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propofol injectable emulsion (contains edetate disodium)
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 edetate disodium) 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:
200 mg of propofol per 20 mL of an oil-in-water emulsion (10 mg per mL), in a 20 mL vial
500 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 randomized controlled trials, cohort studies and case series...
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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 Treatment...
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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
Long-term studies in animals...
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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 patients. Most patients...
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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 Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*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 or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety 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.