AHFS Class:

72:00 Local Anesthetics

Generic Name

• BUPivacaine Hydrochloride

Bupivacaine hydrochloride is available in concentrations of 0.25, 0.5, and 0.75% (2.5, 5, and 7.5 mg/mL, respectively) in 10- and 30-mL single-dose (preservative-free) vials along with sodium chloride for isotonicity and sodium hydroxide and/or hydrochloric acid for pH adjustment.³⁷⁶¹; ³⁷⁶² The 0.25 and 0.5% concentrations also come in 50-mL multiple-dose vials with methylparaben 1 mg/mL as a preservative.³⁷⁶¹; ³⁷⁶²

Bupivacaine hydrochloride also is available in concentrations of 0.25, 0.5, and 0.75% with epinephrine 1:200,000 as the bitartrate in 10- and 30-mL single-dose (preservative-free) vials along with sodium chloride for isotonicity and sodium hydroxide and/or hydrochloric acid for pH adjustment.³⁷⁶¹; ³⁷⁶² The 0.25 and 0.5% concentrations also come in 50-mL multiple-dose vials with methylparaben 1 mg/mL as a preservative.³⁷⁶¹; ³⁷⁶² In addition to bupivacaine hydrochloride, each mL contains epinephrine bitartrate 0.0091 mg (equivalent to epinephrine 0.005 mg).³⁷⁶¹; ³⁷⁶² Other components may be present in some formulations including sodium metabisulfite, sodium lactate, ascorbic acid, edetate calcium disodium, monothioglycerol, and/or citric acid monohydrate.³⁷⁶¹; ³⁷⁶²

A hyperbaric solution of bupivacaine hydrochloride is available in 2-mL ampuls.³⁷⁶³ Each mL contains bupivacaine hydrochloride 7.5 mg and dextrose 82.5 mg (8.25%) with sodium hydroxide or hydrochloric acid to adjust the pH.³⁷⁶³

CAUTION: Care should be taken to ensure that the correct drug product, dose, and administration procedures are used and that no confusion with other products occurs.

pH

Bupivacaine hydrochloride injection and the hyperbaric solution have a pH of 4 to 6.5.³⁷⁶¹; ³⁷⁶²; ³⁷⁶³

Bupivacaine hydrochloride with epinephrine 1:200,000 has a pH of 3.3 to 5.5 (Sensorcaine with epinephrine, Fresenius Kabi) or 3.4 to 4.5 (Marcaine with epinephrine, Hospira).³⁷⁶¹; ³⁷⁶²

Specific Gravity

The hyperbaric solution has a specific gravity of 1.030 to 1.035 at 25°C and 1.03 at 37°C.³⁷⁶³

Trade Name(s)

Marcaine, Sensorcaine, Sensorcaine-MPF

Bupivacaine hydrochloride may be administered by local infiltration or local or epidural injection as a single injection or repeat injections.³⁷⁶¹; ³⁷⁶² Bupivacaine hydrochloride hyperbaric solution is administered intrathecally.³⁷⁶³ Injections should be made slowly, with frequent aspirations to guard against intravascular injection.³⁷⁶¹; ³⁷⁶²; ³⁷⁶³ For epidural administration (e.g., lumbar or caudal epidural block), preservative-free formulations should be used; products containing preservatives should not be administered by these routes.³⁷⁶¹; ³⁷⁶²

CAUTION: Care should be taken to ensure that the correct drug product, dose, and administration procedures are used and that no confusion with other products occurs.

Bupivacaine hydrochloride injections should be stored at controlled room temperature.³⁷⁶¹; ³⁷⁶²; ³⁷⁶³ Products containing epinephrine should be protected from light.³⁷⁶¹; ³⁷⁶² Single-dose vials contain no preservative; unused portions should be discarded³⁷⁶¹; ³⁷⁶²; ³⁷⁶³

Bupivacaine hydrochloride should not be used if a pinkish or darker than slightly yellow color develops or if particulate matter is present.³⁷⁶²

Autoclaving

Bupivacaine hydrochloride without epinephrine and the hyperbaric solution may be autoclaved at 121°C and 15 psi for 15 minutes.³⁷⁶¹; ³⁷⁶²; ³⁷⁶³ Products containing epinephrine should not be autoclaved.³⁷⁶¹; ³⁷⁶²

Syringes

The stability of bupivacaine (salt form unspecified) 5 mg/mL repackaged in polypropylene syringes was evaluated. Little or no change in concentration was found after four weeks of storage at room temperature not exposed to direct light.²¹⁶⁴

Bupivacaine hydrochloride (Astra) 1 mg/mL in sodium chloride 0.9% was packaged in two types in polypropylene syringes. The Omnifix (B. Braun) syringes had polyisoprene piston tips while the Terumo syringes had no natural or synthetic rubber in the product. Stored at 4, 21, and 35°C for 30 days, the test solutions exhibited no visible or pH changes. Although the pH remained within the stability range for the drug, this does not demonstrate stability.²³⁸⁷

Ambulatory Pumps

Bupivacaine hydrochloride (Astra) 7.5 mg/mL was filled into 50-mL ambulatory pump cassette reservoirs (Pharmacia Deltec) and stored at room temperature protected from light for 90 days. The drug concentration increased 12% during the observation period, possibly because of loss of water from the solutions.¹⁸⁵⁰

Implantable Pumps

Bupivacaine hydrochloride 7.5 mg/mL in dextrose 8.25% (Marcaine spinal) stability was evaluated in SynchroMed implantable pumps over 12 weeks at 37°C. Little or no loss of bupivacaine hydrochloride and no adverse effects on the pumps occurred.²⁵⁸³

An admixture of bupivacaine hydrochloride 25 mg/mL, clonidine hydrochloride 2 mg/mL, and morphine sulfate 50 mg/mL in sterile water for injection was reported to be physically and chemically stable for 90 days at 37°C in SynchroMed implantable pumps. Little or no loss of any of the drugs occurred.²⁵⁸⁵

Standardize 4 Safety

One or more standardized concentrations for this drug have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care. (See Standardize 4 Safety in Users Guide.) Recommendations developed to date through this initiative are available at www.ashp.org/pharmacy-practice/standardize-4-safety-initiative.

Table 1: Standardize 4 Safety Epidural Standard Concentrations for Bupivacaine as a Single Drug³⁹⁹⁰

Table 2: Standardize 4 Safety ADULT Epidural Combination Drug Standard Concentrations for Bupivacaine³⁹⁹⁰

Table 3: Standardize 4 Safety PEDIATRIC (50 kg) Epidural Combination Drug Standard Concentrations for Bupivacaine³⁹⁹⁰

Solution Compatibility

Additive Compatibility

Drugs in Syringe Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions September 12, 2024. © Copyright, 2024. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.