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warnings
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.
ADVERSE REACTIONS PREPIDIL Gel is generally well-tolerated. In controlled trials, in which 1731 women were entered, the following events were reported at an occurrence of ≥ 1%: Adverse Reaction PGE 2 (N = 884) Control placebo gel or no treatment (N = 847) Maternal N (%) N (%) Uterine contractile abnormality 58 (6.6) 34 (4.0) Any gastrointestinal effect 50 (5.7) 22 (2.6) Back pain 27 (3.1) 0 (0) Warm feeling in vagina 13 (1.5) 0 (0) Fever 12 (1.4) 10 (1.2) Fetal Any fetal heart rate abnormality 150 (17.0) 123 (14.5) Bradycardia 36 (4.1) 26 (3.1) Deceleration Late 25 (2.8) 18 (2.1) Variable 38 (4.3) 29 (3.4) Unspecified 19 (2.1) 19 (2.2) In addition, in other trials amnionitis and intrauterine fetal sepsis have been associated with extra-amniotic intrauterine administration of PGE 2 . Uterine rupture has been reported in association with the use of PREPIDIL Gel intracervically. Additional events reported in the literature, associated by the authors with the use of PREPIDIL Gel, included premature rupture of membranes, fetal depression (1 min Apgar < 7), and fetal acidosis (umbilical artery pH < 7.15). Post-marketing surveillance Blood and lymphatic system disorders An increased risk of post-partum disseminated intravascular coagulation has been described in patients whose labor was induced by pharmacological means, either with dinoprostone or oxytocin (see WARNINGS ) . The frequency of this adverse event, however, appears to be rare (<1 per 1,000 labors). Immune system disorders Hypersensitivity reactions (e.g., Anaphylactic reaction, Anaphylactic shock, Anaphylactoid reaction).