Bupivacaine
Generic Name: bupivacaine
Brand Names:
Exparel
11 DESCRIPTION EXPAREL (bupivacaine liposome injectable suspension) is a sterile, non-pyrogenic white to off-white preservative-free aqueous suspension consisting of multivesicular liposomes containing bupivacaine. Bupivacaine is present at a concentration of 13.3 mg/mL. After injection of EXPAREL, bupivacaine is released from the multivesicular liposomes. EXPAREL is for infiltration or perineural use.
Overview
11 DESCRIPTION EXPAREL (bupivacaine liposome injectable suspension) is a sterile, non-pyrogenic white to off-white preservative-free aqueous suspension consisting of multivesicular liposomes containing bupivacaine. Bupivacaine is present at a concentration of 13.3 mg/mL. After injection of EXPAREL, bupivacaine is released from the multivesicular liposomes. EXPAREL is for infiltration or perineural use.
Uses
1 INDICATIONS AND USAGE EXPAREL is indicated to produce postsurgical: Local analgesia via infiltration in patients aged 6 years and older Regional analgesia via an interscalene brachial plexus nerve block in adults Regional analgesia via a sciatic nerve block in the popliteal fossa in adults Regional analgesia via an adductor canal block in adults EXPAREL contains bupivacaine, an amide local anesthetic, and is indicated to produce postsurgical: Local analgesia via infiltration in patients aged 6 years and older ( 1 ). Regional analgesia via an interscalene brachial plexus nerve block in adults ( 1 ). Regional analgesia via a sciatic nerve block in the popliteal fossa in adults ( 1 ). Regional analgesia via an adductor canal block in adults ( 1 ).
Dosage
2 DOSAGE AND ADMINISTRATION EXPAREL is for single administration only ( 2.1 ). EXPAREL is not substitutable with other bupivacaine products even if the strength is the same. Therefore, it is not possible to convert a dose from other bupivacaine products to an EXPAREL dose and vice versa ( 2.1 , 2.5 ). Do not dilute EXPAREL with water or other hypotonic solutions ( 2.1 ). The recommended dose of EXPAREL for: Local infiltration in adults is up to a maximum dose of 266 mg. See Full Prescribing Information for guidance on dose selection ( 2.2 ). Local infiltration in pediatric patients aged 6 to less than 17 years is 4 mg/kg, up to a maximum of 266 mg ( 2.2 ). Interscalene brachial plexus nerve block in adults is 133 mg ( 2.3 ).
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions have been associated with bupivacaine hydrochloride in clinical trials and are described in greater detail in other sections of the labeling: Central Nervous System Reactions [see Warnings and Precautions (5.1) ] Cardiovascular System Reactions [see Warnings and Precautions (5.1) ] Allergic Reactions [see Warnings and Precautions (5.1) ] Chondrolysis [see Warnings and Precautions (5.1) ] Methemoglobinemia [see Warnings and Precautions (5.1) ] Accidental intravascular injection [see Warnings and Precautions (5.2) ] Adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via: Infiltration in adults were nausea, constipation, and vomiting ( 6.1 ).
Interactions
7 DRUG INTERACTIONS The toxic effects of local anesthetics are additive and concomitant use should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic toxicity [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) , and Overdosage (10) ] . Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL.
Warnings
5 WARNINGS AND PRECAUTIONS Monitor cardiovascular status, neurological status, and vital signs during and after injection of EXPAREL ( 5.1 ). 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 ( 5.1 ). Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use ( 5.1 ). Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL ( 5.2 ). 4 CONTRAINDICATIONS EXPAREL is contraindicated in obstetrical paracervical block anesthesia [see Use in Specific Populations (8.1) ]. While EXPAREL has not been tested with this technique, the use of bupivacaine HCl with this technique has resulted in fetal bradycardia and death. EXPAREL is contraindicated in obstetrical paracervical block anesthesia ( 4 ).
Pregnancy
8.1 Pregnancy Risk Summary There are no studies conducted with EXPAREL in pregnant women. In animal reproduction studies, embryo-fetal deaths were observed with subcutaneous administration of bupivacaine to rabbits during organogenesis at a dose equivalent to 1.6 times the maximum recommended human dose (MRHD) of 266 mg. Subcutaneous administration of bupivacaine to rats from implantation through weaning produced decreased pup survival at a dose equivalent to 1.5 times the MRHD [see Data ] . Based on animal data, advise pregnant women of the potential risks to a fetus.
Storage
Storage Store EXPAREL vials refrigerated between 2°C to 8°C (36°F to 46°F). EXPAREL may be held at a controlled room temperature of 20°C to 25°C (68°F to 77°F) for up to 30 days in sealed, intact (unopened) vials. Do not re-refrigerate vials. Do not freeze or expose EXPAREL to high temperatures (greater than 40°C or 104°F) for an extended period.
Frequently Asked Questions
What is Bupivacaine used for?▼
1 INDICATIONS AND USAGE EXPAREL is indicated to produce postsurgical: Local analgesia via infiltration in patients aged 6 years and older Regional analgesia via an interscalene brachial plexus nerve block in adults Regional analgesia via a sciatic nerve block in the popliteal fossa in adults Regional analgesia via an adductor canal block in adults EXPAREL contains bupivacaine, an amide local anesthetic, and is indicated to produce postsurgical: Local analgesia via infiltration in patients aged 6 years and older ( 1 ). Regional analgesia via an interscalene brachial plexus nerve block in adults ( 1 ). Regional analgesia via a sciatic nerve block in the popliteal fossa in adults ( 1 ). Regional analgesia via an adductor canal block in adults ( 1 ).
What are the side effects of Bupivacaine?▼
6 ADVERSE REACTIONS The following serious adverse reactions have been associated with bupivacaine hydrochloride in clinical trials and are described in greater detail in other sections of the labeling: Central Nervous System Reactions [see Warnings and Precautions (5.1) ] Cardiovascular System Reactions [see Warnings and Precautions (5.1) ] Allergic Reactions [see Warnings and Precautions (5.1) ] Chondrolysis [see Warnings and Precautions (5.1) ] Methemoglobinemia [see Warnings and Precautions (5.1) ] Accidental intravascular injection [see Warnings and Precautions (5.2) ] Adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via: Infiltration in adults were nausea, constipation, and vomiting ( 6.1 ).
Can I take Bupivacaine during pregnancy?▼
8.1 Pregnancy Risk Summary There are no studies conducted with EXPAREL in pregnant women. In animal reproduction studies, embryo-fetal deaths were observed with subcutaneous administration of bupivacaine to rabbits during organogenesis at a dose equivalent to 1.6 times the maximum recommended human dose (MRHD) of 266 mg. Subcutaneous administration of bupivacaine to rats from implantation through weaning produced decreased pup survival at a dose equivalent to 1.5 times the MRHD [see Data ] . Based on animal data, advise pregnant women of the potential risks to a fetus.
What are the important warnings for Bupivacaine?▼
5 WARNINGS AND PRECAUTIONS Monitor cardiovascular status, neurological status, and vital signs during and after injection of EXPAREL ( 5.1 ). 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 ( 5.1 ). Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use ( 5.1 ). Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL ( 5.2 ). 4 CONTRAINDICATIONS EXPAREL is contraindicated in obstetrical paracervical block anesthesia [see Use in Specific Populations (8.1) ]. While EXPAREL has not been tested with this technique, the use of bupivacaine HCl with this technique has resulted in fetal bradycardia and death. EXPAREL is contraindicated in obstetrical paracervical block anesthesia ( 4 ).
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.