Bupivacaine

Pharmacologic Category

Local Anesthetic

Dosing: Adult

Note: Dose varies with procedure, depth of anesthesia, vascularity of tissues, duration of anesthesia, and condition of patient. Do not use solutions containing preservatives for caudal or epidural block.

Local anesthesia: Infiltration: 0.25% infiltrated locally; maximum: 175 mg. Note: Aspiration should be performed prior to each injection; however, absence of blood in the syringe does not guarantee that intravascular injection has been avoided (Mulroy 2010).

Caudal block (preservative free): 15 to 30 mL of 0.25% or 0.5%

Epidural block (other than caudal block; preservative free): Administer in 3 to 5 mL increments, allowing sufficient time to detect toxic manifestations of inadvertent IV or intrathecal administration: 10 to 20 mL of 0.25% or 0.5%

Surgical procedures requiring a high degree of muscle relaxation and prolonged effects only: 10 to 20 mL of 0.75% (Note: Not to be used in obstetrical cases)

Peripheral nerve block: 5 mL of 0.25% or 0.5%; maximum: 400 mg/day

Sympathetic nerve block: 20 to 50 mL of 0.25%

Retrobulbar anesthesia: 2 to 4 mL of 0.75%

Spinal anesthesia: Preservative free solution of 0.75% bupivacaine in 8.25% dextrose:

Lower extremity and perineal procedures: 1 mL

Lower abdominal procedures: 1.6 mL

Normal vaginal delivery: 0.8 mL (higher doses may be required in some patients)

Cesarean delivery: 1 to 1.4 mL

Combined spinal-epidural (CSE) technique for labor analgesia (off-label dosing [spinal component]): 1.75 to 2.5 mg combined with fentanyl 15 mcg (Eltzschig 2003; Ngan Kee 2014; Whitty 2007).

Combined spinal-epidural (CSE) technique for anesthesia for Cesarean delivery (off-label dosing [spinal component]): 9 to 12 mg combined with fentanyl 15 mcg; in addition to fentanyl, may also include a longer-acting opioid (ie, morphine 100 to 150 mcg) for postoperative analgesia (Santos 2015).

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Dosing: Pediatric

Note: Dose varies with procedure, depth of anesthesia, vascularity of tissues, duration of anesthesia, and condition of patient. Preservative-free formulations are recommended for administration into the CNS space (eg, epidural, caudal, spinal). Consider incremental administration with negative aspiration prior to each injection; however, absence of blood in the syringe does not guarantee that intravascular injection has been avoided (Mulroy 2010). Should only be administered under the supervision of a qualified physician experienced in the use of anesthetics. In obese pediatric patients, the preferred weight used for dose calculation is undefined and specific pediatric data are sparse (Lerman 2018; Nafiu 2018); some have suggested the use of lean body mass/weight not ideal body weight (IBW) (Coté 2018).

Central nerve block/anesthesia:

Caudal block: Reported dosing variable based on procedure; dependent on necessary dermatome level and corresponding volume of space:

Infants and Children: Limited data available: Usual concentration ≤0.25% solution with or without epinephrine: Usual reported dose range: 0.5 to 1.3 mL/kg (maximal volume of drug: 20 mL); dose should not exceed 2 mg/kg plain solution, or 3 mg/kg with epinephrine. In infants, routine use of concentrations ≤0.25% have been suggested to reduce risk of bupivacaine cardiotoxicity (Coté 2013; Ingelmo 2007; Ivani 1998; Ivani 2002; Karkera 2016; Miller 2015; Payne 1993; Schrock 2003; Schwartz 2010).

Adolescents: Usual concentration 0.25 to 0.5% solution with or without epinephrine: 15 to 30 mL (manufacturer's labeling).

Epidural block: Reported dosing variable; among other factors, dose dependent on necessary dermatome level and corresponding volume of epidural space (Coté 2013):

Infants: Limited data available: Usual concentration ≤0.25% with or without epinephrine: 0.7 to 0.75 mL/kg; maximum dose: 2.5 mg/kg; Note: For infants (particularly young infants), if repeat injections necessary, a decreased dose may be necessary to prevent drug accumulation. Some experts suggest if at least 45 minutes since initial dose, reduce dose to 1/3 of the initial or if at least 90 minutes since initial dose, then reduce dose to half of the initial. If additional doses are necessary, doses should be reduced to half of the previous dose (Ivani 1999; Miller 2015; Monsel 2007).

Children: Limited data available: Usual concentration 0.25% solution: Initial: 0.3 to 0.6 mL/kg (maximal volume of drug: 20 mL); maximum dose: 2.5 mg/kg (Ingelmo 2007; Ingelmo 2007a).

Adolescents: 0.25% or 0.5% solution: 10 to 20 mL administered in 3 to 5 mL increments; if high degree of muscle relaxation and prolonged effects needed, may consider 0.75% solution: 10 to 20 mL (manufacturer's labeling).

Epidural, continuous infusion: Limited data available in infants and children <12 years (Berde 1992; Miller 2015; Moriarty 2012): Note: Use has generally been replaced by other agents (eg, ropivacaine) (Miller 2015; Moriarty 2012).

Loading dose: Usual concentration: 0.25%: 2 to 2.5 mg/kg.

Infusion:

Infants <4 months: 0.2 mg/kg/hour.

Infants ≥4 months: 0.25 mg/kg/hour.

Children and Adolescents: 0.3 mg/kg/hour.

Peripheral nerve block: Limited data available in infants and children: Note: Dose varies with location of block (ie, procedure), depth of anesthesia, vascularity of tissues, duration of anesthesia, and condition of patient.

Infants ≥6 months and Children: Usual concentration 0.125% or 0.25% solution with or without epinephrine: The volume of dose (mL/kg) and concentration of solution are site specific based upon anatomy and variable among patients and procedure; see below ranges. For infants <6 months, maximum doses should be reduced by 30% (Coté 2013; Miller 2015). Maximum dose plain solution: 2 mg/kg or 150 mg, whichever is less, or maximum dose with epinephrine: 3 mg/kg or 200 mg of bupivacaine, whichever is less.

Commonly suggested doses (Coté 2013):

Head and neck: 0.05 mL/kg.

Upper extremity:

Brachial plexus: 0.2 to 0.3 mL/kg.

Digital nerve: 0.05 mL/kg.

Truncal blocks:

Transversus abdominis plane: 0.2 to 0.5 mL/kg (Jöhr 2015).

Rectus sheath: 0.1 mL/kg.

Ilioinguinal: 0.075 mL/kg.

Lower extremity blocks:

Femoral nerve: 0.2 to 0.3 mL/kg.

Sciatic nerve: 0.2 to 0.3 mL/kg.

Adolescents: 0.25% or 0.5% solution with or without epinephrine: 5 mL; maximum daily dose: 400 mg/day (manufacturer's labeling).

Local anesthesia: Infants, Children, and Adolescents: Limited data in infants and children: Usual concentration 0.25% solution: Infiltrate area local; maximum dose in infants and children: 2.5 mg/kg or 150 mg, whichever is less; maximum dose in adolescents: 175 mg (Coté 2013).

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Use: Labeled Indications

Local or regional anesthesia; spinal anesthesia (0.75% in dextrose 8.25% injection); diagnostic and therapeutic procedures; obstetrical procedures (only 0.25% and 0.5% concentrations)

0.25%: Local infiltration, peripheral nerve block, sympathetic block, caudal or epidural block

0.5%: Peripheral nerve block, caudal and epidural block

0.75% (not for obstetrical anesthesia): Retrobulbar block, epidural block. Note: Reserve for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary

* See Uses in AHFS Essentials for additional information.

Class and Related Monographs

Injectable Local Anesthetics

Administration: Injectable Detail

pH: 4 to 6.5

Administration: Other

Solutions containing preservatives should not be used for epidural or caudal blocks. The On-Q infusion pump is used to slowly administer local anesthetics (eg, bupivacaine, lidocaine, ropivacaine) to or around surgical wound sites and/or in close proximity to peripheral nerves for postoperative analgesia. When infused directly into the shoulder, destruction of articular cartilage (chondrolysis) has occurred. On-Q pumps should never be placed directly into any joint (see https://www.ismp.org/Newsletters/acutecare/archives/May09.asp).

Administration: Pediatric

Parenteral: Solutions containing preservatives should not be used for epidural or caudal blocks; for epidural infusion, may use undiluted or diluted with preservative-free NS. Consider incremental administration with negative aspiration prior to each injection; however, absence of blood in the syringe does not guarantee that intravascular injection has been avoided (Mulroy 2010).

Storage/Stability

Store at controlled room temperature of 20°C to 25°C (68°F to 77°F).

Preparation for Administration: Pediatric

Epidural continuous infusion: Use preservative-free formulation, further dilute with preservative-free NS.

Compatibility

See Trissel’s IV Compatibility Database

Open Trissel's IV Compatibility

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to numb an area before a procedure.

• It is used to ease pain after surgery.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Implant:

• Change in taste

• Headache

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

For all uses of this drug:

• Acidosis like confusion; fast breathing; fast heartbeat; a heartbeat that does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak

• Methemoglobinemia like blue or gray color of the lips, nails, or skin; a heartbeat that does not feel normal; seizures; very bad dizziness or passing out; very bad headache; feeling very sleepy; feeling tired or weak; or shortness of breath

• Fast, slow, or abnormal heartbeat

• Chest pain or pressure

• Dizziness or passing out

• Feeling lightheaded, sleepy, confused, or having blurred eyesight

• Change in balance

• Anxiety

• Change in speech

• Restlessness

• Shakiness

• Twitching

• Ringing in the ears

• Feeling nervous and excitable

• Trouble breathing, slow breathing, or shallow breathing

• Very upset stomach or throwing up

• Feeling hot or cold

• Sneezing

• Sweating a lot

• Seizures

• Numbness or tingling in the mouth

• Metallic taste

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Spinal:

• Trouble passing urine

• Loss of bladder or bowel control

• Not able to get or keep an erection

• Long-lasting burning, numbness, tingling, or paralysis in the lower half of the body

• Backache

• Fever or chills

• Stiff neck

• If bright lights bother your eyes

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Medication Safety Issues

​Sound-alike/look-alike issues:

​High alert medication:

Contraindications

Hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formulation; obstetrical paracervical block anesthesia

Note: Use as intravenous regional anesthesia (Bier block) is considered contraindicated per accepted clinical practice due to reports of cardiac arrest and death.

Canadian labeling: Additional contraindications (not in US labeling): IV regional anesthesia (Bier block); severe shock and in heart block where there is inflammation and/or sepsis near the proposed injection site (Marcaine only).

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular effects: Bupivacaine-containing products have been associated with rare occurrences of arrhythmias, cardiac arrest, and death.

• Intra-articular infusion related chondrolysis: Continuous intra-articular infusion of local anesthetics after arthroscopic or other surgical procedures is not an approved use; chondrolysis (primarily shoulder joint) has occurred following infusion, with some patients requiring arthroplasty or shoulder replacement.

• Methemoglobinemia: Has been reported with local anesthetics; clinically significant methemoglobinemia requires immediate treatment along with discontinuation of the anesthetic and other oxidizing agents. Onset may be immediate or delayed (hours) after anesthetic exposure. Patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, exposure to oxidizing agents or their metabolites, or infants <6 months of age are more susceptible and should be closely monitored for signs and symptoms of methemoglobinemia (eg, cyanosis, headache, rapid pulse, shortness of breath, light-headedness, fatigue).

• Respiratory arrest: Local anesthetics have been associated with rare occurrences of sudden respiratory arrest, especially when administered near the head or neck.

• Seizures: Convulsions due to systemic toxicity leading to cardiac arrest have also been reported, presumably following unintentional intravascular injection or administration near the head or neck.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease including patients with hypotension or heart block.

• Hepatic impairment: Use with caution in patients with hepatic impairment.

Special populations:

• Acutely ill patients: Use with caution in acutely ill patients; dose reduction may be required.

• Debilitated patients: Use with caution in debilitated patients; dose reduction may be required.

• Elderly: Use with caution in the elderly; dose reduction may be required.

Dosage form specific issues:

• Obstetrical anesthesia: [US Boxed Warning]: The bupivacaine 0.75% concentration is not recommended for obstetrical anesthesia. There have been reports of cardiac arrest with difficult resuscitation or death during use of bupivacaine for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. Cardiac arrest has occurred after convulsions resulting from systemic toxicity, presumably following unintentional intravascular injection. The 0.75% concentration should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary.

• Preservative-containing solutions: Do not use solutions containing preservatives for caudal or epidural block.

• Sodium metabisulfite: May contain sodium metabisulfite; use caution in patients with asthma or a sulfite allergy.

Other warnings/precautions:

• Administration: Intravascular injections should be avoided; aspiration should be performed prior to administration; the needle must be repositioned until no return of blood can be elicited by aspiration; however, absence of blood in the syringe does not guarantee that intravascular injection has been avoided. Intravenous regional anesthesia (Bier block) is not recommended; cardiac arrest and death have occurred with this method of administration.

• Test dose: A test dose is recommended prior to epidural administration (prior to initial dose) and all reinforcing doses with continuous catheter technique.

• Trained personnel: Clinicians using local anesthetic agents should be well trained in diagnosis and management of emergencies that may arise from the use of these agents. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use.

* See Cautions in AHFS Essentials for additional information.

Warnings: Additional Pediatric Considerations

Infants may be at greater risk for bupivacaine toxicity because α1-acid-glycoprotein concentration, the major serum protein to which bupivacaine is bound, is lower in neonates and infants compared with older children leading to an increase of free fraction of local anesthetic; use epidural infusions with caution in neonates and infants and monitor closely. Fat emulsion has been used to manage local anesthetic toxicity (refer to Fat Emulsion (Plant Based) monograph for additional information) (McCloskey 1992).

Pregnancy Considerations

Bupivacaine crosses the placenta.

Small amounts of bupivacaine can be found in maternal plasma following epidural, caudal, or pudendal nerve block anesthesia, and potentially causing varying degrees of maternal, fetal, and neonatal toxicity involving the CNS, peripheral vascular tone, and cardiac function.

Bupivacaine is approved for use at term in obstetrical anesthesia or analgesia. It is used as a component of regional anesthesia for labor analgesia and operative anesthesia, for intra-incisional analgesia at the end of a cesarean section, and for pudendal nerve blocks used in the second stage of labor or for repairing perineal lacerations (ACOG 2019). Use in obstetrical paracervical block anesthesia is contraindicated (may cause fetal bradycardia and death).

[US Boxed Warning]: The bupivacaine 0.75% concentration is not recommended for obstetrical anesthesia. There have been reports of cardiac arrest with difficult resuscitation or death during use of bupivacaine for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. Cardiac arrest has occurred after convulsions resulting from systemic toxicity, presumably following unintentional intravascular injection. The 0.75% concentration should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary.

Breast-Feeding Considerations

Bupivacaine and its active metabolite are present in breast milk.

Breast milk concentrations of bupivacaine were evaluated in a study of 27 women (~38 weeks gestation) administered bupivacaine 0.5% combined with lidocaine 2% for local anesthesia prior to cesarean delivery. Maternal serum and breast milk were sampled prior to, then at 2, 6, and 12 hours after the epidural infusion. Peak breast milk concentrations occurred 2 hours after the maternal dose for bupivacaine and 12 hours after the dose for the active metabolite. Adverse events were not observed in the breastfed infants (Ortega 1999). In a second study, bupivacaine was not detected in the serum of a breastfed 10-month old infant, feeding 4 times daily following maternal use of a continuous intrapleural bupivacaine 0.25% infusion (10 mL/hour) after a cholecystectomy. Breastfeeding resumed ~22 hours after the maternal infusion began; infant blood was sampled ~5 hours after a morning feed and ~52 hours after a maternal bolus dose (Baker 1989).

Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends a decision be made to discontinue breastfeeding or not administer the drug, considering the importance of treatment to the mother. However, the Academy of Breast Feeding Medicine considers local anesthetics such as bupivacaine compatible with breastfeeding. Elective surgery should be postponed until milk supply and breastfeeding are established. Milk should be expressed ahead of surgery when possible. In general, when the child is healthy and full term, breastfeeding may resume, or milk may be expressed once the mother is awake and in recovery. For children who are at risk for apnea, hypotension, or hypotonia, milk may be saved for later use when the child is at lower risk (ABM [Reece-Stremtan 2017]).

Adverse Reactions

Implant:

>10%: Local: Edema at insertion site (15%)

1% to 10%:

Gastrointestinal: Dysgeusia (8%)

Genitourinary: Scrotal edema (3%)

Nervous system: Headache (4%)

Neuromuscular & skeletal: Tremor (4%)

Ophthalmic: Blurred vision (4%)

Miscellaneous: Fever (2%), seroma (3%)

Frequency not defined: Infection: Wound infection

Injection:

Reactions listed are based on reports for bupivacaine, bupivacaine/epinephrine, and/or other local anesthetics.

Frequency not defined:

Cardiovascular: Bradycardia, cardiac insufficiency, circulatory shock, heart block, hypotension, low cardiac output, ventricular arrhythmia

Gastrointestinal: Fecal incontinence, loss of anal sphincter control, nausea, vomiting

Genitourinary: Prolonged labor, sexual disorder (loss of function), urinary incontinence, urinary retention

Hematologic & oncologic: Methemoglobinemia

Hypersensitivity: Hypersensitivity reaction

Infection: Septic meningitis

Nervous system: Anxiety, arachnoiditis, central nervous system depression, central nervous system stimulation, chills, coma, confusion, cranial nerve palsy, dizziness, drowsiness, headache, localized numbness (perineal), loss of consciousness, meningism, paralysis, paraplegia, paresthesia, persistent anesthesia, restlessness, seizure, shivering

Neuromuscular & skeletal: Asthenia, back pain, lower extremity weakness, tremor

Ophthalmic: Blurred vision, miosis

Otic: Tinnitus

Respiratory: Apnea, hypoventilation, respiratory depression, respiratory paralysis

* See Cautions in AHFS Essentials for additional information.

Allergy and Idiosyncratic Reactions

• Local Anesthetic Hypersensitivity/Allergy

Toxicology

• Local Anesthetics

Metabolism/Transport Effects

Substrate of CYP1A2 (minor), CYP2C19 (minor), CYP2D6 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions Open Interactions

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Risk D: Consider therapy modification

Amisulpride (Oral): May enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Beta-Blockers: May increase the serum concentration of Bupivacaine. Risk C: Monitor therapy

Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Bromperidol: May diminish the hypotensive effect of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Risk X: Avoid combination

Bupivacaine (Liposomal): Bupivacaine may enhance the adverse/toxic effect of Bupivacaine (Liposomal). Management: Bupivacaine may be administered immediately before, or administered in the same admixture syringe as liposomal bupivacaine as long as the ratio of the milligram dose of bupivacaine to liposomal bupivacaine does not exceed 1:2. Risk D: Consider therapy modification

Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Exceptions are discussed in separate monographs. Risk D: Consider therapy modification

Cyclophosphamide: May enhance the adverse/toxic effect of Bupivacaine. Specifically, the risk of methemoglobinemia may be increased. Risk C: Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy

Fexinidazole [INT]: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole [INT]. Risk X: Avoid combination

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Hyaluronidase: May enhance the adverse/toxic effect of Local Anesthetics. Risk C: Monitor therapy

Hydroxyurea: May enhance the adverse/toxic effect of Bupivacaine. Specifically, the risk of methemoglobinemia may be increased. Risk C: Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

Ifosfamide: May enhance the adverse/toxic effect of Bupivacaine. Specifically, the risk of methemoglobinemia may be increased. Risk C: Monitor therapy

Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Risk C: Monitor therapy

Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Risk C: Monitor therapy

Levodopa-Containing Products: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Containing Products. Risk C: Monitor therapy

Local Anesthetics: May enhance the adverse/toxic effect of Bupivacaine. Management: Avoid using any additional local anesthetics within 96 hours after insertion of the bupivacaine implant (Xaracoll). Risk C: Monitor therapy

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Methemoglobinemia Associated Agents: May enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy

Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Neuromuscular-Blocking Agents: Local Anesthetics may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy

Nitrous Oxide: May enhance the adverse/toxic effect of Bupivacaine. Specifically, the risk of methemoglobinemia may be increased. Risk C: Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider therapy modification

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk C: Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Ruxolitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Management: Ruxolitinib Canadian product labeling recommends avoiding use with bradycardia-causing agents to the extent possible. Risk C: Monitor therapy

Siponimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. Risk D: Consider therapy modification

Technetium Tc 99m Tilmanocept: Local Anesthetics may diminish the diagnostic effect of Technetium Tc 99m Tilmanocept. Management: Avoid mixing and simultaneously co-injecting technetium Tc 99m tilmanocept with local anesthetics. This interaction does not appear to apply to other uses of these agents in combination. Risk C: Monitor therapy

Terlipressin: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Valproate Products: May enhance the adverse/toxic effect of Bupivacaine. Specifically, the risk of methemoglobinemia may be increased. Risk C: Monitor therapy

Genes of Interest

• G6PD - Bupivacaine

Monitoring Parameters

Vital signs, state of consciousness; signs of CNS toxicity

Advanced Practitioners Physical Assessment/Monitoring

Monitor for return of sensation to area anesthetized. Teach patient appropriate interventions to promote safety.

Nursing Physical Assessment/Monitoring

Monitor for return of sensation. Teach patient appropriate interventions to promote safety.

Product Availability

Xaracoll implant: FDA approved August 2020; anticipated availability currently unknown. Information pertaining to this product within the monograph is pending revision. Xaracoll is indicated in adults for placement into the surgical site to produce postsurgical analgesia for up to 24 hours following open inguinal hernia repair. Consult the prescribing information for additional information.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Kit, Injection, as hydrochloride:

P-Care M: 0.5%

Kit, Injection, as hydrochloride [preservative free]:

ReadySharp Bupivacaine: 0.5% [DSC]

Solution, Injection, as hydrochloride:

Marcaine: 0.25% (50 mL); 0.5% (50 mL) [contains methylparaben]

Sensorcaine: 0.25% (50 mL); 0.5% (50 mL) [contains methylparaben]

Generic: 0.25% (30 mL [DSC], 50 mL); 0.5% (50 mL)

Solution, Injection, as hydrochloride [preservative free]:

Bupivacaine Fisiopharma: 2.5 mg/mL (5 mL, 10 mL); 5 mg/mL (5 mL, 10 mL)

Marcaine: 0.75% (10 mL, 30 mL)

Marcaine Preservative Free: 0.25% (10 mL, 30 mL); 0.5% (10 mL, 30 mL)

Sensorcaine-MPF: 0.25% (10 mL, 30 mL); 0.5% (10 mL, 30 mL); 0.75% (10 mL, 30 mL) [methylparaben free]

Generic: 0.25% (10 mL, 30 mL); 0.5% (10 mL, 20 mL [DSC], 30 mL); 0.75% (10 mL, 30 mL)

Solution, Intrathecal, as hydrochloride:

Generic: 0.75% [7.5 mg/mL] (2 mL)

Solution, Intrathecal, as hydrochloride [preservative free]:

Bupivacaine Spinal: 0.75% [7.5 mg/mL] (2 mL)

Marcaine Spinal: 0.75% [7.5 mg/mL] (2 mL)

Sensorcaine-MPF Spinal: 0.75% [7.5 mg/mL] (2 mL [DSC])

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection:

Marcaine: 0.75% (20 mL)

Solution, Injection, as hydrochloride:

Marcaine: 0.25% (10 mL, 20 mL, 50 mL)

Marcaine: 0.25% (50 mL) [contains methylparaben]

Marcaine: 0.5% (10 mL, 20 mL)

Marcaine: 0.5% (50 mL) [contains methylparaben]

Sensorcaine: 0.25% (10 mL, 20 mL); 0.5% (10 mL, 20 mL)

Generic: 0.25% (10 mL, 20 mL); 0.5% (10 mL, 20 mL)

Solution, Intrathecal, as hydrochloride:

Marcaine Spinal: 0.75% [7.5 mg/mL] (2 mL)

Generic: 0.75% [7.5 mg/mL] (2 mL)

Anatomic Therapeutic Chemical (ATC) Classification

• N01BB01

Generic Available (US)

Yes

Pricing: US

Solution (Bupivacaine HCl (PF) Injection)

0.25% (per mL): $0.06 - $0.11

0.5% (per mL): $0.07 - $0.12

0.75% (per mL): $0.24 - $0.36

Solution (Bupivacaine HCl Injection)

0.25% (per mL): $0.07 - $0.10

0.5% (per mL): $0.06 - $0.08

Solution (Bupivacaine in Dextrose Intrathecal)

0.75-8.25% (per mL): $2.94

Solution (Marcaine Injection)

0.25% (per mL): $0.14

0.5% (per mL): $0.12

0.75% (per mL): $0.47

Solution (Marcaine Preservative Free Injection)

0.25% (per mL): $0.39

0.5% (per mL): $0.46

Solution (Marcaine Spinal Intrathecal)

0.75-8.25% (per mL): $0.72

Solution (Sensorcaine Injection)

0.25% (per mL): $0.24

0.5% (per mL): $0.27

Solution (Sensorcaine-MPF Injection)

0.25% (per mL): $0.26

0.5% (per mL): $0.25

0.75% (per mL): $0.57

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Blocks both the initiation and conduction of nerve impulses by decreasing the neuronal membrane's permeability to sodium ions, which results in inhibition of depolarization with resultant blockade of conduction

Pharmacodynamics/Kinetics

Onset of action: Anesthesia (route and dose dependent):

Epidural: Up to 17 minutes to spread to T6 dermatome (Scott 1980)

Infiltration: Fast (Barash 2009); Dental injection: 2 to 10 minutes

Spinal: Within 1 minute; maximum dermatome level achieved within 15 minutes in most cases

Duration (route and dose dependent):

Epidural: 2 to 7.7 hours (Barash 2009)

Infiltration: 2 to 8 hours (Barash 2009); Dental injection: Up to 7 hours

Spinal: 1.5 to 2.5 hours (Tsai 2007)

Distribution: Vd: Infants: 3.9 ± 2 L/kg; Children: 2.7 ± 0.2 L/kg

Protein binding: 84% to 95%

Metabolism: Hepatic; forms metabolite (pipecoloxylidine [PPX])

Half-life elimination (age dependent): Neonates: 8.1 hours; Adults: 2.7 hours

Time to peak, plasma: Caudal, epidural, or peripheral nerve block: 30 to 45 minutes

Excretion: Urine (~6% unchanged)

Clearance: Infants: 7.1 ± 3.2 mL/kg/minute; Children: 10 ± 0.7 mL/kg/minute

Pharmacodynamics/Kinetics: Additional Considerations

Geriatric: Elderly patients reached the maximal spread of analgesia and maximal motor blockade more rapidly than younger patients. Elderly patients also exhibited higher peak plasma concentrations following administration of this product. The total plasma clearance was decreased in these patients.

Dental Use

None; not to be confused with bupivacaine and epinephrine dental anesthetic. Refer to Bupivacaine and Epinephrine.

* See Uses in AHFS Essentials for additional information.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Related Information

• Bupivacaine and Epinephrine

Index Terms

Bupivacaine HCl; Bupivacaine Hydrochloride

FDA Approval Date

May 04, 1984

References

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Brand Names: International

Anawin (BD); Anekain (HR); Betolina (LB); Bucain (DE, HU, ID); Bucaine (AE, CY, HU, IQ, IR, JO, LB, LY, OM, SA, SY, YE); Bunascan Spinal (ID); Bupicaina (AR); Bupican (BH, LK, QA, ZW); Bupican Heavy (LK); Bupilon (PH); Bupine (PK); Bupinest S.P. (PE); Bupinex (PY, UY); Bupiright (PH); Bupivacain Jenapharm (DE); Bupivacain-RPR (DE); Bupivacain-RPR CO!2 (DE); Bupivacaine Aguettant (FR); Bupivacaine B. Braun (FR); Buvacaina (EC); Buvacainas (CO); Buvanest Spinal (ID); Carbostesin (AT, CH, DE); Chirocaina (VE); Chlorhydrate de Bupivacaine Dakota (FR); Dolanaest (DE); Duracain (BD); Duracaine (CL); Indevus Spinal Heavy (ID); Inibsacain (ES); Kamacaine (IL); Longocain (UA); Macaine (ZA); Marcain (AU, DK, FI, GB, HN, HU, IE, IS, IT, JP, LK, MY, NO, NZ, PT, RU, SE, SG, VN); Marcain Spinal (BG, DK, EG, IS, LT, PL, SI, SK); Marcaina (BR, GT, SV); Marcaine (AE, BG, CY, CZ, EE, EG, FR, GR, HK, IL, IQ, IR, JO, KR, LT, LU, LV, LY, NL, OM, PH, PL, RO, SA, SI, SK, SY, TH, TR, TW, UA, YE); Marcaine Heavy (KR); Marcaine Plain (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW); Marcaine Spinal Heavy (VN); Markyrene (EG); Nerkein (BD); Omnicain (UA); Picain (FI); Pinacain (BD); Pucaine (KR); Recain (ID); Regivell (PH); Sanspen (PH); Senpivac (PH); Sensorcaine (IN, PH); Sivicaine Heavy (BD); Spica Spinal (ID); Sunnypivacaine (EG); Ultracaine (BD)

Last Updated 10/14/20