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Caffeine and Sodium Benzoate Injection

[08 July 2014]

Products Affected - Description

Caffeine, anhydrous (125 mg/mL) / Sodium benzoate (125 mg/mL), American Regent
2 mL single-dose vial, package of 10 (NDC 00517-2502-10)

Reason for the Shortage

  • American Regent had temporarily suspended manufacture of multiple drug products including caffeine and sodium benzoate injection in April, 2011.1
  • American Regent resumed manufacturing in Shirley, New York in early-May, 2011.1
  • American Regent is the sole manufacturer of caffeine and sodium benzoate injection.
  • Caffeine citrate injection is not affected by this shortage.

Available Products

No presentations are available.

Estimated Resupply Dates

American Regent has caffeine and sodium benzoate injection on back order and the company cannot estimate a release date.1

Implications for Patient Care

Caffeine and sodium benzoate is labeled for the treatment of acute respiratory depression associated with overdosage of CNS depressant agents, although it is no longer a preferred agent for this indication.2-4 Caffeine and sodium benzoate is more commonly used off-label for the treatment of postdural puncture headache and in combination with electroconvulsive therapy (ECT) to prolong seizure duration.2, 4

Safety

Do not interchange caffeine citrate with caffeine and sodium benzoate.2 Caffeine citrate is labeled for the treatment of idiopathic apnea of prematurity.2, 4

Alternative Agents & Management

  • American Regent is the sole manufacturer of caffeine and sodium benzoate injection.
  • Data are limited describing alternative pharmacologic therapies for postdural puncture headache and ECT seizure prolongation. Oral caffeine solution is not affected by the shortage and may be used for treating postdural puncture headache. Intravenous aminophylline, intravenous theophylline, and oral theophylline have been used with ECT in small clinical trials to prolong seizure duration. The Table includes potential alternatives for ECT and postdural puncture headaches.

Table. Selected Clinical Uses of Caffeine and Sodium Benzoate and Potential Therapeutic Alternatives

Indication

Treatment of Choice

Alternatives

Comments

Postdural Puncture Headache2, 5-10

Caffeine and Sodium Benzoate 500 mg in 1,000 mL normal saline infused over 1 hour, followed by 1,000 mL normal saline infused over 1 hour. A second dose may be given after 4 hours if necessary.

Oral caffeine solution 300 mg as a single dose.
 
Refractory cases:
Epidural sodium chloride 0.9% 24 hour infusion or 20-30 mL injection.
Conservative measures such as bed rest, analgesics, and oral hydration are recommended for the first 24-48 hours. An epidural blood patch is a treatment option for severe headaches or if conservative measures fail.
 
The effects of both IV and oral caffeine are transient and the headache may return.

Electroconvulsive Therapy2, 11-17

Caffeine and Sodium Benzoate 500 mg (maximum of 2000 mg) IV infused over 20-30 seconds 5 minutes prior to electrical stimulation

Aminophylline 3-5 mg/kg IV 10 minutes prior to electrical stimulation
 
Theophylline 200-400 mg sustained-release tablets orally 10 hours prior to electrical stimulation13,15,17 
 
Theophylline injection 100-200 mg IV over several minutes, given 30 minutes prior to electrical stimulation16

Theophylline may cause status epilepticus in patients with slightly higher than therapeutic plasma concentrations.

Related Shortages

References

  1. American Regent (personal communications and website). August 11, September 2, October 31, December 9, 2011; January 10, February 10, March 7, April 18, May 15, June 29, September 5, November 13, 2012; January 14, March 8, May 30, August 8, October 11, 2013; January 27, April 17, and July 8, 2014.
  2. Lexi-Drugs Online. Hudson, OH: Lexi-Comp, Inc.; 2011.
  3. American Regent. Caffeine and Sodium Benzoate Injection, USP [product information]. Shirley, NY: American Regent, Inc.; 2005.
  4. McEvoy GK, Snow EK, Kester L, Litvak K, Miller J, Welsh OH, eds. AHFS DI (Lexi-Comp Online). Bethesda, MD: American Society of Health-System Pharmacists; 2011.
  5. Drug Evaluation: Caffeine. In: Hutchison TA, Shahan DR, Anderson ML, eds. Drugdex System [internet database]. Greenwood Village, CO: Thomson Healthcare; 2011. Updated periodically.
  6. Camann WR, Murray RS, Mushlin PS, Lambert DH. Effects of oral caffeine on postdural puncture headache. A double-blind, placebo-controlled trial. Anesth Analg. Feb 1990;70(2):181-184.
  7. Choi A, Laurito CE, Cunningham FE. Pharmacologic management of postdural puncture headache. Ann Pharmacother. Jul-Aug 1996;30(7-8):831-839.
  8. Janssens E, Aerssens P, Alliet P, Gillis P, Raes M. Post-dural puncture headaches in children. A literature review. Eur J Pediatr. Mar 2003;162(3):117-121.
  9. Morewood GH. A rational approach to the cause, prevention and treatment of postdural puncture headache. Cmaj. Oct 15 1993;149(8):1087-1093.
  10. Rice GG, Dabbs CH. The use of peridural and subarachnoid injections of saline solution in the treatment of severe postspinal headache. Anesthesiology. Jan 1950;11(1):17-23, illust.
  11. Drug Consult: Drugs for Seizure Prolongation in ECT. In: Hutchison TA, Shahan DR, Anderson ML, eds. Drugdex System [internet database]. Greenwood Village, CO: Thomson Healthcare; 2005.
  12. Drug Evaluation: Aminophylline. In: Hutchison TA, Shahan DR, Anderson ML, eds. Drugdex System [internet database]. Greenwood Village, CO: Thomson Healthcare; 2011. Updated periodically.
  13. Fink M, Sackeim HA. Theophylline and ECT. J Ect. Dec 1998;14(4):286-290.
  14. Stern L, Dannon PN, Hirschmann S, et al. Aminophylline increases seizure length during electroconvulsive therapy. J Ect. Dec 1999;15(4):252-257.
  15. Swartz CM, Lewis RK. Theophylline reversal of electroconvulsive therapy (ECT) seizure inhibition. Psychosomatics. Winter 1991;32(1):47-51.
  16. Leentjens AF, van den Broek WW, Kusuma A, Bruijn JA. Facilitation of ECT by intravenous administration of theophylline. Convuls Ther. Dec 1996;12(4):232-237.
  17. Ueda S, Sakayori T, Yamaoka N, Okubo Y. Successful switching from sine-wave to pulse-wave with oral theophylline the night before electroconvulsive therapy for depression. Psychiatry Clin Neurosci. Oct 2011;65(6):604-605.

Updated

Updated July 8, 2014 by Michelle Wheeler, PharmD, Drug Information Specialist. Created August 15, 2011, by Megan Dryer, PharmD, Drug Information Specialist. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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