Adult and Pediatric Patients

A lower induction dose and a slower maintenance rate of administration should be used in elderly, debilitated, or ASA-PS III or IV patients (see DOSAGE AND ADMINISTRATION). Patients should be continuously monitored for early signs of hypotension and/or bradycardia. Apnea requiring ventilatory support often occurs during induction and may persist for more than 60 seconds. Propofol Injectable Emulsion use requires caution when administered to patients with disorders of lipid metabolism such as primary hyperlipoproteinemia, diabetic hyperlipemia, and pancreatitis.

Very rarely the use of Propofol Injectable Emulsion may be associated with the development of a period of postoperative unconsciousness which may be accompanied by an increase in muscle tone. This may or may not be preceded by a brief period of wakefulness. Recovery is spontaneous. 

When Propofol Injectable Emulsion is administered to an epileptic patient, there is a risk of seizure during the recovery phase. 

Attention should be paid to minimize pain on administration of Propofol Injectable Emulsion. Transient local pain can be minimized if the larger veins of the forearm or antecubital fossa are used. Pain during intravenous injection may also be reduced by prior injection of IV lidocaine (1 mL of a 1% solution). Pain on injection occurred frequently in pediatric patients (45%) when a small vein of the hand was utilized without lidocaine pretreatment. With lidocaine pretreatment or when antecubital veins were utilized, pain was minimal (incidence less than 10%) and well-tolerated. There have been reports in the literature indicating that the addition of lidocaine to Propofol Injectable Emulsion in quantities greater than 20 mg lidocaine/200 mg Propofol Injectable Emulsion results in instability of the emulsion which is associated with increases in globule sizes over time and (in rat studies) a reduction in anesthetic potency. Therefore, it is recommended that lidocaine be administered prior to Propofol Injectable Emulsion administration or that it be added to Propofol Injectable Emulsion immediately before administration and in quantities not exceeding 20 mg lidocaine/200 mg propofol. 

Venous sequelae, i.e., phlebitis or thrombosis, have been reported rarely (less than 1%). In two clinical studies using dedicated intravenous catheters, no instances of venous sequelae were observed up to 14 days following induction. 

Intra-arterial injection in animals did not induce local tissue effects. Accidental intra-arterial injection has been reported in patients, and, other than pain, there were no major sequelae. 

Intentional injection into subcutaneous or perivascular tissues of animals caused minimal tissue reaction. During the postmarketing period, there have been rare reports of local pain, swelling, blisters, and/or tissue necrosis following accidental extravasation of Propofol Injectable Emulsion. 

Perioperative myoclonia, rarely including convulsions and opisthotonos, has occurred in association with Propofol Injectable Emulsion administration. 

Clinical features of anaphylaxis, including angioedema, bronchospasm, erythema, and hypotension, occur rarely following Propofol Injectable Emulsion administration. 

There have been rare reports of pulmonary edema in temporal relationship to the administration of Propofol Injectable Emulsion, although a causal relationship is unknown. 

Rarely, cases of unexplained postoperative pancreatitis (requiring hospital admission) have been reported after anesthesia in which Propofol Injectable Emulsion was one of the induction agents used. Due to a variety of confounding factors in these cases, including concomitant medications, a causal relationship to Propofol Injectable Emulsion is unclear. 

Propofol Injectable Emulsion has no vagolytic activity. Reports of bradycardia, asystole, and rarely, cardiac arrest have been associated with Propofol Injectable Emulsion. Pediatric patients are susceptible to this effect, particularly when fentanyl is given concomitantly. The intravenous administration of anticholinergic agents (e.g., atropine or glycopyrrolate) should be considered to modify potential increases in vagal tone due to concomitant agents (e.g., succinylcholine) or surgical stimuli.