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
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See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
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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)
There is limited information regarding Propofol FDA-Labeled Indications and Dosage (Adult) in the drug label.
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
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See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
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There is limited information regarding Propofol Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Propofol Clinical Trials Experience in the drug label.
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
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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.