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Bupivacaine Injection

Last Updated: January 23, 2023
Status: Current

Products Affected - Description
    • 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, Hikma, 0.75%, 30 mL preservative-free vial, 10 count, NDC 00143-9335-10
    • 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 glass ampule, 25 count, NDC 00409-1158-01 - discontinued
    • 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
    • Marcaine injection, Pfizer, 0.75% in 8.25% dextrose, 15 mg/2 mL ampule, 10 count, NDC 00409-1761-02 - discontinued
    • Marcaine injection, Pfizer, 0.75% in 8.25% dextrose, 15 mg/2 mL ampule, 10 count, NDC 00409-1761-10
    • Bupivacaine injection, Baxter, 0.75% in 8.25% dextrose, 15 mg/2 mL ampule, 10 count, NDC 36000-0092-10
    • Bupivacaine injection, Pfizer, 0.75% in 8.25% dextrose, 15 mg/2 mL ampule, 10 count, NDC 00409-3613-01
Reason for the Shortage
    • AuroMedics has bupivacaine on back order due to shortage of active ingredient..
    • Baxter has 0.75% bupivacaine in 8.25% dextrose 2 mL ampules for spinal use on shortage due to manufacturing delays.
    • Fresenius Kabi had Sensorcaine on shortage due to increased demand for the product.
    • Hikma launched bupivacaine in November 2021.
    • Pfizer has bupivacaine on shortage due to manufacturing delays. Pfizer discontinued 0.5% bupivacaine 30 mL glass ampules in December 2017.
Available Products
    • Bupivacaine solution for injection, Areva, 0.25%, 10 mL ampule, 10 count, NDC 59923-0719-10
    • Bupivacaine solution for injection, Areva, 0.25%, 5 mL ampule, 10 count, NDC 59923-0717-05
    • Bupivacaine solution for injection, Areva, 0.5%, 10 mL ampule, 10 count, NDC 59923-0720-10
    • Bupivacaine solution for injection, Areva, 0.5%, 5 mL ampule, 10 count, NDC 59923-0718-05

Estimated Resupply Dates

    • Areva is temporarily importing 0.25% bupivacaine and 0.5% bupivacaine 5 mL and 10 mL ampules. FDA is allowing temporary importation of product from Italy manufactured by Areva's supplier, Fisiopharma. Details on how to obtain product and differences between the US and Italian labeling can be found at: https://www.fda.gov/files/drugs/published/BupivacaineDHCPLet033121.pdf.
    • Eugia has 0.25% bupivacaine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of February 2023. The 0.25% bupivacaine 50 mL vials are on back order and the company estimates a release date of late-January 2023. The 0.5% bupivacaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of February 2023. The 0.5% bupivacaine 50 mL vials are on back order and the company estimates a release date of late-January 2023. The 0.75% bupivacaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of February 2023.
    • Baxter has 7.5 mg/mL bupivacaine in 8.25% dextrose 2 mL ampules on back order and the company cannot estimate a release date.
    • Fresenius Kabi has 0.25% Sensorcaine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of late-January to early-February 2023 for the 10 mL vials and late-February 2023 for the 30 mL vials. The 0.25% Sensorcaine 50 mL vials are on back order and the company estimates a release date of early-February 2023. The 0.5% Sensorcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of late-January to early-February 2023 for the 10 mL vials and mid-March 2023 for the 30 mL vials. The 0.5% Sensorcaine 50 mL vials are on back order and the company estimates a release date of mid-February 2023. The 0.75% Sensorcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of mid-February 2023 for the 10 mL vials and late-February to early-March 2023 for the 30 mL vials.
    • Hikma has 0.25% bupivacaine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of late-May to early-June 2023 for the 10 mL vials and late-July to early-August 2023 for the 30 mL vials. The 0.5% bupivacaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of late-May to early-June 2023 for the 10 mL vials and late-July to early-August 2023 for the 30 mL vials. The 0.75% bupivacaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of late-May to early-June 2023 for the 10 mL vials and late-February to early-March 2023 for the 30 mL vials.
    • Pfizer has 0.25% bupivacaine 10 mL preservative-free vials are on back order and the company estimates a release date of January 2023. The 0.25% bupivacaine 10 mL preservative-free vials 30 mL vials are available in limited supply. The 0.25% bupivacaine 50 mL vials are on back order and the company estimates a release date of March 2023. The 0.5% bupivacaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of May 2023 for the 10 mL vials and June 2023 for the 30 mL vials. The 0.5% bupivacaine 50 mL vials are on back order and the company estimates a release date of April 2023. The 0.75% bupivacaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of July 2023 for the 10 mL vials and January 2023 for the 30 mL vials. The 7.5 mg/mL bupivacaine in 8.25% dextrose 2 mL ampules are on back order and the company estimates a release date of May 2023.
    • Pfizer has 0.25% Marcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of January 2023 for the 10 mL vials and July 2023 for the 30 mL vials. The 0.25% Marcaine 50 mL vials are on back order and the company estimates a release date of January 2023. The 0.5% Marcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of January 2023 for the 10 mL vials and August 2023 for the 30 mL vials. The 0.5% Marcaine 50 mL vials are on back order and the company estimates a release date of February 2023. The 0.75% Marcaine 10 mL and 30 mL vials are on back order and the company estimates a release date of January 2023 for the 10 mL vials and July 2023 for the 30 mL vials. The 7.5 mg/mL Marcaine in 8.25% dextrose 2 mL ampules are on back order and the company estimates a release date of April 2023.

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
    Property Bupivacaine Lidocaine
    * 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 Action Infiltration: 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 Dose Single 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 binding 82%-96% 60%-80%
    Volume of distribution ~2.5 L/kg 1.5 + 0.6 L/kg
    Half-life, terminal Adults: 1.5-5 h
    Neonates: 8.1 h
    Adults: 1.5-2 h
    Premature infants: 3.2 h
    Metabolism Undergoes N-dealkylation in the liver. Extensive hepatic metabolism (90%) with active metabolites.
    Elimination Excreted 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 January 23, 2023 by Michelle Wheeler, PharmD, Drug Information Specialist. Created November 16, 2011 by Leslie Jensen, PharmD, Drug Information Specialist. © 2023, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

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