Propofol: Difference between revisions

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|offLabelAdultGuideSupport=There is limited information about <i>Off-Label Guideline-Supported Use</i> of Propofol in adult patients.
|offLabelAdultGuideSupport=There is limited information about <i>Off-Label Guideline-Supported Use</i> of Propofol in adult patients.
|offLabelAdultNoGuideSupport=There is limited information about <i>Off-Label Non–Guideline-Supported Use</i> of Propofol in adult patients.
|offLabelAdultNoGuideSupport=There is limited information about <i>Off-Label Non–Guideline-Supported Use</i> of Propofol in adult patients.
|fdaLIADPed=General anesthesia: (3 to 16 years) induction, 2.5 to 3.5 mg/kg IV over 20 to 30 seconds [3]
General anesthesia: (2 months to 16 years) maintenance, 125 to 300 mcg/kg/min IV (7.5 to 18 mg/kg/hr) [3]
Procedural sedation: 1 mg/kg IV followed by 0.5 mg/kg every 3 to 5 minutes as needed for sedation [9][10][11
|offLabelPedGuideSupport=There is limited information about <i>Off-Label Guideline-Supported Use</i> of Propofol in pediatric patients.
|offLabelPedGuideSupport=There is limited information about <i>Off-Label Guideline-Supported Use</i> of Propofol in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information about <i>Off-Label Non–Guideline-Supported Use</i> of Propofol in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information about <i>Off-Label Non–Guideline-Supported Use</i> of Propofol in pediatric patients.
|warnings=Use of DIPRIVAN Injectable Emulsion has been associated with both fatal and life-threatening anaphylactic and anaphylactoid reactions.
|clinicalTrials=General


For general anesthesia or monitored anesthesia care (MAC) sedation, DIPRIVAN Injectable Emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure.  Sedated patients should be continuously monitored, and facilities for maintenance of a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available.  Patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation.  These cardiorespiratory effects are more likely to occur following rapid bolus administration, especially in the elderly, debilitated, or ASA-PS III or IV patients.
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.


For sedation of intubated, mechanically ventilated patients in the Intensive Care Unit (ICU), DIPRIVAN Injectable Emulsion should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management.
Anesthesia and MAC Sedation in Adults


Use of DIPRIVAN Injectable Emulsion infusions for both adult and pediatric ICU sedation has been associated with a constellation of metabolic derangements and organ system failures, referred to as Propofol Infusion Syndrome, that have resulted in death.  The syndrome is characterized by severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, renal failure, ECG changes* and/or cardiac failure.  The following appear to be major risk factors for the development of these events: decreased oxygen delivery to tissues; serious neurological injury and/or sepsis; high dosages of one or more of the following pharmacological agents: vasoconstrictors, steroids, inotropes and/or prolonged, high-dose infusions of propofol (> 5 mg/kg/h for > 48h).  The syndrome has also been reported following large-dose, short-term infusions during surgical anesthesia.  In the setting of prolonged need for sedation, increasing propofol dose requirements to maintain a constant level of sedation, or onset of metabolic acidosis during administration of a propofol infusion, consideration should be given to using alternative means of sedation.
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.


*Coved ST segment elevation (similar to ECG changes of the Brugada syndrome).
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.


Abrupt discontinuation of DIPRIVAN Injectable Emulsion prior to weaning or for daily evaluation of sedation levels should be avoided.  This may result in rapid awakening with associated anxiety, agitation, and resistance to mechanical ventilation.  Infusions of DIPRIVAN Injectable Emulsion should be adjusted to maintain a light level of sedation through the weaning process or evaluation of sedation level (see PRECAUTIONS).
Anesthesia in Pediatric Patients


DIPRIVAN Injectable Emulsion should not be coadministered through the same IV catheter with blood or plasma because compatibility has not been established.  In vitro tests have shown that aggregates of the globular component of the emulsion vehicle have occurred with blood/plasma/serum from humans and animals.  The clinical significance of these findings is not known.
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.


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 death.  Do not use if contamination is suspected.  Discard unused drug product as directed within the required time limits (see DOSAGE AND ADMINISTRATION, Handling Procedures).
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.
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 vial is never to be accessed more than once or used on more than one person.
 
                    Incidence greater than 1% - Probably Causally Related
[[File:FILENAME.jpg|thumb|none|400px|left|This image is provided by the National Library of Medicine.]]
 
Events without an * or % had an incidence of 1% to 3%
 
*Incidence of events 3% to 10%
 
[[File:FILENAME.jpg|thumb|none|400px|left|This image is provided by the National Library of Medicine.]]
[[File:FILENAME.jpg|thumb|none|400px|left|This image is provided by the National Library of Medicine.]]
                   
|alcohol=Alcohol-Propofol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=Alcohol-Propofol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
}}
}}

Revision as of 17:37, 24 June 2014

Propofol
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

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
File:FILENAME.jpg
This image is provided by the National Library of Medicine.

Events without an * or % had an incidence of 1% to 3%

  • Incidence of events 3% to 10%
File:FILENAME.jpg
This image is provided by the National Library of Medicine.
File:FILENAME.jpg
This image is provided by the National Library of Medicine.

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

There is limited information regarding Propofol overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

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

{{#ask: Page Name::Propofol |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Propofol |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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.

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