Bupivacaine Hydrochloride Prescribing Information
5.1 Risk of Cardiac Arrest with Use of Bupivacaine Hydrochloride Injection in Obstetrical AnesthesiaThere have been reports of cardiac arrest with difficult resuscitation or death during use of bupivacaine hydrochloride for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) 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% (7.5 mg/mL) concentration of bupivacaine hydrochloride is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary.
Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection is recommended for each type of block indicated to produce local or regional anesthesia or analgesia
2.2 Recommended Concentrations and Dosages of Bupivacaine Hydrochloride InjectionThe dosage of bupivacaine hydrochloride injection administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. Administer the smallest dosage and concentration required to produce the desired result.
The types of block and recommended bupivacaine hydrochloride injection concentrations are shown in Table 1.
Type of Block | Bupivacaine Hydrochloride Injection | ||
0.25% (2.5 mg/mL) | 0.5% (5 mg/mL) | 0.75% (7.5 mg/mL)* | |
| Local infiltration | ![]() | ||
| Peripheral nerve block | ![]() | ![]() | |
| Retrobulbar block | ![]() | ||
| Sympathetic block | ![]() | ||
| Caudal block | ![]() | ![]() | |
| Lumbar epidural block | ![]() | ![]() | (not for obstetrical anesthesia) |
| Epidural test dose | |||
| Dental block | |||
*Bupivacaine hydrochloride injection 0.75% (7.5 mg/mL) is not recommended for nonobstetrical surgical procedures in pregnant patients.

= indicated use
At recommended dosages, bupivacaine hydrochloride injection produces complete sensory block, but the effect on motor function differs among the three concentrations. Table 2 provides information on the expected effect on motor function for the three concentrations.
Bupivacaine Hydrochloride Injection Concentration | Motor Function |
| 0.25% (2.5 mg/mL) | When used for caudal, epidural, or peripheral nerve block, produces incomplete motor block. Should be used for operations in which muscle relaxation is not important, or when another means of providing muscle relaxation is used concurrently. Onset of action may be slower than with the 0.5% (5 mg/mL) or 0.75% (7.5 mg/mL) solutions. |
| 0.5% (5 mg/mL) | Provides motor blockade for caudal, epidural, or nerve block, but muscle relaxation may be inadequate for operations in which complete muscle relaxation is essential. |
| 0.75% (7.5 mg/mL) | Produces complete motor block. Most useful for epidural block in abdominal operations requiring complete muscle relaxation, and for retrobulbar anesthesia. Not for obstetrical anesthesia. |
The duration of anesthesia with bupivacaine hydrochloride injection is such that for most indications, a single-dose is sufficient.
The maximum dosage limit within the recommended dosage range must be individualized in each case after evaluating the size and physical status of the patient, as well as the anticipated rate of systemic absorption from a particular injection site.
The dosages in Table 3 are recommended as a guide for use in the average adult. These doses may be repeated once every three hours. Do not exceed a total daily dosage of 400 mg in 24 hours. The duration of anesthetic effect may be prolonged by the addition of epinephrine.
Type of Block | Concentration of Bupivacaine Hydrochloride Injection | Each Dose | Motor Blocka | |
mL | mg of Bupivacaine Hydrochloride Injection | |||
Local infiltration | 0.25% (2.5 mg/mL)b | Up to 70 (without epinephrine) | Up to 175 (without epinephrine) | ― |
Peripheral nerve block | 0.5% (5 mg/mL)b | 5 to 35 (without epinephrine) | 25 to 175 (without epinephrine) | moderate to complete |
0.25% (2.5 mg/mL)b | 5 to 70 (without epinephrine) | 12.5 to 175 (without epinephrine) | moderate to complete | |
| Retrobulbar block [see Dosage and Administration (2.6)] | 0.75% (7.5 mg/mL) | 2 to 4 | 15 to 30 | complete |
| Sympathetic block | 0.25% (2.5 mg/mL) | 20 to 50 | 50 to 125 | ― |
| Caudal block | 0.5% (5 mg/mL)b | 15 to 30 | 75 to 150 | moderate to complete |
| 0.25% (2.5 mg/mL)b | 15 to 30 | 37.5 to 75 | moderate | |
| Lumbar epidural block [see Dosage and Administration (2.3)] | 0.75% (7.5 mg/mL)c | 10 to 20 | 75 to 150 | complete |
| 0.5% (5 mg/mL)b | 10 to 20 | 50 to 100 | moderate to complete | |
| 0.25% (2.5 mg/mL)b | 10 to 20 | 25 to 50 | partial to moderate | |
a. With continuous (intermittent) techniques, repeat doses increase the degree of motor block. The first repeat dose of 0.5% (5 mg/mL) may produce complete motor block. Intercostal nerve block with 0.25% (2.5 mg/mL) also may produce complete motor block for intra-thoracic and upper intra-abdominal surgery.
b. Solutions with or without epinephrine (i.e., applies to bupivacaine hydrochloride injection).
c. For single-dose use; not for intermittent epidural technique. Not for obstetrical anesthesia.











Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use
2.2 Recommended Concentrations and Dosages of Bupivacaine Hydrochloride InjectionThe dosage of bupivacaine hydrochloride injection administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. Administer the smallest dosage and concentration required to produce the desired result.
The types of block and recommended bupivacaine hydrochloride injection concentrations are shown in Table 1.
Type of Block | Bupivacaine Hydrochloride Injection | ||
0.25% (2.5 mg/mL) | 0.5% (5 mg/mL) | 0.75% (7.5 mg/mL)* | |
| Local infiltration | ![]() | ||
| Peripheral nerve block | ![]() | ![]() | |
| Retrobulbar block | ![]() | ||
| Sympathetic block | ![]() | ||
| Caudal block | ![]() | ![]() | |
| Lumbar epidural block | ![]() | ![]() | (not for obstetrical anesthesia) |
| Epidural test dose | |||
| Dental block | |||
*Bupivacaine hydrochloride injection 0.75% (7.5 mg/mL) is not recommended for nonobstetrical surgical procedures in pregnant patients.

= indicated use
At recommended dosages, bupivacaine hydrochloride injection produces complete sensory block, but the effect on motor function differs among the three concentrations. Table 2 provides information on the expected effect on motor function for the three concentrations.
Bupivacaine Hydrochloride Injection Concentration | Motor Function |
| 0.25% (2.5 mg/mL) | When used for caudal, epidural, or peripheral nerve block, produces incomplete motor block. Should be used for operations in which muscle relaxation is not important, or when another means of providing muscle relaxation is used concurrently. Onset of action may be slower than with the 0.5% (5 mg/mL) or 0.75% (7.5 mg/mL) solutions. |
| 0.5% (5 mg/mL) | Provides motor blockade for caudal, epidural, or nerve block, but muscle relaxation may be inadequate for operations in which complete muscle relaxation is essential. |
| 0.75% (7.5 mg/mL) | Produces complete motor block. Most useful for epidural block in abdominal operations requiring complete muscle relaxation, and for retrobulbar anesthesia. Not for obstetrical anesthesia. |
The duration of anesthesia with bupivacaine hydrochloride injection is such that for most indications, a single-dose is sufficient.
The maximum dosage limit within the recommended dosage range must be individualized in each case after evaluating the size and physical status of the patient, as well as the anticipated rate of systemic absorption from a particular injection site.
The dosages in Table 3 are recommended as a guide for use in the average adult. These doses may be repeated once every three hours. Do not exceed a total daily dosage of 400 mg in 24 hours. The duration of anesthetic effect may be prolonged by the addition of epinephrine.
Type of Block | Concentration of Bupivacaine Hydrochloride Injection | Each Dose | Motor Blocka | |
mL | mg of Bupivacaine Hydrochloride Injection | |||
Local infiltration | 0.25% (2.5 mg/mL)b | Up to 70 (without epinephrine) | Up to 175 (without epinephrine) | ― |
Peripheral nerve block | 0.5% (5 mg/mL)b | 5 to 35 (without epinephrine) | 25 to 175 (without epinephrine) | moderate to complete |
0.25% (2.5 mg/mL)b | 5 to 70 (without epinephrine) | 12.5 to 175 (without epinephrine) | moderate to complete | |
| Retrobulbar block [see Dosage and Administration (2.6)] | 0.75% (7.5 mg/mL) | 2 to 4 | 15 to 30 | complete |
| Sympathetic block | 0.25% (2.5 mg/mL) | 20 to 50 | 50 to 125 | ― |
| Caudal block | 0.5% (5 mg/mL)b | 15 to 30 | 75 to 150 | moderate to complete |
| 0.25% (2.5 mg/mL)b | 15 to 30 | 37.5 to 75 | moderate | |
| Lumbar epidural block [see Dosage and Administration (2.3)] | 0.75% (7.5 mg/mL)c | 10 to 20 | 75 to 150 | complete |
| 0.5% (5 mg/mL)b | 10 to 20 | 50 to 100 | moderate to complete | |
| 0.25% (2.5 mg/mL)b | 10 to 20 | 25 to 50 | partial to moderate | |
a. With continuous (intermittent) techniques, repeat doses increase the degree of motor block. The first repeat dose of 0.5% (5 mg/mL) may produce complete motor block. Intercostal nerve block with 0.25% (2.5 mg/mL) also may produce complete motor block for intra-thoracic and upper intra-abdominal surgery.
b. Solutions with or without epinephrine (i.e., applies to bupivacaine hydrochloride injection).
c. For single-dose use; not for intermittent epidural technique. Not for obstetrical anesthesia.











4 CONTRAINDICATIONSBupivacaine hydrochloride is contraindicated in:
• obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death.
• intravenous regional anesthesia (Bier Block)
• patients with a known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of bupivacaine hydrochloride.
• Obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death.
• Intravenous regional anesthesia (Bier Block).
• Known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of bupivacaine.
5.1 Risk of Cardiac Arrest with Use of Bupivacaine Hydrochloride Injection in Obstetrical AnesthesiaThere have been reports of cardiac arrest with difficult resuscitation or death during use of bupivacaine hydrochloride for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) 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% (7.5 mg/mL) concentration of bupivacaine hydrochloride is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary.
5.5 Chondrolysis with Intra-Articular InfusionIntra-articular infusions of local anesthetics including bupivacaine hydrochloride 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 associated with chondrolysis. 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 2ndmonth 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.
5.7 Risk of Cardiac Arrest with Intravenous Regional Anesthesia Use (Bier Block)There have been reports of cardiac arrest and death during the use of bupivacaine for intravenous regional anesthesia (Bier Block). Information on safe dosages and techniques of administration of bupivacaine hydrochloride in this procedure is lacking. Therefore, bupivacaine hydrochloride is contraindicated for use with this technique
5.9 Risk of Systemic Toxicities with Unintended Intravascular or Intrathecal InjectionUnintended intravascular or intrathecal injection of bupivacaine hydrochloride may be associated with systemic toxicities, including CNS or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest. Unintentional intrathecal injection during the intended performance of caudal or lumbar epidural block or nerve blocks near the vertebral column has resulted in underventilation or apnea (“Total or High Spinal”). A high spinal has been characterized by paralysis of the legs, loss of consciousness, respiratory paralysis, and bradycardia
Aspirate for blood or cerebrospinal fluid (where applicable) before injecting bupivacaine hydrochloride, both the initial dose and all subsequent doses, to avoid intravascular or intrathecal injection. However, a negative aspiration for blood or cerebrospinal fluid does not ensure against an intravascular or intrathecal injection.
• Not for intrathecal use. (
2.1 Important Dosage and Administration Information• Bupivacaine hydrochloride injection is not for intrathecal use.
• Discard unused portions of solution not containing preservatives, i.e., those supplied in single-dose vials, following initial use.
• Visually inspect this product for particulate matter and discoloration prior to administration whenever solution and container permit. Bupivacaine hydrochloride injection is a clear, colorless solution. Do not administer solutions which are discolored or contain particulate matter.
• Mixing or the prior or intercurrent use of any other local anesthetic with bupivacaine hydrochloride injection is not recommended because of insufficient data on the clinical use of such mixtures.
• Use bupivacaine hydrochloride injection only if the following are immediately available: oxygen, cardiopulmonary resuscitative equipment and drugs, and the personnel resources needed for proper management of toxic reactions and related emergencies
• The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity when additional local anesthetics are administered with bupivacaine hydrochloride injection
• Aspirate for blood or cerebrospinal fluid (where applicable) prior to injecting bupivacaine hydrochloride injection, both the initial dose and all subsequent doses, to avoid intravascular or intrathecal injection. However, a negative aspiration for blood or cerebrospinal fluid does not ensure against an intravascular or intrathecal injection
• Avoid rapid injection of a large volume of bupivacaine hydrochloride injection and use fractional (incremental) doses when feasible.
• During major regional nerve blocks, such as those of the brachial plexus or lower extremity, the patient should have an indwelling intravenous catheter to assure adequate intravenous access. The lowest dosage of bupivacaine hydrochloride injection that results in effective anesthesia should be used to avoid high plasma levels and serious adverse reactions.
• Perform careful and constant monitoring of cardiovascular and respiratory (adequacy of oxygenation and ventilation) vital signs and the patient’s level of consciousness after each local anesthetic injection.
• Avoid use of solutions containing antimicrobial preservatives (i.e., multiple-dose vials) for epidural or caudal anesthesia. (
2.1 Important Dosage and Administration Information• Bupivacaine hydrochloride injection is not for intrathecal use.
• Discard unused portions of solution not containing preservatives, i.e., those supplied in single-dose vials, following initial use.
• Visually inspect this product for particulate matter and discoloration prior to administration whenever solution and container permit. Bupivacaine hydrochloride injection is a clear, colorless solution. Do not administer solutions which are discolored or contain particulate matter.
• Mixing or the prior or intercurrent use of any other local anesthetic with bupivacaine hydrochloride injection is not recommended because of insufficient data on the clinical use of such mixtures.
• Use bupivacaine hydrochloride injection only if the following are immediately available: oxygen, cardiopulmonary resuscitative equipment and drugs, and the personnel resources needed for proper management of toxic reactions and related emergencies
• The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity when additional local anesthetics are administered with bupivacaine hydrochloride injection
• Aspirate for blood or cerebrospinal fluid (where applicable) prior to injecting bupivacaine hydrochloride injection, both the initial dose and all subsequent doses, to avoid intravascular or intrathecal injection. However, a negative aspiration for blood or cerebrospinal fluid does not ensure against an intravascular or intrathecal injection
• Avoid rapid injection of a large volume of bupivacaine hydrochloride injection and use fractional (incremental) doses when feasible.
• During major regional nerve blocks, such as those of the brachial plexus or lower extremity, the patient should have an indwelling intravenous catheter to assure adequate intravenous access. The lowest dosage of bupivacaine hydrochloride injection that results in effective anesthesia should be used to avoid high plasma levels and serious adverse reactions.
• Perform careful and constant monitoring of cardiovascular and respiratory (adequacy of oxygenation and ventilation) vital signs and the patient’s level of consciousness after each local anesthetic injection.
• See full prescribing information for:
− Recommended concentrations and dosages of bupivacaine hydrochloride injection according to type of block. (
2.2 Recommended Concentrations and Dosages of Bupivacaine Hydrochloride InjectionThe dosage of bupivacaine hydrochloride injection administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. Administer the smallest dosage and concentration required to produce the desired result.
The types of block and recommended bupivacaine hydrochloride injection concentrations are shown in Table 1.
Type of Block | Bupivacaine Hydrochloride Injection | ||
0.25% (2.5 mg/mL) | 0.5% (5 mg/mL) | 0.75% (7.5 mg/mL)* | |
| Local infiltration | ![]() | ||
| Peripheral nerve block | ![]() | ![]() | |
| Retrobulbar block | ![]() | ||
| Sympathetic block | ![]() | ||
| Caudal block | ![]() | ![]() | |
| Lumbar epidural block | ![]() | ![]() | (not for obstetrical anesthesia) |
| Epidural test dose | |||
| Dental block | |||
*Bupivacaine hydrochloride injection 0.75% (7.5 mg/mL) is not recommended for nonobstetrical surgical procedures in pregnant patients.

= indicated use
At recommended dosages, bupivacaine hydrochloride injection produces complete sensory block, but the effect on motor function differs among the three concentrations. Table 2 provides information on the expected effect on motor function for the three concentrations.
Bupivacaine Hydrochloride Injection Concentration | Motor Function |
| 0.25% (2.5 mg/mL) | When used for caudal, epidural, or peripheral nerve block, produces incomplete motor block. Should be used for operations in which muscle relaxation is not important, or when another means of providing muscle relaxation is used concurrently. Onset of action may be slower than with the 0.5% (5 mg/mL) or 0.75% (7.5 mg/mL) solutions. |
| 0.5% (5 mg/mL) | Provides motor blockade for caudal, epidural, or nerve block, but muscle relaxation may be inadequate for operations in which complete muscle relaxation is essential. |
| 0.75% (7.5 mg/mL) | Produces complete motor block. Most useful for epidural block in abdominal operations requiring complete muscle relaxation, and for retrobulbar anesthesia. Not for obstetrical anesthesia. |
The duration of anesthesia with bupivacaine hydrochloride injection is such that for most indications, a single-dose is sufficient.
The maximum dosage limit within the recommended dosage range must be individualized in each case after evaluating the size and physical status of the patient, as well as the anticipated rate of systemic absorption from a particular injection site.
The dosages in Table 3 are recommended as a guide for use in the average adult. These doses may be repeated once every three hours. Do not exceed a total daily dosage of 400 mg in 24 hours. The duration of anesthetic effect may be prolonged by the addition of epinephrine.
Type of Block | Concentration of Bupivacaine Hydrochloride Injection | Each Dose | Motor Blocka | |
mL | mg of Bupivacaine Hydrochloride Injection | |||
Local infiltration | 0.25% (2.5 mg/mL)b | Up to 70 (without epinephrine) | Up to 175 (without epinephrine) | ― |
Peripheral nerve block | 0.5% (5 mg/mL)b | 5 to 35 (without epinephrine) | 25 to 175 (without epinephrine) | moderate to complete |
0.25% (2.5 mg/mL)b | 5 to 70 (without epinephrine) | 12.5 to 175 (without epinephrine) | moderate to complete | |
| Retrobulbar block [see Dosage and Administration (2.6)] | 0.75% (7.5 mg/mL) | 2 to 4 | 15 to 30 | complete |
| Sympathetic block | 0.25% (2.5 mg/mL) | 20 to 50 | 50 to 125 | ― |
| Caudal block | 0.5% (5 mg/mL)b | 15 to 30 | 75 to 150 | moderate to complete |
| 0.25% (2.5 mg/mL)b | 15 to 30 | 37.5 to 75 | moderate | |
| Lumbar epidural block [see Dosage and Administration (2.3)] | 0.75% (7.5 mg/mL)c | 10 to 20 | 75 to 150 | complete |
| 0.5% (5 mg/mL)b | 10 to 20 | 50 to 100 | moderate to complete | |
| 0.25% (2.5 mg/mL)b | 10 to 20 | 25 to 50 | partial to moderate | |
a. With continuous (intermittent) techniques, repeat doses increase the degree of motor block. The first repeat dose of 0.5% (5 mg/mL) may produce complete motor block. Intercostal nerve block with 0.25% (2.5 mg/mL) also may produce complete motor block for intra-thoracic and upper intra-abdominal surgery.
b. Solutions with or without epinephrine (i.e., applies to bupivacaine hydrochloride injection).
c. For single-dose use; not for intermittent epidural technique. Not for obstetrical anesthesia.











− Additional dosage and administration information pertaining to use in epidural anesthesia and use in ophthalmic surgery. (
2.3 Use in Epidural AnesthesiaDuring epidural administration, administer bupivacaine hydrochloride injection, 0.5% (5 mg/mL) and bupivacaine hydrochloride injection 0.75% (7.5 mg/mL) solutions in incremental doses of 3 mL to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. Administer injections slowly, with frequent aspirations before and during the injection to avoid intravascular injection. Perform syringe aspirations before and during each supplemental injection in continuous (intermittent) catheter techniques. In obstetrics, use ONLY the 0.5% (5 mg/mL) and 0.25% (2.5 mg/mL) concentrations of bupivacaine hydrochloride injection
2.6 Use in Ophthalmic SurgeryWhen bupivacaine hydrochloride injection 0.75% (7.5 mg/mL) is used for retrobulbar block, complete corneal anesthesia usually precedes onset of clinically acceptable external ocular muscle akinesia. Therefore, presence of akinesia rather than anesthesia alone should determine readiness of the patient for surgery
Bupivacaine hydrochloride injection, USP is a clear and colorless sterile, isotonic solution available as:
• 0.25% (25 mg/10 mL) (2.5 mg/mL) in single-dose vials.
• 0.25% (75 mg/30 mL) (2.5 mg/mL) in single-dose vials.
• 0.5% (50 mg/10 mL) (5 mg/mL) in single-dose vials.
• 0.5% (150 mg/30 mL) (5 mg/mL) in single-dose vials.
• 0.75% (75 mg/10 mL) (7.5 mg/mL) in single-dose vials.
• 0.75% (225 mg/30 mL) (7.5 mg/mL) in single-dose vials.
•
8.4 Pediatric UseBupivacaine hydrochloride is approved for use in adults. Administration of bupivacaine hydrochloride in pediatric patients younger than 12 years is not recommended.
Continuous infusions of bupivacaine in pediatric patients have been reported to result in high systemic levels of bupivacaine and seizures; high plasma levels may also be associated with cardiovascular abnormalities.
•
8.5 Geriatric UsePatients 65 years and over, particularly those with hypertension, may be at increased risk for developing hypotension while undergoing anesthesia with bupivacaine hydrochloride.
In clinical studies of bupivacaine, elderly patients reached the maximal spread of analgesia and maximal motor blockade more rapidly than younger adult patients.
Differences in various pharmacokinetic parameters have been observed between elderly and younger adult patients
This product is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Elderly patients may require lower doses of bupivacaine hydrochloride.
•
8.6 Hepatic ImpairmentAmide-type local anesthetics, such as bupivacaine, are metabolized by the liver. Patients with severe hepatic impairment, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations, and potentially local anesthetic systemic toxicity. Therefore, consider reduced dosing and increased monitoring for local anesthetic systemic toxicity in patients with moderate to severe hepatic impairment treated with bupivacaine hydrochloride, especially with repeat doses
Bupivacaine hydrochloride is contraindicated in:
• obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death.
• intravenous regional anesthesia (Bier Block)
5.7 Risk of Cardiac Arrest with Intravenous Regional Anesthesia Use (Bier Block)There have been reports of cardiac arrest and death during the use of bupivacaine for intravenous regional anesthesia (Bier Block). Information on safe dosages and techniques of administration of bupivacaine hydrochloride in this procedure is lacking. Therefore, bupivacaine hydrochloride is contraindicated for use with this technique
• patients with a known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of bupivacaine hydrochloride.