Bupivacaine

Bupivacaine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

There is limited information regarding Bupivacaine Contraindications in the drug label.

Warnings

There is limited information regarding Bupivacaine Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Bupivacaine Clinical Trials Experience in the drug label.

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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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.