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Propofol Injection

Last Updated: June 19, 2014
Status: Resolved

Products Affected - Description

Propofol injection, 10 mg/mL, Fresenius Kabi (formerly APP)

20 mL vial (NDC 63323-0270-25) - discontinued
50 mL vial (NDC 63323-0270-50) - discontinued
100 mL vial (NDC 63323-0270-65) - discontinued

Reason for the Shortage

  • Hospira had propofol on shortage due to manufacturing delays.1
  • Sagent is distributing propofol presentations from Teva.2,4
  • Fresenius Kabi (formerly APP) is transitioning all presentations to Diprivan in mid-2013. They will no longer make generic propofol once the current supply is depleted. Diprivan 25 counts are transitioning to 10 count sizes.3
  • In cooperation with FDA, Fresenius Kabi was providing Propoven 10 mg/mL injection to the US market again to help alleviate the shortage. They are no longer importing Propoven due to increased supply of product supplied in the US. Propoven is manufactured in FDA-approved facilities by Fresenius Kabi AG, the parent company of Fresenius Kabi, USA.6 Propoven is different from Diprivan in that it is preservative-free and contains medium-chain triglycerides as well as long-chain triglycerides. (Diprivan contains only long-chain triglycerides and also contains EDTA).5,6 Fresenius Kabi has a Dear Healthcare professional letter at .5,6 Report any offers to sell Propoven by an entity other than Fresenius Kabi to drugshortages@fda.hhs.gov.

Available Products

Diprivan injection, 10 mg/mL, Fresenius Kabi (formerly APP)

20 mL vial, 10 count (NDC 63323-0269-29)
50 mL vial (NDC 63323-0269-50)
100 mL vial (NDC 63323-0269-65)
20 mL Novaplus vial (NDC 63323-0269-37)
50 mL Novaplus vial (NDC 63323-0269-57)
100 mL Novaplus vial (NDC 63323-0269-67)
20 mL PremierProRx vial (NDC 63323-0269-94)
50 mL PremierProRx vial (NDC 63323-0269-59)
100 mL PremierProRx vial (NDC 63323-0269-69)

Propofol injection 10 mg/mL, Hospira
20 mL vial (NDC 00409-4699-30)
50 mL vial (NDC 00409-4699-33)
100 mL vial (NDC 00409-4699-24) 
 
Propofol injection 10 mg/mL, Sagent (Teva label)
20 mL vial (NDC 00703-2856-04)
50 mL vial (NDC 00703-2858-09)
100 mL vial (NDC 00703-2859-03)  

Estimated Resupply Dates

All presentations are available.

Implications for Patient Care

  • Propofol is a sedative hypnotic agent labeled for the induction of anesthesia in patients 3 years and older as part of an overall anesthesia regimen in patients undergoing surgery. Propofol is labeled for maintenance of anesthesia in patients 2 months of age and older, as part of an overall anesthesia regimen in patients undergoing surgery. Propofol is labeled for monitored anesthesia care in patients undergoing diagnostic or surgical procedures. Propofol is labeled for continuous sedation in adult patients who are mechanically ventilated in the intensive care unit.5,7
  • Unlabeled uses of propofol include management of refractory status epilepticus or complex-partial seizures, treatment of postoperative nausea and vomiting or prevention of chemotherapy induced nausea and vomiting, conscious sedation, and treatment of itching secondary to cholestasis or opioid use.7
  • Strict aseptic technique is recommended for all propofol products, but is essential for Propoven which is preservative-free. Propoven products are single-dose vials and each vial may only be used for a single patient. Propoven also differs from Diprivan in lipid composition. Clinicians must take this difference into account for patients receiving total parenteral nutrition (TPN), patients with fat metabolism disorders, or patients in which lipid emulsions must be used cautiously.5,6
  • Propoven and US-labeled propofol products both contain soybean oil.4,5 The product labeling for Propoven includes a contraindication for use in patients with peanut or soy allergy due to a theoretical concern for cross-reactivity.6

Alternative Agents & Management

  • Alternative intravenous hypnotic agents for the induction and maintenance of anesthesia vary in time of onset and duration of action, as shown in Table 1.
  • Intravenous sedative medications used in the ICU include propofol, benzodiazepines (eg, midazolam, lorazepam), opioids, haloperidol, and dexmedetomidine.8,9 Table 2 compares select intravenous medications used for sedation in the intensive care unit.
  • Intravenous medications used for procedural sedation include propofol, methohexital, dexmedetomidine, and benzodiazepines (eg, midazolam, lorazepam) in combination with opioids (eg, fentanyl, morphine). Table 3 summarizes alternatives for specific clinical situations.
  • Minimize any potential drug waste. Propofol must be used within 12 hours.5

Table 1. Characteristics of injectable agents for anesthesia induction and maintenance.7,10,11 

Agent

Onset of Action (min)

Clinical Duration (min)

Usual Adult Doses for Anesthesia

Induction and Maintenance

Etomidate

< 1

3-5

Induction: 0.2 to 0.6 mg/kg IV (average 0.3 mg/kg IV)

Maintenance: 5-20 mcg/kg/minute IV

Ketamine

1-2

5-15

Induction: 1 to 2 mg/kg IV

Maintenance: 0.33 to 2 mg/kg IV (33-100% of initial dose) as needed

Methohexital

<1

3-8

Induction: 50 to 100 mg IV OR 1 to 1.5 mg/kg IV

Maintenance: 20 to 40 mg IV as needed, usually every 4 to 7 minutes; or 6 mg/minute IV by continuous infusion

Propofol

< 1

3-10

Induction: 1 to 2.5 mg/kg IV; or 20 to 40 mg IV every 10 seconds until onset of anesthesia

Maintenance: 0.05 to 0.2 mg/kg/minute IV by continuous infusion OR 25 to 50 mg IV in increments as needed

Thiopental

< 1

4-15

Induction: 50 to 75 mg IV OR 3 to 5 mg/kg IV, every 20 to 40 seconds

Maintenance: 25 to 100 mg IV as needed (whenever the patient moves)

Table 2. Characteristics of selected intravenous medications used for sedation of adult patients in the intensive care unit.5,7,9,10,11 

Agent

FDA Labeled Indications

Pharmacology

Onset of Action (min)

Duration of Action (hours)

Half-life
(hours)

Active Metabolite

Dexmedetomidine

·    short term sedation  (= 24 hours) of adult mechanically ventilated patients in critical care settings

·    procedural sedation

·    CNS receptors: sedation, analgesia, hypotension, decreased heart rate

·    peripheral receptors: vasoconstriction, hypertension

30

4

2

No

Diazepam

·    anxiety

·    adjunct for status epilepticus and severe recurrent convulsive seizures

·    preoperative sedation

·    adjunct to cardioversion

·    endoscopic procedural sedation

·    muscle spasms or spasticity

·    acute agitation, tremor, delirium tremens, and hallucinosis during acute alcohol withdrawal.

·    sedation, hypnosis anterograde amnesia

1–5

0.25–1

20–120

Yes

Lorazepam

·    anxiety

·    preoperative sedation, anxiolysis, and anterograde amnesia

·    status epilepticus

·    sedation, hypnosis, anterograde amnesia

5–20

6-8

12

No

Midazolam

·    sedation in critical care settings

·    preoperative sedation, anxiolysis, and anterograde amnesia

·    procedural sedation

·    induction and maintenance of anesthesia

·      anesthesia, sedation, hypnosis, amnesia

1–5

<2*

1-4

Yes

Propofol

·    sedation in mechanically ventilated patients in critical care settings

·    induction and maintenance of anesthesia

·    monitored anesthesia care sedation

·      anesthesia, sedation, hypnosis, amnesia

0.5 - 1

0.05-0.17

1.5-12.4

No

*The pharmacologic effect of midazolam may last up to 6 hours in some patients.
 

Table 3. Alternatives for Specific Clinical Situations
 

Situation

Alternatives

Procedural sedation5,7,10-15

NOTE: These agents must be given in conjunction with other appropriate interventions as prescribed by current practice.

Diazepam: Up to 10–20 mg IV given immediately before OR  5–10 mg IM given 30 minutes before procedure

Lorazepam: 0.044 mg/kg (up to a maximum of 4 mg) IV given 15–20 minutes before procedure

Midazolam: 1–2.5 mg IV, then small incremental doses to achieve the desired effect

Propofol: 

Monitored Anesthesia Care (labeled dose): 0.5 mg/kg over 3 to 5 minutes followed by infusion at 1.5 to 4.5 mg/kg/hr

Procedural sedation (unlabeled): 1 mg/kg followed by supplemental doses of 0.5 mg/kg every 3 minutes as needed

Methohexital: 0.75 to 1 mg/kg IV followed by supplemental doses of 0.5 mg/kg every 2 to 5 min as needed

Dexmedetomidine: 0.5 to 1 microgram/kilogram (mcg/kg) intravenously (IV) over 10 minutes, followed by a maintenance infusion of 0.6 mcg/kg/hour IV titrated to desired clinical effect, (maintenance dose range: 0.2 to 1 mcg/kg/hour)

Ketamine: 1 to 2 mg/kg IV over 1 to 2 minutes followed by 0.25 to 0.5 mg/kg every 5 to 10 minutes as needed

Etomidate: 0.1 to 0.15 mg/kg IV over 30 to 60 seconds, followed by 0.05 mg/kg every 3 to 5 minutes as needed

 

 

Related Shortages

References

  1. Hospira (personal communications and website). April 2, May 22, June 4 and 18, July 30, September 12, October 15, November 18, December 10, 2012; February 5 and 15, and March 12, April 4, May 1, June 4, July 3 and 11, August 29 and 30, September 19, November 15, and December 2 and 27, 2013; February 6, April 10 and 28, and June 19, 2014.
  2. Teva (personal communications). June 2, 2010; April 4, May 2, July 11, August 26, September 19, November 13 and 22, 2013.
  3. Fresenius Kabi (personal communications). March 29, April 5, 6, and 11, May 23, June 4 and 29, July 30, September 12, October 3, November 19, December 12, 2012; February 4, March 7, April 4, May 1, June 4, July 11 and 19, August 29, September 19, November 12 and 28, and December 20, 2013; January 31, April 10 and 28, and June 17, 2014.
  4. Sagent (personal communications). November 26, and December 19, 2013; February 3, April 10 and 28, and June 13, 2014. 
  5. Diprivan (propofol injection) product information. Schaumburg, IL: APP, 2009.
  6. APP. Dear Healthcare Professional Letters (customer letter). Accessed July 2, 2012.
    7. McEvoy GK, Snow EK, Kester L, Litvak K, Miller J, Welsh OH, eds. AHFS 2009 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2009.
    8. Rhoney DH, Murry KR. National survey of the use of sedating drugs, neuromuscular blocking agents, and reversal agents in the intensive care unit. J Intensive Care Med 2003; 18: 139-45.
    9. Precedex (dexmedetomidine injection) product information. Lake Forest, IL: Hospira; 2008.
    10. Donnelly AJ, Baughman VL, Gonzales JP, Golembiewski J, Tomsik EA, eds. Anesthesiology and Critical Care Drug Handbook. 8th ed. Hudson, OH: Lexi-Comp; 2008.
    11. Hutchison TA, Shahan DR, Anderson ML, eds. Drugdex System [internet database]. Greenwood Village, CO: Thomson Healthcare; 2009. Updated periodically.
    12. Bahn EL, Holt, KR. Procedural sedation and analgesia: a review and new concepts. Emerg Med Clin N Am 2005; 23:503-15.
    13. Miner JR, Burton JH. Clinical practice advisory: emergency department procedural sedation with propofol. Ann Emerg Med 2007; 50:182-7.
    14. Miner JR, Danahy M, Moch A, Biros M. Randomized clinical trial of etomidate versus propofol for procedural sedation in the emergency department. Ann Emerg Med 2007; 49:15-22.
    15. Falk J, Zed PJ. Etomidate for procedural sedation in the emergency department. Ann Pharmacother 2004; 38:1272-7.

Updated

Updated June 19, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist; April 4, 2013 by Michelle Wheeler, PharmD, Drug Information Specialist; March 12, 2013 by Michelle Wheeler, PharmD, Drug Information Specialist. Created October 28, 2009 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.

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