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Bupivacaine is a brand name for Bupivacaine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1. INDICATIONS AND USAGE Bupivacaine liposome injectable suspension is indicated to produce postsurgical: Local analgesia via infiltration in adults Regional analgesia via an interscalene brachial plexus nerve block in adults Limitations of Use The safety and effectiveness of bupivacaine liposome injectable suspension…
Verbatim from this product's FDA label. Tap a section to expand.
2. 1 ). Bupivacaine liposome injectable suspension is not substitutable with other bupivacaine products even if the strength is the same. 5 ). 1 ).
The recommended dose of bupivacaine liposome injectable suspension for:
Local infiltration in adults is up to a maximum dose of 266 mg. 2 ). 3 ). 3 ). 5 ). 1 Important Dose, Preparation, and Administration Instructions Bupivacaine liposome injectable suspension is for single administration only. Bupivacaine liposome injectable suspension is not substitutable with other bupivacaine products even if the strength is the same.
Therefore, it is not possible to convert a dose from other bupivacaine products to a bupivacaine liposome injectable suspension dose and vice versa. Do not dilute bupivacaine liposome injectable suspension with water or other hypotonic agents, as it will result in disruption of the liposomal particles.
Do not administer bupivacaine liposome injectable suspension if it is suspected that the vial has been frozen or exposed to high temperature (greater than 40°C or 104°F) for an extended period. Inspect bupivacaine liposome injectable suspension visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Do not administer bupivacaine liposome injectable suspension if the product is discolored. Do not heat or autoclave before use. Do not filter during administration. 2 )].
In adult patients undergoing:
Bunionectomy, a total of 106 mg (8 mL) of bupivacaine liposome injectable suspension was administered, with 7 mL infiltrated into the tissues surrounding the osteotomy, and 1 mL infiltrated into the subcutaneous tissue. Hemorrhoidectomy, a total of 266 mg (20 mL) of bupivacaine liposome injectable suspension was diluted with 10 mL of saline, for a total of 30 mL, divided into six 5 mL aliquots, injected by visualizing the anal sphincter as a clock face and slowly infiltrating one aliquot to each of the even numbers to produce a field block.
3 Recommended Dose for Regional Analgesia The maximum recommended dose of bupivacaine liposome injectable suspension via perineural use for interscalene brachial plexus nerve block is 133 mg. For all nerve blocks, administer additional analgesics, which may include other immediate-release local anesthetics, as appropriate.
6. 1 ). 1 ). To report SUSPECTED ADVERSE REACTIONS, contact eVenus Pharmaceutical Laboratories, Inc. gov/medwatch . 1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
2 ) ]) that included 823 adult patients who had various surgical procedures. Patients were administered a bupivacaine liposome injectable suspension dose ranging from 66 to 532 mg (two times the maximum recommended dose of 266 mg). In these studies, following bupivacaine liposome injectable suspension administration, the: Most common adverse reactions (incidence greater than or equal to 10%) were nausea, constipation, and vomiting.
Common adverse reactions (incidence greater than or equal to 2% to less than 10%) were pyrexia, dizziness, peripheral edema, anemia, hypotension, pruritus, tachycardia, headache, insomnia, postoperative anemia, muscle spasms, hemorrhagic anemia, back pain, somnolence, and procedural pain.
Less common adverse reactions (incidence less than 2%) were chills, erythema, bradycardia, anxiety, urinary retention, pain, edema, tremor, postural dizziness, paresthesia, syncope, incision site edema, procedural hypertension, procedural hypotension, procedural nausea, muscular weakness, neck pain, generalized pruritus, pruritic rash, hyperhidrosis, cold sweat, urticaria, palpitations, sinus bradycardia, supraventricular extrasystoles, ventricular extrasystoles, ventricular tachycardia, hypertension, pallor, anxiety, confusional state, depression, agitation, restlessness, hypoxia, laryngospasm, apnea, respiratory depression, respiratory failure, increased body temperature, increased blood pressure (BP),decreased BP, decreased oxygen saturation, urinary incontinence, blurred vision, tinnitus, drug hypersensitivity, and hypersensitivity.
5. 1 ). Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, use bupivacaine liposome injectable suspension cautiously in patients with hepatic disease. 1 ). 1 ). 2 ). 1 Warnings and Precautions for Bupivacaine-Containing Products The safety and effectiveness of bupivacaine liposome injectable suspension, other bupivacaine products, and other amide-containing products depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies.
As there is a potential risk of severe life-threatening adverse reactions associated with the administration of bupivacaine, any bupivacaine-containing product should be administered in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurological or cardiac toxicity [ see Overdosage ( 10 ) ].
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 bupivacaine and other amide-containing products.
Restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness may be early warning signs of central nervous system toxicity.
Bupivacaine liposome injectable suspension, other bupivacaine products, and other amide-containing products should also be used with caution in patients with impaired cardiovascular function because they may be less able to compensate for functional changes associated with the prolongation of AV conduction produced by these drugs.
Injection of multiple doses of bupivacaine liposome injectable suspension, other bupivacaine products, and other amide-containing products may cause significant increases in plasma concentrations with each repeated dose due to slow accumulation of the drug or its metabolites, or to slow metabolic degradation.
4. 1 ) ]. While bupivacaine liposome injectable suspension has not been tested with this technique, the use of bupivacaine HCl with this technique has resulted in fetal bradycardia and death. Bupivacaine liposome injectable suspension is contraindicated in obstetrical paracervical block anesthesia ( 4 ).
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3 ) ]. 4 Preparation and Administration Instructions Invert vials of bupivacaine liposome injectable suspension multiple times to re-suspend the particles immediately prior to withdrawal from the vial. 9% preservative-free Sodium Chloride Injection or lactated Ringer’s solution.
Use diluted bupivacaine liposome injectable suspension within 4 hours of preparation in a syringe. Administer bupivacaine liposome injectable suspension with a 25 gauge or larger bore needle to maintain the structural integrity of the liposomal bupivacaine particles.
Administer bupivacaine liposome injectable suspension slowly via infiltration or perineural use with frequent aspiration to check for blood and minimize the risk of inadvertent intravascular injection. Discard unused portion. 5 Compatibility Considerations Some physicochemical incompatibilities exist between bupivacaine liposome injectable suspension and certain other drugs.
Direct contact of bupivacaine liposome injectable suspension with these drugs results in a rapid increase in free (unencapsulated) bupivacaine, altering bupivacaine liposome injectable suspension characteristics and potentially affecting the safety and efficacy of bupivacaine liposome injectable suspension.
Therefore, admixing bupivacaine liposome injectable suspension with other drugs prior to administration is not recommended [ see Drug Interactions ( 7 ) ]. Non-bupivacaine based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from bupivacaine liposome injectable suspension if administered together locally.
The administration of bupivacaine liposome injectable suspension may follow the administration of lidocaine after a delay of 20 minutes or more. Bupivacaine HCl administered together with bupivacaine liposome injectable suspension may impact the pharmacokinetic and/or physicochemical properties of bupivacaine liposome injectable suspension, and this effect is concentration dependent.
Therefore, bupivacaine HCl and bupivacaine liposome injectable suspension may be administered simultaneously in the same syringe, and bupivacaine HCl may be injected immediately before bupivacaine liposome injectable suspension if the ratio of the milligram dose of bupivacaine HCl solution to bupivacaine liposome injectable suspension does not exceed 1:2.
1 ) and Overdosage ( 10 ) ]. , Betadine) is applied, the site should be allowed to dry before bupivacaine liposome injectable suspension is administered into the site. Bupivacaine liposome injectable suspension should not be allowed to come into contact with antiseptics such as povidone iodine in solution.
Studies conducted with bupivacaine liposome injectable suspension demonstrated that the most common implantable materials (polypropylene, PTFE, silicone, stainless steel, and titanium) are not affected by the presence of bupivacaine liposome injectable suspension any more than they are by saline.
None of the materials studied had an adverse effect on bupivacaine liposome injectable suspension.
3%). 6%). 2 ) ] that compared 106 mg of bupivacaine liposome injectable suspension (8 mL) to placebo and 266 mg of bupivacaine liposome injectable suspension (20 mL) to placebo are shown in Table 1.
Table 1:
Treatment-Emergent Adverse Reactions with an Incidence Greater than or Equal to 2%: Local Infiltration Placebo-Controlled Studies in Adults (Studies 1 and 2) a Study 1: Bunionectomy b Study 2: Hemorrhoidectomy; TEAE = treatment-emergent adverse event.
At each level of summation (overall, system organ class, preferred term), patients are only counted once. Preferred terms are included where at least 2% of patients reported the event in any treatment group. 4 )] involving 469 bupivacaine liposome injectable suspension-treated adult patients and 357 placebo-treated patients who had various surgical procedures.
Patients were administered placebo or a bupivacaine liposome injectable suspension dose of either 133 or 266 mg (two times the maximum recommended dose for these nerve blocks). In these studies, following bupivacaine liposome injectable suspension administration via nerve block (perineural use) the: Most Common adverse reactions (incidence greater than or equal to 10%) were nausea, pyrexia, and constipation.
Common adverse reactions (incidence greater than or equal to 2% to less than 10%) were muscle twitching, dysgeusia, urinary retention, fatigue, headache, confusional state, hypotension, hypertension, oral hypoesthesia, generalized pruritus, hyperhidrosis, tachycardia, sinus tachycardia, anxiety, fall, increased body temperature, peripheral edema, sensory loss, increased hepatic enzyme, hiccups, hypoxia, and post-procedural hematoma.
Less common adverse reactions (incidence less than 2%) were arrhythmia, atrial fibrillation, first degree atrioventricular block, bradycardia, left bundle branch block, right bundle branch block, cardiac arrest, impaired hearing, blurred vision, visual impairment, asthenia, chills, hyperthermia, cellulitis, lung infection, pneumonia, procedural nausea, wound dehiscence, wound secretion, electrocardiogram QT prolonged, white blood cell count increased, arthralgia, back pain, joint swelling, decreased mobility, muscle spasms, muscular weakness, musculoskeletal pain, paraesthesia, presyncope, sedation, somnolence, syncope, delirium, dysuria, urinary incontinence, atelectasis, cough, dyspnea, lung infiltration, blister, drug eruption, erythema, rash, urticaria, deep vein thrombosis, hematoma, and orthostatic hypotension.
The most common and common adverse reactions for the four randomized, double-blind, placebo-controlled nerve block clinical studies (Studies 3, 6, 7, 8) are shown in Table 3. 3%). 3%).
Table 3:
Treatment-Emergent Adverse Reactions with an Incidence Greater than or Equal to 2%: Nerve Block Placebo-Controlled Studies (Studies 3, 6, 7, and 8) At each level of summation (overall, system organ class, preferred term), patients are only counted once.
Preferred terms are included where at least 2% of patients reported the event in any treatment group. TEAE = treatment-emergent adverse event. 2 Postmarketing Experience Because adverse reactions reported during postmarketing are 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.
, bradycardia, cardiac arrest).
Tolerance to elevated blood concentrations varies with the status of the patient. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, these drugs should be used cautiously in patients with hepatic disease.
Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. Central Nervous System Reactions 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.
Many of these effects may be related to local anesthetic techniques, with or without a contribution from the drug. Neurologic effects following infiltration of soft tissue may include persistent anesthesia, paresthesia, weakness, and paralysis, all of which may have slow, incomplete, or no recovery.
Central nervous system reactions are characterized by excitation and/or depression. Restlessness, anxiety, dizziness, tinnitus, blurred vision, or tremors may occur, possibly proceeding to convulsions. However, excitement may be transient or absent, with depression being the first manifestation of an adverse reaction.
This may quickly be followed by drowsiness merging into unconsciousness and respiratory arrest. Other central nervous system effects may be nausea, vomiting, chills, and constriction of the pupils. The incidence of convulsions associated with the use of local anesthetics varies with the procedure used and the total dose administered.
Cardiovascular System Reactions Toxic blood concentrations depress cardiac conductivity 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 [ See Overdosage ( 10 ) ].
Allergic Reactions Allergic-type reactions are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients. These reactions are characterized by signs such as urticaria, pruritus, erythema, angioneurotic edema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly anaphylactoid-like symptoms (including severe hypotension).
Cross-sensitivity among members of the amide-type local anesthetic group has been reported. The usefulness of screening for sensitivity has not been definitively established. Chondrolysis Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been postmarketing reports of chondrolysis in patients receiving such infusions.
The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric patients andadult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours.
There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness, and loss of motion can be variable, but may begin as early as the second month after surgery.
Currently, there is no effective treatment for chondrolysis; patients who have experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement. Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use.
Although all patients are at risk for methemoglobinemia, patients 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. Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood.
Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue bupivacaine liposome injectable suspension and any oxidizing agents.
, oxygen therapy, hydration. A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. 2 Warnings and Precautions Specific for Bupivacaine Liposome Injectable Suspension As there is a potential risk of severe life-threatening adverse reactions associated with the administration of bupivacaine, bupivacaine liposome injectable suspension should be administered in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurological or cardiac toxicity [ See Overdosage ( 10 ) ].
Caution should be taken to avoid accidental intravascular injection of bupivacaine liposome injectable suspension. Convulsions and cardiac arrest have occurred following accidental intravascular injection of bupivacaine and other amide-containing products.
3 ) ]. Bupivacaine liposome injectable suspension has not been evaluated for the following uses and, therefore, is not recommended for these routes of administration or types of analgesia: epidural intrathecal intravascular or intra-articular use regional nerve blocks other than interscalene brachial plexus nerve block Bupivacaine liposome injectable suspension has not been evaluated for use in the following patient populations and, therefore, is not recommended for administration to these groups.
patients younger than 6 years old for infiltration patients younger than 18 years old for interscalene brachial plexus nerve block pregnant patients The potential sensory and/or motor loss with bupivacaine liposome injectable suspension is temporary and varies in degree and duration depending on the site of injection and dose administered and may last for up to 5 days as seen in clinical trials.