Sensorcaine MPF

Sensorcaine MPF is an FDA-registered drug product whose active ingredient is BUPIVACAINE HYDROCHLORIDE. It is labelled by Fresenius Kabi USA, LLC taken by epidural and marketed as a human prescription drug product. Identifiers on file: NDC 63323-464, application ANDA070552, label effective 20230512. It is one of 18 FDA drug label records sharing the active ingredient BUPIVACAINE HYDROCHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BUPIVACAINE HYDROCHLORIDE are most often described in connection with: sensorcaine sensorcaine, local regional, anesthesia analgesia, epinephrine indicated, surgery dental, procedures diagnostic, specific concentrations, type block. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 )] .

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 ) 2.1 Important 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 consciousness after each local anesthetic injection. Use SENSORCAINE WITH EPINEPHRINE in carefully restricted quantities in areas of the body supplied by end arteries or having otherwise compromised blood supply such as digits, nose, external ear, or penis [see Warnings and Precautions ( 5.12 )] . 2.2 Recommended Concentrations and Dosages of SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE The dosage of SENSORCAINE / SENSORCAINE WITH EPINEPHRINE administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. Administer the smallest dosage and concentration required to produce the desired result. The types of block and recommended SENSORCAINE / SENSORCAINE WITH EPINEPHRINE concentrations are shown in Table 1 Table 1. Types of Block and Recommended SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE Concentrations * SENSORCAINE 0.75% (7.5 mg/mL) is not recommended for nonobstetrical surgical procedures in pregnant patients. ** Avoid use of multiple dose vials of SENSORCAINE / SENSORCAINE WITH EPINEPHRINE for caudal or epidural anesthesia [see Warnings and Precautions ( 5.4 )] . ✓= indicated use [see Warnings and Precautions ( 5.1 )]. SENSORCAINE-MPF SENSORCAINE-MPF WITH EPINEPHRINE (1:200,000) SENSORCAINE SENSORCAINE WITH EPINEPHRINE (1:200,000) Type of Block 0.25% 0.50% 0.75%* 0.25% 0.50% 0.75%* 0.25% 0.50% 0.25% 0.50% (2.5 mg/mL) (5 mg/ml) (7.5 mg per mL) (2.5 mg/mL) (5 mg/mL) (7.5 mg /mL) (2.5 mg/mL) (5 mg/mL) (2.5 mg/mL) (5 mg/mL) Local infiltration ✓ ✓ ✓ ✓ Peripheral nerve block ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ Retrobulbar block ✓ ✓ Sympathetic block ✓ ✓ Caudal block** ✓ ✓ ✓ ✓ Lumbar epidural block** ✓ ✓ ✓ (Not for obstetrical anesthesia.) ✓ ✓ ✓ (Not for obstetrical anesthesia.) Epidural test dose** ✓ Dental block ✓ ✓ At recommended dosages, SENSORCAINE / SENSORCAINE WITH EPINEPHRINE produces complete sensory block, but the effect on motor function differs among the three concentrations. Table 2 provides information on the expected effect on motor function for the three concentrations. Table 2. SENSORCAINE / SENSORCAINE WITH EPINEPHRINE Concentration vs. Motor Function * These products include SENSORCAINE / SENSORCAINE WITH EPINEPHRINE [the epinephrine concentration (1:200,000) is not included in the table]. Sensorcaine Concentration Motor Function 0.25% (2.5 mg/mL) * When used for caudal, epidural, or peripheral nerve block, produces incomplete motor block. Should be used for operations in which muscle relaxation is not important, or when another means of providing muscle relaxation is used concurrently. Onset of action may be slower than with the 0.5% (5 mg/mL) or 0.75% (7.5 mg/mL) solutions. 0.5% (5 mg/mL)* Provides motor blockade for caudal, epidural, or nerve block, but muscle relaxation may be inadequate for operations in which complete muscle relaxation is essential. 0.75% (7.5 mg/mL)* Produces complete motor block. Most useful for epidural block in abdominal operations requiring complete muscle relaxation, and for retrobulbar anesthesia. Not for obstetrical anesthesia. The duration of anesthesia with SENSORCAINE / SENSORCAINE WITH EPINEPHRINE is such that for most indications, a single dose is sufficient. The maximum dosage limit within the recommended dosage range must be individualized in each case after evaluating the size and physical status of the patient, as well as the anticipated rate of systemic absorption from a particular injection site. The dosages in Table 3 are recommended as a guide for use in the average adult. These doses may be repeated once every three hours. Do not exceed a total daily dosage of 400 mg in 24 hours. The duration of anesthetic effect may be prolonged by the addition of epinephrine. Table 3. Recommended Concentrations and Doses of SENSORCAINE / SENSORCAINE WITH EPINEPHRINE in Adults a. With continuous (intermittent) techniques, repeat doses increase the degree of motor block. The first repeat dose of 0.5% (5 mg/mL) may produce complete motor block. Intercostal nerve block with 0.25% (2.5 mg/mL) also may produce complete motor block for intra-thoracic and upper intra-abdominal surgery. b. Solutions with or without epinephrine. The SENSORCAINE WITH EPINEPHRINE products include epinephrine (1:200,000). c. For single dose use; not for intermittent epidural technique. Not for obstetrical anesthesia. Type of Block Concentration of SENSORCAINE Each Dose Motor Block a mL mg of SENSORCAINE Local infiltration 0.25% (2.5 mg/mL) b Up to 70 (without epinephrine) Up to 175 (without epinephrine) – Up to 90 (with epinephrine) Up to 225 (with epinephrine) Peripheral nerve block 0.5% (5 mg/mL) b 5-35 (without epinephrine) 25-175 (without epinephrine) moderate to complete 5-45 (with epinephrine) 25-225 (with epinephrine) 0.25% (2.5 mg/mL) b 5-70 (without epinephrine) 12.5-175 (without epinephrine) moderate to complete 5-90 (with epinephrine) 12.5-225 (with epinephrine) Retrobulbar block [see Dosage and Administration ( 2.6 )] 0.75% (7.5 mg/mL) b 2-4 15-30 complete Sympathetic block 0.25% (2.5 mg/mL) 20-50 50-125 – Caudal block [see Dosage and Administration ( 2.4 )] 0.5% (5 mg/mL) b 15-30 75-150 moderate to complete 0.25% (2.5 mg/mL) b 15-30 37.5-75 moderate Lumbar epidural block [see Dosage and Administration ( 2.3 )] 0.75% (7.5 mg/mL) c 10-20 75-150 complete 0.5% (5 mg/mL) b 10-20 50-100 moderate to complete 0.25% (2.5 mg/mL) b 10-20 25-50 partial to moderate Epidural test dose [see Dosage and Administration ( 2.4 )] 0.5% (5 mg/mL) 2-3 10-15 (10-15 micrograms epinephrine) – Dental [see Dosage and Administration ( 2.5 )] 0.5% (5 mg/mL) with epinephrine 1.8-3.6 per site 9-18 per site – 2.3 Use in Epidural Anesthesia During the administration of epidural anesthesia, it is recommended that a test dose of SENSORCAINE-MPF WITH EPINEPHRINE without antimicrobial preservative (0.5% bupivacaine with 1:200,000 epinephrine) be administered initially and the effects monitored before the full dose is given. When using a “continuous” catheter technique, test doses should be given prior to both the initial and all supplemental doses, because a catheter in the epidural space can migrate into a blood vessel or through the dura [see Dosage and Administration ( 2.4 )] . During epidural administration, administer SENSORCAINE-MPF / SENSORCAINE-MPF WITH EPINEPHRINE, 0.5% (5 mg/mL) and SENSORCAINE-MPF 0.75% (7.5 mg/mL) solutions in incremental doses of 3 mL to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. Administer injections slowly, with frequent aspirations before and during the injection to avoid intravascular injection. Perform syringe aspirations before and during each supplemental injection in continuous (intermittent) catheter techniques. In obstetrics, use ONLY the 0.5% (5 mg/mL) and 0.25% (2.5 mg/mL) concentrations of SENSORCAINE-MPF / SENSORCAINE-MPF WITH EPINEPHRINE [see Warnings and Precautions ( 5.1 )] ; incremental doses of 3 mL to 5 mL of the 0.5% (5 mg/mL) solution not exceeding 50 mg to 100 mg at any dosing interval are recommended. Repeat doses should be preceded by a test dose containing epinephrine if not clinically contraindicated. Use only the single dose vials for caudal or epidural anesthesia; avoid use of the multiple dose vials for these procedures, which contain a preservative [see Dosage and Administration ( 2.1 , 2.4 ), Warnings and Precautions ( 5.4 , 5.9 )] . 2.4 Test Dose for Caudal and Lumbar Epidural Blocks 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. This test dose may serve as a warning of unintended intravascular or intrathecal injection. Closely monitor for early clinical signs of toxicity following each test dose [see Warnings and Precautions ( 5.9 )] . Allot adequate time for onset of spinal block to detect possible intrathecal injection. An intravascular or intrathecal injection is still possible even if results of the test dose are negative. The test dose itself may produce a systemic toxic reaction, high spinal, or cardiovascular effects from the epinephrine [see Warnings and Precautions ( 5.2 , 5.9 ), Overdosage ( 10 )]. 2.5 Use in Dentistry SENSORCAINE WITH EPINEPHRINE 0.5% (5 mg/mL) is recommended for infiltration and block injection in the maxillary and mandibular area when a longer duration of local anesthesia is desired, such as for procedures generally associated with significant postoperative pain. The average dose of 1.8 mL (9 mg) per injection site will usually suffice; an occasional second dose of 1.8 mL (9 mg) may be used if necessary to produce adequate anesthesia after allowing 2 to 10 minutes for block onset [see Clinical Pharmacology ( 12.2 )] . Use the lowest effective dose and allow time between injections; it is recommended that the total dose for all injection sites, spread out over a single dental sitting, not exceed 90 mg for a healthy adult patient (ten 1.8 mL injections of 0.5% (5 mg/mL) SENSORCAINE WITH EPINEPHRINE). Inject slowly and with frequent aspirations. 2.6 Use in Ophthalmic Surgery When SENSORCAINE-MPF/SENSORCAINE-MPF with EPINEPHRINE 0.75% (7.5 mg/mL) is used for retrobulbar block, complete corneal anesthesia usually precedes onset of clinically acceptable external ocular muscle akinesia. Therefore, presence of akinesia rather than anesthesia alone should determine readiness of the patient for surgery [see Warnings and Precautions ( 5.15 )] .

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 )

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 fluid. Neurologic effects following other procedures or routes of administration have included persistent anesthesia, paresthesia, weakness, paralysis, all with slow, incomplete, or no recovery. Convulsions : Incidence varied with the procedure used and the total dose administered. In a survey of studies of epidural anesthesia, overt toxicity progressing to convulsions occurred in approximately 0.1% of local anesthetic administrations. The incidences of adverse neurologic reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration, and the physical status of the patient. Cardiac Disorders : High doses or unintentional intravascular injection have led to high plasma levels and related depression of the myocardium, decreased cardiac output, heartblock, hypotension, bradycardia, ventricular arrhythmias, including ventricular tachycardia and ventricular fibrillation, and cardiac arrest [see Warnings and Precautions ( 5.9 )] . Immune System Disorders : Allergic-type reactions have occurred as a result of sensitivity to bupivacaine or to other formulation ingredients, such as the antimicrobial preservative methylparaben contained in multiple dose vials or sulfites in epinephrine-containing solutions. These reactions were characterized by signs such as urticaria, pruritus, erythema, angioneurotic edema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and severe hypotension. Cross sensitivity among members of the amide-type local anesthetic group has been reported [see Warnings and Precautions ( 5.8 )] . Most common adverse reactions are related to the central nervous system and the cardiovascular system. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

FDA lists 18 drug label records with BUPIVACAINE HYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Sensorcaine MPF used for?
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 …

Who makes Sensorcaine MPF?
Fresenius Kabi USA, LLC is the labeler of record for Sensorcaine MPF. 18 FDA label records share the active ingredient BUPIVACAINE HYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Sensorcaine MPF come in?
administered by epidural. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Sensorcaine MPF prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing BUPIVACAINE HYDROCHLORIDE?
Yes. 18 FDA drug label records list BUPIVACAINE HYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Sensorcaine MPF been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.