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L-Cysteine Hydrochloride Injection

[03 May 2016]

Products Affected - Description

L-cysteine hydrochloride injection, American Regent
50 mg/mL, 10 mL vial, 25 count (NDC 00517-2050-05)
50 mg/mL, 50 mL vial, 5 count (NDC 00517-2064-25)

Reason for the Shortage

  • American Regent has L-cysteine hydrochloride injection on back order due to manufacturing delays.
  • Sandoz has L-cysteine hydrochloride injection available.

Available Products

L-cysteine hydrochloride injection, Sandoz
50 mg/mL, 10 mL vial, 10 count (NDC 66758-0004-02)
50 mg/mL, 50 mL vial, 5 count (NDC 66758-0005-02)

Estimated Resupply Dates

American Regent has L-cysteine hydrochloride injection 10 mL and 50 mL vials on back order and the company cannot estimate a release date.

Alternative Agents & Management

The American Society for Parenteral and Enteral Nutrition (ASPEN) has detailed recommendations for managing this shortage.
 
Key recommendations include:
  • Reserve supplies for neonatal patients <1 kg or neonatal patient who are >1 kg after surgery or with sepsis.
  • Avoid use of L-cysteine if patient is receiving at least 3 gram/kg per day of protein.
  • Consider oral or enteral routes for supplementation if possible.
  • Avoid using L-cysteine for catheter patency.
  • Compound in central location and add L-cysteine as a separate product from amino acid solutions to help conserve supplies.
  • Purchase only the supply needed, do not stockpile.

Related Shortages

Updated

May 3, March 8, February 16, 2016; November 3, October 23, 12 and 5, September 21 and 10, June 25 and 5, May 27 and 8, April 27, March 9, February 12, January 26, 2015; December 31 and 12, November 25, 2014, University of Utah, Drug Information Service. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient 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. Vizient, 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 Vizient, 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 Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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