BUPIVACAINE HYDROCHLORIDE injection, solution 5 mg/mL
BUPIVACAINE HYDROCHLORIDE injection, solution · INJECTION, SOLUTION · HF Acquisition Co LLC, DBA HealthFirst
BUPIVACAINE HYDROCHLORIDE injection, solution is a injection, solution containing bupivacaine hydrochloride injection, solution at 5 mg/mL, taken perineural. Manufactured by HF Acquisition Co LLC, DBA HealthFirst.
Key Facts
- Brand Name
- BUPIVACAINE HYDROCHLORIDE injection, solution
- Generic Name
- BUPIVACAINE HYDROCHLORIDE injection, solution
- NDC Code (Product)
51662-1638- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- PERINEURAL
- Marketing Status
- Application #
- ANDA207183
- Marketing Start
- 05/13/2016
Recall History
No Recall HistoryFull 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, 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 & Administration
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. Mixing or the prior or intercurrent use of any other local anesthetic with bupivacaine hydrochloride injection is not recommended because of insufficient data on the clinical use of such mixtures. Administration Precautions Bupivacaine hydrochloride injection is to be administered in carefully adjusted dosages by or under the supervision of experienced clinicians who are well versed in the diagnosis and management of dose-related toxicity and oth…
Contraindications
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 ]. 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.
Drug 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
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 ] 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 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 are characteristic of those associated with other amide-type local anesthetics. A major cause of adverse reactions to t…
Frequently Asked Questions
What is BUPIVACAINE HYDROCHLORIDE injection, solution used for?
BUPIVACAINE HYDROCHLORIDE injection, solution contains BUPIVACAINE HYDROCHLORIDE injection, solution. It is a injection, solution taken perineural. Consult your doctor for specific uses.
Is BUPIVACAINE HYDROCHLORIDE injection, solution a controlled substance?
BUPIVACAINE HYDROCHLORIDE injection, solution is not classified as a controlled substance by the DEA.
What is the generic name for BUPIVACAINE HYDROCHLORIDE injection, solution?
The generic name for BUPIVACAINE HYDROCHLORIDE injection, solution is BUPIVACAINE HYDROCHLORIDE injection, solution. There are no other listed brand versions of BUPIVACAINE HYDROCHLORIDE injection, solution.
What is the NDC code for BUPIVACAINE HYDROCHLORIDE injection, solution 5 mg/mL?
The NDC (National Drug Code) for BUPIVACAINE HYDROCHLORIDE injection, solution 5 mg/mL is 51662-1638, listed by HF Acquisition Co LLC, DBA HealthFirst.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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