PROPOFOL- propofol injection, emulsion
Hospira, Inc.
PROPOFOL Injectable Emulsion Rx only
10 mg/mL
CONTAINS BENZYL ALCOHOL (See PRECAUTIONSsection.)
Fliptop Vial
FOR INTRAVENOUS ADMINISTRATION Shake Well Before Use
Strict aseptic technique must always be maintained during handling. Propofol injectable emulsion is a single-use parenteral product which contains benzyl alcohol 1.5 mg/mL and sodium benzoate 0.7 mg/mL to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental extrinsic contamination. However, propofol injectable emulsion can still support the growth of microorganisms as it is not an antimicrobially preserved product under USP standards. Accordingly, strict aseptic technique must still be adhered to. Do not use if contamination is suspected. Discard unused portions as directed within the required time limits (see DOSAGE AND ADMINISTRATION� Handling Procedures ). There have been reports in which failure to use aseptic technique when handling propofol injectable emulsion was associated with microbial contamination of the product and with fever, infection/sepsis, other life-threatening illness, and/or death.
There have been reports, in the literature and other public sources, of the transmission of bloodborne pathogens (such as Hepatitis B, Hepatitis C, HIV) from unsafe injection practices, and use of propofol vials intended for single use on multiple persons. Propofol injectable emulsion vials are never to be accessed more than once or used on more than one person.
DESCRIPTION
Propofol injectable emulsion is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration. Propofol is chemically described as 2,6-diisopropylphenol and has a molecular weight of 178.27.
Propofol is slightly soluble in water and, thus, is formulated in a white, oil-in-water emulsion. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6.0 to 8.5. In addition to the active component, propofol, the formulation also contains soybean oil (100 mg/mL), glycerol (22.5 mg/mL), egg lecithin (12 mg/mL), benzyl alcohol (1.5 mg/mL) and sodium benzoate (0.7 mg/mL) added. The pH is adjusted with sodium hydroxide. The propofol injectable emulsion is isotonic and has a pH of 6.0 to 8.5.
CLINICAL PHARMACOLOGY
General
Propofol is an intravenous sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation. Intravenous injection of a therapeutic dose of propofol induces hypnosis with minimal excitation, usually within 40 seconds from the start of injection (the time for one arm-brain circulation). As with other rapidly acting intravenous anesthetic agents, the half-time of the blood-brain equilibration is approximately 1 to 3 minutes, accounting for the rate of induction of anesthesia. The mechanism of action, like all general anesthetics, is poorly understood. However, propofol is thought to produce its sedative/anesthetic affects by the positive modulation of the inhibitory function of the neurotransmitter GABA through the ligand-gated GABAA receptors.
