Bupivacaine
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
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Overview
Bupivacaine is a local anesthetic that is FDA approved for the {{{indicationType}}} of administration of analgesic, local, administration of analgesic, regional, anesthesia - dental procedure, anesthesia for procedures on eye, local anesthesia, regional anesthesia. Common adverse reactions include cardiovascular: bradyarrhythmia, heart block, ventricular arrhythmia immunologic: bacterial meningitis, septic, immune hypersensitivity reaction (rare ), musculoskeletal: chondrolysis of articular cartilage, neurologic: central nervous system depression, central nervous system stimulation, cranial nerve disorder, paraplegia, seizure (0.1% ), total spinal nerve blockade following local anesthetic injection, respiratory: respiratory arrest.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Administration of analgesic, Local: INTRAPLEURAL, 10 to 30 mL bolus of 0.25%, 0.375%, or 0.5% every 4 to 8 hours
- Administration of analgesic, Local: INTRAPLEURAL, continuous infusion 0.375% bupivacaine with epinephrine at 6 mL/hr after 20 mL loading dose
- Administration of analgesic, Regional: EPIDURAL, continuous infusion, 6.25 to 18.75 mg/hr as a 0.0625% to 0.125% solution
- Anesthesia - Dental procedure: 1.8 to 3.6 mL of 0.5% solution (9 to 18 mg) with epinephrine; a second dose (9 mg) may be administered; MAX total dose 90 mg
- Anesthesia for procedures on eye: complete motor blockade, 2 to 4 mL (15 to 30 mg) of 0.75% solution
- Local anesthesia: dosage varies with anesthetic procedure, area to be anesthetized, vascularity of the tissues, number of neuronal segments to be blocked, depth of anesthesia and degree and muscle relaxation required, duration of anesthesia desired, individual tolerance, and physical condition of the patient
- Local anesthesia: INFILTRATION, 0.25% solution up to max doses (MAX 225 mg with epinephrine or 175 mg without epinephrine)
- Local anesthesia: SACRAL EPIDURAL BLOCK, moderate to complete blockade, 15 to 30 mL of 0.5% solution (75 to 150 mg) OR 0.25% solution (37.5 to 75 mg), repeated once every 3 h as needed
- Regional anesthesia: dosage varies with anesthetic procedure, area to be anesthetized, vascularity of the tissues, number of neuronal segments to be blocked, depth of anesthesia and degree and muscle relaxation required, duration of anesthesia desired, individual tolerance, and physical condition of the patient
- Regional anesthesia: EPIDURAL, partial to moderate motor blockade, 10 to 20 mL (25 to -50 mg) of a 0.25% solution; moderate to complete motor blockade, 10 to 20 mL (50 to 100 mg) as a 0.5% solution; complete motor blockade, 10 to 20 mL (75 to 150 mg) as a 0.75% solution; repeat once every 3 hours as needed
- Regional anesthesia: (obstetrical) hyperbaric SPINAL (bupivacaine in dextrose formulation only), normal vaginal delivery, 0.8 mL (6 mg) bupivacaine in dextrose as 0.75% solution; cesarean section, 1 to 1.4 mL (7.5 to 10.5 mg) bupivacaine in dextrose as 0.75% solution
- Regional anesthesia: hyperbaric SPINAL (bupivacaine in dextrose formulation only), lower extremity and perineal procedures, 1 mL (7.5 mg) bupivacaine in dextrose as 0.75% solution; lower abdominal procedures, 1.6 mL (12 mg) bupivacaine in dextrose as 0.75% solution; upper abdominal surgery, 2 mL (15 mg) bupivacaine in dextrose, in horizontal position
- Regional anesthesia: PERIPHERAL NERVE BLOCK, moderate to complete motor blockade, 5 to 37.5 mL (25 to 175 mg) of 0.5% solution OR 5 to 70 mL (12.5 to 175 mg) of 0.25% solution, repeat every 3 hours if necessary
- Regional anesthesia: SYMPATHETIC NERVE BLOCK, 20 to 50 mL (50 to 125 mg) of 0.25% solution, repeat once every 3 hours as needed
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
- Pain
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Bupivacaine in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
- Administration in children younger than 12 years is not recommended
- Bupivacaine spinal with dextrose not recommended in children younger than 18 years
- Administration of analgesic, Local: INTRAPLEURAL, continuous infusion 0.25% bupivacaine with epinephrine at 0.5 mL/kg/hr.
- Administration of analgesic, Regional: (body weight 10 kg or less) CAUDAL, single dose 1 to 1.25 mg/kg as a 0.125% or 0.25% solution
- Administration of analgesic, Regional: (body weight 10 kg or less) CAUDAL, continuous infusion 0.1 to 0.2 mg/kg/hr as a 0.1%, 0.125%, or 0.25% solution; MAX 0.2 mg/kg/hr
- Administration of analgesic, Regional: (body weight 10 kg or less) CAUDAL or EPIDURAL, single dose 1 to 1.25 mg/kg as a 0.125% or 0.25% solution
- Administration of analgesic, Regional: (body weight 10 kg or less) CAUDAL or EPIDURAL, continuous infusion 0.1 to 0.2 mg/kg/hr as a 0.1%, 0.125%, or 0.25% solution; MAX 0.2 mg/kg/hr
- Administration of analgesic, Regional: (body weight greater than 10 kg) CAUDAL, single dose 1 to 2.5 mg/kg as a 0.125% or 0.25% solution
- Administration of analgesic, Regional: (body weight greater than 10 kg) CAUDAL, continuous infusion 0.2 to 0.4 mg/kg/hr as a 0.1%, 0.125%, or 0.25% solution, MAX 0.4 mg/kg/hr
- Anesthesia - Dental procedure: (12 years or older) 1.8 to 3.6 mL of 0.5% solution (9 to 18 mg) with epinephrine; a second dose (9 mg) may be administered; MAX total dose 90 mg
- Anesthesia for procedures on eye: (12 years or older) complete motor blockade, 2 to 4 mL (15 to 30 mg) of 0.75% solution
- Local anesthesia: INFILTRATION, 0.5 to 2.5 mg/kg as a 0.25% or 0.5% solution; MAX 1 mL/kg of 0.25% solution, 0.5 mL/kg of 0.5% solution
- Local anesthesia: SACRAL EPIDURAL BLOCK, (body weight greater than 10 kg) single dose 1 to 2.5 mg/kg as a 0.125% or 0.25% solution
- Local anesthesia: SACRAL EPIDURAL BLOCK, (body weight greater than 10 kg) continuous infusion 0.2 to 0.4 mg/kg/hr as a 0.1%, 0.125%, or 0.25% solution, MAX 0.4 mg/kg/hr
- Regional anesthesia: EPIDURAL, (body weight greater than 10 kg) single dose 1 to 2.5 mg/kg as a 0.125% or 0.25% solution
- Regional anesthesia: EPIDURAL, (body weight greater than 10 kg) continuous infusion 0.2 to 0.4 mg/kg/hr as a 0.1%, 0.125%, or 0.25% solution, MAX 0.4 mg/kg/hr
- Regional anesthesia: hyperbaric SPINAL (bupivacaine in dextrose formulation only), 0.3 to 0.6 mg/kg bupivacaine in dextrose as a 0.75% solution
- Regional anesthesia: PERIPHERAL NERVE BLOCK, 0.3 to 2.5 mg/kg as a 0.25% or 0.5% solution; MAX 1 mL/kg of 0.25% solution, 0.5 mL/kg of 0.5% solution
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Bupivacaine in pediatric patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Bupivacaine in pediatric patients.
Contraindications
MARCAINE Spinal is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide-type.
The following conditions preclude the use of spinal anesthesia:
Severe hemorrhage, severe hypotension or shock and arrhythmias, such as complete heart block, which severely restrict cardiac output.
Local infection at the site of proposed lumbar puncture.
Septicemia.
Warnings
LOCAL ANESTHETICS SHOULD ONLY BE EMPLOYED BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES WHICH MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED, AND THEN ONLY AFTER INSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY RESUSCITATIVE EQUIPMENT, AND THE PERSONNEL RESOURCES NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES. (See also ADVERSE REACTIONS and PRECAUTIONS.) DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST, AND, POSSIBLY, DEATH.
Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement.
Spinal anesthetics should not be injected during uterine contractions, because spinal fluid current may carry the drug further cephalad than desired.
A free flow of cerebrospinal fluid during the performance of spinal anesthesia is indicative of entry into the subarachnoid space. However, aspiration should be performed before the anesthetic solution is injected to confirm entry into the subarachnoid space and to avoid intravascular injection.
MARCAINE solutions containing epinephrine or other vasopressors should not be used concomitantly with ergot-type oxytocic drugs, because a severe persistent hypertension may occur. Likewise, solutions of MARCAINE containing a vasoconstrictor, such as epinephrine, should be used with extreme caution in patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types, because severe prolonged hypertension may result.
Until further experience is gained in patients younger than 18 years, administration of MARCAINE in this age group is not recommended.
Mixing or the prior or intercurrent use of any other local anesthetic with MARCAINE cannot be recommended because of insufficient data on the clinical use of such mixtures.
Adverse Reactions
Clinical Trials Experience
Reactions to bupivacaine are characteristic of those associated with other amide-type local anesthetics.
The most commonly encountered acute adverse experiences which demand immediate countermeasures following the administration of spinal anesthesia are hypotension due to loss of sympathetic tone and respiratory paralysis or underventilation due to cephalad extension of the motor level of anesthesia. These may lead to cardiac arrest if untreated. In addition, dose-related convulsions and cardiovascular collapse may result from diminished tolerance, rapid absorption from the injection site, or from unintentional intravascular injection of a local anesthetic solution. Factors influencing plasma protein binding, such as acidosis, systemic diseases which alter protein production, or competition of other drugs for protein binding sites, may diminish individual tolerance.
Respiratory System: Respiratory paralysis or underventilation may be noted as a result of upward extension of the level of spinal anesthesia and may lead to secondary hypoxic cardiac arrest if untreated. Preanesthetic medication, intraoperative analgesics and sedatives, as well as surgical manipulation, may contribute to underventilation. This will usually be noted within minutes of the injection of spinal anesthetic solution, but because of differing maximal onset times, differing intercurrent drug usage and differing surgical manipulation, it may occur at any time during surgery or the immediate recovery period.
Cardiovascular System: Hypotension due to loss of sympathetic tone is a commonly encountered extension of the clinical pharmacology of spinal anesthesia. This is more commonly observed in elderly patients, particularly those with hypertension, and patients with shrunken blood volume, shrunken interstitial fluid volume, cephalad spread of the local anesthetic, and/or mechanical obstruction of venous return. Nausea and vomiting are frequently associated with hypotensive episodes following the administration of spinal anesthesia. High doses, or inadvertent intravascular injection, may lead to high plasma levels and related depression of the myocardium, decreased cardiac output, bradycardia, heart block, ventricular arrhythmias, and, possibly, cardiac arrest. (See WARNINGS, PRECAUTIONS, and OVERDOSAGE sections.)
Central Nervous System: Respiratory paralysis or underventilation secondary to cephalad spread of the level of spinal anesthesia (see Respiratory System) and hypotension for the same reason (see Cardiovascular System) are the two most commonly encountered central nervous system-related adverse observations which demand immediate countermeasures.
High doses or inadvertent intravascular injection may lead to high plasma levels and related central nervous system toxicity characterized by excitement and/or depression. Restlessness, anxiety, dizziness, tinnitus, blurred vision, or tremors may occur, possibly proceeding to convulsions. However, excitement may be transient or absent, with depression being the first manifestation of an adverse reaction. This may quickly be followed by drowsiness merging into unconsciousness and respiratory arrest.
Neurologic: The incidences of adverse neurologic reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration, and the physical status of the patient. Many of these effects may be related to local anesthetic techniques, with or without a contribution from the drug.
Neurologic effects following spinal anesthesia may include loss of perineal sensation and sexual function; persistent anesthesia, paresthesia, weakness and paralysis of the lower extremities, and loss of sphincter control all of which may have slow, incomplete, or no recovery; hypotension, high or total spinal block; urinary retention; headache; backache; septic meningitis, meningismus; arachnoiditis; slowing of labor; increased incidence of forceps delivery; shivering; cranial nerve palsies due to traction on nerves from loss of cerebrospinal fluid; and fecal and urinary incontinence.
Allergic: Allergic-type reactions are rare and may occur as a result of sensitivity to the local anesthetic. These reactions are 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 symptomatology (including severe hypotension). Cross sensitivity among members of the amide-type local anesthetic group has been reported. The usefulness of screening for sensitivity has not been definitely established.
Other: Nausea and vomiting may occur during spinal anesthesia.
Postmarketing Experience
There is limited information regarding Bupivacaine Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Bupivacaine Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Bupivacaine in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Bupivacaine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Bupivacaine during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Bupivacaine in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Bupivacaine in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Bupivacaine in geriatric settings.
Gender
There is no FDA guidance on the use of Bupivacaine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Bupivacaine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Bupivacaine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Bupivacaine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Bupivacaine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Bupivacaine in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Bupivacaine Administration in the drug label.
Monitoring
There is limited information regarding Bupivacaine Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Bupivacaine and IV administrations.
Overdosage
There is limited information regarding Bupivacaine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Bupivacaine Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Bupivacaine Mechanism of Action in the drug label.
Structure
There is limited information regarding Bupivacaine Structure in the drug label.
Pharmacodynamics
There is limited information regarding Bupivacaine Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Bupivacaine Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Bupivacaine Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Bupivacaine Clinical Studies in the drug label.
How Supplied
There is limited information regarding Bupivacaine How Supplied in the drug label.
Storage
There is limited information regarding Bupivacaine Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Bupivacaine Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Bupivacaine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Bupivacaine Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Bupivacaine Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.