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Exparel
EXPAREL can be administered via infiltration, interscalene brachial plexus nerve block, and fascial plane blocks to provide long-lasting non-opioid pain control.
Pacira Biosciences
Pacira Biosciences
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EXPAREL is available in two doses: 266 mg (20 mL) and 133 mg (10 mL). To ensure optimal analgesic coverage, the volume should be expanded for larger surgical sites. To attain early analgesic onset, bupivacaine HCl can be administered immediately before EXPAREL or admixed in the same syringe as part of the total expanded volume.
The recommended dose of EXPAREL is based on the size of the surgical site, volume required to cover the area, and individual patient factors that may impact the safety of an amide local anesthetic
Maximum dose should not exceed 266 mg (20 mL)
Dosing for EXPAREL in patients under 17 is weight based: 4 mg/kg
The 133 mg (10 mL) dose is appropriate for procedures such as*
- Facial/plastic
- Foot
- Hand
- Oral/maxillofacial
EXPAREL is indicated for single-dose infiltration in patients aged 6 years and older to produce postsurgical local analgesia and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks.
EXPAREL is contraindicated in obstetrical paracervical block anesthesia.
Monitor cardiovascular status, neurological status, and vital signs during and after injection of EXPAREL. • Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, use EXPAREL cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. • Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use. • Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL.
• Lidocaine or other non-bupivacaine local anesthetics: Do not admix with EXPAREL. EXPAREL may be administered at least 20 minutes or more following local administration of lidocaine. • Bupivacaine HCl: Do not exceed a milligram dose of bupivacaine HCl solution to EXPAREL of 1:2 when admixing, as this may impact the pharmacokinetics and/or physicochemical properties of the drugs. • Do not dilute EXPAREL with water or other hypotonic agents, as it will result in disruption of the liposomal particles.
USE IN SPECIFIC POPULATIONS • Pregnancy: May cause fetal harm.
Adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via infiltration in adults were nausea, constipation, and vomiting. Adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via nerve block in adults were nausea, pyrexia, and constipation. Adverse reactions with an incidence greater than or equal to 10% following EXPAREL administration via infiltration in pediatric patients six to less than 17 years of age were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia. To report SUSPECTED ADVERSE REACTIONS, contact Pacira Pharmaceuticals, Inc. at 1-855-RX-EXPAREL (1-855-793-9727) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.