dinoprostone

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

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 ). 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 institute symptomatic and supportive therapy, as needed.