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Sufentanil Injection

Last Updated: February 13, 2017
Status: Resolved

Products Affected - Description
    • Sufentanil solution for injection, Pfizer, 50 mcg/mL, 1 mL ampule, 10 count, NDC 00409-3380-31
    • Sufentanil solution for injection, Pfizer, 50 mcg/mL, 2 mL ampule, 10 count, NDC 00409-3380-32
    • Sufentanil solution for injection, Pfizer, 50 mcg/mL, 5 mL ampule, 10 count, NDC 00409-3380-35
    • Sufentanil solution for injection, West-Ward, 50 mcg/mL, 1 mL ampule, 10 count, NDC 00641-6110-10
    • Sufentanil solution for injection, West-Ward, 50 mcg/mL, 2 mL ampule, 10 count, NDC 00641-6111-10
Reason for the Shortage
    • West-Ward is no longer actively marketing sufentanil 1 mL and 2 mL ampules. The 5 mL ampules are available.[1]
    • Pfizer had sufentanil on shortage due to material shortage. Pfizer discontinued sufentanil ampules in October 2016. The vials continue to be marketed.[2]
    • Akorn has Sufenta available.[3]
Available Products
    • Sufenta solution for injection, Akorn, 50 mcg/mL, 1 mL ampule, 10 count, NDC 17478-0050-01
    • Sufenta solution for injection, Akorn, 50 mcg/mL, 2 mL ampule, 10 count, NDC 17478-0050-02
    • Sufenta solution for injection, Akorn, 50 mcg/mL, 5 mL ampule, 10 count, NDC 17478-0050-05
    • Sufentanil solution for injection, Pfizer, 50 mcg/mL, 1 mL vial, 10 count, NDC 00409-3382-21
    • Sufentanil solution for injection, Pfizer, 50 mcg/mL, 2 mL vial, 10 count, NDC 00409-3382-22
    • Sufentanil solution for injection, Pfizer, 50 mcg/mL, 5 mL vial, 10 count, NDC 00409-3382-25
    • Sufentanil solution for injection, West-Ward, 50 mcg/mL, 5 mL ampule, 10 count, NDC 00641-6112-10

Estimated Resupply Dates

    • All marketed presentations are available.

Implications for Patient Care

    • Sufentanil is labeled for use as an adjunct for general anesthesia maintenance.[4] Sufentanil is also labeled for use with oxygen as an anesthetic agent in high risk patients, including those undergoing complicated neurosurgical procedures or cardiovascular surgery.[4] Sufentanil, given by the epidural route and in combination with bupivacaine, is also labeled for analgesia during labor and delivery.[4]

Safety

    • Sufentanil, alfentanil, fentanyl, and remifentanil may sound alike/look alike. However, dosage recommendations vary significantly between the agents.[4-7] Patient harm can occur if these agents are used erroneously. Use extra caution not to confuse these agents.

Alternative Agents & Management

    • Alternative opiate agonists vary in onset time, duration of action, and how supplied, see Tables 1, 2 and 3 below. [10-14,4-9]
    • No single agent can be substituted for sufentanil. The choice of an alternative agent must be patient-specific and based on the clinical situation, venous access, renal and hepatic function, and other comorbid conditions. Utilize stakeholder clinicians to help make specific plans for individual patient populations. Table 4 provides some alternatives to sufentanil for specific clinical situations.
    • Some presentations of alternative agents including fentanyl and butorphanol are in short supply.[15]
    Table 1. Comparison of Selected Short Acting Opiate Agonist Used for Adjunct Anesthesia4-7
    Opioid Agonists How Supplied
    Alfentanil (Alfenta, generic) 500 mcg/mL
    Ampules: 2 mL, 5 mL, 10 mL, 20 mL
    Fentanyl (generic) 50 mcg/mL
    Ampules: 2 mL, 5 mL, 10 mL, 20 mL
    Remifentanil Vials: 1 mg, 2mg, 5 mg
    Sufentanil (Sufenta, generic) 50 mcg/mL
    Ampules: 1 mL, 2 mL, 5 mL

    Table 2. Onset of Action and Half-Life of Selected Short Acting Opiate Agonists Used for Adjunct Anesthesia 10-14,4-9
    Opioid Agonists Onset of action, intravenous (minutes) Initial
    Half-life
    (minutes)
    Re-distribution
    half-life (minutes)
    Terminal
    half-life (minutes)
    Context Sensitive (minutes)
    Alfentanil (Alfenta, generic) <2 1 14 90-111 58.5
    Fentanyl (generic) <5 1.7 13 219 262.5
    Remifentanil 1 to 3 1 6 10-20 3.7
    Sufentanil (Sufenta, generic) 1 to 3 1.4 17 164 33.9

    Table 3. Duration of Action of Selected Short Acting Opiate Agonists Used for Adjunct Anesthesia10-14,4-9
    Opioid Agonists Intravenous duration of action (minutes) Dose and duration dependent (duration of action)
    Alfentanil (Alfenta, generic) 30-60 min

    Single dose: 10 min
    Yes
    Fentanyl (generic) 30-60 min Yes
    Remifentanil 3-10 min No
    Sufentanil (Sufenta, generic) Single dose: 36 min Yes

    Table 4. Selected Alternatives to Sufentanil for Specific Clinical Situations
    Use Alternative Regimen Comments
    Analgesia in Labor and Delivery Epidural
    Fentanyl: 25 to 100 mcg16
    Fentanyl: 50 to 100 mcg plus 10 mL bupivacaine; may repeat dose when pain returns or initiate patient controlled epidural analgesia.17-20

    Intravenous
    Butorphanol: 1 to 2 mg every 3 to 4 hours as needed11,17,21
    Nalbuphine: 5 to 10 mg every 3 to 6 hours as needed11,17,22
    Fentanyl: 50 mcg once, then 25 mcg every 20 to 30 minutes as needed20

    Patient controlled intravenous analgesia
    Remifentanil: 0.2 to 0.93 mcg/kg bolus dosing with 1 to 3 minute lockout intervals.17,23
    Remifentanil is not given intraspinally because it contains glycine.12

    Optimal dosing has not been established for remifentanil in labor analgesia.23

References

    1. West-Ward (personal communications). January 11, February 14, April 5, May 10, June 17 and 28, August 10, September 30, November 2, December 7 and 28, 2011; January 20, February 9 and 28, March 23, April 9, May 2 and 24, June 21, July 3, August 6, September 4 and 14, October 12, December 17, 2012; January 21, February 25, April 22, May 24, June 4, July 3 and 29, August 9, October 3 and 18, December 6, 2013; January 11, March 3 and 28, April 18, May 2 and 30, June 25, July 16, August 21, October 7 and 23, November 26, 2014; January 7, March 11, April 29, July 1, September 15, November 2 and 23, 2015; January 6, February 18, March 29, April 29, May 9, June 9, July 27, November 2, 2016; January 31, and February 8, 2017.
    2. Pfizer (personal communications and website). January 11, February 15, April 5, May 10, June 17 and 28, August 8 and 22, September 27, October 11 and 31, December 7 and 27, 2011; January 26, February 10 and 27, March 27, April 12, May 2 and 24, June 4 and 18, July 3, August 13, September 5 and 17, October 31, December 19, 2012; January 23, February 25, April 17, May 24, July 29, August 12, October 3 and 23, November 11, 2013; January 14, March 4 and 31, April 23, May 9 and 30, June 30, July 21, August 22, October 8 and 23, November 26, 2014; January 8, March 19, May 4, July 9, September 22, November 2 and 24, 2015; January 27, February 29, April 8, May 2, June 9, August 15, October 9, 2016; January 31, and February 7, 2017.
    3. Akorn (personal communications).February 14, June 21, August 10, September 29, October 31, December 7 and 28, 2011; January 26, February 10 and 29, March 30, April 12, May 2 and 22, June 6 and 20, July 3, August 16, September 5 and 18, October 30, December 19, 2012; January 23, February 26, April 19, May 24, July 29, August 12, October 3 and 23, December 10, 2013; January 13, March 4 and 31, April 23, May 8, June 30, July 21, August 18, October 7, November 3 and 26, 2014; January 5, March 17, May 4, July 9, August 28, November 2 and 20, 2015; January 20, February 25, April 8 and 29, June 8, August 15, October 11, 2016; January 18, and February 8, 2017.
    4. Sufentanil Injection [product information]. Lake Forest, IL: Hospira; 2004.
    5. Fentanyl Injection [product information]. Lake Forest, IL: Hospira; 2008.
    6. Alfentanil Injection [product information]. Lake Forest, IL: Hospira; 2004.
    7. Ultiva (remifentanil) Injection [product information]. Lake Forest, IL: Mylan Institutional; 2009 March.
    8. Hutchison TA, Shahan DR, Anderson ML, eds. Drugdex System [internet database]. Greenwood Village, CO: Thomson Healthcare; 2011. Updated periodically.
    9. Lacy CF, Armstrong LL, Goldman MP, Lance LL, eds. Drug Information Handbook. 17th ed. Hudson, OH: Lexi-Comp; 2010.
    10. Opiate Agonists. In: McEvoy GK, Snow EK, Miller J, Kester L, Welsh OH, eds. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2011: 2188-2231.
    11. Nonvolatile Anesthetic Agents. In: Morgan GE, Mikhail, MS, Murray, MJ. Clinical Anesthesiology. 4th ed. New York, NY: McGraw-Hill; 2006:179-204.
    12. Opioids, Analgesia, and Pain Management. In: Brunton LL, Chabner BA, Knollman BC, eds. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 12th ed. New York, NY: McGraw-Hill; 2011: 481-525.
    13. Scott LJ, Perry CM. Remifentanil: a review of its use during the induction and maintenance of general anaesthesia. Drugs. 2005;65(13):1793-1823.
    14. Scholz J, Steinfath M, Schulz M. Clinical pharmacokinetics of alfentanil, fentanyl and sufentanil. An update. Clin Pharmacokinet. Oct 1996;31(4):275-292.
    15. American Society of Health-System Pharmacists. Drug Shortage Resource Center. Available at: http://www.ashp.org/shortages. Accessed on November 2, 2011.
    16. Baughman VL, Golembiewski J, Gonzales JP, Alvarez, W, eds. Anesthesiology and Critical Care Drug Handbook. 9th ed. Hudson, OH: Lexi-Comp; 2010.
    17. Gibbs RS, Karlan BY, Haney AF, Nygaard I, eds. Danforth's Obstetrics and Gynecology. 10th ed. Philadelphia, PA: Wolters Kluwer Health / Lippincott Williams & Wilkins; 2008.
    18. Morgan GE, Mikhail MS, Murray MJ. Clinical Anesthesiology. 4th ed. New York, NY: Lange Medical Books; 2006.
    19. Bankowski BJ, Hearne AE, Lambrou NC, Fox HE, Wallach EE. The John Hopkins Manual of Gynecology and Obstetrics. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2002.
    20. Weiner C, Buhimschi C. Drugs for Pregnant and Lactating Women. 2nd ed. Philadelphia, PA: Saunders Elsevier; 2009.
    21. Butorphanol Injection [product information]. Lake Forest, IL: Hospira; 2004.
    22. Nalbuphine Injection [product information]. Lake Forest, IL: Hospira; 2007.
    23. Hinova A, Fernando R. Systemic remifentanil for labor analgesia. Anesth Analg. 2009;109(6):1925-1929.

Updated

Updated February 13, 2017 by Michelle Wheeler, PharmD, Drug Information Specialist. Created August 19, 2015 by Leslie Jensen, PharmD, Drug Information Specialist. Copyright 2017, Drug Information Service, University of Utah, Salt Lake City, UT.

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