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Bupivacaine Official FDA information, side effects and uses.

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Drug ClassLocal injectable anesthetics

Approval HistoryDrug history at FDA

AvailabilityPrescription only

PregnancyCategoryRisk cannot be ruledout

CSA ScheduleNot a controlled drug

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BupivacaineGeneric Name: Bupivacaine hydrochlorideDosage Form: injection, solution

0.25% Bupivacaine HCL 2.5 mg/mL Injection, USP 50 mL Multi Dose Vial

DescriptionBupivacaine Hydrochloride is 2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride,monohydrate, a white crystalline powder thatis freely soluble in 95 percent ethanol, solublein water, and slightly soluble in chloroform oracetone. It has the following structural formula:

Epinephrine is (-)-3,4-Dihydroxy-a-[(methylamino)methyl] benzyl alcohol. It has the followingstructural formula:

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cefotaximepiperacillinClaforancefoxitinMefoxincefotetanNaropinropivacaineSensorcaineCefotanMore...Bupivacaine Hydrochloride is available in sterile isotonic solutions with and without epinephrine

(as bitartrate) 1:200,000 for injection via local infiltration, peripheral nerve block, and caudal andlumbar epidural blocks. Solutions of Bupivacaine Hydrochloride may be autoclaved if they do notcontain epinephrine. Solutions are clear and colorless. Bupivacaine is related chemically andpharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and ischemically related to lidocaine. All three of these anesthetics contain an amide linkage betweenthe aromatic nucleus and the amino, or piperidine group. They differ in this respect from theprocaine-type local anesthetics, which have an ester linkage.Bupivacaine Hydrochloride Injection, USP is available in sterile, isotonic solutions containingBupivacaine hydrochloride in water for injection with characteristics as follows:

Bupivacaine Hydrochloride Injection, USP (withoutepinephrine)

Concentration Bupivacaine Hydrochloridemg/mL

Sodium Chloridemg/mL

0.25% 2.5 8.6

0.5% 5 8.1

0.75% 7.5 7.6

May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. (See HOWSUPPLIED section for pH information.)Multiple-dose vials contain methylparaben 1 mg/mL added as a preservative.Bupivacaine and Epinephrine Injection, USP is available in sterile, isotonic solutions containingBupivacaine hydrochloride and epinephrine 1:200,000 with characteristics as follows:

Bupivacaine and Epinephrine Injection, USP

Concentration(Bupivacaine HCL)

BupivacaineHydrochloride(mg/mL)

Epinephrine1:200,000(mcg/mL)

SodiumChloride(mg/mL)

0.25% 2.5 5 8.5

0.5% 5 5 8.5

0.75 - - -

Sodium metabisulfite 0.1 mg/mL added as antioxidant and edetate calcium disodium, anhydrous0.1 mg/mL added as stabilizer. May contain sodium hydroxide and/or hydrochloric acid for pHadjustment. (See HOW SUPPLIED section for pH information.) Multipledose vials containmethylparaben 1 mg/mL added as a preservative. Single-dose solutions contain no addedbacteriostat or anti-microbial agent and unused portions should be discarded after use.

Clinical PharmacologyLocal anesthetics block the generation and the conduction of nerve impulses, presumably byincreasing the threshold for electrical excitation in the nerve, by slowing the propagation of the

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nerve impulse, and by reducing the rate of rise of the action potential. In general, the progressionof anesthesia is related to the diameter, myelination, and conduction velocity of affected nervefibers. Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3)touch, (4) proprioception, and (5) skeletal muscle tone. Systemic absorption of local anestheticsproduces effects on the cardiovascular and central nervous systems (CNS). At bloodconcentrations 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 toatrioventricular block, ventricular arrhythmias, and cardiac arrest, sometimes resulting in fatalities.In addition, myocardial contractility is depressed and peripheral vasodilation occurs, leading todecreased cardiac output and arterial blood pressure. Recent clinical reports and animalresearch suggest that these cardiovascular changes are more likely to occur after unintendedintravascular injection of Bupivacaine. Therefore, incremental dosing is necessary. Followingsystemic absorption, local anesthetics can produce central nervous system stimulation,depression, or both. Apparent central stimulation is manifested as restlessness, tremors andshivering progressing to convulsions, followed by depression and coma progressing ultimately torespiratory arrest. However, the local anesthetics have a primary depressant effect on themedulla and on higher centers. The depressed stage may occur without a prior excited state.Pharmacokinetics: The rate of systemic absorption of local anesthetics is dependent upon thetotal dose and concentration of drug administered, the route of administration, the vascularity ofthe administration site, and the presence or absence of epinephrine in the anesthetic solution. Adilute concentration of epinephrine (1:200,000 or 5 mcg/mL) usually reduces the rate ofabsorption and peak plasma concentration of Bupivacaine Hydrochloride, permitting the use ofmoderately larger total doses and sometimes prolonging the duration of action.The onset of action with Bupivacaine Hydrochloride is rapid and anesthesia is long lasting. Theduration of anesthesia is significantly longer with Bupivacaine Hydrochloride than with any othercommonly used local anesthetic. It has also been noted that there is a period of analgesia thatpersists after the return of sensation, during which time the need for strong analgesics isreduced. Local anesthetics are bound to plasma proteins in varying degrees. Generally, the lowerthe plasma concentration of drug the higher the percentage of drug bound to plasma proteins.Local anesthetics appear to cross the placenta by passive diffusion. The rate and degree ofdiffusion 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 local anesthetics appear to beinversely related to the degree of plasma protein binding, because only the free, unbound drug isavailable for placental transfer. Bupivacaine Hydrochloride with a high protein binding capacity(95%) has a low fetal/maternal ratio (0.2 to 0.4). The extent of placental transfer is alsodetermined by the degree of ionization and lipid solubility of the drug. Lipid soluble, nonionizeddrugs readily enter the fetal blood from the maternal circulation. Depending upon the route ofadministration, local anesthetics are distributed to some extent to all body tissues, with highconcentrations found in highly perfused organs such as the liver, lungs, heart, and brain.Pharmacokinetic studies on the plasma profile of Bupivacaine Hydrochloride after directintravenous injection suggest a three compartment open model. The first compartment isrepresented by the rapid intravascular distribution of the drug. The second compartmentrepresents 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 thedrug with poorly perfused tissues, such as muscle and fat. The elimination of drug from tissuedistribution depends largely upon the ability of binding sites in the circulation to carry it to the liverwhere it is metabolized. After injection of Bupivacaine Hydrochloride for caudal, epidural, orperipheral nerve block in man, peak levels of Bupivacaine in the blood are reached in 30 to 45minutes, followed by a decline to insignificant levels during the next three to six hours. Variouspharmacokinetic parameters of the local anesthetics can be significantly altered by the presenceof hepatic or renal disease, addition of epinephrine, factors affecting urinary pH, renal blood flow,the route of drug administration, and the age of the patient. The half-life of BupivacaineHydrochloride in adults is 2.7 hours and in neonates 8.1 hours. In clinical studies, elderly patientsreached the maximal spread of analgesia and maximal motor blockade more rapidly thanyounger patients. Elderly patients also exhibited higher peak plasma concentrations followingadministration of this product. The total plasma clearance was decreased in these patients.Amide-type local anesthetics such as Bupivacaine Hydrochloride are metabolized primarily in theliver via conjugation with glucuronic acid. Patients with hepatic disease, especially those withsevere hepatic disease, may be more susceptible to the potential toxicities of the amide-typelocal anesthetics. Pipecoloxylidine is the major metabolite of Bupivacaine Hydrochloride. Thekidney is the main excretory organ for most local anesthetics and their metabolites. Urinaryexcretion is affected by urinary perfusion and factors affecting urinary pH. Only 6% ofBupivacaine is excreted unchanged in the urine. When administered in recommended doses and

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concentrations, Bupivacaine Hydrochloride does not ordinarily produce irritation or tissue damageand does not cause methemoglobinemia.

Indications and UsageBupivacaine Hydrochloride is indicated for the production of local or regional anesthesia oranalgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures,and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated forobstetrical anesthesia. (See WARNINGS.) Experience with nonobstetrical surgical procedures inpregnant patients is not sufficient to recommend use of 0.75% concentration of BupivacaineHydrochloride in these patients. Bupivacaine Hydrochloride is not recommended for intravenousregional anesthesia (Bier Block). (See WARNINGS.) The routes of administration and indicatedBupivacaine Hydrochloride concentrations are:

local infiltration 0.25%

peripheral nerve block 0.25% and 0.5%

retrobulbar block 0.75%

sympathetic block 0.25%

lumbar epidural 0.25%, 0.5%, and 0.75%(0.75% not for obstetrical anesthesia)

caudal 0.25% and 0.5%

epidural test dose 0.5% with epinephrine 1:200,000

(See DOSAGE AND ADMINISTRATION for additional information.)Standard textbooks should be consulted to determine the accepted procedures and techniquesfor the administration of Bupivacaine Hydrochloride.

ContraindicationsBupivacaine Hydrochloride is contraindicated in obstetrical paracervical block anesthesia. Its usein this technique has resulted in fetal bradycardia and death.Bupivacaine Hydrochloride is contraindicated in patients with a known hypersensitivity to it or toany local anesthetic agent of the amide-type or to other components of BupivacaineHydrochloride solutions.

WarningsTHE 0.75% CONCENTRATION OF Bupivacaine HYDROCHLORIDE IS NOT RECOMMENDEDFOR OBSTETRICAL ANESTHESIA.

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THERE HAVE BEEN REPORTS OF CARDIAC ARREST WITH DIFFICULT RESUSCITATIONOR DEATH DURING USE OF Bupivacaine HYDROCHLORIDE FOR EPIDURAL ANESTHESIAIN OBSTETRICAL PATIENTS. IN MOST CASES, THIS HAS FOLLOWED USE OF THE 0.75%CONCENTRATION. RESUSCITATION HAS BEEN DIFFICULT OR IMPOSSIBLE DESPITEAPPARENTLY ADEQUATE PREPARATION AND APPROPRIATE MANAGEMENT. CARDIACARREST HAS OCCURRED AFTER CONVULSIONS RESULTING FROM SYSTEMIC TOXICITY,PRESUMABLY FOLLOWING UNINTENTIONAL INTRAVASCULAR INJECTION. THE 0.75%CONCENTRATION SHOULD BE RESERVED FOR SURGICAL PROCEDURES WHERE AHIGH DEGREE OF MUSCLE RELAXATION AND PROLONGED EFFECT ARE NECESSARY.

LOCAL ANESTHETICS SHOULD ONLY BE EMPLOYED BY CLINICIANS WHO ARE WELLVERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHERACUTE EMERGENCIES WHICH MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED, ANDTHEN ONLY AFTER INSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHERRESUSCITATIVE DRUGS, CARDIOPULMONARY RESUSCITATIVE EQUIPMENT, AND THEPERSONNEL RESOURCES NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONSAND RELATED EMERGENCIES. (See also ADVERSE REACTIONS, PRECAUTIONS, andOVERDOSAGE.) DELAY IN PROPER MANAGEMENT OF DOSERELATED TOXICITY,UNDERVENTILATION FROM ANY CAUSE, AND/OR ALTERED SENSITIVITY MAY LEAD TOTHE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH.

Local anesthetic solutions containing antimicrobial preservatives, i.e., those supplied in multiple-dose vials, should not be used for epidural or caudal anesthesia because safety has not beenestablished with regard to intrathecal injection, either intentionally or unintentionally, of suchpreservatives. Intra-articular infusions of local anesthetics following arthroscopic and othersurgical procedures is an unapproved use, and there have been post-marketing reports ofchondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysishave involved the shoulder joint; cases of gleno-humeral chondrolysis have been described inpediatric and adult patients following intraarticular infusions of local anesthetics with and withoutepinephrine for periods of 48 to 72 hours. There is insufficient information to determine whethershorter 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 the2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients whoexperienced chondrolysis have required additional diagnostic and therapeutic procedures andsome required arthroplasty or shoulder replacement. It is essential that aspiration for blood orcerebrospinal fluid (where applicable) be done prior to injecting any local anesthetic, both theoriginal dose and all subsequent doses, to avoid intravascular or subarachnoid injection.However, a negative aspiration does not ensure against an intravascular or subarachnoidinjection. Bupivacaine Hydrochloride with epinephrine 1:200,000 or other vasopressors shouldnot be used concomitantly with ergot-type oxytocic drugs, because a severe persistenthypertension may occur. Likewise, solutions of Bupivacaine Hydrochloride containing avasoconstrictor, such as epinephrine, should be used with extreme caution in patients receivingmonoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types,because severe prolonged hypertension may result. Until further experience is gained in pediatricpatients younger than 12 years, administration of Bupivacaine Hydrochloride in this age group isnot recommended. Mixing or the prior or intercurrent use of any other local anesthetic withBupivacaine Hydrochloride cannot be recommended because of insufficient data on the clinicaluse of such mixtures. There have been reports of cardiac arrest and death during the use ofBupivacaine Hydrochloride for intravenous regional anesthesia (Bier Block). Information on safedosages and techniques of administration of Bupivacaine Hydrochloride in this procedure islacking. Therefore, Bupivacaine Hydrochloride is not recommended for use in this technique.Bupivacaine Hydrochloride with epinephrine 1:200,000 contains sodium metabisulfite, a sulfitethat may cause allergic-type reactions including anaphylactic symptoms and life-threatening orless severe asthmatic episodes in certain susceptible people. Theoverall prevalence of sulfite sensitivity in the general population is unknown and probably low.Sulfite sensitivity is seen morefrequently in asthmatic than in nonasthmatic people. Single-dose ampuls and single-dose vials ofBupivacaine Hydrochloride withoutepinephrine do not contain sodium metabisulfite.

PrecautionsGeneral:

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The safety and effectiveness of local anesthetics depend on proper dosage, correct technique,adequate precautions, and readiness for emergencies. Resuscitative equipment, oxygen, andother resuscitative drugs should be available for immediate use. (See WARNINGS, ADVERSEREACTIONS, and OVERDOSAGE.) During major regional nerve blocks, the patient should haveIV fluids running via an indwelling catheter to assure a functioning intravenous pathway. Thelowest dosage of local anesthetic that results in effective anesthesia should be used to avoid highplasma levels and serious adverse effects. The rapid injection of a large volume of localanesthetic solution should be avoided and fractional (incremental) doses should be used whenfeasible.Epidural Anesthesia: During epidural administration of Bupivacaine Hydrochloride, 0.5% and0.75% solutions should be administered in incremental doses of 3 mL to 5 mL with sufficient timebetween doses to detect toxic manifestations of unintentional intravascular or intrathecal injection.Injections should be made slowly, with frequent aspirations before and during the injection toavoid intravascular injection. Syringe aspirations should also be performed before and duringeach supplemental injection in continuous (intermittent) catheter techniques. An intravascularinjection is still possible even if aspirations for blood are negative. During the administration ofepidural anesthesia, it is recommended that a test dose be administered initially and the effectsmonitored before the full dose is given. When using a “continuous” catheter technique, test dosesshould be given prior to both the original and all reinforcing doses, because plastic tubing in theepidural space can migrate into a blood vessel or through the dura. When clinical conditionspermit, the test dose should contain epinephrine (10 mcg to 15 mcg has been suggested) toserve as a warning of unintended intravascular injection. If injected into a blood vessel, thisamount of epinephrine is likely to produce a transient “epinephrine response” within 45 seconds,consisting of an increase in heart rate and/or systolic blood pressure, circumoral pallor,palpitations, and nervousness in the unsedated patient. The sedated patient may exhibit only apulse rate increase of 20 or more beats per minute for 15 or more seconds. Therefore, followingthe test dose, the heart rate should be monitored for a heart rate increase. Patients on beta-blockers may not manifest changes in heart rate, but blood pressure monitoring can detect atransient rise in systolic blood pressure. The test dose should also contain 10 mg to 15 mg ofBupivacaine Hydrochloride or an equivalent amount of another local anesthetic to detect anunintended intrathecal administration. This will be evidenced within a few minutes by signs ofspinal block (e.g., decreased sensation of the buttocks, paresis of the legs, or, in the sedatedpatient, absent knee jerk). The Test Dose formulation of Bupivacaine Hydrochloride contains 15mg of Bupivacaine and 15 mcg of epinephrine in a volume of 3 mL. An intravascular orsubarachnoid injection is still possible even if results of the test dose are negative. The test doseitself may produce a systemic toxic reaction, high spinal or epinephrine-induced cardiovasculareffects. Injection of repeated doses of local anesthetics may cause significant increases inplasma levels with each repeated dose due to slow accumulation of the drug or its metabolites,or to slow metabolic degradation. Tolerance to elevated blood levels varies with the status of thepatient. Debilitated, elderly patients and acutely ill patients should be given reduced dosescommensurate with their age and physical status. Local anesthetics should also be used withcaution in patients with hypotension or heartblock. Careful and constant monitoring ofcardiovascular and respiratory (adequacy of ventilation) vital signs and the patient’s state ofconsciousness should be performed after each local anesthetic injection. It should be kept inmind at such times that restlessness, anxiety, incoherent speech, lightheadedness, numbnessand 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 systemtoxicity. Local anesthetic solutions containing a vasoconstrictor should be used cautiously and incarefully restricted quantities in areas of the body supplied by end arteries or having otherwisecompromised blood supply such as digits, nose, external ear, or penis. Patients with hypertensivevascular disease may exhibit exaggerated vasoconstrictor response. Ischemic injury or necrosismay result. Because amide-local anesthetics such as Bupivacaine Hydrochloride are metabolizedby the liver, these drugs, especially repeat doses,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 ofdeveloping toxic plasma concentrations. Local anesthetics should also be used with caution inpatients with impaired cardiovascular function because they may be less able to compensate forfunctional changes associated with the prolongation of AV conduction produced by these drugs.Serious dose-related cardiac arrhythmias may occur if preparations containing a vasoconstrictorsuch as epinephrine are employed in patients during or following the administration of potentinhalation anesthetics. In deciding whether to use these products concurrentlyin the same patient, the combined action of both agents upon the myocardium, the concentrationand volume of vasoconstrictor used, and the time since injection, when applicable, should betaken into account. Many drugs used during the conduct of anesthesia are considered potential

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triggering agents for familial malignant hyperthermia. Because it is not known whether amide-type local anesthetics may trigger this reaction and because the need for supplemental generalanesthesia cannot be predicted in advance, it is suggested that a standard protocol formanagement should be available. Early unexplained signs of tachycardia, tachypnea, labile bloodpressure, and metabolic acidosis may precede temperature elevation. Successful outcome isdependent on early diagnosis, prompt discontinuance of the suspect triggering agent(s) andprompt institution of treatment, including oxygen therapy, indicated supportive measures anddantrolene. (Consult dantrolene sodium intravenous package insert before using.)

Use in Head and Neck Area: Small doses of local anesthetics injected into the head and neckarea, including retrobulbar, dental, andstellate ganglion blocks, may produce adverse reactionssimilar to systemic toxicity seen with unintentional intravascular injections of larger doses. Theinjection procedures require the utmost care. Confusion, convulsions, respiratory depression,and/or respiratory arrest, and cardiovascular stimulation or depression have been reported.These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flowto the cerebral circulation. They may also be due to puncture of the dural sheath of the opticnerve during retrobulbar block with diffusion of any local anesthetic along the subdural space tothe midbrain. Patients receiving these blocks should have their circulation and respirationmonitored and be constantly observed. Resuscitative equipment and personnel for treatingadverse reactions should be immediately available. Dosage recommendations should not beexceeded. (See DOSAGE AND ADMINISTRATION.)

Use in Ophthalmic Surgery: Clinicians who perform retrobulbar blocks should be aware that therehave been reports of respiratory arrest following local anesthetic injection. Prior to retrobulbarblock, as with all other regional procedures, the immediate availability of equipment, drugs, andpersonnel to manage respiratory arrest or depression, convulsions, and cardiac stimulation ordepression should be assured (see also WARNINGS and Use In Head and Neck Area, above).As with other anesthetic procedures, patients should be constantly monitored followingophthalmic blocks for signs of these adverse reactions, which may occur following relatively lowtotal doses. A concentration of 0.75% Bupivacaine is indicated for retrobulbar block; however,this concentration is not indicated for any other peripheral nerve block, including the facial nerve,and not indicated for local infiltration, including the conjunctiva (seeINDICATIONS AND USAGE and PRECAUTIONS, General). Mixing Bupivacaine Hydrochloridewith other local anesthetics is not recommended because of insufficient data on the clinical use ofsuch mixtures. When Bupivacaine Hydrochloride 0.75% is used for retrobulbar block, completecorneal anesthesia usually precedes onset of clinically acceptable external ocular muscleakinesia. Therefore, presence of akinesia rather than anesthesia alone should determinereadiness of the patient for surgery.

Information for Patients:When appropriate, patients should be informed in advance that they may experience temporaryloss of sensation and motor activity, usually in the lower half of the body, following properadministration of caudal or epidural anesthesia. Also, when appropriate, the physician shoulddiscuss other information including adverse reactions in the package insert of BupivacaineHydrochloride.

Clinically Significant Drug Interactions:The administration of local anesthetic solutions containing epinephrine or norepinephrine topatients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe,prolonged hypertension. Concurrent use of these agents should generally be avoided. Insituations when concurrent therapy is necessary, careful patient monitoring is essential.Concurrent administration of vasopressor drugs and of ergot-type oxytocic drugs may causesevere, persistent hypertension or cerebrovascular accidents. Phenothiazines andbutyrophenones may reduce or reverse the pressor effect of epinephrine.

Carcinogenesis, Mutagenesis, Impairment of Fertility:Long-term studies in animals of most local anesthetics including Bupivacaine to evaluate thecarcinogenic potential have not been conducted. Mutagenic potential or the effect on fertility hasnot been determined. There is no evidence from human data that Bupivacaine Hydrochloridemay be carcinogenic or mutagenic or that it impairs fertility.

Pregnancy Category C:Decreased pup survival in rats and an embryocidal effect in rabbits have been observed whenBupivacaine hydrochloride was administered to these species in doses comparable to nine andfive times respectively the maximum recommended daily human dose (400 mg). There are noadequate and well-controlled studies in pregnant women of the effect of Bupivacaine on the

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developing fetus. Bupivacaine hydrochloride should be used during pregnancy only if thepotential benefit justifies the potential risk to the fetus. This does not exclude the use ofBupivacaine Hydrochloride at term for obstetrical anesthesia or analgesia. (See Labor andDelivery.)

Labor and Delivery:SEE BOXED WARNING REGARDING OBSTETRlCAL USE OF 0.75% BupivacaineHYDROCHLORIDE. Bupivacaine Hydrochloride is contraindicated for obstetrical paracervicalblock anesthesia. Local anesthetics rapidly cross the placenta, and when used for epidural,caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonataltoxicity. (See CLINICAL PHARMACOLOGY, Pharmacokinetics.) The incidence and degree oftoxicity depend upon the procedure performed, the type, and amount of drug used, and thetechnique of drug administration. Adverse reactions in the parturient, fetus, and neonate involvealterations of the central nervous system, peripheral vascular tone, and cardiac function.Maternal hypotension has resulted from regional anesthesia. Local anesthetics producevasodilation by blocking sympathetic nerves. Elevating the patient’s legs and positioning her onher left side will help prevent decreases in blood pressure. The fetal heart rate also should bemonitored continuously and electronic fetal monitoring is highly advisable. Epidural, caudal, orpudendal anesthesia may alter the forces of parturition through changes in uterine contractility ormaternal expulsive efforts. Epidural anesthesia has been reported to prolong the second stage oflabor 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 ofsome local anesthetic drug products during labor and delivery may be followed by diminishedmuscle strength and tone for the first day or two of life. This has not been reported withBupivacaine. It is extremely important to avoid aortocaval compression by the gravid uterusduring administration of regional block to parturients. To do this, the patient must be maintainedin the left lateral decubitus position or a blanket roll or sandbag may be placed beneath the righthip and gravid uterus displaced to the left.

Nursing Mothers:Bupivacaine has been reported to be excreted in human milk suggesting that the nursing infantcould be theoretically exposed to a dose of the drug. Because of the potential for serious adversereactions in nursing infants from Bupivacaine, a decision should be made whether to discontinuenursing or not administer Bupivacaine, taking into account the importance of the drug to themother.

Pediatric Use:Until further experience is gained in pediatric patients younger than 12 years, administration ofBupivacaine Hydrochloride in this age group is not recommended. Continuous infusions ofBupivacaine in children have been reported to result in high systemic levels of Bupivacaine andseizures; high plasma levels may also be associated with cardiovascular abnormalities. (SeeWARNINGS, PRECAUTIONS, and OVERDOSAGE.)

Geriatric Use:Patients over 65 years, particularly those with hypertension, may be at increased risk fordeveloping hypotension while undergoing anesthesia with Bupivacaine Hydrochloride. (SeeADVERSE REACTIONS.) Elderly patients may require lower doses of BupivacaineHydrochloride. (See PRECAUTIONS, Epidural Anesthesia and DOSAGE ANDADMINISTRATION.) In clinical studies, differences in various pharmacokinetic parameters havebeen observed between elderly and younger patients. (See CLINICAL PHARMACOLOGY.) Thisproduct is known to be substantially excreted by the kidney, and the risk of toxic reactions to thisdrug may be greater in patients with impaired renal function. Because elderly patients are morelikely to have decreased renal function, care should be taken in dose selection, and it may beuseful to monitor renal function. (See CLINICAL PHARMACOLOGY.)

Adverse ReactionsReactions to Bupivacaine Hydrochloride are characteristic of those associated with other amide-type local anesthetics. A major cause of adverse reactions to this group of drugs is excessiveplasma levels, which may be due to overdosage, unintentional intravascular injection, or slowmetabolic degradation. The most commonly encountered acute adverse experiences whichdemand immediate counter-measures are related to the central nervous system and thecardiovascular system. These adverse experiences are generally dose related and due to high

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plasma levels which may result 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 subarachnoid injection of drug duringthe intended performance of caudal or lumbar epidural block or nerve blocks near the vertebralcolumn (especially in the head and neck region) may result in underventilation or apnea (“Total orHigh Spinal”). Also, hypotension due to loss of sympathetic toneand respiratory paralysis or underventilation due to cephalad extension of the motor level ofanesthesia may occur. This may lead to secondary cardiac arrest if untreated. Patients over 65years, particularly those with hypertension, may be at increased risk for experiencing thehypotensive effects of Bupivacaine Hydrochloride. Factors influencing plasma protein binding,such as acidosis, systemic diseases which alter protein production, or competition of other drugsfor protein binding sites, may diminish individual tolerance.Central Nervous System Reactions: These are characterized by excitation and/or depression.Restlessness, anxiety, dizziness, tinnitus, blurred vision, or tremors may occur, possiblyproceeding to convulsions. However, excitement may be transient or absent, with depressionbeing the first manifestation of an adverse reaction. This may quickly be followed by drowsinessmerging into unconsciousness and respiratory arrest. Other central nervous system effects maybe nausea, vomiting, chills, and constriction of the pupils. The incidence of convulsionsassociated with the use of local anesthetics varies with the procedure used and the total doseadministered. In a survey of studies of epidural anesthesia, overt toxicity progressing toconvulsions occurred in approximately 0.1% of local anesthetic administrations.Cardiovascular System Reactions: High doses or unintentional intravascular injection may lead tohigh plasma levels and related depression of the myocardium, decreased cardiac output,heartblock, hypotension, bradycardia, ventricular arrhythmias, including ventricular tachycardiaand ventricular fibrillation, and cardiac arrest. (See WARNINGS, PRECAUTIONS, andOVERDOSAGE sections.)Allergic: Allergic-type reactions are rare and may occur as a result of sensitivity to the localanesthetic or to other formulation ingredients, such as the antimicrobial preservativemethylparaben contained in multiple-dose vials or sulfites in epinephrinecontaining solutions.These reactions are characterized by signs such as urticaria, pruritus, erythema, angioneuroticedema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope,excessive sweating, elevated temperature, and possibly, anaphylactoid-like symptomatology(including severe hypotension). Cross sensitivity among members of the amide-type localanesthetic group has been reported. The usefulness of screening for sensitivity has not beendefinitely established.Neurologic: The incidences of adverse neurologic reactions associated with the use of localanesthetics may be related to the total dose of local anesthetic administered and are alsodependent upon the particular drug used, the route of administration, and the physical status ofthe patient. Many of these effects may be related to local anesthetic techniques, with or without acontribution from the drug. In the practice of caudal or lumbar epidural block, occasionalunintentional penetration of the subarachnoid space by the catheter or needle may occur.Subsequent adverse effects may depend partially on the amount of drug administeredintrathecally and the physiological and physical effects of a dural puncture. A high spinal ischaracterized by paralysis of the legs, loss of consciousness, respiratory paralysis, andbradycardia. Neurologic effects following epidural or caudal anesthesia may include spinal blockof 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 ofsphincter control all of which may have slow, incomplete, or no recovery; headache; backache;septic meningitis; meningismus; slowing of labor; increased incidence of forceps delivery; andcranial nerve palsies due to traction on nerves from loss of cerebrospinal fluid.Neurologic effects following other procedures or routes of administration may include persistentanesthesia, paresthesia, weakness, paralysis, all of which may have slow, incomplete, or norecovery.

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OverdosageAcute emergencies from local anesthetics are generally related to high plasma levelsencountered during therapeutic use of local anesthetics or to unintended subarachnoid injectionof local anesthetic solution. (See ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS.)Management of Local Anesthetic Emergencies: The first consideration is prevention, bestaccomplished by careful and constant monitoring of cardiovascular and respiratory vital signs andthe patient’s state of consciousness after each local anesthetic injection. At the first sign ofchange, oxygen should be administered.The first step in the management of systemic toxic reactions, as well as underventilation or apneadue to unintentional subarachnoid injection of drug solution, consists of immediate attention tothe establishment and maintenance of a patent airway and effective assisted or controlledventilation with 100% oxygen with a delivery system capable of permitting immediate positiveairway pressure by mask. This may prevent convulsions if they have not already occurred. Ifnecessary, use drugs to control the convulsions. A 50 mg to 100 mg bolus IV injection ofsuccinylcholine will paralyze the patient without depressing the central nervous or cardiovascularsystems and facilitate ventilation. A bolus IV dose of 5 mg to 10 mg ofdiazepam or 50 mg to 100 mg of thiopental will permit ventilation and counteract central nervoussystem stimulation, but these drugs also depress central nervous system, respiratory, andcardiac function, add to postictal depression and may result in apnea. Intravenous barbiturates,anticonvulsant agents, or muscle relaxants should only be administered by those familiar withtheir use. Immediately After the institution of these ventilatory measures, the adequacy of thecirculation should be evaluated. Supportive treatment of circulatory depression may requireadministration of intravenous fluids, and when appropriate, a vasopressor dictated by the clinicalsituation (such as ephedrine or epinephrine to enhance myocardial contractile force).Endotracheal intubation, employing drugs and techniques familiar to the clinician, may beindicated after initial administration of oxygen by mask if difficulty is encountered in themaintenance of a patent airway, or if prolonged ventilatory support (assisted or controlled) isindicated. Recent clinical data from patients experiencing local anesthetic-induced convulsionsdemonstrated rapid development of hypoxia, hypercarbia, and acidosis with Bupivacaine within aminute of the onset of convulsions. These observations suggest that oxygen consumption andcarbon dioxide production are greatly increased during local anesthetic convulsions andemphasize the importance of immediate and effective ventilation with oxygen which may avoidcardiac arrest.If not treated immediately, convulsions with simultaneous hypoxia, hypercarbia, and acidosis plusmyocardial depression from the direct effects of the local anesthetic may result in cardiacarrhythmias, bradycardia, asystole, ventricular fibrillation, or cardiac arrest. Respiratoryabnormalities, including apnea, may occur. Underventilation or apnea due to unintentionalsubarachnoid injection of local anesthetic solution may produce these same signs and also leadto cardiac arrest if ventilatory support is not instituted. If cardiac arrest should occur, successfuloutcome may require prolonged resuscitative efforts. The supine position is dangerous inpregnant women at term because of aortocaval compression by the gravid uterus. Thereforeduring treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regionalblock, the parturient should be maintained in the left lateral decubitus position if possible, ormanual displacement of the uterus off the great vessels be accomplished. The mean seizuredosage of Bupivacaine in rhesus monkeys was found to be 4.4 mg/kg with mean arterial plasmaconcentration of 4.5 mcg/mL. The intravenous and subcutaneous LD50 in mice is 6 mg/kg to 8mg/kg and 38 mg/kg to 54 mg/kg respectively.

Dosage and AdministrationThe dose of any local anesthetic administered varies with the anesthetic procedure, the area tobe 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 anesthesiadesired, individual tolerance, and the physical condition of the patient. The smallest dose and

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concentration required to produce the desired result should be administered. Dosages ofBupivacaine Hydrochloride should be reduced for elderly and/or debilitated patients and patientswith cardiac and/or liver disease. The rapid injection of a large volume of local anesthetic solutionshould be avoided and fractional (incremental) doses should be used when feasible. For specifictechniques and procedures, refer to standard textbooks. There have been adverse event reportsof chondrolysis in patients receiving intra-articular infusions of local anesthetics followingarthroscopic and other surgical procedures. Bupivacaine Hydrochloride is not approved for thisuse (see WARNINGS and DOSAGE AND ADMINISTRATION).In recommended doses, Bupivacaine Hydrochloride produces complete sensory block, but theeffect on motor function differs among the three concentrations.0.25%# when used for caudal, epidural, or peripheral nerve block, produces incomplete motorblock. Should be used for operations in which muscle relaxation is not important, or whenanother means of providing muscle relaxation is used concurrently. Onset of action may beslower than with the 0.5% or 0.75% solutions. 0.5% # provides motor blockade for caudal,epidural, or nerve block, but muscle relaxation may be inadequate for operations in whichcomplete muscle relaxation is essential.0.75% # produces complete motor block. Most useful for epidural block in abdominal operationsrequiring complete muscle relaxation, and for retrobulbar anesthesia. Not for obstetricalanesthesia. The duration of anesthesia with Bupivacaine Hydrochloride is such that for mostindications, a single dose is sufficient. Maximum dosage limit must be individualized in each caseafter evaluating the size and physical status of the patient, as well as the usual rate of systemicabsorption from a particular injection site. Most experience to date is with single doses ofBupivacaine Hydrochloride up to 225 mg with epinephrine 1:200,000 and 175 mg withoutepinephrine; more or less drug may be used depending on individualization of each case.These doses may be repeated up to once every three hours. In clinical studies to date, total dailydoses have been up to 400 mg. Until further experience is gained, this dose should not beexceeded in 24 hours. The duration of anesthetic effect may be prolonged by the addition ofepinephrine. The dosages in Table 1 have generally proved satisfactory and are recommendedas a guide for use in the average adult. These dosages should be reduced for elderly ordebilitated patients. Until further experience is gained, Bupivacaine Hydrochloride is notrecommended for pediatric patients younger than 12 years. Bupivacaine Hydrochloride iscontraindicated for obstetrical paracervical blocks, and is not recommended for intravenousregional anesthesia (Bier Block).Use in Epidural Anesthesia: During epidural administration of Bupivacaine Hydrochloride, 0.5%and 0.75% solutions should be administered in incremental doses of 3 mL to 5 mL with sufficienttime between doses to detect toxic manifestations of unintentional intravascular or intrathecalinjection. In obstetrics, only the 0.5% and 0.25% concentrations should be used; incrementaldoses of 3 mL to 5 mL of the 0.5% solution not exceeding 50 mg to 100 mg at any dosinginterval are recommended. Repeat doses should be preceded by a test dose containingepinephrine if not contraindicated. Use only the single-dose ampuls and single-dose vials forcaudal or epidural anesthesia; the multiple-dose vials contain a preservative and thereforeshould not be used for these procedures.Test Dose for Caudal and Lumbar Epidural Blocks: The Test Dose of Bupivacaine Hydrochloride(0.5% Bupivacaine with 1:200,000 epinephrine in a 3 mL ampul) is recommended for use as atest dose when clinical conditions permit prior to caudal and lumbar epidural blocks. This mayserve as a warning of unintended intravascular or subarachnoid injection. (See PRECAUTIONS.)The pulse rate and other signs should be monitored carefully immediately following each testdose administration to detect possible intravascular injection, and adequate time for onset ofspinal block should be allotted to detect possible intrathecal injection. An intravascular orsubarachnoid injection is still possible even if results of the test dose are negative. The test doseitself may produce a systemic toxic reaction, high spinal or cardiovascular effects from theepinephrine. (See WARNINGS and OVERDOSAGE.) Unused portions of solution not containingpreservatives, i.e., those supplied in single-dose ampuls and single-dose vials, should bediscarded following initial use. This product should be inspected visually for particulate matter anddiscoloration prior to administration whenever solution and container permit. Solutions which arediscolored or which contain particulate matter should not be administered.

Table 1.

Recommended Concentrations and Doses of Bupivacaine Hydrochloride

Type of Each Dose Motor

Block Conc. (mL) (mg) Block(1)

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Local Infiltration 0.25%(4) up to max. up to max. -

Epidural 0.75%(2,4)0.5%(4)0.25%(4)

10-2010-2010-20

75-15050-10025-50

completemoderate to completepartial to complete

Caudal 0.5%(4)0.25%(4)

15-3015-30

75-15037.5-75

moderate to completemoderate

Peripheral nerves 0.5%(4)0.25%(4)

5 to max.5 to max.

25 to max.12.5 to max.

moderate to completemoderate to complete

Retrobulbar(3) 0.75%(4) 2-4 15-30 complete

Sympathetic 0.25% 20-50 50-125 -

Epidural(3) 0.5% 2-3 10-15 -

Test Dose w/ epi 10-15 micrograms epinephrine)

(1)With continuous (intermittent) techniques, repeat doses increase the degree of motor block.The first repeat dose of 0.5% may produce complete motor block. Intercostal nerve block with0.25% may also produce complete motor block for intra-abdominal surgery.(2)For single-dose use, not for intermittent epidural technique. Not for obstetrical anesthesia.(3)See PRECAUTIONS.(4)Solutions with or without epinephrine.

How SuppliedThese solutions are not for spinal anesthesia.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Bupivacaine Hydrochloride # Solutions of Bupivacaine Hydrochloride that do not containepinephrine may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes.Do not autoclave product packaged in Abboject® Syringes.

NDC No. Conc. Size pH Package

0409-1158-01 0.25% 30 mL 6.0 (4.0 to 6.5) Ampul

0409-1158-02 50 mL 6.0 (4.0 to 6.5) Ampul

0409-4272-01 0.25% 20 mL 6.0 (4.0 to 6.5) Steril Pack Ampul

0409-1159-01 0.25% 10 mL 5.4 (4.0 to 6.5) Teartop Vial

0409-1159-02 30 mL 5.4 (4.0 to 6.5) Teartop Vial

0409-1160-01 0.25% 50 mL 5.4 (4.0 to 6.5) Fliptop vial(Multiple-Dose)

0409-1161-01 0.5% 30 mL 6.0 (4.0 to 6.5) Ampul






0409-1164-01 0.75% 30 mL 6.0 (4.0 to 6.5) Ampul



Bupivacaine Hydrochloride with epinephrine 1:200,000 (as bitartrate)#Solutions of BupivacaineHydrochloride that contain epinephrine should not be autoclaved and should be protected fromlight. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains aprecipitate.

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ConcentrationBupivacaine

NDC No. HCL Size pH Package







Revised: December, 2009

Printed in USA EN-2349

Hospira, IncLake Forest, IL 600415USA

Sample Package Label

Bupivacaine HYDROCHLORIDE Bupivacaine hydrochloride injection

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Product Information

Product Type HUMAN PRESCRIPTIONDRUG

NDC ProductCode (Source)

52584-160 (0409-1160)

Route ofAdministration

INFILTRATION DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength

Bupivacaine Hydrochloride (Bupivacaine) Bupivacaine Hydrochloride 2.5 mg in 1 mL

Inactive Ingredients

Ingredient Name Strength

No Inactive Ingredients Found

Product Characteristics

Color Score

Shape Size

Flavor Imprint Code

Contains

Packaging

# NDC Package Description Multilevel Packaging

1 52584-160-01

1 VIAL In 1 BAG contains a VIAL, MULTI-DOSE

1 50 mL In 1 VIAL, MULTI-DOSE

This package is contained within the BAG (52584-160-01)

Marketing InformationMarketingCategory

Application Number orMonograph Citation

Marketing StartDate

Marketing EndDate

ANDA ANDA070590 07/01/2010

Labeler - General Injectables & Vaccines, Inc (108250663)

Revised: 07/2010 General Injectables & Vaccines, Inc

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drugs.comBupivacaine Official FDA information, side effects and uses.

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bupivacaine official fda information, side effects and uses. · breakthrough back pain.. imagine...

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