1 INDICATIONS AND USAGE
Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for:
- Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age
- Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age
- Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients
- Sedation for Adult Patients in Combination with Regional Anesthesia
- Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients
Limitations of Use
Propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see Pediatric Use (8.4)].
Safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for MAC sedation in the pediatric population; therefore, it is not recommended for this use [see Pediatric Use (8.4)].
Propofol injectable emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established [see Pediatric Use (8.4)].