Generic Name and Formulations:
Bupivacaine 13.3mg/mL; liposome injectable suspension; preservative-free.
Pacira Pharmaceuticals, Inc.
Indications for EXPAREL:
For infiltration to produce postsurgical local analgesia. As interscalene brachial plexus nerve block to produce postsurgical regional analgesia.
For single-dose administration only. Inject slowly (usually 1–2mL per inj); perform frequent aspiration to check for blood. Local infiltration (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: max 133mg (10mL). See full labeling for administration.
<18yrs: not recommended.
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. 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. 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 20 mins 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).
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.
Single-use vial (10mL, 20mL)—4, 10