Bupivacaine 13.3 mg/mL
Bupivacaine · INJECTION, SUSPENSION, LIPOSOMAL · Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Bupivacaine is a injection, suspension, liposomal containing bupivacaine at 13.3 mg/mL, taken infiltration. Manufactured by Jiangsu Hengrui Pharmaceuticals Co., Ltd..
Key Facts
- Brand Name
- Bupivacaine
- Generic Name
- Bupivacaine
- NDC Code (Product)
57884-3252- Manufacturer
- Jiangsu Hengrui Pharmaceuticals Co., Ltd.
- Strength
- 13.3 mg/mL
- Dosage Form
- INJECTION, SUSPENSION, LIPOSOMAL
- Route
- INFILTRATION
- Marketing Status
- Application #
- ANDA214348
- Drug Class
- Amide Local Anesthetic [EPC]
- Marketing Start
- 07/01/2024
Recall History
Pharmedium Services, LLC
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
SCA Pharmaceuticals
cGMP deviations: due to shipment of rejected units.
Pharmedium Services, LLC
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Pharmedium Services, LLC
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Med Shop Total Care Inc.
Non-Sterility
Hospira Inc.
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine 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/Bupivacaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2) ]. Bupivacaine Hydrochloride Injection contains bupivacaine, an amide local anesthetic, and Bupivacaine Hydrochloride and Epinephrine Injection is a combination of bupivacaine, an amide local anesthetic, and epinephrine, an alpha and beta-adrenergic agonist. Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine 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. For each type of block indicated to produce local or re…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • 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 ) • Three mL of Bupivacaine Hydrochloride and Epinephrine Injection without antimicrobial preservative (0.5% bupivacaine with 1:200,000 epinephrine) is recommended for use as a test dose prior to caudal and lumbar epidural blocks when clinical conditions permit. ( 2.4 ) • See full prescribing information for: - Recommended concentrations and dosages of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection according to type of block. ( 2.2 ) - Additional dosage and administration information pertaining to use in epidural anesthesia, test dose for caudal and lumbar epidural blocks, use in dentistry, and use in ophthalmic surgery. ( 2.3 , 2.4 , 2.5 , 2.6 ) 2.1 Important Dosage and Administration Information • Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is not for intrathecal use. • Avoid use of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection solutions containing antimicr…
Contraindications
4 CONTRAINDICATIONS Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection 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 (5.7) ]. • patients with a known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection. • Obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. ( 4 ) • Intravenous regional anesthesia (Bier Block). ( 4 ) • Known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Local Anesthetics : The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects when additional local anesthetics are administered. ( 7.1 ) • Monoamine Oxidase Inhibitors and Tricyclic Antidepressants : Administration of Bupivacaine Hydrochloride and Epinephrine Injection to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe, prolonged hypertension. Concurrent use of these agents should generally be avoided. ( 5.6 , 7.2 ) • Ergot-Type Oxytocic Drugs : Concurrent administration of Bupivacaine Hydrochloride and Epinephrine Injection and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. ( 5.6 , 7.3 ) • Nonselective Beta-Adrenergic Antagonists : Administration of Bupivacaine Hydrochloride and Epinephrine Injection (containing a vasoconstrictor) in patients receiving nonselective beta-adrenergic antagonists may cause severe hypertension and bradycardia. Concurrent use of these agents should generally be avoided. ( 5.6 , 7.4 ) • Drugs Associated with Methemoglobinemia : Patients are at increased risk of developing methemoglobinemia …
Adverse Reactions
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 (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) ] • Severe, Persistent Hypertension, Cerebrovascular Accidents, and Bradycardia Due to Drug Interactions [see Warnings and Precautions (5.6) ] • Cardiac Arrest with Intravenous Regional Anesthesia Use [see Contraindications (4) , Warnings and Precautions (5.7) ] • Allergic-Type Reactions [see Warnings and Precautions (5.8) ] • Systemic Toxicities with Unintended Intravascular or Intrathecal Injection [see Warnings and Precautions (5.9) ] • Respiratory Arrest Following Retrobulbar Block [see Warnings and Precautions (5.15) ] The following adverse reactions from voluntary reports or clinical studies have been reported with bupivacaine or bupivacaine and epinephrine. Because many of these reactions were reported voluntarily from a population of u…
Frequently Asked Questions
What is Bupivacaine used for?
Bupivacaine contains Bupivacaine. It is a injection, suspension, liposomal taken infiltration. Consult your doctor for specific uses.
Is Bupivacaine a controlled substance?
Bupivacaine is not classified as a controlled substance by the DEA.
What is the generic name for Bupivacaine?
The generic name for Bupivacaine is Bupivacaine. There are 11 other brand versions of Bupivacaine.
What is the NDC code for Bupivacaine 13.3 mg/mL?
The NDC (National Drug Code) for Bupivacaine 13.3 mg/mL is 57884-3252, listed by Jiangsu Hengrui Pharmaceuticals Co., Ltd..
Other Bupivacaine Brands
See all →- Bupivacaine Hydrochloride2.5 mg/mL85766-074
- Bupivacaine Hydrochloride7.5 mg/mL0143-9332
- Bupivacaine Hydrochloride2.5 mg/mL55150-167
- Bupivacaine Hydrochloride5 mg/mL0409-1163
- Marcaine150 mg/30mL0409-1530
- Marcaine with Epinephrine5 mg/mL0409-1749
- Marcaine with Epinephrine5 mg/mL0409-4208
- Marcaine with Epinephrine2.5 mg/mL0409-5738
- Marcaine with Epinephrine5 mg/mL0409-6581
- Marcaine with Epinephrine5 mg/mL0409-8126
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)