Bupivacaine Hydrochloride Injection, Solution
Generic Name: bupivacaine hydrochloride injection, solution
Brand Names:
Bupivacaine Hydrochloride Injection, Solution
11 DESCRIPTION Bupivacaine hydrochloride injection, USP contains bupivacaine hydrochloride, USP an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for bupivacaine hydrochloride injection is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. Multiple-dose vials contain methylparaben [see WARNINGS AND PRECAUTIONS ].
Overview
11 DESCRIPTION Bupivacaine hydrochloride injection, USP contains bupivacaine hydrochloride, USP an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for bupivacaine hydrochloride injection is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. Multiple-dose vials contain methylparaben [see WARNINGS AND PRECAUTIONS ].
Uses
1 INDICATIONS AND USAGE Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, 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 ]. Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [see DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , WARNINGS AND PRECAUTIONS ].
Dosage
2 DOSAGE AND ADMINISTRATION 2.1 Important Dosage and Administration Information Bupivacaine hydrochloride injection is not for intrathecal use. Avoid use of bupivacaine hydrochloride injection solutions containing antimicrobial preservatives (i.e., multiple-dose vials) for epidural or caudal anesthesia [see WARNINGS AND PRECAUTIONS ]. 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 clear, colorless solution. Do not administer solutions which are discolored or contain particulate matter.
Side Effects
6 ADVERSE REACTIONS 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 ] Dose-Related Toxicity [see WARNINGS AND PRECAUTIONS ] Methemoglobinemia [see WARNINGS AND PRECAUTIONS ] Chondrolysis with Intra-Articular Infusion [see WARNINGS AND PRECAUTIONS ] Cardiac Arrest with Intravenous Regional Anesthesia Use [see CONTRAINDICATIONS , WARNINGS AND PRECAUTIONS ] Systemic Toxicities with Unintended Intravascular or Intrathecal Injection [see WARNINGS AND PRECAUTIONS ] Respiratory Arrest Following Retrobulbar Block [see WARNINGS AND PRECAUTIONS ] The following adverse reactions from voluntary reports or clinical studies have been repo...
Interactions
7 DRUG INTERACTIONS 7.1 Local Anesthetics The toxic effects of local anesthetics are additive. If coadministration of other local anesthetics with bupivacaine hydrochloride cannot be avoided, monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity [see DOSAGE AND ADMINISTRATION , WARNINGS AND PRECAUTIONS ]. 7.5 Drugs Associated with Methemoglobinemia Patients who are administered bupivacaine hydrochloride are at increased risk of developing methemoglobinemia when concurrently exposed to following drugs, which could include other local anesthetics [see WARNINGS AND PRECAUTIONS ]. DRUG INTERACTION TABLE
Warnings
BOXED WARNING WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE IN OBSTETRICAL ANESTHESIA There 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. 5 WARNINGS AND PRECAUTIONS 5.1 Risk of Cardiac Arrest with Use of Bupivacaine Hydrochloride in Obstetrical Anesthesia There 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. 4 CONTRAINDICATIONS 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) [see WARNINGS AND PRECAUTIONS ].
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Bupivacaine hydrochloride injection, USP is a clear, colorless, sterile isotonic solution and is available as follows: Solutions of bupivacaine hydrochloride injection, USP may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes. Protect from light. This product is clear and colorless.
Frequently Asked Questions
What is Bupivacaine Hydrochloride Injection, Solution used for?▼
1 INDICATIONS AND USAGE Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, 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 ]. Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [see DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , WARNINGS AND PRECAUTIONS ].
What are the side effects of Bupivacaine Hydrochloride Injection, Solution?▼
6 ADVERSE REACTIONS 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 ] Dose-Related Toxicity [see WARNINGS AND PRECAUTIONS ] Methemoglobinemia [see WARNINGS AND PRECAUTIONS ] Chondrolysis with Intra-Articular Infusion [see WARNINGS AND PRECAUTIONS ] Cardiac Arrest with Intravenous Regional Anesthesia Use [see CONTRAINDICATIONS , WARNINGS AND PRECAUTIONS ] Systemic Toxicities with Unintended Intravascular or Intrathecal Injection [see WARNINGS AND PRECAUTIONS ] Respiratory Arrest Following Retrobulbar Block [see WARNINGS AND PRECAUTIONS ] The following adverse reactions from voluntary reports or clinical studies have been repo...
What are the important warnings for Bupivacaine Hydrochloride Injection, Solution?▼
BOXED WARNING WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE IN OBSTETRICAL ANESTHESIA There 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. 5 WARNINGS AND PRECAUTIONS 5.1 Risk of Cardiac Arrest with Use of Bupivacaine Hydrochloride in Obstetrical Anesthesia There 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. 4 CONTRAINDICATIONS 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) [see WARNINGS AND PRECAUTIONS ].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.