Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling: Hypersensitivity reaction [see Warnings and Precautions ( 5.1 )] Hypotension and/or bradycardia [see Warnings and Precautions ( 5.4 )] Propofol Infusion Syndrome [see Warnings and Precautions ( 5.9 )] In the description below, rates of the more common events represent US/Canadian clinical study results.
Less frequent events are also derived from publications and marketing experience in over 8 million patients;
there are insufficient data to support an accurate estimate of their incidence rates.
These studies were conducted using a variety of premedicants, varying lengths of surgical/diagnostic procedures, and various other anesthetic/sedative agents.
Most adverse events were mild and transient.
Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Anesthesia and MAC Sedation in Adults The following estimates of adverse events for propofol injectable emulsion include data from clinical trials in general anesthesia/MAC sedation (N=2,889 adult patients).
The adverse events listed below as probably causally related are those events in which the actual incidence rate in patients treated with propofol injectable emulsion was greater than the comparator incidence rate in these trials.
Therefore, incidence rates for anesthesia and MAC sedation in adults generally represent estimates of the percentage of clinical trial patients which appeared to have probable causal relationship.
The adverse experience profile from reports of 150 patients in the MAC sedation clinical trials is similar to the profile established with propofol injectable emulsion during anesthesia (see Table 3 below).
5 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.
Like all medications, Propofol can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: