Indications for EXPAREL:
For infiltration to produce postsurgical local analgesia in patients aged ≥6yrs. As interscalene brachial plexus nerve block to produce postsurgical regional analgesia in adults.
Limitations of Use:
Safety and efficacy have not been established in other nerve blocks.
Adults and Children:
<6yrs for infiltration and <18yrs for regional nerve block: not recommended. For single-dose administration only. Inject slowly (usually 1–2mL per inj); perform frequent aspiration to check for blood. Local infiltration (6–17yrs): 4mg/kg; (≥18yrs; base dose on surgical site and volume required to cover area): up to max 266mg (20mL); bunionectomy: 106mg (8mL); hemorrhoidectomy: 266mg (20mL). Regional nerve block (≥18yrs): max 133mg (10mL). See full labeling for administration.
Obstetrical paracervical block.
Not interchangeable with other forms of bupivacaine. Avoid intravascular, intra-articular, intrathecal, epidural, or other regional nerve blocks. To be administered under the supervision of experienced clinicians. Cardiovascular disease. Increased risk of methemoglobinemia in G6PD deficiency, congenital/idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants <6mos; monitor and discontinue if occurs. Potential temporary sensory and/or motor loss lasting up to 5 days. Renal or moderate to severe hepatic impairment (monitor for toxicity). Monitor neurologic, cardiovascular and respiratory vital signs. Elderly. Pregnancy: not recommended. Nursing mothers.
Local anesthetic (amide-type).
Do not dilute with water or hypotonic agents (may result in disruption of liposomal particles). Do not mix with lidocaine or other non-bupivacaine-based local anesthetics. Avoid additional local anesthetics within 96hrs following administration of Exparel. May administer after at least 20mins following local administration of lidocaine. Bupivacaine HCl, when injected immediately before or admixed with Exparel, may impact the pharmacokinetic and/or physicochemical properties of the drugs; may be admixed simultaneously or inject bupivacaine HCl immediately before Exparel as long as the mg dose ratio of bupivacaine HCl to Exparel does not exceed 1:2. Avoid contact with antiseptics (eg, povidone iodine). Increased risk of methemoglobinemia with concomitant other local anesthetics, acetaminophen, sulfonamides, nitrates, phenytoin, phenobarbital; see full labeling.
Nausea, constipation, vomiting, pyrexia; CNS effects (eg, excitation, depression, restlessness, anxiety, dizziness, tinnitus, blurred vision, tremors), cardiovascular effects (eg, decreased cardiac output, AV block, ventricular arrhythmias, cardiac arrest), allergic-type reactions, neurologic effects (eg, paresthesia, weakness, paralysis), chondrolysis.
Generic Drug Availability:
Single-use vial (10mL, 20mL)—4, 10