1 INDICATIONS AND USAGE Sodium nitroprusside is a direct acting vasodilator indicated for: • Immediate reduction of blood pressure ( 1.1 ) • Producing controlled hypotension to reduce bleeding during surgery.

( 1.2 ) • Treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure.

( 1.3 ) 1.1 Immediate Reduction of Blood Pressure Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises.

1.2 Induction and Maintenance of Controlled Hypotension Sodium nitroprusside indicated for induction and maintenance of controlled hypotension in adults and children during surgery, to reduce bleeding.

1.3 Treatment of Acute Heart Failure Sodium nitroprusside is indicated for the treatment of acute heart failure to reduce, left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure.

6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: • Hypotension [see Warnings and Precautions ( 5.1 )] • Cyanide Toxicity [see Warnings and Precautions ( 5.2 )] • Thiocyanate Toxicity [see Warnings and Precautions ( 5.3 )] • Methemoglobinemia [see Warnings and Precautions ( 5.4 )] • Increased Intracranial Pressure [see Warnings and Precautions ( 5.5 )] • Anemia and Hypovolemia [see Warnings and Precautions ( 5.6 )] Less common adverse reactions include: Cardiovascular: Bradycardia, electrocardiographic changes, tachycardia, palpitations, retrosternal discomfort Dermatologic: Rash Endocrine: Hypothyroidism Gastrointestinal: Ileus, nausea, abdominal pain Hematologic: Decreased platelet aggregation Musculoskelatal: Muscle twitching Neurologic: Increased intracranial pressure, dizziness, headache Miscellaneous: Flushing, diaphoresis, venous streaking, irritation at the infusion site Most common adverse reactions are hypotension and cyanide toxicity ( 6 ).

To report SUSPECTED ADVERSE REACTIONS, Contact Exela Pharma Sciences, LLC at 1-888-451-4321 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.