HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 USAGEPropofol 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 ADMINISTRATIONSee Full Prescribing Information for detailed dosing instructions. (2) DOSAGE FORMS AND STRENGTHSInjectable 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) CONTRAINDICATIONSKnown hypersensitivity to propofol, egg or soybean (4) WARNINGS AND PRECAUTIONSHypersensitivity 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) ADVERSE REACTIONSThe 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. DRUG INTERACTIONSSee 17 for PATIENT COUNSELING INFORMATION. Revised: 2/2023 |
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
propofol injectable emulsion (contains benzyl alcohol) Highlights
Did you find an answer to your question?
Yes
No
Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.