pharmacopeia
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Boxed warning

RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA There have been reports of cardiac arrest with diffcult resuscitation or death during use of bupivacaine hydrochloride injection 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 diffcult 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 injection 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 (5.1). WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA See full prescribing information for complete boxed warning. There have been reports of cardiac arrest with diffcult resuscitation or death during use of bupivacaine hydrochloride injection 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 diffcult or impossible despite apparently adequate preparation and appropriate management.

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Prostaglandin Receptor Antagonists; Sodium Channel Interactions.

Prostaglandin Receptor

Indications

Sourced from openFDA
  • Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [ see Dosage and Administration (2.2) ].

Contraindications

Sourced from openFDA
  • Bupivacaine hydrochloride injection is contraindicated in: obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death.contraindicated

Dosage & administration

Sourced from openFDA

• Not for intrathecal use. (2.1) • Avoid use of solutions containing antimicrobial preservatives (i.e., multiple-dose vials) for epidural or caudal anesthesia. (2.1, 5.4) • See full prescribing information for: - Recommended concentrations and dosages of bupivacaine hydrochloride injection according to type of block. (2.2)

Warnings & precautions

Sourced from openFDA

• Dose-Related Toxicity : Monitor cardiovascular and respiratory vital signs and patient’s state of consciousness after injection of bupivacaine hydrochloride injection. (5.2) • Methemoglobinemia : Cases of methemoglobinemia have been reported in association with local anesthetic use. See full prescribing information for more detail on managing these risks. (5.3) • Chondrolysis with Intra-Articular Infusion : Intra-articular infusions of local anesthetics including bupivacaine hydrochloride injection following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. (5.5) • 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). (5.7) • Risk of Systemic Toxicities with Unintended Intravascular or Intrathecal Injection : Unintended intravascular or intrathecal injection may be associated with systemic toxicities, including CNS or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest. Aspirate for blood or cerebrospinal fluid (where applicable) prior to each dose. (5.9)

Adverse reactions

Sourced from openFDA

The following clinically significant adverse reactions have been reported and described in the Warnings and Precautions section of the labeling: • Cardiac Arrest in Obstetrical Anesthesia [ see Warnings and Precautions (5.1) ] • Dose-Related Toxicity [ see Warnings and Precautions (5.2) ] • Methemoglobinemia [ see Warnings and Precautions (5.3) ] • Chondrolysis with Intra-Articular Infusion [ see Warnings and Precautions (5.5) ] • Cardiac Arrest with Intravenous Regional Anesthesia Use [ see Contraindications (4), Warnings and Precautions (5.7) ] • Systemic Toxicities with Unintended Intravascular or Intrathecal Injection [ see Warnings and Precautions (5.9) ] The following adverse reactions from voluntary reports or clinical studies have been reported with bupivacaine. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions to bupivacaine hydrochloride injection are characteristic of those associated with other amide-type local anesthetics. A major cause of adverse reactions to this group of drugs is excessive plasma levels, which may be due to overdosage, unintentional intravascular injection, or slow metabolic degradation. The most commonly encountered acute adverse reactions that demand immediate counter-measures were related to the CNS and the cardiovascular system.

Use in specific populations

Sourced from openFDA

• Pediatric Use : Administration of bupivacaine hydrochloride injection in pediatric patients younger than 12 years is not recommended. (8.4) • Geriatric Use : Patients 65 years and over, particularly those with hypertension, may be at increased risk for developing hypotension while undergoing anesthesia with bupivacaine hydrochloride injection. (8.5) • Moderate to Severe Hepatic Impairment : Consider increased monitoring for bupivacaine systemic toxicity. (8.6)

Overdosage

Sourced from openFDA

Clinical Presentation Acute emergencies from use of bupivacaine hydrochloride injection are generally related to high plasma levels encountered during therapeutic use or to unintended intrathecal injection [ see Warnings and Precautions (5.2, 5.9), Adverse Reactions (6) ]. If not treated immediately, convulsions with simultaneous hypoxia, hypercarbia, and acidosis plus myocardial depression from the direct effects of bupivacaine may result in cardiac arrhythmias, bradycardia, asystole, ventricular fibrillation, or cardiac arrest. Respiratory abnormalities, including apnea, may occur. Hypoventilation or apnea due to unintentional intrathecal injection of bupivacaine hydrochloride injection may produce these same signs and also lead to cardiac arrest if ventilatory support is not instituted. If cardiac arrest should occur, successful outcome may require prolonged resuscitative efforts.

Approval history

Sourced from openFDA
  • Oct 3, 1972NDANDA016964Hospira
  • Dec 30, 1981NDANDA018304Fresenius Kabi Usa
  • May 4, 1984NDANDA018692Hospira
  • May 21, 1986ANDAANDA070552Fresenius Kabi Usa
  • May 21, 1986ANDAANDA070553Fresenius Kabi Usa
  • May 21, 1986ANDAANDA070554Fresenius Kabi Usa
  • Oct 28, 2011NDANDA022496Pacira Pharms Inc
  • May 12, 2021NDANDA211988Heron Theraps Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
16,670 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective3,30020%
  2. 2Off Label Use1,1426.9%
  3. 3Pain1,0936.6%
  4. 4Hypotension8054.8%
  5. 5Anaesthetic Complication7904.7%
  6. 6Hypoaesthesia6113.7%
  7. 7Maternal Exposure During Pregnancy6103.7%
  8. 8Nausea5933.6%
  9. 9Exposure During Pregnancy4562.7%
  10. 10Vomiting4322.6%
  11. 11Dyspnoea4012.4%
  12. 12Dizziness3892.3%
  13. 13Headache3652.2%
  14. 14Drug Withdrawal Syndrome3412.0%
  15. 15Bradycardia3272.0%

Literature

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Recent PubMed references pinned to Bupivacaine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 4,613 ClinicalTrials.gov registrations naming Bupivacaine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Bupivacaine work?
Mechanism-of-action classes: Prostaglandin Receptor Antagonists; Sodium Channel Interactions.
What is Bupivacaine used for?
According to FDA labeling, Bupivacaine carries indications including: Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [ see Dosage and Administration (2.2) ].. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Bupivacaine?
Bupivacaine is classified as Amides, Amide Local Anesthetic, Prostaglandin Receptor Antagonists, Sodium Channel Interactions, Decreased Organized Electrical Activity, Local Anesthesia.
What are the brand names for Bupivacaine?
Bupivacaine is marketed under brand names including Exparel, Marcaine, Marcaine with Epinephrine, Nocita, Posimir, Sensorcaine, Sensorcaine with Epinephrine, Vivacaine.
What are the contraindications for Bupivacaine?
Bupivacaine labeling lists contraindications including: Bupivacaine hydrochloride injection is contraindicated in: obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death.. Always consult the full prescribing information and a clinician.
Note. Data for bupivacaine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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