Propofol
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
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Black Box Warning
|
FOR INTRAVENOUS ADMINISTRATION
See full prescribing information for complete Boxed Warning.
Rx only
Strict aseptic technique must always be maintained during handling. DIPRIVAN Injectable Emulsion is a single access parenteral product (single patient infusion vial) which contains 0.005% disodium edetate (EDTA) to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental extrinsic contamination. However, DIPRIVAN Injectable Emulsion can still support the growth of microorganisms, as it is not an antimicrobially preserved product under USP standards. Do not use if contamination is suspected. Discard unused drug product as directed within the required time limits. There have been reports in which failure to use aseptic technique when handling DIPRIVAN 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, and HIV) from unsafe injection practices, and use of propofol vials intended for single use on multiple persons. DIPRIVAN Injectable Emulsion vials are never to be accessed more than once or used on more than one person. (See WARNINGS and DOSAGE AND ADMINISTRATION, Handling Procedures). |
Overview
Propofol is a general anesthetic that is FDA approved for the {{{indicationType}}} of general anesthesia,monitored anesthesia care sedation, sedation for a mechanically ventilated patient, intensive care unit. There is a Black Box Warning for this drug as shown here. Common adverse reactions include dermatologic: injection site pain (up to 28.5% ), gastrointestinal: nausea and vomiting (2% to 2.5% ), musculoskeletal: involuntary movement, muscle (17%).
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
General anesthesia: (healthy adults less than 55 years of age) induction, 40 mg IV every 10 seconds until induction onset (2 to 2.5 mg/kg); dose varies for age and surgery type [3] General anesthesia: (healthy adults less than 55 years of age) maintenance, 100 to 200 mcg/kg/min IV infusion (6 to 12 mg/kg/hr); dose varies for age and surgery type [3] General anesthesia: (healthy adults less than 55 years of age) maintenance, 20 to 50 mg increments IV bolus as needed [3] Migraine: 10 mg slow IV push, every 5 to 10 minutes, MAX 80 mg; mixed with 1 mL lidocaine 2% per 10 mL of propofol 1%; infuse at rate of 1 mL/10 sec [4] Monitored anesthesia care sedation: (healthy adults less than 55 years of age) MAC initiation: 100 to 150 mcg/kg/min (6 to 9 mg/kg/hr) IV infusion or 0.5 mg/kg slow IV injection for 3 to 5 min followed immediately by maintenance infusion [3] Monitored anesthesia care sedation: (healthy adults less than 55 years of age) MAC maintenance: 25 to 75 mcg/kg/min (1.5 to 4.5 mg/kg/hr) IV infusion or 10 to 20 mg incremental IV bolus doses [3] Procedural sedation: 1 mg/kg IV followed by 0.5 mg/kg every 3 to 5 minutes as needed for sedation [5][6][7][8] Sedation for a mechanically ventilated patient, Intensive care unit: 5 mcg/kg/min (0.3 mg/kg/hr) IV infusion for 5 min then titrate in 5 to 10 mcg/kg/min (0.3 to 0.6 mg/kg/hr) increments to achieve desired level of sedation; allow minimum of 5 min between dose adjustments; usual maintenance rates 5 to 50 mcg/kg/min (0.3 to 3 mg/kg/hr) or higher [3]
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Propofol in adult patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Propofol in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Propofol FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Propofol in pediatric patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Propofol in pediatric patients.
Contraindications
There is limited information regarding Propofol Contraindications in the drug label.
Warnings
|
FOR INTRAVENOUS ADMINISTRATION
See full prescribing information for complete Boxed Warning.
Rx only
Strict aseptic technique must always be maintained during handling. DIPRIVAN Injectable Emulsion is a single access parenteral product (single patient infusion vial) which contains 0.005% disodium edetate (EDTA) to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental extrinsic contamination. However, DIPRIVAN Injectable Emulsion can still support the growth of microorganisms, as it is not an antimicrobially preserved product under USP standards. Do not use if contamination is suspected. Discard unused drug product as directed within the required time limits. There have been reports in which failure to use aseptic technique when handling DIPRIVAN 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, and HIV) from unsafe injection practices, and use of propofol vials intended for single use on multiple persons. DIPRIVAN Injectable Emulsion vials are never to be accessed more than once or used on more than one person. (See WARNINGS and DOSAGE AND ADMINISTRATION, Handling Procedures). |
There is limited information regarding Propofol Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
General
Adverse event information is derived from controlled clinical trials and worldwide marketing experience. 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.
Anesthesia and MAC Sedation in Adults
The following estimates of adverse events for DIPRIVAN Injectable Emulsion include data from clinical trials in general anesthesia/MAC sedation (N=2889 adult patients). The adverse events listed below as probably causally related are those events in which the actual incidence rate in patients treated with DIPRIVAN 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 DIPRIVAN Injectable Emulsion during anesthesia (see below). During MAC sedation clinical trials, significant respiratory events included cough, upper airway obstruction, apnea, hypoventilation, and dyspnea.
Anesthesia in Pediatric Patients
Generally the adverse experience profile from reports of 506 DIPRIVAN Injectable Emulsion pediatric patients from 6 days through 16 years of age in the US/Canadian anesthesia clinical trials is similar to the profile established with DIPRIVAN Injectable Emulsion during anesthesia in adults (see Pediatric percentages [Peds %] below). Although not reported as an adverse event in clinical trials, apnea is frequently observed in pediatric patients.
ICU Sedation in Adults
The following estimates of adverse events include data from clinical trials in ICU sedation (N=159 adult patients). Probably related incidence rates for ICU sedation were determined by individual case report form review. Probable causality was based upon an apparent dose response relationship and/or positive responses to rechallenge. In many instances the presence of concomitant disease and concomitant therapy made the causal relationship unknown. Therefore, incidence rates for ICU sedation generally represent estimates of the percentage of clinical trial patients which appeared to have a probable causal relationship.
Incidence greater than 1% - Probably Causally Related
Events without an * or % had an incidence of 1% to 3%
- Incidence of events 3% to 10%
Postmarketing Experience
There is limited information regarding Propofol Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Propofol Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Propofol in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Propofol in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Propofol during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Propofol in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Propofol in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Propofol in geriatric settings.
Gender
There is no FDA guidance on the use of Propofol with respect to specific gender populations.
Race
There is no FDA guidance on the use of Propofol with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Propofol in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Propofol in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Propofol in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Propofol in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Propofol Administration in the drug label.
Monitoring
There is limited information regarding Propofol Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Propofol and IV administrations.
Overdosage
If overdosage occurs, DIPRIVAN Injectable Emulsion administration should be discontinued immediately. Overdosage is likely to cause cardiorespiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen. Cardiovascular depression may require repositioning of the patient by raising the patient's legs, increasing the flow rate of intravenous fluids, and administering pressor agents and/or anticholinergic agents.
Pharmacology
There is limited information regarding Propofol Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Propofol Mechanism of Action in the drug label.
Structure
There is limited information regarding Propofol Structure in the drug label.
Pharmacodynamics
There is limited information regarding Propofol Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Propofol Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Propofol Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Propofol Clinical Studies in the drug label.
How Supplied
There is limited information regarding Propofol How Supplied in the drug label.
Storage
There is limited information regarding Propofol Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Propofol Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Propofol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Propofol Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Propofol Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.