Bupivacaine Injection Shortage

• • Marcaine solution for injection, Pfizer, 0.25%, 50 mL multiple dose vial, 1 count, NDC 00409-1587-50
  • 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
  • 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, 0.5%, 10 mL preservative-free vial, 25 count, NDC 55150-0169-10
  • 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%, 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%, 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, 0.5%, 30 mL preservative-free vial, 25 count, NDC 00409-1162-02

• • Eugia stated there is an increased demand for some of their bupivacaine products.
  • 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 most bupivacaine injection available.
  • Somerset has bupivacaine injection available.

• • 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, 0.5%, 10 mL preservative-free vial, 10 count, NDC 00409-1560-10
  • Marcaine solution for injection, Pfizer, 0.5%, 10 mL preservative-free vial, 25 count, NDC 00409-5010-25
  • 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, 25 count, NDC 00409-0525-25
  • 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%, 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%, 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, 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, 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%, 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
  • 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

• • Eugia has 0.25% and 0.5% bupivacaine 10 mL and 0.75% bupivacaine 30 mL preservative-free vials preservative-free vials on back order and the company cannot estimate a release date.
  • Hikma has 0.25% bupivacaine 50 mL vials and 0.5% bupivacaine 50 mL vials on back order and the company cannot estimate a release date. The 0.75% bupivacaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of early-June 2025 for the 10 mL vials and mid-June 2025 for the 30 mL vials.
  • Pfizer has 0.5% bupivacaine 30 mL preservative-free vials available in limited supply.
  • Pfizer has 0.25% Marcaine 50 mL vials on back order and the company estimates a release date of June 2025. The 0.75% Marcaine 10 mL and 30 mL preservative-free vials are available in limited supply.

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.