Black Box Warning

WARNING: PROPENSITY FOR ABUSE AND DEPENDENCE Propofol contains no preservatives and supports rapid microbial growth. Strict aseptic technique must always be maintained during its handling and administration. Propofol should be used only in a continuously monitored environment by trained personnel. Propofol should not be administered by the person(s) receiving the drug. PRIS (Propofol Infusion Syndrome) is a rare, but serious, sometimes fatal, metabolic disturbance that has been reported in patients receiving propofol, especially in those with serious infections or other significant comorbid conditions and who received propofol for extended periods at doses greater than 4 mg/kg/hr. The syndrome has been characterized by bradycardia or other cardiac arrhythmias, metabolic acidosis, rhabdomyolysis, hyperlipidemia, fatty liver, hepatomegaly, acute renal failure, hyperkalemia, and/or cardiac failure. The use of general anesthesia for minor procedures in outpatients has been associated with an increased risk of death, heart attack, and stroke. Although these events are rare, they are more common in older patients with underlying heart or lung disease.