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Bupivacaine Injection

Last Updated: November 30, 2018
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, 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%, 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, 0.5%, 30 mL preservative-free vial, sterile pack, 25 count, NDC 63323-0466-31
    • 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, 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
    • Bupivacaine solution for injection, Pfizer, 0.25%, 30 mL glass ampule, 25 count, NDC 00409-1158-01
    • 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%, 20 mL glass ampule, sterile pack, 5 count, NDC 00409-4273-01
    • Bupivacaine solution for injection, Pfizer, 0.5%, 30 mL glass ampule, 25 count, NDC 00409-1161-01
    • 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
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
    • Marcaine injection, Pfizer, 0.75% in 8.25% dextrose, 15 mg/2 mL ampule, 10 count, NDC 00409-1761-02
    • Bupivacaine injection, Baxter (formerly Claris), 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 10 mL preservative-free vials on back order and the company estimates a release date of mid-December 2018. The 0.25% 30 mL preservative-free vials are on back order and the company estimates a release date of early-December 2018. The 0.25% 50 mL vials are on back order and the company estimates a release date of early-December 2018. The 0.5% Sensorcaine 10 mL preservative-free vials are on back order and the company estimates release dates of mid-December 2018. The 0.5% Sensorcaine 30 mL preservative-free vials are on back order and the company estimates release dates of mid-December 2018. The 0.5% Sensorcaine 50 mL vials are on back order and the company estimates a release date of mid-December 2018. The 0.75% 10 mL preservative-free vials are on back order and the company estimates a release date of early- December 2018. The 0.75% 30 mL preservative-free vials are on back order and the company estimates a release date of early-January 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 and 30 mL preservative-free vials on back order and the company estimates a release date of December 2018 for the 10 mL vials and 1st quarter 2019 for the 30 mL vials. The 0.25% bupivacaine 50 mL vials are on back order and the company estimates release dates of December 2018. The 0.5% bupivacaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of December 2018. The 0.5% bupivacaine 50 mL vials are on back order and the company estimates a release date of 1st quarter 2019. The 0.75% bupivacaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of January 2019.
    • Pfizer has all Marcaine vials on back order and the company estimates a release date of 1st quarter 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
    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 November 30, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. Created November 16, 2011 by Leslie Jensen, PharmD, Drug Information Specialist. Copyright 2018, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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