Usual Adult Dose for Pain

Local Analgesia via Infiltration:

• Dose will be dependent on size of surgical site, volume required to cover area, and individual patient factors that may impact the safety of an amide local anesthetic.
• Maximum infiltration dose: 266 mg (20 mL)

Regional Analgesia via Interscalene Branchial Plexus Nerve Block:

• Based upon study of patients undergoing total shoulder arthroplasty or rotator cuff repair: 133 mg (10 mg)

Maximum dose for interscalene brachial plexus nerve block: 133 mg (10 mg)

Comments:

• This drug has not been evaluated for the following uses and, therefore, is not recommended for epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, and intravascular or intra-articular use.
• Different formulations of bupivacaine are not bioequivalent.

Uses: For single-dose infiltration to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.

Renal Dose Adjustments

Caution is recommended; risk of toxic reactions may be greater in patients with impaired renal function

Liver Dose Adjustments

Mild hepatic impairment: Use with caution
Moderate to severe hepatic impairment: Consider increased monitoring for local anesthetic systemic toxicity

Dose Adjustments

Dosing Examples for Local Analgesia via Infiltration:

• BUNIONECTOMY: A total of 106 mg (8 mL) administered as 7 mL infiltrated into the tissues surrounding the osteotomy and 1 mL infiltrated into the subcutaneous tissue.
• HEMORRHOIDECTOMY: A total of 266 mg (20 mL) diluted with 10 mL of saline (30 mL total) divided into six 5 mL aliquots and injected by visualizing the anal sphincter as a clock face and slowly infiltrating one 5 mL aliquot into each of the even numbers to produce a field block.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For single-dose administration only
• Inject slowly (generally 1 to 2 mL per injection) with frequent aspiration to check for blood and minimize the risk of intravascular injection
• May administer undiluted or may dilute suspension to increase injection volume; final concentration should not exceed 0.89 mg/mL (i.e., 1:14 dilution by volume)
• Administer with a 25 gauge or larger bore needle to maintain the structural integrity of the liposomal particles
• The potential sensory and/or motor loss will vary depending on site of injection and dose administered; may last up to 5 days

Reconstitution/preparation techniques:

• Dilute with preservative-free normal saline or lactated Ringer's solution if desired to increase volume (up to 0.89 mg/mL)
• Do not dilute with water for injection or other hypotonic agents as this will result in disruption of the liposomal particles
• Do not filter; do not heat before use; do not autoclave
• Vials should be inverted multiple times to re-suspend the particles immediately prior to withdrawal from the vial

Storage requirements:

• Store between 2C and 8C (36F and 46F); may be held at 20C to 25C (68 to 77F) for up to 30 days in sealed, unopened vials, but vials should not be re-refrigerated
• Following withdrawal from the vial, store at 20C to 25C (68F to 77F) for up to 4 hours
• Do not freeze or expose to high temperatures (greater than 40C or 104F); do not use if vial has been frozen or exposed to high temperatures; do not use if vial stopper is bulging

IV compatibility:

• Admixing this drug with certain other drugs may result in a rapid increase in free (unencapsulated) bupivacaine, therefore, admixing prior to administration is not recommended
• Non-bupivacaine based local anesthetics, including lidocaine, may cause an immediate release of liposomal bupivacaine if administered together locally; wait 20 minutes or more to administer liposomal bupivacaine following lidocaine
• Bupivacaine HCl administered with liposomal bupivacaine may affect the release of liposomal bupivacaine in a concentration dependent manner; these agents may be administered simultaneously (either in the same syringe or bupivacaine HCL immediately before the bupivacaine liposomal) if the bupivacaine HCl to bupivacaine liposomal milligram dose ratio does not exceed 1:2 bupivacaine HCl to bupivacaine liposomal
• This drug should not come into contact with antiseptics such as povidone iodine in solution; allow site to dry before drug administration

General:

• Dose is based on size of surgical site, volume required to cover the area, individual patient factors that may impact the safety of an amide local anesthetic, and a maximum dose of 266 mg.
• Different formulations of bupivacaine are not bioequivalent even if the milligram strength is the same; it is not possible to convert dosing from any other bupivacaine formulations to this drug.

Monitoring: Perform careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient's state of consciousness after injection of this drug.

Patient advice:

• Advise pregnant women of the potential risks to a fetus.
• Inform patients that this drug can cause temporary loss of sensation or motor activity.