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propofol injectable emulsion (contains edetate disodium) Indications and Usage

INDICATIONS AND USAGE

Propofol Injectable Emulsion is an intravenous general anesthetic and sedation drug that can be used as described in the table below.

Table 3 Indications for Propofol Injectable Emulsion
IndicationApproved Patient Population
Initiation and maintenance of Monitored Anesthesia Care (MAC) sedationAdults only
Combined sedation and regional anesthesiaAdults only (see PRECAUTIONS)
Induction of General AnesthesiaPatients ≥ 3 years of age
Maintenance of General AnesthesiaPatients ≥ 2 months of age
Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patientsAdults only

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 PRECAUTIONS, Pediatric 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.

In the Intensive Care Unit (ICU), Propofol Injectable Emulsion 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 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 is not recommended for obstetrics, including Cesarean section deliveries. Propofol Injectable Emulsion crosses the placenta, and as with other general anesthetic agents, the administration of Propofol Injectable Emulsion may be associated with neonatal depression (see PRECAUTIONS).

Propofol Injectable Emulsion 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).

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