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propofol injectable emulsion (contains benzyl alcohol)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
propofol injectable emulsion (contains benzyl alcohol) Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for:
- •
- Induction of General Anesthesia for Patients Greater than or Equal to 3 Years...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Information
Parenteral drug products should be inspected visually for particulate matter and...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Propofol Injectable Emulsion, USP is available in single-patient use vials as follows:
1 g of propofol per 100 mL of an oil-in-water emulsion (10 mg per mL), in a 100 mL vial
200 mg...
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Contraindications
4 CONTRAINDICATIONS
Propofol injectable emulsion is contraindicated in patients with a known hypersensitivity to propofol or any of propofol injectable emulsion components.
Propofol injectable emulsion is...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Anaphylactic and Anaphylactoid Reactions
Use of propofol injectable emulsion has been associated with both fatal and life threatening...
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Adverse Reactions
6 ADVERSE REACTIONS
The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling:
- •
- Hypersensitivity reaction [see...
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Drug Interactions
7 DRUG INTERACTIONS
Opioids and Sedatives
The induction dose requirements of propofol injectable emulsion may be reduced in patients with intramuscular or intravenous premedication,...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Data from...
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Drug Abuse and Dependence
9 DRUG ABUSE AND DEPENDENCE
9.2 Abuse
There are reports of the abuse of propofol for recreational and other improper purposes, which have resulted in fatalities and...
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Overdosage
10 OVERDOSAGE
10.1 Symptoms
Overdosage is likely to cause cardiorespiratory depression.
10.2...
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Description
11 DESCRIPTION
Propofol Injectable Emulsion, USP is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration. The structural formula is:
...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
Propofol injectable emulsion is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. Intravenous injection of a therapeutic dose of...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Pediatric Anesthesia
Propofol injectable emulsion was studied in clinical trials which included cardiac surgical...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Propofol Injectable Emulsion, USP is supplied as follows:
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Medication Guide
17 PATIENT COUNSELING INFORMATION
17.1 Impaired Mental Alertness
Advise patients that performance of activities requiring mental alertness, such as operating a motor...
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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.