sustained. Feto-pelvic relationships should be carefully evaluated before use of PREPIDIL Gel (see CONTRAINDICATIONS).

Caution should be exercised in administration of PREPIDIL (dinoprostone cervical gel) Gel in patients with:

  • asthma or history of asthma
  • glaucoma or raised intraocular pressure

Caution should be taken so as not to administer PREPIDIL (dinoprostone cervical gel) Gel above the level of the internal os. Careful vaginal examination will reveal the degree of effacement which will regulate the size of the shielded endocervical catheter to be used. That is, the 20 mm endocervical catheter should be used if no effacement is present, and the 10 mm catheter should be used if the cervix is 50% effaced. Placement of PREPIDIL (dinoprostone cervical gel) Gel into the extra-amniotic space has been associated with uterine hyperstimulation.

As PREPIDIL (dinoprostone cervical gel) Gel is extensively metabolized in the lung, liver, and kidney, and the major route of elimination is the kidney, PREPIDIL (dinoprostone cervical gel) Gel should be used with caution in patients with renal and hepatic dysfunction.

Patients With Ruptured Membranes

Caution should be exercised in the administration of PREPIDIL (dinoprostone cervical gel) Gel in patients with ruptured membranes. The safety of use of PREPIDIL (dinoprostone cervical gel) Gel in these patients has not been determined.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenic bioassay studies have not been conducted in animals with PREPIDIL (dinoprostone cervical gel) Gel due to the limited indications for use and short duration of administration. No evidence of mutagenicity was observed in the Micronucleus Test or Ames Assay.

Pregnancy, Teratogenic Effects

Pregnancy Category C

Prostaglandin E2 produced an increase in skeletal anomalies in rats and rabbits. No effect would be expected clinically, when used as indicated, since PREPIDIL (dinoprostone cervical gel) Gel is administered after the period of organogenesis. PREPIDIL (dinoprostone cervical gel) Gel has been shown to be embryotoxic in rats and rabbits, and any dose that produces sustained increased uterine tone could put the embryo or fetus at risk. See statements under General PRECAUTIONS.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Last reviewed on RxList: 2/26/2010
This monograph has been modified to include the generic and brand name in many instances.

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