SENSORCAINE MPF BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE 2.5 mg/mL; .005 mg/mL Injection, Solution — NDC 63323-468-38 (Billing 63323-0468-38)
This is a package of SENSORCAINE MPF BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE 2.5 mg/mL; .005 mg/mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Nov 2010 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 63323-468-38 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 63323 labeler · 468 product · 38 package
- Package marketed since
- Jul 29, 2022
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0363323468088
- FDA record last changed
- Oct 1, 2026
Past resolved recalls for this product (3)
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 052187
- GCN: 19750
- GPI-14 (Medi-Span): 69991002102012
- HICL (First Databank): 025242
- AHFS class code: 12:12.12.00
- RxCUI (RxNorm): 1867594
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Amide Local Anesthetic class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It is a long-acting numbing injection used in adults to block pain during surgery, dental work, diagnostic or treatment procedures, and obstetrical procedures. The epinephrine in s...
- A trained clinician injects it, so you have nothing to take at home. It may be injected near a nerve, into tissue, or in the epidural or caudal area, depending on the procedure. Yo...
- How is it given, and do I need to do anything?
- Some people feel dizzy, restless, drowsy or nauseated, or notice ringing in the ears or blurred vision. After an epidural, headache or backache can occur. Tell your care team right...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 63323-0468-17 63323-468-17 | 25 VIAL, SINGLE-DOSE in 1 TRAY / 10 mL in 1 VIAL, SINGLE-DOSE | 2010-11-19 | — | Discontinued by firm |
| 63323-0468-37 63323-468-37 Main listing | 25 VIAL, SINGLE-DOSE in 1 TRAY / 30 mL in 1 VIAL, SINGLE-DOSE | 2010-11-19 | — | Discontinued by firm |
| 63323-0468-38 You're viewing this | 25 VIAL, SINGLE-DOSE in 1 TRAY / 30 mL in 1 VIAL, SINGLE-DOSE | 2022-07-29 | — | Active |
This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of SENSORCAINE MPF BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE 2.5 mg/mL; .005 mg/mL Injection, Solution?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sensorcaine Mpf 2.5 mg/mL; .005 mg/mLthis 63323-0468-38 | Fresenius | 25 vials | — | AP | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
0.2 mg / 1 mL
UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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8 mg / 1 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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0.5 mg / 1 mL
UNII 4VON5FNS3C
Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
More NDCs from Fresenius Kabi USA, LLC labeler code 63323
- SENSORCAINE MPF BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE 5 mg/mL; .005 mg/mL Injection, Solution NDC 63323-462-17
- SENSORCAINE BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE 5 mg/mL; .005 mg/mL Injection, Solution NDC 63323-463-57
- SENSORCAINE MPF BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Injection, Solution NDC 63323-464-17
- SENSORCAINE BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Injection, Solution NDC 63323-465-57
- SENSORCAINE MPF BUPIVACAINE HYDROCHLORIDE 5 mg/mL Injection, Solution NDC 63323-466-17
- SENSORCAINE BUPIVACAINE HYDROCHLORIDE 5 mg/mL Injection, Solution NDC 63323-467-57
- Haloperidol Decanoate 50 mg/mL Injection NDC 63323-469-01
- Haloperidol Decanoate 100 mg/mL Injection NDC 63323-471-01
- SENSORCAINE MPF BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Injection, Solution NDC 63323-472-17
- Haloperidol 5 mg/mL Injection, Solution NDC 63323-474-01
- Nesacaine CHLOROPROCAINE HYDROCHLORIDE 10 mg/mL Injection, Solution NDC 63323-475-37
- Nesacaine CHLOROPROCAINE HYDROCHLORIDE 20 mg/mL Injection, Solution NDC 63323-476-37
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: RISK OF CARDIAC ARREST WITH USE OF SENSORCAINE IN OBSTETRICAL ANESTHESIA There have been reports of cardiac arrest with difficult resuscitation or death during use of SENSORCAINE 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. The 0.75% (7.5 mg/mL) concentration of SENSORCAINE 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 [see Warnings and Precautions ( 5.1 )]. WARNING: RISK OF CARDIAC ARREST WITH USE OF SENSORCAINE IN OBSTETRICAL ANESTHESIA See full prescribing information for complete boxed warning.
There have been reports of cardiac arrest with difficult resuscitation or death during use of SENSORCAINE 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. The 0.75% (7.5 mg/mL) concentration of SENSORCAINE 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 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE SENSORCAINE / SENSORCAINE WITH EPINEPHRINE 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 SENSORCAINE / SENSORCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration ( 2.2 )]. SENSORCAINE contains bupivacaine, an amide local anesthetic, and SENSORCAINE WITH EPINEPHRINE is a combination of bupivacaine, an amide local anesthetic, and epinephrine, an alpha and beta-adrenergic agonist.
SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE 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 regional anesthesia or analgesia, specific concentrations and presentations are recommended. ( 1 , 2.2 ) Limitations of Use Not all blocks are indicated for use with SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE 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 indicated for use with SENSORCAINE / SENSORCAINE WITH EPINEPHRINE given clinically significant risks associated with use [see Dosage and Administration ( 2.2 ), Contraindications ( 4 ), Warnings and Precautions ( 5.1 , 5.4 , 5.5 , 5.7 , 5.9 )] .
⏱️ Dosage and 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 SENSORCAINE-MPF WITH EPINEPHRINE 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 SENSORCAINE / SENSORCAINE WITH EPINEPHRINE 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 )
2.1Important Dosage and Administration Information SENSORCAINE / SENSORCAINE WITH EPINEPHRINE is not for intrathecal use. Avoid use of SENSORCAINE / SENSORCAINE WITH EPINEPHRINE 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. SENSORCAINE are clear, colorless solutions. Do not administer solutions which are discolored or contain particulate matter.
SENSORCAINE WITH EPINEPHRINE are clear, colorless to slightly yellow solutions. Do not administer solutions which are pinkish or darker than slightly yellow or contain particulate matter. Mixing or the prior or intercurrent use of any other local anesthetic with SENSORCAINE / SENSORCAINE WITH EPINEPHRINE is not recommended because of insufficient data on the clinical use of such mixtures.
Administration Precautions SENSORCAINE / SENSORCAINE WITH EPINEPHRINE are 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 other acute emergencies which might arise from the block to be employed. Use SENSORCAINE / SENSORCAINE WITH EPINEPHRINE only if the following are immediately available: oxygen, cardiopulmonary resuscitative equipment and drugs, and the personnel resources needed for proper management of toxic reactions and related emergencies [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6 ), Overdosage ( 10 )].
The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity when additional local anesthetics are administered with SENSORCAINE / SENSORCAINE WITH EPINEPHRINE [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.1 ), Overdosage ( 10 )]. Aspirate for blood or cerebrospinal fluid (where applicable) prior to injecting SENSORCAINE / SENSORCAINE WITH EPINEPHRINE, both the initial dose and all subsequent doses, to avoid intravascular or intrathecal injection.
However, a negative aspiration for blood or cerebrospinal fluid does not ensure against an intravascular or intrathecal injection [see Warnings and Precautions ( 5.9 )] . Avoid rapid injection of a large volume of SENSORCAINE / SENSORCAINE WITH EPINEPHRINE and use fractional (incremental) doses when feasible. During major regional nerve blocks, such as those of the brachial plexus or lower extremity, the patient should have an indwelling intravenous catheter to assure adequate intravenous access.
The lowest dosage of SENSORCAINE / SENSORCAINE WITH EPINEPHRINE that results in effective anesthesia should be used to avoid high plasma levels and serious adverse reactions. Perform careful and constant monitoring of cardiovascular and respiratory (adequacy of oxygenation and ventilation) vital signs and the patient's level of con… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS SENSORCAINE ® -MPF (bupivacaine hydrochloride) injection is a clear, colorless, methyl paraben free solution available as: 0.25% (25 mg per 10 mL) (2.5 mg/mL), in 10 mL Single Dose Vial 0.25% (75 mg per 30 mL) (2.5 mg/mL), in 30 mL Single Dose Vial 0.5% (50 mg per 10 mL) (5 mg/mL), in 10 mL Single Dose Vial 0.5% (150 mg per 30 mL) (5 mg/mL), in 30 mL Single Dose Vial 0.75% (75 mg per 10 mL) (7.5 mg/mL), in 10 mL Single Dose Vial 0.75% (225 mg per 30 mL) (7.5 mg/mL), in 30 mL Single Dose Vial SENSORCAINE ® -MPF WITH EPINEPHRINE 1:200,000 (bupivacaine hydrochloride and epinephrine injection, USP) is a clear, colorless to slightly yellow, methyl paraben free solution available as: 0.25% (75 mg per 30 mL) (2.5 mg/mL), in 30 mL Single Dose Vial 0.25% (25 mg per 10 mL) (2.5 mg/mL), in 10 mL Single Dose Vial 0.5% (50 mg per 10 mL) (5 mg/mL), in 10 mL Single Dose Vial 0.5% (150 mg per 30 mL) (5 mg/mL), in 30 mL Single Dose Vial 0.75% (225 mg per 30 mL) (7.5 mg/mL), in 30 mL Single Dose Vial SENSORCAINE ® (bupivacaine hydrochloride), injection is a clear, colorless solution available as: 0.25% (125 mg per 50 mL) (2.5 mg/mL), in 50 mL Multiple Dose Vial 0.5% (250 mg per 50 mL) (5 mg/mL), in 50 mL Multiple Dose Vial SENSORCAINE ® WITH EPINEPHRINE 1:200,000 (bupivacaine hydrochloride and epinephrine, USP) injection is a clear, colorless to slightly yellow solution available as: 0.25% (125 mg per 50 mL) (2.5 mg/mL), 50 mL Multiple Dose Vial 0.5% (250 mg per 50 mL) (5 mg/mL), 50 mL Multiple Dose Vial SENSORCAINE-MPF/SENSORCAINE-MPF WITH EPINEPHRINE and SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE injections are available in multiple concentrations.
See full prescribing information for detailed description of each formulation. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS SENSORCAINE / SENSORCAINE WITH EPINEPHRINE 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 SENSORCAINE / SENSORCAINE WITH EPINEPHRINE. Obstetrical paracervical block anesthesia.
( 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 SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Dose-Related Toxicity : Monitor cardiovascular and respiratory vital signs and patient's state of consciousness after injection of SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE. ( 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 SENSORCAINE 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 ) Allergic-Type Reactions to Sulfites in SENSORCAINE WITH EPINEPHRINE : SENSORCAINE WITH EPINEPHRINE contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
( 5.8 ) 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 and consider using a test dose of SENSORCAINE-MPF WITH EPINEPHRINE. ( 5.9 )
5.1Risk of Cardiac Arrest with Use of SENSORCAINE in Obstetrical Anesthesia There have been reports of cardiac arrest with difficult resuscitation or death during use of SENSORCAINE 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. The 0.75% (7.5 mg/mL) concentration of SENSORCAINE 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.
5.2Dose-Related Toxicity The safety and effectiveness of SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient's state of consciousness should be performed after injection of SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE solutions. Possible early warning signs of central nervous system (CNS) toxicity are restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, CNS depression, or drowsiness.
Delay in proper management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest, and, possibly, death. During major regional nerve blocks, such as those of the brachial plexus or lower extremity, the patient should have an indwelling intravenous catheter to assure adequate intravenous access. Use the lowest dosage of SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE that results in effective anesthesia to avoid high plasma levels and serious adverse effects.
Avoid rapid injection of a large volume of SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE solution and administer fractional (incremental) doses when feasible. Injection of repeated doses of SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE may cause significant increases in plasma levels with each repeated dose… [Excerpted — this section continues on DailyMed.]
🤒 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 uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions to SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE 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. These adverse reactions were generally dose-related and due to high plasma levels which may have resulted from overdosage, rapid absorption from the injection site, diminished tolerance, or from unintentional intravascular injection of the local anesthetic solution. In addition to systemic dose-related toxicity, unintentional intrathecal injection of drug during the intended performance of caudal or lumbar epidural block or nerve blocks near the vertebral column (especially in the head and neck region) has resulted in underventilation or apnea (“Total or High Spinal”).
Also, hypotension due to loss of sympathetic tone and respiratory paralysis or underventilation due to cephalad extension of the motor level of anesthesia have occurred. This has led to secondary cardiac arrest when untreated. Nervous System Disorders : Adverse reactions were characterized by excitation and/or depression of the central nervous system and included restlessness, anxiety, dizziness, tinnitus, blurred vision, tremors, convulsions, drowsiness, unconsciousness, respiratory arrest, nausea, vomiting, chills, pupillary constriction.
In the practice of caudal or lumbar epidural block, unintentional penetration of the subarachnoid space by the catheter or needle has occurred. Subsequent adverse effects may have depended partially on the amount of drug administered intrathecally and the physiological and physical effects of a dural puncture. A high spinal has been characterized by paralysis of the legs, loss of consciousness, respiratory paralysis, and bradycardia.
Neurologic effects following epidural or caudal anesthesia have included spinal block of varying magnitude (including high or total spinal block); hypotension secondary to spinal block; urinary retention; fecal and urinary incontinence; loss of perineal sensation and sexual function; persistent anesthesia, paresthesia, weakness, paralysis of the lower extremities and loss of sphincter control, all of which had slow, incomplete, or no recovery; headache; backache; septic meningitis; meningismus; slowing of labor; increased incidence of forceps delivery; and cranial nerve palsies due to traction on nerves from loss of cerebrospinal… [Excerpted — this section continues on DailyMed.]
🔄 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 SENSORCAINE WITH EPINEPHRINE 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 SENSORCAINE WITH EPINEPHRINE and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. ( 5.6 , 7.3 ) Nonselective Beta-Adrenergic Antagonists : Administration of SENSORCAINE WITH EPINEPHRINE (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 when concurrently exposed to nitrates, nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, and other drugs. ( 7.5 ) Potent Inhalation Anesthetics : Serious dose-related cardiac arrhythmias may occur if preparations containing a vasoconstrictor such as epinephrine are used in patients during or following the administration of potent inhalation anesthetics.
( 5.13 , 7.6 )
7.1Local Anesthetics The toxic effects of local anesthetics are additive. If coadministration of other local anesthetics with SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE 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 )] .
7.2Monoamine Oxidase Inhibitors and Tricyclic Antidepressants The administration of SENSORCAINE WITH EPINEPHRINE to patients receiving monoamine oxidase inhibitors, or tricyclic antidepressants may produce severe, prolonged hypertension. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful monitoring of the patient's hemodynamic status is essential [see Warnings and Precautions ( 5.6 )] .
7.3Ergot-Type Oxytocic Drugs Concurrent administration of SENSORCAINE WITH EPINEPHRINE and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. Avoid use of SENSORCAINE WITH EPINEPHRINE concomitantly with ergot-type oxytocic drugs [see Warnings and Precautions ( 5.6 )].
7.4Nonselective Beta-Adrenergic Antagonists Administration of SENSORCAINE WITH EPINEPHRINE (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. In situations when concurrent therapy is necessary, careful monitoring of the patient's blood pressure and heart rate is essential [see Warnings and Precautions ( 5.6 )].
7.5Drugs Associated with Methemoglobinemia Patients who are administered SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE 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/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants phenobarbital, phenytoin, sodium valproate Other drugs acetaminop… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pediatric Use : Administration of SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE 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 SENSORCAINE/SENSORCAINE WITH EPINEPHRINE ( 8.5 ) Moderate to Severe Hepatic Impairment : Consider increased monitoring for bupivacaine systemic toxicity. ( 8.6 )
8.1Pregnancy Risk Summary SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE is contraindicated for obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . There are no available data on use of SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE in pregnant women to inform a drug-associated risk of adverse developmental outcomes.
In animal studies, embryo-fetal lethality was noted when bupivacaine was administered subcutaneously to pregnant rabbits during organogenesis at clinically relevant doses. Decreased pup survival was observed in a rat pre- and post-natal developmental study (dosing from implantation through weaning) at a dose level comparable to the daily maximum recommended human dose (MRHD) on a body surface area (BSA) basis. Based on animal data, advise pregnant women of the potential risks to a fetus (see Data ).
Local anesthetics rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity [see Clinical Pharmacology ( 12.3 )]. The incidence and degree of toxicity depend upon the procedure performed, the type, and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus, and neonate involve alterations of the CNS, peripheral vascular tone, and cardiac function.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, inform the patient of the potential hazard to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations Maternal Adverse Reactions Maternal hypotension has resulted from regional anesthesia. Local anesthetics produce vasodilation by blocking sympathetic nerves. The supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus.
Therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels be accomplished. Elevating the patient's legs will also help prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously and electronic fetal monitoring is highly advisable.
Labor or Delivery Epidural, caudal, or pudendal anesthesia may alter the forces of parturition through changes in uterine contractility or maternal expulsive efforts. Epidural anesthesia has been reported to prolong the second stage of labor by removing the parturient's reflex urge to bear down or by interfering with motor function. The use of obstetrical anesthesia may increase the need for forceps assistance.
The use of some local anesthetic drug products during labor and delivery may be followed by diminished muscle strength and tone for the first day or two of life. This has not been reported with bupivacaine. It is extremely important to avoid aortocaval compression by the gravid uterus during administration of regional block to parturients.
To do this, the patient must be maintained in the left lateral decubitus posit… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE is contraindicated for obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . There are no available data on use of SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE in pregnant women to inform a drug-associated risk of adverse developmental outcomes.
In animal studies, embryo-fetal lethality was noted when bupivacaine was administered subcutaneously to pregnant rabbits during organogenesis at clinically relevant doses. Decreased pup survival was observed in a rat pre- and post-natal developmental study (dosing from implantation through weaning) at a dose level comparable to the daily maximum recommended human dose (MRHD) on a body surface area (BSA) basis. Based on animal data, advise pregnant women of the potential risks to a fetus (see Data ).
Local anesthetics rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity [see Clinical Pharmacology ( 12.3 )]. The incidence and degree of toxicity depend upon the procedure performed, the type, and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus, and neonate involve alterations of the CNS, peripheral vascular tone, and cardiac function.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, inform the patient of the potential hazard to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations Maternal Adverse Reactions Maternal hypotension has resulted from regional anesthesia. Local anesthetics produce vasodilation by blocking sympathetic nerves. The supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus.
Therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels be accomplished. Elevating the patient's legs will also help prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously and electronic fetal monitoring is highly advisable.
Labor or Delivery Epidural, caudal, or pudendal anesthesia may alter the forces of parturition through changes in uterine contractility or maternal expulsive efforts. Epidural anesthesia has been reported to prolong the second stage of labor by removing the parturient's reflex urge to bear down or by interfering with motor function. The use of obstetrical anesthesia may increase the need for forceps assistance.
The use of some local anesthetic drug products during labor and delivery may be followed by diminished muscle strength and tone for the first day or two of life. This has not been reported with bupivacaine. It is extremely important to avoid aortocaval compression by the gravid uterus during administration of regional block to parturients.
To do this, the patient must be maintained in the left lateral decubitus position or a blanket roll or sandbag may be placed beneath the right hip and gravid uterus displaced to the left. Data Animal Data Bupivacaine hydrochloride produced developmental toxicity when administered subcutaneously to pregnant rats and rabbits at clinically relevant doses. Bupivacaine hydrochloride was administered subcutaneously to rats at doses of 4.4, 13.3, & 40 mg/kg and to rabbits at doses of 1.3, 5.8, & 22.2 mg/kg during the period of organogenesis (implantation to closure of the hard palate).… [Excerpted — this section continues on DailyMed.]
🧒 Pediatric Use ▾
8.4Pediatric Use SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE is approved for use in adults. Administration of SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE in pediatric patients younger than 12 years is not recommended. Continuous infusions of bupivacaine in pediatric patients have been reported to result in high systemic levels of bupivacaine and seizures; high plasma levels may also be associated with cardiovascular abnormalities.
🧓 Geriatric Use ▾
8.5Geriatric Use Patients 65 years and over, particularly those with hypertension, may be at increased risk for developing hypotension while undergoing anesthesia with SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE. In clinical studies of bupivacaine, elderly patients reached the maximal spread of analgesia and maximal motor blockade more rapidly than younger adult patients. Differences in various pharmacokinetic parameters have been observed between elderly and younger adult patients [see Clinical Pharmacology ( 12.3 )] .
This product is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Elderly patients may require lower doses of SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE.
🆘 Overdosage ▾
10 OVERDOSAGE Clinical Presentation Acute emergencies from use of SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE 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 SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE 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.
Management The first step in the management of systemic toxic reactions, as well as hypoventilation or apnea due to unintentional intrathecal injection of SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE, consists of immediate attention to the establishment and maintenance of a patent airway and effective assisted or controlled ventilation with 100% oxygen with a delivery system capable of permitting immediate positive airway pressure by mask. Endotracheal intubation, using drugs and techniques familiar to the clinician, may be indicated after initial administration of oxygen by mask if difficulty is encountered in the maintenance of a patent airway, or if prolonged ventilatory support (assisted or controlled) is indicated.
If necessary, use drugs to manage the convulsions. A bolus intravenous dose of a benzodiazepine will counteract CNS stimulation related to SENSORCAINE. Immediately after the institution of ventilatory measures, evaluate the adequacy of the circulation.
Supportive treatment of circulatory depression may require Advance Cardiac Life Support measures.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Bupivacaine blocks the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination, and conduction velocity of affected nerve fibers. Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone.
Epinephrine is a vasoconstrictor added to bupivacaine to slow absorption into the general circulation and thus prolong maintenance of an active tissue concentration.
12.2Pharmacodynamics Systemic absorption of bupivacaine produces effects on the cardiovascular system and CNS. At blood concentrations achieved with normal therapeutic doses, changes in cardiac conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are minimal. However, toxic blood concentrations depress cardiac conduction and excitability, which may lead to atrioventricular block, ventricular arrhythmias, and cardiac arrest, sometimes resulting in fatalities.
In addition, myocardial contractility is depressed and peripheral vasodilation occurs, leading to decreased cardiac output and arterial blood pressure. These cardiovascular changes are more likely to occur after unintended intravascular injection of bupivacaine [see Warnings and Precautions ( 5.9 )] . Following systemic absorption, bupivacaine can produce CNS stimulation, CNS depression, or both.
Apparent central stimulation is manifested as restlessness, tremors, and shivering, progressing to convulsions, followed by CNS depression and coma progressing ultimately to respiratory arrest. However, bupivacaine has a primary depressant effect on the medulla and on higher centers. The depressed stage may occur without a prior excited state.
The duration of local anesthesia after administration of SENSORCAINE is longer than that observed after administration of other commonly used short-acting local anesthetics. There appears to be period of analgesia that persists after the resolution of the block and return of sensation. The onset of action following dental injections is usually 2 to 10 minutes and may last up to 7 hours.
The duration of anesthetic effect is prolonged by the addition of epinephrine 1:200,000.
12.3Pharmacokinetics Systemic plasma levels of bupivacaine following administration of SENSORCAINE do not correlate with local efficacy. Absorption The rate of systemic absorption of bupivacaine is dependent upon the total dose and concentration of drug administered, the route of administration, the vascularity of the administration site, and the presence or absence of epinephrine in the anesthetic solution. A dilute concentration of epinephrine (1:200,000) usually reduces the rate of absorption and peak plasma concentration of bupivacaine, permitting the use of moderately larger total doses and sometimes prolonging the duration of action [see Dosage and Administration ( 2 )] .
After injection of SENSORCAINE for caudal, epidural, or peripheral nerve block, peak levels of bupivacaine in the blood are reached in 30 to 45 minutes, followed by a decline to insignificant levels during the next three to six hours. Distribution Bupivacaine appears to cross the placenta by passive diffusion. The rate and degree of diffusion is governed by (1) the degree of plasma protein binding, (2) the degree of ionization, and (3) the degree of lipid solubility.
Fetal/ maternal ratios of bupivacaine appear to be inversely related to the degree of plasma protein binding, because only the free, unbound drug is available for placental transfer. Bupivacaine with a high protein binding capacity (95%) has a low fetal/maternal ratio (0.2 to 0.4). The extent of placental transfer is also determined by the degree of io… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Bupivacaine blocks the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination, and conduction velocity of affected nerve fibers. Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone.
Epinephrine is a vasoconstrictor added to bupivacaine to slow absorption into the general circulation and thus prolong maintenance of an active tissue concentration.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Solutions should be stored at 20° to 25°C (68° to 77°F); excursion permitted between 15 ⁰ C to 30 ⁰C (59 ⁰ F to 86 ⁰ F) [see USP Controlled Room Temperature]. These solutions are not for spinal anesthesia. SENSORCAINE ® -MPF (methylparaben free) does not contain epinephrine and is clear and colorless.
Do not use the solution if it is discolored or if it contains a precipitate. SENSORCAINE ® -MPF is available in the following forms: Product Code Unit of Sale Strength Each 460417 NDC 63323-464-17 Trays of 25 0.25% 25 mg per 10 mL (2.5 mg per mL) NDC 63323-464-01 10 mL Single Dose Vial 460437 NDC 63323-464-37 Trays of 25 0.25% 75 mg per 30 mL (2.5 mg per mL) NDC 63323-464-02 30 mL Single Dose Vial 460617 NDC 63323-466-17 Trays of 25 0.5% 50 mg per 10 mL (5 mg per mL) NDC 63323-466-03 10 mL Single Dose Vial 460637 NDC 63323-466-37 Trays of 25 0.5% 150 mg per 30 mL (5 mg per mL) NDC 63323-466-01 30 mL Single Dose Vial 470217 NDC 63323-472-17 Trays of 25 0.75% 75 mg per 10 mL (7.5 mg per mL) NDC 63323-472-03 10 mL Single Dose Vial 470237 NDC 63323-472-37 Trays of 25 0.75% 225 mg per 30 mL (7.5 mg per mL) NDC 63323-472-01 30 mL Single Dose Vial SENSORCAINE ® - MPF WITH EPINEPHRINE (1:200,000) should be protected from light.
This product is clear, colorless to slightly yellow. Do not use the solution if it is pinkish or darker than slightly yellow or if it contains a precipitate. SENSORCAINE ® -MPF WITH EPINEPHRINE is available in the following forms: Product Code Unit of Sale Strength Each 460837 NDC 63323-468-37 Trays of 25 0.25% 75 mg per 30 mL (2.5 mg per mL) NDC 63323-468-02 30 mL Single Dose Vial 460817 NDC 63323-468-17 Trays of 25 0.25% 25 mg per 10 mL (2.5 mg per mL) NDC 63323-468-01 10 mL Single Dose Vial 460217 NDC 63323-462-17 Trays of 25 0.5% 50 mg per 10 mL (5 mg per mL) NDC 63323-462-04 10 mL Single Dose Vial 460237 NDC 63323-462-37 Trays of 25 0.5% 150 mg per 30 mL (5 mg per mL) NDC 63323-462-01 30 mL Single Dose Vial 461037 NDC 63323-460-37 Trays of 25 0.75% 225 mg per 30 mL (7.5 mg per mL) NDC 63323-460-01 30 mL Single Dose Vial For Single Dose Vials: Discard unused portion.
SENSORCAINE ® (preserved with methylparaben) does not contain epinephrine and is clear and colorless. Do not use the solution if it is discolored or if it contains a precipitate. SENSORCAINE ® is available in the following forms: Product Code Unit of Sale Strength Each 460557 NDC 63323-465-57 Trays of 25 0.25% 125 mg per 50 mL (2.5 mg per mL) NDC 63323-465-01 50 mL Multiple Dose Vial 460757 NDC 63323-467-57 Trays of 25 0.5% 250 mg per 50 mL (5 mg per mL) NDC 63323-467-01 50 mL Multiple Dose Vial SENSORCAINE ® WITH EPINEPHRINE (1:200,000) should be protected from light.
This product is clear, colorless to slightly yellow. Do not use the solution if it is pinkish or darker than slightly yellow or if it contains a precipitate. SENSORCAINE® WITH EPINEPHRINE is available in the following forms: Product Code Unit of Sale Strength Each 460157 NDC 63323-461-57 Trays of 25 0.25% 125 mg per 50 mL (2.5 mg per mL) NDC 63323-461-01 50 mL Multiple Dose Vial 460357 NDC 63323-463-57 Trays of 25 0.5% 250 mg per 50 mL (5 mg per mL) NDC 63323-463-01 50 mL Multiple Dose Vial
📋 Description ▾
11 DESCRIPTION SENSORCAINE-MPF / SENSORCAINE-MPF WITH EPINEPHRINE injections contains bupivacaine hydrochloride, a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000. The route of administration for SENSORCAINE-MPF / SENSORCAINE-MPF WITH EPINEPHRINE is parenterally by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. SENSORCAINE-MPF / SENSORCAINE-MPF WITH EPINEPHRINE injections are Methyl Paraben Free (MPF).
SENSORCAINE/SENSORCAINE WITH EPINEPHRINE injections contains bupivacaine hydrochloride, a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000. The route of administration for SENSORCAINE / SENSORCAINE WITH EPINEPHRINE is parenterally by injection, for infiltration and perineural use. Bupivacaine hydrochloride is a white or almost white, crystalline powder or colorless crystals, soluble in water, freely soluble in alcohol.
Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group.
They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Bupivacaine hydrochloride chemical name is 2-piperidinecarboxamide, 1-butyl- N -(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. The molecular formula is C 18 H 28 N 2 O·HCl·H 2 O, with a molecular weight of 342.9 g/mol.
Bupivacaine hydrochloride monohydrate has the following chemical structure: The pK a of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Epinephrine bitartrate is a white to greyish white or light brownish-grey, odorless, crystalline powder, freely soluble in water, slightly soluble in 96% ethanol and methanol, practically insoluble in chloroform, methylene chloride and ether.
Epinephrine bitartrate chemical name is (-)-3,4-Dihydroxy- α [(methylamino)methyl] benzyl alcohol (+) tartrate (1:1) salt. The molecular formula is C 9 H 13 NO 3 ·C 4 H 6 O 6 , with a molecular weight of 333.29 g/mol. Epinephrine bitartrate has the following chemical structure: Bupivacaine Hydrochloride Monohydrate Chemical Structure Epinephrine Bitartrate Chemical Structure SENSORCAINE-MPF in single dose vials is a sterile, isotonic, clear, colorless, and preservative-free solution.
Each mL contains 2.64 mg, 5.27 mg, or 7.92 mg of bupivacaine hydrochloride monohydrate (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, and also equivalent to 2.5 mg, 5.0 mg, or 7.5 mg of bupivacaine hydrochloride anhydrous; respectively), 8.0 mg sodium chloride for isotonicity, and sodium hydroxide and/or hydrochloric acid as pH adjusters. The pH of these solutions is adjusted to between 4.0 and 6.5. SENSORCAINE-MPF WITH EPINEPHRINE 1:200,000 (as bitartrate) in single dose vials is a sterile, isotonic, clear, colorless to slightly yellow and preservative-free solution.
Each mL contains 2.64 mg, 5.27 mg, or 7.92 mg of bupivacaine hydrochloride monohydrate (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, and also equivalent to 2.5 mg, 5.0 mg or 7.5 mg bupivacaine hydrochloride anhydrous; respectively), 0.0091 mg or 9.09 mcg of epinephrine bitartrate (equivalent to 0.005 mg of epinephrine base), 0.5 mg sodium metabisulfite as an antioxidant, 0.2 mg citric acid (anhydrous) as a stabilizer, 8.0 mg sodium chloride for isotonicity, and sodium hydroxide and/or hydrochloric acid as pH adjusters.
The pH of these solutions is adjusted to between 3.3 to 5.5. SENSORCAINE in multiple dose vials is a sterile, isotonic, clear, colorless solution. Each mL contains 2.64 mg, or 5.27 mg, of bupivacaine hydrochloride monohydrate (equivalent to 2.22 mg, or 4.44 mg of bupivacaine, and also equivalent to 2.5 mg and 5.0 mg of bupivacaine hydroch… [Excerpted — this section continues on DailyMed.]
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Allergic-Type Reactions Assess if the patient has had allergic-type reactions to amide-type local anesthetics or to other formulation ingredients, such as the antimicrobial preservative methylparaben contained in multiple dose vials or sulfites in epinephrine-containing solutions [see Contraindications ( 4 ), Warnings and Precautions ( 5.8 ), Adverse Reactions ( 6 )] . Temporary Loss of Sensation and Motor Activity After Caudal or Epidural Anesthesia When appropriate, patients should be informed in advance that they may experience temporary loss of sensation and motor activity, usually in the lower half of the body, following proper administration of caudal or epidural anesthesia.
Instructions After Dental Injection of Sensorcaine Advise patients receiving dental injections of SENSORCAINE not to chew solid foods or to test the anesthetized area by biting or probing until anesthesia has worn off (up to 7 hours) [see Warnings and Precautions ( 5.16 )] . Methemoglobinemia Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue [see Warnings and Precautions ( 5.3 )] .
All trademarks are the property of Fresenius Kabi. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451106J Fresenius Kabi Logo
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Systemic plasma levels of bupivacaine following administration of SENSORCAINE do not correlate with local efficacy. Absorption The rate of systemic absorption of bupivacaine is dependent upon the total dose and concentration of drug administered, the route of administration, the vascularity of the administration site, and the presence or absence of epinephrine in the anesthetic solution. A dilute concentration of epinephrine (1:200,000) usually reduces the rate of absorption and peak plasma concentration of bupivacaine, permitting the use of moderately larger total doses and sometimes prolonging the duration of action [see Dosage and Administration ( 2 )] .
After injection of SENSORCAINE for caudal, epidural, or peripheral nerve block, peak levels of bupivacaine in the blood are reached in 30 to 45 minutes, followed by a decline to insignificant levels during the next three to six hours. Distribution Bupivacaine appears to cross the placenta by passive diffusion. The rate and degree of diffusion is governed by (1) the degree of plasma protein binding, (2) the degree of ionization, and (3) the degree of lipid solubility.
Fetal/ maternal ratios of bupivacaine appear to be inversely related to the degree of plasma protein binding, because only the free, unbound drug is available for placental transfer. Bupivacaine with a high protein binding capacity (95%) has a low fetal/maternal ratio (0.2 to 0.4). The extent of placental transfer is also determined by the degree of ionization and lipid solubility of the drug.
Lipid soluble, nonionized drugs readily enter the fetal blood from the maternal circulation. Depending upon the route of administration, bupivacaine is distributed to some extent to all body tissues, with high concentrations found in highly perfused organs such as the liver, lungs, heart, and brain. Pharmacokinetic studies on the plasma profile of bupivacaine after direct intravenous injection (SENSORCAINE is not approved for intravenous use) suggest a three-compartment open model.
The first compartment is represented by the rapid intravascular distribution of the drug. The second compartment represents the equilibration of the drug throughout the highly perfused organs such as the brain, myocardium, lungs, kidneys, and liver. The third compartment represents an equilibration of the drug with poorly perfused tissues, such as muscle and fat.
Elimination The half-life of bupivacaine in adults is 2.7 hours. Metabolism Amide-type local anesthetics such as bupivacaine are metabolized primarily in the liver via conjugation with glucuronic acid. Pipecoloxylidine is the major metabolite of bupivacaine.
The elimination of drug from tissue distribution depends largely upon the availability of binding sites in the circulation to carry it to the liver where it is metabolized. Excretion The kidney is the main excretory organ for most local anesthetics and their metabolites. Urinary excretion is affected by urinary perfusion and factors affecting urinary pH.
Only 6% of bupivacaine is excreted unchanged in the urine. Specific Populations Geriatric Patients Elderly patients exhibited higher peak plasma concentrations than younger patients following administration of SENSORCAINE. The total plasma clearance was decreased in these patients [see Use in Specific Populations ( 8.5 )] .
Patients with Hepatic Impairment Various pharmacokinetic parameters of the local anesthetics can be significantly altered by the presence of hepatic disease. Patients with hepatic disease, especially those with severe hepatic disease, may be more susceptible to the potential toxicities of the amide-type local anesthetics [see Use in Specific Populations ( 8.6 )] . Patients with Renal Impairment Various pharmacokinetic parameters of the local anesthetics can be significantly altered by the presence of renal disease, factors affecting urinary pH, and renal blood flow [see Use in Specific Populations ( 8.5 , 8.7 )] .
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Systemic absorption of bupivacaine produces effects on the cardiovascular system and CNS. At blood concentrations achieved with normal therapeutic doses, changes in cardiac conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are minimal. However, toxic blood concentrations depress cardiac conduction and excitability, which may lead to atrioventricular block, ventricular arrhythmias, and cardiac arrest, sometimes resulting in fatalities.
In addition, myocardial contractility is depressed and peripheral vasodilation occurs, leading to decreased cardiac output and arterial blood pressure. These cardiovascular changes are more likely to occur after unintended intravascular injection of bupivacaine [see Warnings and Precautions ( 5.9 )] . Following systemic absorption, bupivacaine can produce CNS stimulation, CNS depression, or both.
Apparent central stimulation is manifested as restlessness, tremors, and shivering, progressing to convulsions, followed by CNS depression and coma progressing ultimately to respiratory arrest. However, bupivacaine has a primary depressant effect on the medulla and on higher centers. The depressed stage may occur without a prior excited state.
The duration of local anesthesia after administration of SENSORCAINE is longer than that observed after administration of other commonly used short-acting local anesthetics. There appears to be period of analgesia that persists after the resolution of the block and return of sensation. The onset of action following dental injections is usually 2 to 10 minutes and may last up to 7 hours.
The duration of anesthetic effect is prolonged by the addition of epinephrine 1:200,000.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals to evaluate the carcinogenic potential of bupivacaine hydrochloride have not been conducted. Mutagenesis The mutagenic potential of bupivacaine hydrochloride has not been determined. Impairment of Fertility The effect of bupivacaine on fertility has not been determined.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals to evaluate the carcinogenic potential of bupivacaine hydrochloride have not been conducted. Mutagenesis The mutagenic potential of bupivacaine hydrochloride has not been determined. Impairment of Fertility The effect of bupivacaine on fertility has not been determined.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine 50 mL Multiple Dose Vial Label NDC 63323- 461 -01 460157 SENSOR caine ® (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate) 0.25% 125 mg per 50 mL (2.5 mg per mL) For infiltration and nerve block only. Not for caudal, epidural or spinal anesthesia. Warning: Contains sulfites.
50 mL Multiple Dose Vial Rx only PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine 50 mL Multiple Dose Vial Label
PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine 50 mL Multiple Dose Vial Tray Label NDC 63323- 461 -57 460157 SENSOR caine ® (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate) 0.25% 125 mg per 50 mL (2.5 mg per mL) For infiltration and nerve block only. Not for caudal, epidural or spinal anesthesia. Warning: Contains sulfites.
25 Multiple Dose Vials, 50 mL Rx only PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine 50 mL Multiple Dose Vial Tray Label
PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine 50 mL Multiple Dose Vial Label NDC 63323- 463 -01 460357 SENSOR caine ® (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate) 0.5% 250 mg per 50 mL (5 mg per mL) For nerve block only. Not for caudal, epidural or spinal anesthesia. Warning: Contains sulfites. 50 mL Multiple Dose Vial Rx only PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine 50 mL Multiple Dose Vial Label
PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine 50 mL Multiple Dose Vial Tray Label NDC 63323- 463 -57 460357 SENSOR caine ® (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate) 0.5% 250 mg per 50 mL (5 mg per mL) For nerve block only. Not for caudal, epidural or spinal anesthesia. Warning: Contains sulfites.
25 Multiple Dose Vials, 50 mL Rx only PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine 50 mL Multiple Dose Vial Tray Label
PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine 30 mL Single Dose Vial Label NDC 63323- 468 -02 460837 SENSOR caine ® – MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate) 0.25% 75 mg per 30 mL (2.5 mg per mL) For infiltration, nerve block, caudal and epidural anesthesia . Not for spinal anesthesia. Methylparaben free.
Warning: Contains sulfites. 30 mL Single Dose Vial Rx only PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine 30 mL Single Dose Vial Label
PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine 30 mL Single Dose Vial Tray Label NDC 63323- 468 -37 460837 SENSOR caine ® – MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate) 0.25% 75 mg per 30 mL (2.5 mg per mL) For infiltration, nerve block, caudal and epidural anesthesia . Not for spinal anesthesia. Methylparaben free.
Warning: Contains sulfites. 25 Single Dose Vials, 30 mL Rx only PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine 30 mL Single Dose Vial Tray Label
PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine 10 mL Single Dose Vial Label NDC 63323- 472 -03 470217 SENSOR caine ® – MPF (Bupivacaine HCl Injection, USP) 0.75% 75 mg per 10 mL (7.5 mg per mL) For epidural and retrobulbar anesthesia. Not for obstetric anesthesia. Not for spinal anesthesia. Methylparaben free. 10 mL Single Dose Vial Rx only PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine 10 mL Single Dose Vial Label
PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine 10 mL Single Dose Vial Tray Label NDC 63323- 472 -17 470217 SENSOR caine ® – MPF (Bupivacaine HCl Injection, USP) 0.75% 75 mg per 10 mL (7.5 mg per mL) For epidural and retrobulbar anesthesia. Not for obstetric anesthesia. Not for spinal anesthesia. Methylparaben free. 25 Single Dose Vials, 10 mL PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine 10 mL Single Dose Vial Tray Label
PACKAGE LABEL – PRINCIPAL DISPLAY – Sensorcaine 30 mL Single Dose Vial Label NDC 63323- 472 -01 470237 SENSOR caine ® – MPF (Bupivacaine HCl Injection, USP) 0.75% 225 mg per 30 mL (7.5 mg per mL) For epidural and retrobulbar ane… [Excerpted — this section continues on DailyMed.]
Medicaid utilization by pack size
Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)
Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |