Operol Warnings

Use of Propofol injectable emulsion has been associated with both fatal and life-threatening anaphylactic and anaphylastoid reactions.
For general anesthesia or monitored anesthesia care (MAC) sedation, Propofol injectable emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. Sedated patients should be continuously monitored, and facilities for maintenance of a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available. Patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. These cardio respiratory effects are more likely to occur following rapid bolus administration, especially in the elderly, debilitated, or ASA-PSIII or IV patients.
For sedation of intubated mechanically ventilated patients in the Intensive Care Unit (ICU). Propofol injectable emulsion should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management.
Use of Propofol injectable emulsion infusions for both adult and pediatric ICU sedation has been associated with a constellation of metabolic derangements and organ system failures, referred to as Propofol Infusion Syndrome, that have resulted in death. The syndrome is characterized by severe metabolic acidosis, hyperkalemia, lipidemia, rhabdomyolysis, hepatomegaly, cardiac and renal failure. The syndrome is most often associated with prolonged, high-dose infusions (a 5 mg/kg/h for >48h) but has also been reported following large-dose, short-term infusions during surgical anesthesia. In the setting of prolonged need for sedation, increasing Propofol dose requirements to maintain a constant level of sedation, or onset of metabolic acidosis during administration of a Propofol infusion, consideration should be given to using alternative mensal sedation.
Abrupt discontinuation of Propofol injectable emulsion prior to weaning or for daily evaluation of sedation levels should be avoided. This may result in rapid awakening with associated anxiety, agitation, and resistance to mechanical ventilation. Infusions Propofol injectable emulsion should be adjusted to maintain a light level of sedation through the weaning process or evaluation of sedation level. There have been reports in which failure to use aseptic technique when handling Propofol Injectable emulsion was associated with microbial contamination of the product and with fever, infection, sepsis, other life-threatening illness, and death. Do not use if contamination is suspected. Discard unused portions as directed within the required time limits.
May cause extrapyramidal-like symptoms characterized as involuntary skeletal muscle movements in susceptible individual.