Hospira Inc.
Product Description:Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Status:Ongoing
City:Lake Forest
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Telephone
Distribution Pattern:Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.
Classification:Class I
Product Quantity:2,500 vials
Reason For Recall:Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Recall Initiation Date:20141006
Report Date:20150225
Hospira Inc.
Product Description:Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Status:Ongoing
City:Lake Forest
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Telephone
Distribution Pattern:Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.
Classification:Class I
Product Quantity:2,500 vials
Reason For Recall:Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Recall Initiation Date:20141006
Report Date:20150225

Propofol

Propofol

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Questions & Answers

Side Effects & Adverse Reactions

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, Propofol Injectable Emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure.  Sedated patients should be continuously monitored, and facilities for maintenance of a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available.  Patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation.  These cardiorespiratory effects are more likely to occur following rapid bolus administration, especially in the elderly, debilitated, or ASA-PS III or IV patients.

For sedation of intubated, mechanically ventilated patients in the Intensive Care Unit (ICU), Propofol Injectable Emulsion should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management.

Use of Propofol Injectable Emulsion infusions for both adult and pediatric ICU sedation has been associated with a constellation of metabolic derangements and organ system failures, referred to as Propofol Infusion Syndrome, that have resulted in death.  The syndrome is characterized by severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, cardiac and renal failure.  The following appear to be major risk factors for the development of these events: decreased oxygen delivery to tissues; serious neurological injury and/or sepsis; high dosages of one or more of the following pharmacological agents: vasoconstrictors, steroids, inotropes and/or prolonged, high-dose infusions of propofol (> 5 mg/kg/h for > 48h).  The syndrome has also been reported following large-dose, short-term infusions during surgical anesthesia.  In the setting of prolonged need for sedation, increasing propofol dose requirements to maintain a constant level of sedation, or onset of metabolic acidosis during administration of a propofol infusion, consideration should be given to using alternative means of sedation.

Abrupt discontinuation of Propofol Injectable Emulsion prior to weaning or for daily evaluation of sedation levels should be avoided.  This may result in rapid awakening with associated anxiety, agitation, and resistance to mechanical ventilation.  Infusions of Propofol Injectable Emulsion should be adjusted to maintain a light level of sedation through the weaning process or evaluation of sedation level (see PRECAUTIONS).

Propofol Injectable Emulsion should not be coadministered through the same IV catheter with blood or plasma because compatibility has not been established.  In vitro tests have shown that aggregates of the globular component of the emulsion vehicle have occurred with blood/plasma/serum from humans and animals.  The clinical significance of these findings is not known.

There have been reports in which failure to use aseptic technique when handling Propofol Injectable Emulsion was associated with microbial contamination of the product and with fever, infection, sepsis, other life-threatening illness, and death.  Do not use if contamination is suspected.  Discard unused portions as directed within the required time limits (see DOSAGE AND ADMINISTRATION, Handling Procedures ).

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Propofol Injectable Emulsion is an IV sedative-hypnotic agent that can be used as described in the table below.

Table 3.  Indications for Propofol Injectable Emulsion

Indication

Approved Patient Population

Initiation and maintenance of Monitored Anesthesia Care (MAC) sedation

Adults only

Combined sedation and regional anesthesia

Adults only (see PRECAUTIONS)

Induction of General Anesthesia

Patients ≥ 3 years of age

Maintenance of General Anesthesia

Patients ≥ 2 months of age

Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patients

Adults only

Safety, effectiveness and dosing guidelines for Propofol Injectable Emulsion have not been established for MAC Sedation in the pediatric population; therefore, it is not recommended for this use (see PRECAUTIONS, Pediatric Use).

Propofol Injectable Emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations.

In the Intensive Care Unit (ICU), Propofol Injectable Emulsion can be administered to intubated, mechanically ventilated adult patients to provide continuous sedation and control of stress responses only by persons skilled in the medical management of critically ill patients and trained in cardiovascular resuscitation and airway management.

Propofol Injectable Emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established (see PRECAUTIONS, Pediatric Use).

Propofol Injectable Emulsion is not recommended for obstetrics, including Cesarean section deliveries.  Propofol Injectable Emulsion crosses the placenta, and as with other general anesthetic agents, the administration of Propofol Injectable Emulsion may be associated with neonatal depression (see PRECAUTIONS).

Propofol Injectable Emulsion is not recommended for use in nursing mothers because Propofol Injectable Emulsion has been reported to be excreted in human milk, and the effects of oral absorption of small amounts of propofol are not known (see PRECAUTIONS).

History

There is currently no drug history available for this drug.

Other Information

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:

propofol-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), glycerol (22.5 mg/mL), egg lecithin (12 mg/mL); and disodium edetate (0.005%); with sodium hydroxide to adjust pH.  The Propofol Injectable Emulsion, USP is isotonic and has a pH of 7 to 8.5.

Propofol Manufacturers


  • App Pharmaceuticals, Llc
    Propofol Injection, Emulsion [App Pharmaceuticals, Llc]
  • App Pharmaceuticals, Llc
    Propofol Injection, Emulsion [App Pharmaceuticals, Llc]
  • App Pharmaceuticals, Llc
    Propofol Injection, Emulsion [App Pharmaceuticals, Llc]
  • Fresenius Kabi Usa, Llc
    Propofol Injection, Emulsion [Fresenius Kabi Usa, Llc]
  • Teva Parenteral Medicines, Inc.
    Propofol Injection, Emulsion [Teva Parenteral Medicines, Inc.]
  • Sagent Pharmaceuticals
    Propofol Injection, Emulsion [Sagent Pharmaceuticals]
  • Hospira, Inc.
    Propofol Injection, Emulsion [Hospira, Inc.]
  • General Injectables And Vaccines, Inc
    Propofol Injection, Emulsion [General Injectables And Vaccines, Inc]

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