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11/3/2024

Bupivacaine Injection

Products Affected - Description

    • Bupivacaine solution for injection, Hikma, 0.25%, 50 mL vial, 10 count, NDC 00143-9328-10
    • Bupivacaine solution for injection, Hikma, 0.5%, 50 mL vial, 10 count, NDC 00143-9329-10
    • Bupivacaine solution for injection, Hikma, 0.75%, 30 mL preservative-free vial, 10 count, NDC 00143-9335-10

Reason for the Shortage

    • Eugia has bupivacaine injection available.
    • Baxter discontinued 0.75% bupivacaine in 8.25% dextrose 2 mL ampules in early-2023.
    • Fresenius Kabi has Sensorcaine injection available.
    • Hikma did not provide a reason for the shortage.
    • Meitheal has bupivacaine injection available.
    • Pfizer has bupivacaine injection available.
    • Somerset has bupivacaine injection available.
    • Xellia has bupivacaine injection available.

Available Products

    • Marcaine solution for injection, Pfizer, 0.25%, 10 mL preservative-free vial, 10 count, NDC 00409-1559-10
    • Marcaine solution for injection, Pfizer, 0.25%, 30 mL preservative-free vial, 10 count, NDC 00409-1559-30
    • Marcaine solution for injection, Pfizer, 0.25%, 50 mL multiple dose vial, 1 count, NDC 00409-1587-50
    • Marcaine solution for injection, Pfizer, 0.5%, 10 mL preservative-free vial, 10 count, NDC 00409-1560-10
    • Marcaine solution for injection, Pfizer, 0.5%, 30 mL preservative-free vial, 10 count, NDC 00409-1560-29
    • Marcaine solution for injection, Pfizer, 0.5%, 50 mL multiple dose vial, 1 count, NDC 00409-1610-50
    • Marcaine solution for injection, Pfizer, 0.75%, 10 mL preservative-free vial, 10 count, NDC 00409-1582-10
    • Marcaine solution for injection, Pfizer, 0.75%, 30 mL preservative-free vial, 10 count, NDC 00409-1582-29
    • Sensorcaine solution for injection, Fresenius Kabi, 0.25%, 50 mL multiple dose vial, 25 count, NDC 63323-0465-57
    • Sensorcaine solution for injection, Fresenius Kabi, 0.5%, 50 mL multiple dose vial, 25 count, NDC 63323-0467-57
    • Sensorcaine-MPF solution for injection, Fresenius Kabi, 0.25%, 10 mL preservative-free vial, 25 count, NDC 63323-0464-17
    • Sensorcaine-MPF solution for injection, Fresenius Kabi, 0.25%, 30 mL preservative-free vial, 25 count, NDC 63323-0464-37
    • Sensorcaine-MPF solution for injection, Fresenius Kabi, 0.5%, 10 mL preservative-free vial, 25 count, NDC 63323-0466-17
    • Sensorcaine-MPF solution for injection, Fresenius Kabi, 0.5%, 30 mL preservative-free vial, 25 count, NDC 63323-0466-37
    • Sensorcaine-MPF solution for injection, Fresenius Kabi, 0.75%, 10 mL preservative-free vial, 25 count, NDC 63323-0472-17
    • Sensorcaine-MPF solution for injection, Fresenius Kabi, 0.75%, 30 mL preservative-free vial, 25 count, NDC 63323-0472-37
    • Bupivacaine solution for injection, Eugia US, 0.25%, 10 mL preservative-free vial, 25 count, NDC 55150-0167-10
    • Bupivacaine solution for injection, Eugia US, 0.25%, 30 mL preservative-free vial, 25 count, NDC 55150-0168-30
    • Bupivacaine solution for injection, Eugia US, 0.25%, 50 mL vial, 25 count, NDC 55150-0249-50
    • Bupivacaine solution for injection, Eugia US, 0.5%, 10 mL preservative-free vial, 25 count, NDC 55150-0169-10
    • Bupivacaine solution for injection, Eugia US, 0.5%, 30 mL preservative-free vial, 25 count, NDC 55150-0170-30
    • Bupivacaine solution for injection, Eugia US, 0.5%, 50 mL vial, 25 count, NDC 55150-0250-50
    • Bupivacaine solution for injection, Eugia US, 0.75%, 10 mL preservative-free vial, 25 count, NDC 55150-0171-10
    • Bupivacaine solution for injection, Eugia US, 0.75%, 30 mL preservative-free vial, 25 count, NDC 55150-0172-30
    • Bupivacaine solution for injection, Hikma, 0.25%, 10 mL preservative-free vial, 10 count, NDC 00143-9330-10
    • Bupivacaine solution for injection, Hikma, 0.25%, 30 mL preservative-free vial, 10 count, NDC 00143-9333-10
    • Bupivacaine solution for injection, Hikma, 0.5%, 10 mL preservative-free vial, 10 count, NDC 00143-9331-10
    • Bupivacaine solution for injection, Hikma, 0.5%, 30 mL preservative-free vial, 10 count, NDC 00143-9334-10
    • Bupivacaine solution for injection, Hikma, 0.75%, 10 mL preservative-free vial, 10 count, NDC 00143-9332-10
    • Bupivacaine solution for injection, Meitheal Pharmaceuticals, 0.25%, 10 mL multiple dose vial, 50 count, NDC 71288-0721-11
    • Bupivacaine solution for injection, Meitheal Pharmaceuticals, 0.25%, 30 mL multiple dose vial, 50 count, NDC 71288-0722-32
    • Bupivacaine solution for injection, Meitheal Pharmaceuticals, 0.25%, 50 mL multiple dose vial, 1 count, NDC 71288-0723-52
    • Bupivacaine solution for injection, Meitheal Pharmaceuticals, 0.5%, 10 mL multiple dose vial, 50 count, NDC 71288-0724-11
    • Bupivacaine solution for injection, Meitheal Pharmaceuticals, 0.5%, 30 mL multiple dose vial, 50 count, NDC 71288-0725-32
    • Bupivacaine solution for injection, Meitheal Pharmaceuticals, 0.5%, 50 mL multiple dose vial, 1 count, NDC 71288-0726-52
    • Bupivacaine solution for injection, Meitheal Pharmaceuticals, 0.75%, 10 mL multiple dose vial, 50 count, NDC 71288-0727-11
    • Bupivacaine solution for injection, Meitheal Pharmaceuticals, 0.75%, 30 mL multiple dose vial, 50 count, NDC 71288-0728-32
    • Bupivacaine solution for injection, Pfizer, 0.25%, 10 mL preservative-free vial, 25 count, NDC 00409-1159-01
    • Bupivacaine solution for injection, Pfizer, 0.25%, 30 mL preservative-free vial, 25 count, NDC 00409-1159-02
    • Bupivacaine solution for injection, Pfizer, 0.25%, 50 mL multiple dose vial, 25 count, NDC 00409-1160-01
    • Bupivacaine solution for injection, Pfizer, 0.5%, 10 mL preservative-free vial, 25 count, NDC 00409-1162-01
    • Bupivacaine solution for injection, Pfizer, 0.5%, 30 mL preservative-free vial, 25 count, NDC 00409-1162-02
    • Bupivacaine solution for injection, Pfizer, 0.5%, 50 mL multiple dose vial, 25 count, NDC 00409-1163-01
    • Bupivacaine solution for injection, Pfizer, 0.75%, 10 mL preservative-free vial, 25 count, NDC 00409-1165-01
    • Bupivacaine solution for injection, Pfizer, 0.75%, 30 mL preservative-free vial, 25 count, NDC 00409-1165-02
    • Bupivacaine solution for injection, Somerset Therapeutics LLC, 0.25%, 50 mL vial, 1 count, NDC 70069-0752-01
    • Bupivacaine solution for injection, Somerset Therapeutics LLC, 0.25%, 50 mL vial, 10 count, NDC 70069-0752-10
    • Bupivacaine solution for injection, Somerset Therapeutics LLC, 0.25%, 50 mL vial, 25 count, NDC 70069-0752-25
    • Bupivacaine solution for injection, Somerset Therapeutics LLC, 0.5%, 50 mL vial, 1 count, NDC 70069-0753-01
    • Bupivacaine solution for injection, Somerset Therapeutics LLC, 0.5%, 50 mL vial, 10 count, NDC 70069-0753-10
    • Bupivacaine solution for injection, Somerset Therapeutics LLC, 0.5%, 50 mL vial, 25 count, NDC 70069-0753-25
    • Bupivacaine solution for injection, Xellia Pharmaceuticals, 0.25%, 10 mL preservative-free vial, 10 count, NDC 70594-0114-02
    • Bupivacaine solution for injection, Xellia Pharmaceuticals, 0.25%, 30 mL preservative-free vial, 1 count, NDC 70594-0115-01
    • Bupivacaine solution for injection, Xellia Pharmaceuticals, 0.25%, 50 mL multiple dose vial, 1 count, NDC 70594-0116-01
    • Bupivacaine solution for injection, Xellia Pharmaceuticals, 0.5%, 10 mL preservative-free vial, 10 count, NDC 70594-0117-02
    • Bupivacaine solution for injection, Xellia Pharmaceuticals, 0.5%, 30 mL preservative-free vial, 1 count, NDC 70594-0118-01
    • Bupivacaine solution for injection, Xellia Pharmaceuticals, 0.5%, 50 mL multiple dose vial, 1 count, NDC 70594-0119-01
    • Bupivacaine solution for injection, Xellia Pharmaceuticals, 0.75%, 10 mL preservative-free vial, 10 count, NDC 70594-0120-02
    • Bupivacaine solution for injection, Xellia Pharmaceuticals, 0.75%, 30 mL preservative-free vial, 1 count, NDC 70594-0121-01
    • Marcaine injection, Pfizer, 0.75% in 8.25% dextrose, 15 mg/2 mL ampule, 10 count, NDC 00409-1761-10
    • Bupivacaine injection, Pfizer, 0.75% in 8.25% dextrose, 15 mg/2 mL ampule, 10 count, NDC 00409-3613-01

Estimated Resupply Dates

    • Hikma has 0.25% bupivacaine 50 mL vials, 0.5% bupivacaine 50 mL vials, and 0.75% bupivacaine 30 mL preservative-free vials on allocation.

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 mangitude 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. Bupivacaine 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 November 3, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. Created November 16, 2011 by Leslie Jensen, PharmD, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. 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, with 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 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 ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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