디노프로스톤

Gel is indicated for ripening an unfavorable cervix in pregnant women at or near term with a medical or obstetrical need for labor induction.

Endocervically administered PREPIDIL Gel is not recommended for the following: a. Patients in whom oxytocic drugs are generally contraindicated or where prolonged contractions of the uterus are considered inappropriate, such as: • cases with a history of cesarean section or major uterine surgery • cases in which cephalopelvic disproportion is present • cases in which there is a history of difficult labor and/or traumatic delivery • grand multiparae with six or more previous term pregnancies cases with non-vertex presentation • cases with hyperactive or hypertonic uterine patterns • cases of fetal distress where delivery is not imminent • in obstetric emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention b. Patients with hypersensitivity to prostaglandins or constituents of the gel (see WARNINGS and ADVERSE REACTIONS ). c. Patients with placenta previa or unexplained vaginal bleeding during this pregnancy. d. Patients for whom …

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 ). 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). There have been post-marketing reports of serious and life-threatening hypersensitivity reactions including anaphylaxis and angioedema with PREPIDIL Gel (dinoprostone). Onset of these reported reactions occurred within minutes to hours after initiation with PREPIDIL Gel (dinoprostone). If a hypersensitivity reaction is suspected, if possible remove PREPIDIL Gel (dinoprostone). Assess for other potential causes of the event, and …

5. Pregnancy Teratogenic Effects Prostaglandin E2 produced an increase in skeletal anomalies in rats and rabbits. No effect would be expected clinically, when used as indicated, since PREPIDIL Gel is administered after the period of organogenesis. PREPIDIL 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 .