Sensorcaine With Dextrose

Drug overview for SENSORCAINE WITH DEXTROSE (bupivacaine hcl/dextrose-water/pf):

Generic name: BUPIVACAINE HCL/DEXTROSE-WATER/PF
Drug class: Local Anesthetics - Parenteral
Therapeutic class: Anesthetics

Bupivacaine hydrochloride is a long-acting local anesthetic of the amide type.

Bupivacaine is used for local or regional anesthesia or analgesia in surgical, obstetrical, dental, diagnostic, and therapeutic procedures. The drug is commercially available as conventional bupivacaine hydrochloride preparations with or without epinephrine or as a liposomal injection containing bupivacaine in an aqueous suspension of multivesicular liposomes (Exparel(R)). Conventional bupivacaine hydrochloride preparations are used for local infiltration anesthesia and for nerve block techniques including peripheral, sympathetic, epidural (including caudal), retrobulbar, and dental block anesthesia.

The concentration used (0.25, 0.5 or 0.75%) is dependent on the anesthetic technique and degree of muscle relaxation desired. The 0.75% concentration of bupivacaine hydrochloride produces complete motor block and should be reserved for procedures that require a high degree of muscle relaxation and prolonged anesthetic effect (e.g., epidural block in abdominal surgeries, retrobulbar block).

Use of bupivacaine hydrochloride 0.75% is not recommended for obstetrical anesthesia since such use has resulted in cardiac arrest and death, presumably from systemic toxicity following inadvertent intravascular injection. A hyperbaric solution containing 0.75%

bupivacaine hydrochloride in 8.25% dextrose is used for spinal anesthesia. Bupivacaine liposomal injection (Exparel(R)) is used for local infiltration or interscalene brachial plexus nerve block in the management of postoperative pain.

Because liposomal encapsulation or incorporation into a lipid complex can substantially alter the physiochemical and functional properties of a drug, liposomal bupivacaine should not be used interchangeably with other bupivacaine-containing preparations. Efficacy of liposomal bupivacaine for local infiltration analgesia is based principally on 2 randomized, double-blind, placebo-controlled studies in adults undergoing bunionectomy or hemorrhoidectomy. In these studies, liposomal bupivacaine (administered directly into the surgical site at the conclusion of surgery) was substantially more effective than placebo in reducing postoperative pain; however, the treatment effect was apparent mainly during the first 12-24 hours after the drug was administered.

Efficacy of liposomal bupivacaine as a brachial plexus nerve block was demonstrated in a randomized, double-blind, placebo-controlled study in patients undergoing total shoulder arthroplasty or rotator cuff repair. In this study, patients receiving liposomal bupivacaine (administered as a brachial plexus nerve block via interscalene approach) had substantially reduced cumulative pain scores through 48 hours compared with those receiving placebo. Use of liposomal bupivacaine was associated with a small reduction in opiate requirements relative to placebo in some of these studies; however, the clinical benefits of these findings are not known.

Although liposomal bupivacaine has been evaluated for other regional nerve block techniques, the manufacturer states that the current data are insufficient to support use of the drug for nerve blocks other than interscalene brachial plexus nerve block because of safety concerns (e.g., risk of falls when used as a femoral nerve block) and/or lack of efficacy (e.g., when used as an intercostal nerve block). Local anesthetics such as bupivacaine should be used as a component of multimodal analgesia (i.e., simultaneous use of a combination of analgesic agents and techniques that target different mechanisms) in the management of postoperative pain. Studies comparing the relative efficacy of liposomal bupivacaine and conventional bupivacaine hydrochloride for postsurgical analgesia have shown variable results; some studies demonstrated improved pain relief and reduced opiate requirements with the liposomal formulation, while other studies demonstrated only minimal or no substantial differences between the formulations.

Bupivacaine should not be used for obstetric paracervical block. Bupivacaine hydrochloride has been used for IV regional anesthesia+ in various orthopedic and general surgical procedures; however, high plasma concentrations of the drug may occur following tourniquet release, and cardiac arrest and death have resulted. Bupivacaine therefore should not be used for IV regional anesthesia.

DRUG IMAGES

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The following indications for SENSORCAINE WITH DEXTROSE (bupivacaine hcl/dextrose-water/pf) have been approved by the FDA:

Indications:
Spinal anesthesia

Professional Synonyms:
Intrathecal block
Local anesthetic intrathecal block
Subarachnoid block

The following dosing information is available for SENSORCAINE WITH DEXTROSE (bupivacaine hcl/dextrose-water/pf):

Dosing
Administration
Dosing Information
Generic

Dosage of bupivacaine varies with the anesthetic procedure, degree of anesthesia required, surgical site, and individual patient response. The usual dosages should generally be reduced in geriatric, debilitated, or acutely ill patients and in patients with cardiac and/or hepatic disease. The lowest effective dose should be used.

Conventional bupivacaine hydrochloride preparations may be administered by local infiltration or by lumbar epidural (including caudal), peripheral, retrobulbar, sympathetic, or dental block. For spinal anesthesia, 0.75% bupivacaine hydrochloride in 8.25%

dextrose is administered by subarachnoid injection. Bupivacaine liposomal injection (Exparel(R)) is administered by local infiltration or interscalene brachial plexus nerve block; the liposomal formulation should not be administered by epidural or intrathecal routes, and should not be used for other regional nerve blocks. Local anesthetics, including bupivacaine, have been administered by continuous intra-articular infusion+ (e.g., for control of postoperative pain); however, such use has been associated with chondrolysis.

(See Cautions: Musculoskeletal Effects in the Local Anesthetics, Parenteral, General Statement 72:00.) Bupivacaine should not be administered using the Bier block technique (IV regional anesthesia) due to the risk of cardiac arrest and death. Bupivacaine solutions containing preservatives should not be used for epidural or caudal block. Partially used solutions that do not contain preservatives should be discarded. The liposomal formulation is not bioequivalent to and should not be used interchangeably with other bupivacaine formulations.

No dosing information available.

No generic dosing information available.

The following drug interaction information is available for SENSORCAINE WITH DEXTROSE (bupivacaine hcl/dextrose-water/pf):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 1 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Long-acting Bupivacaine/Local Anesthetics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1) CLINICAL EFFECTS: Concurrent or use of local anesthetics with 96 hours of use of long-acting bupivacaine may result in neurologic and cardiovascular toxicity. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also result in methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1) PREDISPOSING FACTORS: Use of additional agents that are associated with methemoglobinemia may further increase the risk of methemoglobinemia.(1) Patients who are at increased risk of developing methemoglobinemia include those with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.(1) PATIENT MANAGEMENT: Avoid the use of other local anesthetics within 96 hours following the administration of long-acting bupivacaine. In patients for whom use is required, monitor for neurologic and cardiovascular effects. Also monitor for methemoglobinemia with use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine.(1,2) Non-liposomal bupivacaine may be administered in the same syringe as bupivacaine liposomal or injected immediately before bupivacaine liposomal as long as the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1) DISCUSSION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposome bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally. Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1)	BUPIVACAINE LIPOSOME, EXPAREL, XARACOLL, ZYNRELEF

Drug Interaction

Drug Names

Long-acting Bupivacaine/Local Anesthetics

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1)

CLINICAL EFFECTS: Concurrent or use of local anesthetics with 96 hours of use of long-acting bupivacaine may result in neurologic and cardiovascular toxicity. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also result in methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1)

PREDISPOSING FACTORS: Use of additional agents that are associated with methemoglobinemia may further increase the risk of methemoglobinemia.(1) Patients who are at increased risk of developing methemoglobinemia include those with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.(1)

PATIENT MANAGEMENT: Avoid the use of other local anesthetics within 96 hours following the administration of long-acting bupivacaine. In patients for whom use is required, monitor for neurologic and cardiovascular effects. Also monitor for methemoglobinemia with use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine.(1,2)

Non-liposomal bupivacaine may be administered in the same syringe as bupivacaine liposomal or injected immediately before bupivacaine liposomal as long as the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1)

DISCUSSION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposome bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1)

Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally. Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1)

BUPIVACAINE LIPOSOME, EXPAREL, XARACOLL, ZYNRELEF

There are 0 moderate interactions.

The following contraindication information is available for SENSORCAINE WITH DEXTROSE (bupivacaine hcl/dextrose-water/pf):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

No enhanced Contraindications information available for this drug.

There are 4 contraindications. Absolute contraindication.

Contraindication List
Methemoglobinemia
Regional anesthesia for labor pain
Severe hypotension
Shock

There are 3 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
First degree atrioventricular heart block
Kidney disease with likely reduction in glomerular filtration rate (GFr)
Second degree atrioventricular heart block

There are 4 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Bradycardia
Glucose-6-phosphate dehydrogenase (g6Pd) deficiency
Hemolytic anemia from pyruvate kinase and g6PD deficiencies
Severe hepatic disease

The following adverse reaction information is available for SENSORCAINE WITH DEXTROSE (bupivacaine hcl/dextrose-water/pf):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 23 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Acute respiratory failure Anaphylaxis Angioedema Bradycardia Cardiac arrhythmia Chondrolysis of articular cartilage CNS depression CNS toxicity Excitement Heart block Hemiparesis Hypertension Hypotension Methemoglobinemia Muscle fasciculation Myocardial dysfunction Paralysis Seizure disorder Tachycardia Unconsciousness Urticaria Vasodilation of blood vessels Ventricular arrhythmias

There are 26 less severe adverse reactions.

More Frequent	Less Frequent
Constipation Nausea Vomiting	Drowsy

Rare/Very Rare
Blurred vision Chills Diplopia Dizziness Dysgeusia Erythema Fecal incontinence General weakness Miosis Muscle weakness Nervousness Oral hypoesthesia Paresthesia Pruritus of skin Skin rash Sneezing Symptoms of anxiety Tinnitus Tremor Urinary incontinence Urinary retention Visual changes

The following precautions are available for SENSORCAINE WITH DEXTROSE (bupivacaine hcl/dextrose-water/pf):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

No enhanced Pregnancy information available for this drug.

No enhanced Lactation information available for this drug.

No enhanced Geriatric Use information available for this drug.