Indigotindisulfonate Sodium

5 WARNINGS AND PRECAUTIONS Cardiovascular Reactions: Severe or life-threatening cardiovascular reactions including cardiac arrest, arrhythmia, asystole, atrioventricular block second degree, hypotension, elevation in blood pressure, bradycardia, and tachycardia have been reported. Closely monitor blood pressure and cardiac rhythm during and following the BLUDIGO injection. Interrupt administration if reactions are observed. ( 5.1 ) Hypersensitivity Reactions: Serious anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, or erythema have been reported. Monitor patients for anaphylactic reactions and have emergency equipment and trained personnel readily available. ( 5.2 ) Interference with Oximetry Measurements: Anesthesiologists should be aware of the potential for artifactual reduction in SpO 2 when anesthetized patients are administered BLUDIGO. ( 5.3 ) 5.1 Cardiovascular Reactions Severe or life-threatening cardiovascular reactions including cardiac arrest, arrhythmia, asystole, second degree atrioventricular block, hypotension, elevation in blood pressure, bradycardia, and tachycardia have been reported generally within 60 minutes following administration of indigotindisulfonate sodium injection products and required urgent intervention [see Adverse Reactions ( 6.2 )]. Indigotindisulfonate may cause vasoconstriction by interference with vasodilation mediated by nitric oxide dependent mechanisms and by direct vasoconstriction. Indigotindisulfonate may also cause hypotension. Patients with hypertension, heart rate and conduction disorders, or medications causing bradycardia may be at increased risk for elevated blood pressure, hypotension, and bradycardia. Closely monitor blood pressure and cardiac rhythm during and following the injection of BLUDIGO. Interrupt administration if reactions are observed. 5.2 Hypersensitivity Reactions Serious anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, or erythema have been reported with the use of indigotindisulfonate sodium injection products [see Adverse Reactions ( 6.2 )] . BLUDIGO is contraindicated in patients with known hypersensitivity to indigotindisulfonate [see Contraindications ( 4 )] . Monitor patients for anaphylactic reactions and have emergency equipment and trained personnel readily available. 5.3 Interference with Oximetry Measurements Indigotindisulfonate has been reported to interfere with light absorption and transiently interfere with pulse oximetric methods. Anesthesiologists should be aware of the potential for artifactual reduction in SpO 2 when anesthetized patients are administered BLUDIGO.