Adult Dosing

Postsurgical analgesia-Bunionectomy (Recommended dose based on surgical site and volume required to cover the area)

• 106 mg (8 mL) once via infiltration of surgical site; Infiltrate 7 mL into tissues surrounding osteotomy and 1 mL into subcutaneous tissue

Postsurgical analgesia-Hemorrhoidectomy

• 266 mg (20 mL) once via infiltration of surgical site
• Dilute 20 mL with 10 mL of saline, for a total of 30 mL, and divide the mixture into six 5 mL aliquots
• Perform the anal block by visualizing the anal sphincter as a clock face and slowly infiltrating one aliquot to each of the even numbers

Note:

• Inject slowly into soft tissue via infiltration surgical site with frequent aspiration to check for blood and minimize the risk of intravascular injection
• For single-dose infiltration only
• Do not administer if product discolored
• Do not administer if the vial has been frozen as reflected by the temperature indicator or exposed to high temperature (>40°C or 104°F) for an extended period
• Max: 266 mg

Pediatric Dosing

• Safety and effectiveness in pediatric patients below the age of 18 have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Postsurgical analgesia

• Hypersensitivity to any of the ingredients of the product
• Obstetrical paracervical block anesthesia

Renal Dose Adjustment

• Renal impairment: Risk of toxicity; use with caution; dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Risk of developing toxic plasma concentrations; use with caution; dose adjustments not defined

• The safety and effectiveness of bupivacaine and other amide-containing products depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Administer in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurological or cardiac toxicity
• There is a potential risk of severe life-threatening adverse effects associated with the administration of bupivacaine, any bupivacaine-containing product
• Closely monitor patients for cardiovascular and respiratory (adequacy of ventilation) vital signs. Monitor the patient’s state of consciousnes after injection of bupivacaine and other amide-containing products
• Patients may have symptoms of of central nervous system toxicity such as restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness
• Use cautiously in patients with impaired cardiovascular function because bupivacaine may be less able to compensate for functional changes associated with the prolongation of AV conduction produced by these drugs
• Multiple doses of bupivacaine may cause significant increases in plasma concentrations
• Use cautiously in patients with hepatic disease as the drug is metabolized by the liver
• Patients with severe hepatic disease are at a greater risk of developing toxic plasma concentrations. Toxic blood concentrations depress cardiac conductivity and excitability, which may lead to atrioventricular block, ventricular arrhythmias, and cardiac arrest, sometimes resulting in fatalities
• Patients may experience neurologic effects following infiltration of soft tissue such as persistent anesthesia, paresthesias, weakness, and paralysis, all of which may have slow, incomplete, or no recovery
• Allergic reactions characterized by signs such as urticaria, pruritus, erythema, angioneurotic edema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly anaphylactoid-like symptoms (including severe hypotension) may occur as a result of hypersensitivity to the local anesthetics
• Chondrolysis has occurred in patients receiving intraarticular infusions of local anesthetics; occurrence of joint pain, stiffness and loss of motion may begin as early as the 2nd month after surgery
• Provide additional diagnostic and therapeutic procedures, arthroplasty or shoulder replacement for patients experiencing chondrolysis
• Use caution to avoid accidental intravascular injection. Convulsions and cardiac arrest have occurred following accidental intravascular injection of bupivacaine and other amide-containing products
• Other preparations of bupivacaine should not be administered within 96 hours following administration

Pregnancy Category:C

Breastfeeding: Bupivacaine is excreted in breastmilk in small amounts. However, since it is not absorbed orally, amounts received by the infants are small and would not cause any adverse effects in breastfed infants. May interfere with breastfeeding if administered with anesthetics and analgesics. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 13 August 2013). Manufacturer advises caution.

• CNS: Excitation, depression, drowsiness, restleness, seizures, anxiety, dizziness, headache, tremors, incoherent speech, irritability, unconsciousness, convulsions, syncope, loss of sphincter control, septic meningitis; meningismus, cranial nerve palsies, lightheadedness, numbness, twitching, tingling of the mouth and lips
• GI: Nausea, vomiting, constipation, anal hemorrhage, painful defecation, rectal discharge, decreased appetite, metallic taste
• EENT: Blurred vision, tinnitus, constriction of the pupils
• GU: Urinary retention
• CV: Cardiovascular collapse, ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia bradycardia, hypotension, decreased cardiac output, heart block, cardiac arrest, angioneurotic edema, myocardial depression, severe hypotension
• RESP: Respiratory arrest
• NEURO: Persistent anesthesia, paresthesia, weakness, paralysis
• DERM: Pruritus, urticaria, erythema, excessive sweating
• LAB TESTS: Alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased

• Local anesthetic; blocks both the initiation and conduction of nerve impulses reducing the permeability of neuronal membranes to Na ions and increasing the threshold for electrical excitation in the nerves, resulting in inhibition of depolarization with resultant blockade of conduction
• Rapid onset of action
• Metabolized by liver
• Excreted in urine 6% (unchanged)
• Half-life: Unknown

US Trade Name(s)

• Exparel

US Availability

Exparel

• INJ: 13.3 mg/mL (20 mL vials)

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Anesthesia

Neuromuscular Blocking Agents