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6/28/2019

Bupivacaine Injection

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, 0.5%, 50 mL multiple dose vial, 25 count, NDC 63323-0467-57
    • Sensorcaine-MPF solution for injection, Fresenius Kabi, 0.25%, 30 mL preservative-free vial, sterile pack, 25 count, NDC 63323-0464-31
    • 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%, 30 mL preservative-free vial, sterile pack, 25 count, NDC 63323-0466-31
    • Bupivacaine solution for injection, AuroMedics, 0.25%, 10 mL preservative-free vial, 25 count, NDC 55150-0167-10
    • Bupivacaine solution for injection, AuroMedics, 0.25%, 30 mL preservative-free vial, 25 count, NDC 55150-0168-30
    • Bupivacaine solution for injection, AuroMedics, 0.5%, 10 mL preservative-free vial, 25 count, NDC 55150-0169-10
    • Bupivacaine solution for injection, AuroMedics, 0.5%, 30 mL preservative-free vial, 25 count, NDC 55150-0170-30
    • Bupivacaine solution for injection, AuroMedics, 0.75%, 10 mL preservative-free vial, 25 count, NDC 55150-0171-10
    • Bupivacaine solution for injection, AuroMedics, 0.75%, 30 mL preservative-free vial, 25 count, NDC 55150-0172-30
    • 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%, 20 mL glass ampule, sterile pack, 5 count, NDC 00409-4272-01 - discontinued
    • 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%, 20 mL glass ampule, sterile pack, 5 count, NDC 00409-4273-01 - discontinued
    • Bupivacaine solution for injection, Pfizer, 0.5%, 30 mL glass ampule, 25 count, NDC 00409-1161-01 - discontinued
    • 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%, 30 mL preservative-free vial, 25 count, NDC 00409-1165-02

Reason for the Shortage

    • AuroMedics has not provided a reason for the shortage.
    • Fresenius Kabi had Sensorcaine on shortage due to increased demand for the product.
    • Pfizer has bupivacaine on shortage due to manufacturing delays. Pfizer discontinued 0.5% bupivacaine 30 mL glass ampules in December 2017.

Available Products

    • Sensorcaine solution for injection, Fresenius Kabi, 0.25%, 50 mL multiple dose vial, 25 count, NDC 63323-0465-57
    • 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, 0.5%, 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, Pfizer, 0.75%, 10 mL preservative-free vial, 25 count, NDC 00409-1165-01
    • Marcaine injection, Pfizer, 0.75% in 8.25% dextrose, 15 mg/2 mL ampule, 10 count, NDC 00409-1761-02
    • 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

Estimated Resupply Dates

    • AuroMedics has 0.25% bupivacaine 10 mL and 30 mL preservative-free vials on intermittent back order and the company is releasing product as it becomes available. The 0.5% bupivacaine 10 mL and 30 mL preservative-free vials are on intermittent back order and the company is releasing product as it becomes available. The 0.75% bupivacaine 10 mL and 30 mL preservative-free vials are on intermittent back order and the company is releasing product as it becomes available.
    • Fresenius Kabi has 0.25% Sensorcaine 30 mL preservative-free vials on back order and the company estimates a release date of mid-July 2019. The 0.5% Sensorcaine 50 mL vials are on back order and the company estimates a release date of mid-July 2019. The 0.25% and 0.5% Sensorcaine 30 mL preservative-free vials in sterile packs are on back order and the company cannot estimate release dates.
    • Pfizer has 0.25% bupivacaine 10 mL preservative-free vials on back order and the company estimates a release date of July 2019. The 0.25% bupivacaine 30 mL preservative-free vials are on back order and the company estimates a release date of July 2019. The 0.25% bupivacaine 50 mL vials are on back order and the company estimates release dates of August 2019. The 0.5% bupivacaine 10 mL preservative-free vials are on back order and the company estimates a release date of December 2019. The 0.5% bupivacaine 30 mL preservative-free vials are available in limited supply. The 0.5% bupivacaine 50 mL vials are on back order and the company estimates a release date of August 2019. The 0.75% bupivacaine 30 mL preservative-free vials are on back order and the company estimates a release date of September 2019.
    • Pfizer has 0.25% Marcaine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of December 2019 for the 10 mL vials and September 2019 for the 30 mL vials. The 0.25% 50 mL vials are on back order and the company estimates a release date of January 2020. The 0.5% Marcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of November 2019 for the 10 mL vials and January 2020 for the 30 mL vials. The 0.5% 50 mL vials are on back order and the company estimates a release date of October 2019. The 0.75% Marcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of January 2020.

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 June 28, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. Created November 16, 2011 by Leslie Jensen, 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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