DINOPROSTONE Drug Interactions: What You Need to Know

INTERACTIONS Oxytocic Agents : May augment the activity of oxytocic agents; concomitant use of intravenous oxytocic agents is contraindicated ( 4 , 7.1 ). Remove vaginal insert at least 30 minutes before administering an oxytocic agent. ( 7.1 )

7.1 Oxytocic Agents CERVIDIL is contraindicated in patients receiving intravenous oxytocic agents because CERVIDIL may augment the activity of oxytocic agents. A dosing interval of at least 30 minutes is recommended for the sequential use of an oxytocic agent following the removal of CERVIDIL.

CERVIDIL is contraindicated in patients with: Known hypersensitivity to prostaglandins [see Adverse Reactions (6.2) ] Evidence or clinical suspicion of fetal distress where delivery is not imminent Unexplained vaginal bleeding in the current pregnancy Evidence or clinical suspicion of marked cephalopelvic disproportion Conditions for which induction of labor is contraindicated Conditions for which oxytocic drugs are contraindicated Previous cesarean section or other uterine surgery expected to affect uterine integrity (such as myomectomy) Conditions under which prolonged contraction of the uterus may be detrimental to fetal safety Concurrent use with intravenous oxytocic agents [see Warnings and Precautions (5.4) and Drug Interactions (7) ] Six or more previous term pregnancies CERVIDIL is contraindicated for: Known hypersensitivity to prostaglandins ( 4 ) Evidence or clinical suspicion of fetal distress, where delivery is not imminent ( 4 ) Unexplained vaginal bleeding in the current pregnancy ( 4 ) Evidence or clinical suspicion of marked cephalopelvic disproportion ( 4 ) Contraindication to induction of labor ( 4 ) Concurrent use with intravenous oxytocic agents ( 4 ) History of previous cesarean section or other uterine surgery (such as myomectomy) ( 4 ) Conditions under which prolonged contraction of the uterus may be detrimental to fetal safety. ( 4 ) Six or more previous term pregnancies ( 4 )

AND PRECAUTIONS Disseminated Intravascular Coagulation : Assess for evolving fibrinolysis in the immediate post-partum period. ( 5.2 )

Amniotic Fluid Embolism

Syndrome : Carefully monitor patients for clinical signs of hypotension, hypoxemia and respiratory failure, DIC, coma or seizures. Provide supportive care. ( 5.3 )

Uterine

Tachysystole and Uterine Hypersystole/Hypertonicity : Monitor uterine activity; remove vaginal insert. ( 5.4 ) History of Glaucoma : Consider non-prostaglandin cervical ripening procedures. ( 5.5 )

5.1 For Hospital Use Only CERVIDIL should be administered in a hospital setting with an obstetrical care facility.

5.2 Disseminated Intravascular Coagulation CERVIDIL should be used with caution in women at high risk of postpartum disseminated intravascular coagulation (DIC). Physiologic or pharmacologic induction of labor, including the use of CERVIDIL, is associated with an increased risk of DIC during the postpartum period. Women aged 30 years or older, those with complications during pregnancy and those with a gestational age over 40 weeks have an increased risk of DIC during the postpartum period. As soon as possible, assess for an evolving fibrinolysis in the immediate post-partum period. Therapy consisting of prompt removal of the source of procoagulant material, replacement of depleted clotting factors and, in some cases, anti-coagulation with heparin should be instituted promptly.

5.3 Amniotic Fluid Embolism Syndrome The use of dinoprostone-containing products, including CERVIDIL, can result in inadvertent disruption and subsequent embolization of antigenic tissue causing the development of Amniotic Fluid Embolism Syndrome, a rare and often fatal obstetric condition. Carefully monitor patients for clinical signs of Amniotic Fluid Embolism Syndrome including hypotension, hypoxemia and respiratory failure, DIC, coma or seizures and provide supportive care as needed.

5.4 Uterine Tachysystole and Uterine Hypersystole/Hypertonicity The use of CERVIDIL may cause uterine tachysystole with or without fetal heart rate changes (see Table 1 ). While using CERVIDIL, carefully monitor uterine activity, fetal status and the progression of cervical dilatation and effacement. Remove CERVIDIL with any evidence of uterine tachysystole, uterine hypersystole/hypertonicity, fetal distress, or if labor commences. CERVIDIL is contraindicated when prolonged contraction of the uterus is detrimental to fetal safety or uterine integrity, such as previous cesarean section or major uterine surgery, because of the risk of uterine rupture and obstetrical complications (e.g., need for hysterectomy and the occurrence of fetal or neonatal death). Prostaglandins, including CERVIDIL, may potentiate the effect of oxytocin <span class="opacity-50 text-xs">[see Drug Interactions (7) ]</span> . Remove CERVIDIL at least 30 minutes before administration of an oxytocic agent is initiated and continue to carefully monitor uterine activity. Remove CERVIDIL prior to amniotomy or following rupture of membranes because the higher vaginal pH that occurs with rupture of membranes may result in higher release rate of dinoprostone.

5.5 Glaucoma Prostaglandins, including CERVIDIL, can lead to raised intraocular pressure and constriction of pupils. Consider non-prostaglandin cervical ripening procedures in patients with Glaucoma.