HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Propofol Injectable Emulsion safely and effectively. See full prescribing information for Propofol Injectable Emulsion.
Propofol Injectable Emulsion, for intravenous use
Initial U.S. Approval: 1991
INDICATIONS AND USAGE
Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: (1)
• Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age (1)
• Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age (1)
• Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients (1)
• Sedation for Adult Patients in Combination with Regional Anesthesia (1)
• Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients (1)
Limitations of Use: (1)
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 (1)
MAC sedation in the pediatric population is not recommended (1)
Propofol Injectable Emulsion is not indicated for use in Pediatric ICU sedation (1)
DOSAGE AND ADMINISTRATION
See Full Prescribing Information for detailed dosing instructions. (2)
DOSAGE FORMS AND STRENGTHS
Injectable emulsion: 1 g per 100 mL (10 mg/mL), 200 mg per 20 mL (10 mg/mL), and 500 mg per 50 mL (10 mg/mL) Single-Patient Use Vials (3)
Known hypersensitivity to propofol, egg or soybean (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Serious and sometimes fatal reactions (5.1)
Microbial Contamination: Strict aseptic technique must be maintained during handling. Propofol Injectable Emulsion vials are never to be accessed more than once or used on more than one person. Administration should commence promptly and be completed within 12 hours after the vial has been opened. Discard unused drug product. Do not use if contamination is suspected (5.2)
Cardiovascular Depression: Cases of bradycardia, asystole, and cardiac arrest have been reported. Pediatric patients are susceptible to this effect, particularly when fentanyl is given concomitantly (5.4)
The most common adverse reactions >1% were bradycardia, arrhythmia, tachycardia, hypotension, hypertension, decreased cardiac output, movement, apnea, respiratory acidosis during weaning, rash, pruritus, burning/stinging or pain at injection site, and hyperlipemia (6)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
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