propofol injectable emulsion (contains edetate disodium) Description | Pfizer Medical Information - US

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DESCRIPTION

Propofol Injectable Emulsion, USP is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration. Propofol is chemically described as 2,6-diisopropylphenol. The structural formula is:

Chemical Structure

C12H18O M.W. 178.27

Propofol is slightly soluble in water and, thus, is formulated in a white, oil-in-water emulsion. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. In addition to the active component, propofol, the formulation also contains soybean oil (100 mg/mL), glycerin (22.5 mg/mL), egg phospholipid (12 mg/mL); and edetate disodium (0.005%); with sodium hydroxide to adjust pH. Propofol Injectable Emulsion, USP is isotonic and has a pH of 6 to 8.5.

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

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INDICATIONS AND USAGE

Propofol Injectable Emulsion is an intravenous general anesthetic and sedation drug that can be used as described in the table below.

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DOSAGE AND ADMINISTRATION

Propofol blood concentrations at steady-state are generally proportional to infusion rates, especially in individual patients. Undesirable effects such as cardiorespiratory depression are likely to...

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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 contraindicated...

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WARNINGS

Use of Propofol Injectable Emulsion has been associated with both fatal and life-threatening anaphylactic and anaphylactoid reactions.

For general anesthesia or monitored anesthesia care (MAC) sedation,...

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ADVERSE REACTIONS

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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DRUG ABUSE AND DEPENDENCE

There are reports of the abuse of propofol for recreational and other improper purposes, which have resulted in fatalities and other injuries. Instances of self-administration of Propofol Injectable...

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OVERDOSAGE

If overdosage occurs, Propofol Injectable Emulsion administration should be discontinued immediately. Overdosage is likely to cause cardiorespiratory depression. Respiratory depression should be treated by...

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DESCRIPTION

Propofol Injectable Emulsion, USP is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration. Propofol is chemically described as 2,6-diisopropylphenol. The...

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CLINICAL PHARMACOLOGY

General

Propofol Injectable Emulsion is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of...

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ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY

Published studies in animals demonstrate that the use of anesthetic agents during the period of rapid brain growth or synaptogenesis results in widespread neuronal and oligodendrocyte...

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HOW SUPPLIED

Propofol Injectable Emulsion, USP is available as follows:

Propofol Injectable Emulsion is an isotonic white to almost white homogeneous emulsion containing 10 mg/mL of Propofol drug substance.

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For Intravenous Administration

Rx only

Strict aseptic technique must always be maintained during handling. Propofol...

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Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, 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 this 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.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at https://vaers.hhs.gov or call (800) 822-7967.