Propofol Injection 1% 10mg/mL 20mL Vial

Propofol injectable emulsion, USP is an IV general anesthetic and sedation drug that can be used as described in the table below.

Initiation and maintenance of Monitored Anesthesia Care (MAC) sedation Adults only

Combined sedation and regional anesthesia Adults only (see PRECAUTIONS)

Induction of General Anesthesia Patients greater than or equal to 3 years of age

Maintenance of General Anesthesia Patients greater than or equal to 2 months of age

Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patients Adults only

Safety, effectiveness and dosing guidelines for propofol injectable emulsion, USP have not been established for MAC Sedation in the pediatric population; therefore, it is not recommended for this use (see PRECAUTIONS, PEDIATRIC USE).

Propofol injectable emulsion, USP 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.

In the Intensive Care Unit (ICU), propofol injectable emulsion, USP can be administered to intubated, mechanically ventilated adult patients to provide continuous sedation and control of stress responses only by persons skilled in the medical management of critically ill patients and trained in cardiovascular resuscitation and airway management.

Propofol injectable emulsion, USP is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established (see PRECAUTIONS, PEDIATRIC USE).

Propofol injectable emulsion, USP is not recommended for obstetrics, including Cesarean section deliveries. Propofol injectable emulsion, USP crosses the placenta, and as with other general anesthetic agents, the administration of propofol injectable emulsion, USP may be associated with neonatal depression (see PRECAUTIONS).

Propofol injectable emulsion, USP is not recommended for use in nursing mothers because propofol has been reported to be excreted in human milk, and the effects of oral absorption of small amounts of propofol are not known (see PRECAUTIONS).