Bupivacaine HCl 2.5 mg/mL
Bupivacaine Hydrochloride · INJECTION, SOLUTION · Xellia Pharmaceuticals USA LLC
Bupivacaine HCl is a injection, solution containing bupivacaine hydrochloride at 2.5 mg/mL, taken perineural. Manufactured by Xellia Pharmaceuticals USA LLC.
Key Facts
- Brand Name
- Bupivacaine HCl
- Generic Name
- Bupivacaine Hydrochloride
- NDC Code (Product)
70594-116- Manufacturer
- Xellia Pharmaceuticals USA LLC
- Strength
- 2.5 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- PERINEURAL
- Marketing Status
- Application #
- ANDA091503
- Marketing Start
- 08/01/2023
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.
Pharmedium Services, LLC
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
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.
Pharmedium Services, LLC
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Pharmedium Services, LLC
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Hartley Medical Center Pharmacy, Incorporated
Lack of Assurance of Sterility
Med Shop Total Care Inc.
Non-Sterility
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 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) ]. Bupivacaine hydrochloride injection contains bupivacaine, an amide local anesthetic. 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. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. ( 1 , 2.2 ) Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use. ( 1 , 2.2 , 4 , 5.1 , 5.4 , 5.5 , 5.7 , 5.9 ) Limitations of Use Not all blocks are ind…
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 ) See full prescribing information for: — Recommended concentrations and dosages of bupivacaine hydrochloride injection according to type of block. ( 2.2 ) — Additional dosage and administration information pertaining to use in epidural anesthesia and use in ophthalmic surgery. ( 2.3 , 2.4, 2.5) 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 (5.4) ] . 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 solutions. Do not administer solutions which are discolored or con…
Contraindications
4 CONTRAINDICATIONS Bupivacaine hydrochloride 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. 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. ( 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 ) Drugs Associated with Methemoglobinemia : Patients are at increased risk of developing methemoglobinemia when concurrently exposed to nitrates, nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, and other drugs. ( 7.5 ) 7.1 Local Anesthetics The toxic effects of local anesthetics are additive. If coadministration of other local anesthetics with bupivacaine hydrochloride injection cannot be avoided, monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity [see Dosage and Administration (2.1) , Warnings and Precautions (5.2) ] . 7.5 Drugs Associated with Methemoglobinemia Patients who are administered bupivacaine hydrochloride injection are at increased risk of developing methemoglobinemia when concurrently exposed to following drugs, which could include other local anesthetics [see Warnings and Precautions (5.3) ]. Examples of Drugs Associated with Methemoglobinemia: Class Examples Nitrates/…
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) ] 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) ] 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. 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 l…
Frequently Asked Questions
What is Bupivacaine HCl used for?
Bupivacaine HCl contains Bupivacaine Hydrochloride. It is a injection, solution taken perineural. Consult your doctor for specific uses.
Is Bupivacaine HCl a controlled substance?
Bupivacaine HCl is not classified as a controlled substance by the DEA.
What is the generic name for Bupivacaine HCl?
The generic name for Bupivacaine HCl is Bupivacaine Hydrochloride. There are 12 other brand versions of Bupivacaine Hydrochloride.
What is the NDC code for Bupivacaine HCl 2.5 mg/mL?
The NDC (National Drug Code) for Bupivacaine HCl 2.5 mg/mL is 70594-116, listed by Xellia Pharmaceuticals USA LLC.
Other Bupivacaine Brands
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- 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)