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Diprivan

"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...

Diprivan

DIPRIVAN®
(propofol) Injectable Emulsion

FOR IV ADMINISTRATION

Diprivan

Strict aseptic technique must always be maintained during handling. Diprivan (propofol) Injectable Emulsion is a single-use parenteral product which contains 0.005% disodium edetate to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental extrinsic contamination. However, Diprivan (propofol) Injectable Emulsion can still support the growth of microorganisms, as it is not an antimicrobially preserved product under USP standards. Accordingly, strict aseptic technique must still be adhered to. Do not use if contamination is suspected. Discard unused portions as directed within the required time limits (see DOSAGE AND ADMINSTRATION, Handling Procedures). There have been reports in which failure to use aseptic technique when handling Diprivan (propofol) Injectable Emulsion was associated with microbial contamination of the product and with fever, infection/sepsis, other life-threatening illness, and/or death.

DRUG DESCRIPTION

DIPRIVAN® (propofol) Injectable Emulsion is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration. Propofol is chemically described as 2,6-diisopropylphenol and has a molecular weight of 178.27. The structural and molecular formulas are:

DIPRIVAN® (propofol)    Structural Formula Illustration

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 6-8.5. In addition to the active component, propofol, the formulation also contains soybean oil (100 mg/mL), glycerol (22.5 mg/mL), egg lecithin (12 mg/mL); and disodium edetate (0.005%); with sodium hydroxide to adjust pH. The DIPRIVAN (propofol) Injectable Emulsion is isotonic and has a pH of 7-8.5.

What are the possible side effects of propofol (Diprivan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • pain, swelling, blisters, or skin changes where the medicine was injected;
  • seizure (convulsions);
  • weak or shallow breathing; or
  • fast or slow heart rate.

Less serious side effects may include:

  • nausea;
  • cough;
  • slight burning or stinging around the IV needle;
  • mild itching or skin...

Read All Potential Side Effects and See Pictures of Diprivan »

Last reviewed on RxList: 10/25/2010
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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