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9/9/2019

Lidocaine Injection

Products Affected - Description

    • Xylocaine injection, Fresenius Kabi, 1%, 50 mL vial, 25 count, NDC 63323-0485-57
    • Xylocaine-MPF injection, Fresenius Kabi, 1%, 30 mL sterile-pack vial, 5 count, NDC 63323-0492-31
    • Xylocaine-MPF injection, Fresenius Kabi, 1.5%, 20 mL ampule, 5 count, NDC 63323-0493-91
    • Xylocaine-MPF injection, Fresenius Kabi, 2%, 10 mL ampule, 5 count, NDC 63323-0496-97
    • Lidocaine Hydrochloride injection, AuroMedics, 1%, 30 mL vial, 1 count, NDC 55150-0163-30
    • Lidocaine Hydrochloride injection, AuroMedics, 2%, 5 mL vial, 10 count, NDC 55150-0165-05
    • Lidocaine Hydrochloride injection, Hikma, 2%, 5 mL preservative-free vial, 25 count, NDC 00143-9594-25
    • Lidocaine Hydrochloride injection, Pfizer, 1%, 30 mL preservative-free vial, 25 count, NDC 00409-4279-02
    • Lidocaine Hydrochloride injection, Pfizer, 1%, 5 mL LifeShield syringe, 10 count, NDC 00409-4904-34
    • Lidocaine Hydrochloride injection, Pfizer, 1%, 5 mL preservative-free glass ampule, 50 count, NDC 00409-4713-02
    • Lidocaine Hydrochloride injection, Pfizer, 1.5%, 20 mL preservative-free ampule, 25 count, NDC 00409-4776-01
    • Lidocaine Hydrochloride injection, Pfizer, 2%, 5 mL emergency Ansyr syringe, 10 count, NDC 00409-1323-05
    • Lidocaine Hydrochloride injection, Pfizer, 2%, 5 mL LifeShield syringe, 10 count, NDC 00409-4903-34
    • Lidocaine Hydrochloride injection, Pfizer, 2%, 5 mL preservative-free vial, 10 count, NDC 00409-2066-05

Reason for the Shortage

    • Amphastar had lidocaine 2% emergency syringes available.
    • AuroMedics introduced lidocaine injection in February 2014.
    • Fresenius Kabi had generic lidocaine presentations on shortage due to a supply interruption of raw ingredients.
    • Pfizer has lidocaine presentations on shortage due to manufacturing delays.

Available Products

    • Xylocaine injection, Fresenius Kabi, 0.5%, 50 mL vial, 25 count, NDC 63323-0484-57
    • Xylocaine injection, Fresenius Kabi, 1%, 20 mL vial, 25 count, NDC 63323-0485-27
    • Xylocaine injection, Fresenius Kabi, 2%, 10 mL vial, 25 count, NDC 63323-0486-17
    • Xylocaine injection, Fresenius Kabi, 2%, 20 mL vial, 25 count, NDC 63323-0486-27
    • Xylocaine injection, Fresenius Kabi, 2%, 50 mL vial, 25 count, NDC 63323-0486-57
    • Xylocaine-MPF injection, Fresenius Kabi, 0.5%, 50 mL vial, 25 count, NDC 63323-0491-57
    • Xylocaine-MPF injection, Fresenius Kabi, 1%, 10 mL sterile-pack ampule, 5 count, NDC 63323-0492-97
    • Xylocaine-MPF injection, Fresenius Kabi, 1%, 2 mL vial, 25 count, NDC 63323-0492-27
    • Xylocaine-MPF injection, Fresenius Kabi, 1%, 30 mL vial, 25 count, NDC 63323-0492-37
    • Xylocaine-MPF injection, Fresenius Kabi, 1%, 5 mL vial, 25 count, NDC 63323-0492-57
    • Xylocaine-MPF injection, Fresenius Kabi, 1.5%, 10 mL ampule, 5 count, NDC 63323-0493-97
    • Xylocaine-MPF injection, Fresenius Kabi, 2%, 2 mL vial, 25 count, NDC 63323-0495-27
    • Xylocaine-MPF injection, Fresenius Kabi, 2%, 5 mL vial, 25 count, NDC 63323-0495-07
    • Lidocaine Hydrochloride injection, Amphastar, 2%, 5 mL Luer-Jet Emergency syringe, 10 count, NDC 76329-3390-01
    • Lidocaine Hydrochloride injection, AuroMedics, 1%, 2 mL ampule, 10 count, NDC 55150-0158-72
    • Lidocaine Hydrochloride injection, AuroMedics, 1%, 2 mL vial, 10 count, NDC 55150-0161-02
    • Lidocaine Hydrochloride injection, AuroMedics, 1%, 5 mL ampule, 10 count, NDC 55150-0159-74
    • Lidocaine Hydrochloride injection, AuroMedics, 1%, 5 mL vial, 10 count, NDC 55150-0162-05
    • Lidocaine Hydrochloride injection, AuroMedics, 2%, 2 mL ampule, 10 count, NDC 55150-0160-72
    • Lidocaine Hydrochloride injection, AuroMedics, 2%, 2 mL vial, 10 count, NDC 55150-0164-02
    • Lidocaine Hydrochloride injection, Fresenius Kabi, 1%, 10 mL vial, 25 count, NDC 63323-0201-10
    • Lidocaine Hydrochloride injection, Fresenius Kabi, 1%, 2 mL vial, 25 count, NDC 63323-0201-02
    • Lidocaine Hydrochloride injection, Fresenius Kabi, 2%, 2 mL vial, 25 count, NDC 63323-0202-02
    • Lidocaine Hydrochloride injection, Fresenius Kabi, 2%, 5 mL Tear-top preservative-free vial, 25 count, NDC 63323-0208-05
    • Lidocaine Hydrochloride injection, Hikma, 1%, 5 mL preservative-free vial, 25 count, NDC 00143-9595-25
    • Lidocaine Hydrochloride injection, Hikma, 1%, 50 mL vial, 10 count, NDC 00143-9577-10
    • Lidocaine Hydrochloride injection, Hikma, 2%, 50 mL vial, 10 count, NDC 00143-9575-10
    • Lidocaine Hydrochloride injection, Pfizer, 0.5%, 50 mL SD Tear Top preservative-free vial, 25 count, NDC 00409-4278-01
    • Lidocaine Hydrochloride injection, Pfizer, 0.5%, 50 mL SD Flip Top vial, 25 count, NDC 00409-4275-01
    • Lidocaine Hydrochloride injection, Pfizer, 1%, 2 mL preservative-free glass ampule, 50 count, NDC 00409-4713-32
    • Lidocaine Hydrochloride injection, Pfizer, 1%, 20 mL vial, 25 count, NDC 00409-4276-01
    • Lidocaine Hydrochloride injection, Pfizer, 1%, 5 mL emergency Ansyr syringe, 10 count, NDC 00409-9137-05
    • Lidocaine Hydrochloride injection, Pfizer, 1%, 50 mL vial, 25 count, NDC 00409-4276-02
    • Lidocaine Hydrochloride injection, Pfizer, 2%, 10 mL preservative-free glass ampule, 25 count, NDC 00409-4282-02
    • Lidocaine Hydrochloride injection, Pfizer, 2%, 2 mL preservative-free glass ampule, 25 count, NDC 00409-4282-01
    • Lidocaine Hydrochloride injection, Pfizer, 2%, 20 mL vial, 25 count, NDC 00409-4277-01
    • Lidocaine Hydrochloride injection, Pfizer, 2%, 50 mL vial, 25 count, NDC 00409-4277-02
    • Lidocaine Hydrochloride injection, Pfizer, 4%, 5 mL preservative-free glass ampule, 25 count, NDC 00409-4283-01

Estimated Resupply Dates

    • AuroMedics has 1% lidocaine 30 mL vials on intermittent back order and the company is releasing product as it becomes available. AuroMedics has 2% lidocaine 5 mL vials on intermittent back order and the company is releasing product as it becomes available.
    • Fresenius Kabi has 1% Xylocaine 50 mL vial on back order and the company estimates a release date of late-September to early-October 2019. The 1% Xylocaine-MPF 30 mL vial sterile packs are on back order and the company cannot estimate a release date. The 1.5% Xylocaine-MPF 20 mL ampules are on back order and the company cannot estimate a release date. The 2% Xylocaine-MPF 10 mL ampules are on back order and the company estimates a release date of late-October 2019. Check wholesalers for inventory.
    • Hikma has 2% lidocaine 5 mL vials on back order and the company estimates a release date of late-October to early-November 2019.
    • Pfizer has 1% lidocaine 5 mL preservative-free ampules on back order and the company estimates a release date of March 2020. The 1% lidocaine 30 mL preservative-free vials are on back order and the company estimates a release date of September 2019. The 1% lidocaine 5 mL Lifeshield syringes are on back order and the company estimates a release date of October 2019. The 1.5% lidocaine 20 mL preservative-free ampules are on back order and the company estimates a release date of February 2020. The 2% lidocaine 5 mL vials are on back order and the company estimates a release date of September 2019. The 2% lidocaine 5 mL Lifeshield syringes are on back order and the company estimates a release date of October 2019. The 2% lidocaine 5 mL Ansyr syringes are on back order and the company estimates a release date of December 2019.

Safety

    • There is extended stability data available for 2 strengths of Pfizer's lidocaine products that were reviewed by FDA. These are lots from 1% lidocaine 20 mL vials and 2% lidocaine 20 mL vials. The specific lots and expiration dates can be found at https://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm629245.htm

Alternative Agents & Management

    • Bupivacaine and lidocaine are amide-type local anesthetics commonly used in clinical practice. The following table compares their pharmacodynamic and pharmacokinetic properties. Key differences between the products are onset of action, duration of action, and dose. In general, bupivacaine is a longer-acting local anesthetic, while lidocaine has a more rapid onset, but shorter duration of action.[1-2]
    Table 1. Table. Comparison of Bupivacaine and lidocaine for Local Anesthesia1-6
    PropertyBupivacaineLidocaine
    *Duration of effect is prolonged by use of local anesthetics in combination with epinephrine, although magnitude of effect is not well-defined for all routes.
    Onset of actionInfiltration: 2-10 min
    Epidural: 4-7 min
    Spinal: 1-15 min
    Not well-defined for anesthetic use as a single agent.
    In general local analgesia 1 to 3 min
    Spinal and Epidural rapid onset
    Duration of action:
    As a single agent
    Infiltration: 2-8 h
    Nerve block, minor: 3-6 h
    Epidural: 3-9 h
    Spinal: 1.5-3.5 h
    Infiltration: 0.5-2 h
    Nerve block, minor: 1-2 h
    Epidural: 100 min
    Spinal: 0.5-2 h
    Duration of action: Combined with epinephrine*Infiltration: 3-4 h
    Nerve block, minor: 4-7 h
    Infiltration: 2 h
    Nerve block, minor: 2-3 h
    Maximum doseSingle injections up to 175 mg without epinephrine or 225 mg with epinephrine; may repeat up to once every 3 hours.
    Maximum dosage: 400 mg/24 hours.
    Maximum: 4.5 mg/kg/dose not to exceed 300 mg without epinephrine or 7mg/kg/dose not to exceed 500 mg with epinephrine; do not repeat within 2 hours.
    Maximum dose for spinal anesthesia is 100 mg.
    Protein Binding82%-96%60%-80%
    Volume of distribution~2.5 L/kg1.5 + 0.6 L/kg
    Half-life, terminalAdults: 1.5-5 h
    Neonates: 8.1 h
    Adults: 1.5-2 h
    Premature infants: 3.2 h
    MetabolismUndergoes N-dealkylation in the liver.Extensive hepatic metabolism (90%) with active metabolites.
    EliminationExcreted in urine as metabolites and 5% as unchanged drug. Excreted in urine as metabolites (90%) and unchanged drug (< 10 %).

References

    1. Berde CB, Strichartz GR. Local anesthetics. In: Miller RD, ed. Miller's Anesthesia. 8th ed. Philadelphia, PA: Elsevier Saunders;2015:1028-1054.e4.
    2. Drasner K. Local anesthetics. In: Miller RD, Pardo MC, ed. Basics of Anesthesia. 6th ed. Philadelphia, PA: Elsevier Saunders;2011:130-142.
    3. Drugdex system. Micromedex 2.0 [database online]. http://www.micromedexsolutions.com. Updated March 13, 2018. Greenwood Village, CO: Truven Health Analytics; Accessed March 13, 2018.
    4. Lexi-Drugs Online. Hudson, OH: Lexi-Comp, Inc; 2018.
    5. Lidocaine hydrochloride and epinephrine injection, solution [package insert]. Lake Forest, IL: Hospira Inc; 2017.
    6. 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; 2018.

Updated

Updated September 9, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 23, 2015 by Jane Chandramouli, PharmD, Drug Information Specialist. © 2019, 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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