SENSORCAINE MPF — bupivacaine hydrochloride
Fresenius Kabi USA, LLC
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)].
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)].
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)].
- 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.
- 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)].
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
* 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)|
|Peripheral nerve block||✓||✓||✓||✓||✓||✓||✓||✓|
|Lumbar epidural block**||✓||✓||✓(Not for obstetrical anesthesia.)||✓||✓||✓ (Not for obstetrical anesthesia.)|
|Epidural test dose**||✓|
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.
* 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.
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||1.8-3.6per site||9-18per site||–|
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