DESCRIPTION: The pharmacological/toxicological actions allergic-type reactions including anaphylactic nant hyperthermia should be available. Early formed, the type and amount of drug used, and Xylocaine (lidocaine HCl) Injections are sterile, of these metabolites are similar to, but less symptoms and life-threatening or less severe unexplained signs of tachycardia, tachypnea, the technique of drug administration. Adverse nonpyrogenic, aqueous solutions that contain potent than, those of lidocaine HCl. Approxi- asthmatic episodes in certain susceptible peo- labile blood pressure and metabolic acidosis reactions in the parturient, fetus and neonate a local anesthetic agent with or without epi- mately 90% of lidocaine HCl administered is ple. The overall prevalence of sulfite sensitivity in may precede temperature elevation. Success- involve alterations of the central nervous system, nephrine and are administered parenterally by excreted in the form of various metabolites, the general population is unknown and probably ful outcome is dependent on early diagnosis, peripheral vascular tone and cardiac function. injection. See INDICATIONS for specific uses. and less than 10% is excreted unchanged. The low. Sulfite sensitivity is seen more frequently in prompt discontinuance of the suspect triggering Maternal hypotension has resulted from Xylocaine solutions contain lidocaine HCl, primary metabolite in urine is a conjugate of asthmatic than in non-asthmatic people. agent(s) and institution of treatment, including regional anesthesia. Local anesthetics produce which is chemically designated as acetamide, 4-hydroxy-2,6-dimethylaniline. Anaphylactic reactions may occur following oxygen therapy, indicated supportive measures vasodilation by blocking sympathetic nerves. 2-(diethylamino)-N-(2,6-dimethylphenyl)-, The elimination half-life of lidocaine HCl fol- administration of lidocaine hydrochloride (see and dantrolene (consult dantrolene sodium Elevating the patient’s legs and positioning her monohydrochloride and has the molecular wt. lowing an intravenous bolus injection is typi- ADVERSE REACTIONS). intravenous package insert before using). on her left side will help prevent decreases in 270.8. Lidocaine HCl (C14H22N2O • HCl) has the cally 1.5 to 2 hours. Because of the rapid rate at In the case of severe reaction, discontinue the Proper tourniquet technique, as described in blood pressure. following structural formula: which lidocaine HCl is metabolized, any condi- use of the drug. publications and standard textbooks, is essen- The fetal heart rate also should be monitored tion that affects liver function may alter lidocaine tial in the performance of intravenous regional continuously, and electronic fetal monitoring is CH 3 HCl kinetics. The half-life may be prolonged anesthesia. Solutions containing epinephrine highly advisable. C2H5 PRECAUTIONS: two-fold or more in patients with liver dysfunc- General or other vasoconstrictors should not be used Epidural, spinal, paracervical, or pudendal tion. Renal dysfunction does not affect lidocaine for this technique. anesthesia may alter the forces of parturition NH CO CH2 N • HCl The safety and effectiveness of lidocaine HCl HCl kinetics but may increase the accumulation depend on proper dosage, correct technique, Lidocaine HCl should be used with caution in through changes in uterine contractility or C2H5 of metabolites. adequate precautions, and readiness for emer- persons with known drug sensitivities. Patients maternal expulsive efforts. In one study, para- CH 3 Factors such as acidosis and the use of CNS gencies. Standard textbooks should be con- allergic to para-aminobenzoic acid derivatives cervical block anesthesia was associated with Epinephrine is (-) -3, 4-Dihydroxy-␣- stimulants and depressants affect the CNS sulted for specific techniques and precautions (procaine, tetracaine, benzocaine, etc) have not a decrease in the mean duration of first stage [(methylamino) methyl] benzyl alcohol and levels of lidocaine HCl required to produce for various regional anesthetic procedures. shown cross-sensitivity to lidocaine HCl. labor and facilitation of cervical dilation. How- overt systemic effects. Objective adverse mani- ever, spinal and epidural anesthesia have also has the molecular wt. 183.21. Epinephrine Resuscitative equipment, oxygen, and other Use in the Head and Neck Area (C H NO ) has the following structural formula: festations become increasingly apparent with resuscitative drugs should be available for been reported to prolong the second stage of 9 13 3 increasing venous plasma levels above 6 mcg Small doses of local anesthetics injected into the labor by removing the parturient’s reflex urge to immediate use (see WARNINGS and ADVERSE head and neck area, including retrobulbar, den- OH free base per mL. In the rhesus monkey arterial REACTIONS). The lowest dosage that results bear down or by interfering with motor function. blood levels of 18 to 21 mcg/mL have been tal and stellate ganglion blocks, may produce The use of obstetrical anesthesia may increase in effective anesthesia should be used to avoid adverse reactions similar to systemic toxicity shown to be threshold for convulsive activity. high plasma levels and serious adverse effects. the need for forceps assistance. HO C CH2NHCH3 seen with unintentional intravascular injections Syringe aspirations should also be performed The use of some local anesthetic drug prod- of larger doses. Confusion, convulsions, respira- ucts during labor and delivery may be followed H INDICATIONS AND USAGE: before and during each supplemental injection HO tory depression and/or respiratory arrest, and by diminished muscle strength and tone for the Xylocaine (lidocaine HCl) Injections are indi- when using indwelling catheter techniques. Dur- cardiovascular stimulation or depression have cated for production of local or regional anes- ing the administration of epidural anesthesia, it is first day or two of life. The long-term significance Dosage forms listed as Xylocaine-MPF indi- been reported. These reactions may be due of these observations is unknown. Fetal brady- thesia by infiltration techniques such as per- recommended that a test dose be administered to intra-arterial injection of the local anesthetic cate single dose solutions that are Methyl cutaneous injection and intravenous regional initially and that the patient be monitored for cardia may occur in 20 to 30 percent of patients Paraben Free (MPF). with retrograde flow to the cerebral circulation. receiving paracervical nerve block anesthesia anesthesia by peripheral nerve block techniques central nervous system toxicity and cardiovas- Patients receiving these blocks should have Xylocaine MPF is a sterile, nonpyrogenic, such as brachial plexus and intercostal and by with the amide-type local anesthetics and may isotonic solution containing sodium chloride. cular toxicity, as well as for signs of unintended their circulation and respiration monitored and central neural techniques such as lumbar and intrathecal administration, before proceeding. be associated with fetal acidosis. Fetal heart rate Xylocaine in multiple dose vials: Each mL also be constantly observed. Resuscitative equip- should always be monitored during paracervical caudal epidural blocks, when the accepted When clinical conditions permit, consideration ment and personnel for treating adverse reac- contains 1 mg methylparaben as antiseptic pre- procedures for these techniques as described anesthesia. The physician should weigh the servative. The pH of these solutions is adjusted should be given to employing local anesthetic tions should be immediately available. Dosage in standard textbooks are observed. solutions that contain epinephrine for the test possible advantages against risks when con- to approximately 6.5 (5.0 to 7.0) with sodium recommendations should not be exceeded (see sidering a paracervical block in prematurity, hydroxide and/or hydrochloric acid. dose because circulatory changes compatible DOSAGE AND ADMINISTRATION). CONTRAINDICATIONS: with epinephrine may also serve as a warning toxemia of pregnancy, and fetal distress. Careful Xylocaine MPF with Epinephrine is a ster- Lidocaine HCl is contraindicated in patients adherence to recommended dosage is of the ile, nonpyrogenic, isotonic solution containing sign of unintended intravascular injection. An Information for Patients with a known history of hyper sensitivity to local intravascular injection is still possible even if When appropriate, patients should be informed utmost importance in obstetrical paracervical sodium chloride. Each mL contains lidocaine in advance that they may experience temporary block. Failure to achieve adequate analge- hydrochloride and epinephrine, with 0.5 mg anesthetics of the amide type. aspirations for blood are negative. Repeated doses of lidocaine HCl may cause significant loss of sensation and motor activity, usually sia with recommended doses should arouse sodium metabisulfite as an antioxidant and 0.2 in the lower half of the body, following proper suspicion of intravascular or fetal intracranial mg citric acid as a stabilizer. Xylocaine with WARNINGS: increases in blood levels with each repeated XYLOCAINE INJECTIONS FOR INFILTRATION dose because of slow accumulation of the drug administration of epidural anesthesia. injection. Cases compatible with unintended Epinephrine in multiple dose vials: Each mL fetal intracranial injection of local anesthetic also contains 1 mg methylparaben as antisep- AND NERVE BLOCK SHOULD BE EMPLOYED or its metabolites. Tolerance to elevated blood ONLY BY CLINICIANS WHO ARE WELL levels varies with the status of the patient. Debili- Clinically Significant Drug Interactions solution have been reported following intended tic preservative. The pH of these solutions is The administration of local anesthetic solutions paracervical or pudendal block or both. Babies adjusted to approximately 4.5 (3.3 to 5.5) with VERSED IN DIAGNOSIS AND MANAGEMENT tated, elderly patients, acutely ill patients, and OF DOSE-RELATED TOXICITY AND OTHER children should be given reduced doses com- containing epinephrine or norepinephrine to so affected present with unexplained neonatal sodium hydroxide and/or hydrochloric acid. patients receiving monoamine oxidase inhibitors depression at birth, which correlates with high Filled under nitrogen. ACUTE EMERGENCIES THAT MIGHT ARISE mensurate with their age and physical condition. FROM THE BLOCK TO BE EMPLOYED AND Lidocaine HCl should also be used with caution or tricyclic antidepressants may produce severe, local anesthetic serum levels, and often manifest THEN ONLY AFTER ENSURING THE IMME- in patients with severe shock or heart block. prolonged hypertension. seizures within six hours. Prompt use of sup- CLINICAL PHARMACOLOGY: Phenothiazines and butyrophenones Mechanism of Action DIATE AVAILABILITY OF OXYGEN, OTHER Lumbar and caudal epidural anesthesia portive measures combined with forced urinary RESUSCITATIVE DRUGS, CARDIOPULMO- should be used with extreme caution in persons may reduce or reverse the pressor effect of excretion of the local anesthetic has been used Lidocaine HCl stabilizes the neuronal mem- epinephrine. brane by inhibiting the ionic fluxes required NARY EQUIPMENT AND THE PERSONNEL with the following conditions: existing neurologi- successfully to manage this complication. NEEDED FOR PROPER MANAGEMENT OF cal disease, spinal deformities, septicemia, and Concurrent use of these agents should gener- Case reports of maternal convulsions and for the initiation and conduction of impulses ally be avoided. In situations when concurrent thereby effecting local anesthetic action. TOXIC REACTIONS AND RELATED EMER- severe hypertension. cardiovascular collapse following use of some GENCIES (see also Local anesthetic solutions containing a vaso- therapy is necessary, careful patient monitoring local anesthetics for paracervical block in early ADVERSE REACTIONS is essential. Hemodynamics and PRECAUTIONS). DELAY IN PROPER constrictor should be used cautiously and in pregnancy (as anesthesia for elective abor- Excessive blood levels may cause changes MANAGEMENT OF DOSE-RELATED TOXIC- carefully circumscribed quantities in areas of Concurrent administration of vasopressor tion) suggest that systemic absorption under in cardiac output, total peripheral resistance, ITY, UNDERVENTILATION FROM ANY CAUSE the body supplied by end arteries or having drugs (for the treatment of hypotension related these circumstances may be rapid. The recom- and mean arterial pressure. With central neural AND/OR ALTERED SENSITIVITY MAY LEAD TO otherwise compromised blood supply. Patients to obstetric blocks) and ergot-type oxytocic mended maximum dose of each drug should blockade these changes may be attributable to THE DEVELOPMENT OF ACIDOSIS, CARDIAC with peripheral vascular disease and those with drugs may cause severe, persistent hyperten- not be exceeded. Injection should be made block of autonomic fibers, a direct depressant sion or cerebrovascular accidents. slowly and with frequent aspiration. Allow a 451175D/Revised: November 2014 ARREST AND, POSSIBLY, DEATH. hypertensive vascular disease may exhibit exag- effect of the local anesthetic agent on various Intra-articular infusions of local anesthetics gerated vasoconstrictor response. Ischemic 5-minute interval between sides. components of the cardiovascular system, and/ Drug/Laboratory Test Interactions ® following arthroscopic and other surgical pro- injury or necrosis may result. Preparations The intramuscular injection of lidocaine HCl or the beta-adrenergic receptor stimulating cedures is an unapproved use, and there have containing a vasoconstrictor should be used Nursing Mothers Xylocaine action of epinephrine when present. The net may result in an increase in creatine phospho- It is not known whether this drug is excreted in been post-marketing reports of chondrolysis in with caution in patients during or following the kinase levels. Thus, the use of this enzyme effect is normally a modest hypotension when patients receiving such infusions. The majority administration of potent general anesthetic human milk. Because many drugs are excreted the recommended dosages are not exceeded. determination, without isoenzyme separation, in human milk, caution should be exercised Rx only of reported cases of chondrolysis have involved agents, since cardiac arrhythmias may occur as a diagnostic test for the presence of acute Pharmacokinetics and Metabolism the shoulder joint; cases of gleno-humeral under such conditions. when lidocaine HCl is administered to a nurs- myocardial infarction may be compromised by ing woman. Information derived from diverse formulations, chondrolysis have been described in pedi- Careful and constant monitoring of cardiovas- the intramuscular injection of lidocaine HCl. concentrations and usages reveals that lido- atric and adult patients following intra-articular cular and respiratory (adequacy of ventilation) Pediatric Use caine HCl is completely absorbed following infusions of local anesthetics with and without vital signs and the patient’s state of conscious- Carcinogenesis, Mutagenesis, Impairment of Fertility Dosages in children should be reduced, parenteral administration, its rate of absorp- epinephrine for periods of 48 to 72 hours. There ness should be accomplished after each local commensurate with age, body weight and tion depending, for example, upon various is insufficient information to determine whether anesthetic injection. It should be kept in mind Studies of lidocaine HCl in animals to evaluate the carcinogenic and mutagenic potential or physical condition, see DOSAGE AND factors such as the site of administration and shorter infusion periods are not associated with at such times that restlessness, anxiety, tinnitus, ADMINISTRATION. the presence or absence of a vasoconstrictor these findings. The time of onset of symptoms, dizziness, blurred vision, tremors, depression the effect on fertility have not been conducted. agent. Except for intravascular administration, such as joint pain, stiffness and loss of motion or drowsiness may be early warning signs of Pregnancy ADVERSE REACTIONS: the highest blood levels are obtained follow- can be variable, but may begin as early as the central nervous system toxicity. Teratogenic Effects: Pregnancy Category B. Systemic ing intercostal nerve block and the lowest after 2nd month after surgery. Currently, there is no Since amide-type local anesthetics are Reproduction studies have been performed in Adverse experiences following the administra- subcutaneous administration. effective treatment for chondrolysis; patients metabolized by the liver, Xylocaine Injection rats at doses up to 6.6 times the human dose tion of lidocaine HCl are similar in nature to The plasma binding of lidocaine HCl is depen- who experienced chondrolysis have required should be used with caution in patients with and have revealed no evidence of harm to the those observed with other amide local anes- ® dent on drug concentration, and the fraction addtional diagnostic and therapeutic proce- hepatic disease. Patients with severe hepatic fetus caused by lidocaine HCl. There are, how- thetic agents. These adverse experiences are, in Xylocaine bound decreases with increasing concentra- dures and some required arthroplasty or shoul- disease, because of their inability to metabo- ever, no adequate and well-controlled studies in general, dose-related and may result from high tion. At concentrations of 1 to 4 mcg of free der replacement. lize local anesthetics normally, are at greater (lidocaine HCl Injection, USP) pregnant women. Animal reproduction studies plasma levels caused by excessive dosage, base per mL 60 to 80 percent of lidocaine HCl To avoid intravascular injection, aspiration risk of developing toxic plasma concentrations. are not always predictive of human response. rapid absorption or inadvertent intravascular Xylocaine Injection should also be used with ® is protein bound. Binding is also dependent on should be performed before the local anesthetic General consideration should be given to this injection, or may result from a hypersensitivity, Xylocaine the plasma concentration of the alpha-1-acid solution is injected. The needle must be repo- caution in patients with impaired cardiovascular fact before administering lidocaine HCl to idiosyncrasy or diminished tolerance on the part glycoprotein. sitioned until no return of blood can be elicited function since they may be less able to com- women of childbearing potential, especially of the patient. Serious adverse experiences are (lidocaine HCl and epinephrine Injection, USP) Lidocaine HCl crosses the blood-brain and by aspiration. Note, however, that the absence pensate for functional changes associated with during early pregnancy when maximum organo- generally systemic in nature. The following types placental barriers, presumably by passive of blood in the syringe does not guarantee that the prolongation of A-V conduction produced genesis takes place. are those most commonly reported: For Infiltration and Nerve Block diffusion. intravascular injection has been avoided. by these drugs. Lidocaine HCl is metabolized rapidly by the Local anesthetic solutions containing anti- Many drugs used during the conduct of anes- Labor and Delivery Central Nervous System liver, and metabolites and unchanged drug microbial preservatives (eg, methylparaben) thesia are considered potential triggering agents Local anesthetics rapidly cross the placenta and CNS manifestations are excitatory and/ are excreted by the kidneys. Biotransforma- should not be used for epidural or spinal anes- for familial malignant hyperthermia. Since it is when used for epidural, paracervical, pudendal or depressant and may be characterized by tion includes oxidative N-dealkylation, ring thesia because the safety of these agents has not known whether amide-type local anesthetics or caudal block anesthesia, can cause varying lightheadedness, nervousness, apprehension, hydroxylation, cleavage of the amide linkage, not been established with regard to intrathecal may trigger this reaction and since the need degrees of maternal, fetal and neonatal toxicity euphoria, confusion, dizziness, drowsiness, and conjugation. N-dealkylation, a major path- injection, either intentional or accidental. for supplemental general anesthesia cannot (see CLINICAL PHARMACOLOGY, Pharma- tinnitus, blurred or double vision, vomiting, Reference ID: 4199967 way of biotransformation, yields the metabolites Xylocaine with epinephrine solutions contain be predicted in advance, it is suggested that a cokinetics and Metabolism). The potential sensations of heat, cold or numbness, twitch- monoethylglycinexylidide and glycinexylidide. sodium metabisulfite, a sulfite that may cause standard protocol for the management of malig- for toxicity depends upon the procedure per- ing, tremors, convulsions, uncon sciousness, respiratory depression and arrest. The excitatory when administered intravenously. Should con- 1.5% with epinephrine 30 mL ampules, 30 mL some cases it will be necessary to dilute avail- inspected visually for particulate matter and manifestations may be very brief or may not vulsions persist despite adequate respiratory 1:200,000 single dose solutions able concentrations with 0.9% sodium chloride discoloration prior to administration whenever occur at all, in which case the first manifesta- support, and if the status of the circulation per- 2% without epinephrine 10 mL Plastic Ampule injection in order to obtain the required final the solution and container permit. The Injection tion of toxicity may be drowsiness merging into mits, small increments of an ultra-short acting concentration. is not to be used if its color is pinkish or darker unconsciousness and respiratory arrest. barbiturate (such as thiopental or thiamylal) or 2% with epinephrine 20 mL ampules, 20 mL NOTE: Parenteral drug products should be than slightly yellow or if it contains a precipitate. Drowsiness following the administration of a benzodiazepine (such as diazepam) may be 1:200,000 single dose solutions Table 1: Recommended Dosages lidocaine HCl is usually an early sign of a high administered intravenously. The clinician should Although these solutions are intended specifi- blood level of the drug and may occur as a con- be familiar, prior to the use of local anesthetics, cally for epidural anesthesia, they may also be Xylocaine (lidocaine hydrochloride) sequence of rapid absorption. with these anticonvulsant drugs. Supportive used for infiltration and peripheral nerve block, Injection (without epinephrine) treatment of circulatory depression may require provided they are employed as single dose Procedure Conc (%) Vol (mL) Total Dose (mg) Cardiovascular System administration of intravenous fluids and, when units. These solutions contain no bacteriostatic Infiltration Cardiovascular manifestations are usually appropriate, a vasopressor as directed by the agent. depressant and are characterized by bradycar- clinical situation (eg, ephedrine). Percutaneous 0.5 or 1 1 to 60 5 to 300 In epidural anesthesia, the dosage varies with Intravenous regional 0.5 10 to 60 50 to 300 dia, hypotension, and cardiovascular collapse, If not treated immediately, both convulsions the number of dermatomes to be anesthetized which may lead to cardiac arrest. and cardiovascular depression can result in (generally 2 to 3 mL of the indicated concentra- Peripheral Nerve Blocks, eg, hypoxia, acidosis, bradycardia, arrhythmias and tion per dermatome). Brachial 1.5 15 to 20 225 to 300 Allergic cardiac arrest. Underventilation or apnea due Dental 2 1 to 5 20 to 100 Allergic reactions are characterized by cutane- to unintentional subarachnoid injection of local Caudal and Lumbar Epidural Block Intercostal 1 3 30 ous lesions, urticaria, edema or anaphylactoid anesthetic solution may produce these same As a precaution against the adverse experience Paravertebral 1 3 to 5 30 to 50 reactions. Allergic reactions may occur as a signs and also lead to cardiac arrest if ventilatory sometimes observed following unintentional Pudendal (each side) 1 10 100 result of sensitivity either to local anesthetic support is not instituted. If cardiac arrest should penetration of the subarachnoid space, a test Paracervical agents or to the methylparaben used as a occur, standard cardiopulmonary resuscitative dose such as 2 to 3 mL of 1.5% lidocaine HCl preservative in the multiple dose vials. Allergic Obstetrical analgesia measures should be instituted. should be administered at least 5 minutes prior (each side) 1 10 100 reactions, including anaphylactic reactions, may to injecting the total volume required for a Endotracheal intubation, employing drugs Sympathetic Nerve Blocks, eg, occur as a result of sensitivity to lidocaine, but and techniques familiar to the clinician, may lumbar or caudal epidural block. The test dose are infrequent. If allergic reactions do occur, should be repeated if the patient is moved in a Cervical (stellate ganglion) 1 5 50 be indicated, after initial administration of oxy- Lumbar 1 5 to 10 50 to 100 they should be managed by conventional gen by mask, if difficulty is encountered in the manner that may have displaced the catheter. means. The detection of sensitivity by skin testing maintenance of a patent airway or if prolonged Epinephrine, if contained in the test dose (10 to Central Neural Blocks is of doubtful value. ventilatory support (assisted or controlled) is 15 mcg have been suggested), may serve as Epidural* There have been no reports of cross sensi- indicated. a warning of unintentional intravascular injec- Thoracic 1 20 to 30 200 to 300 tivity between lidocaine hydrochloride and Dialysis is of negligible value in the treatment tion. If injected into a blood vessel, this amount Lumbar procainamide or between lidocaine hydro- of acute overdosage with lidocaine HCl. of epinephrine is likely to produce a transient Analgesia 1 25 to 30 250 to 300 chloride and quinidine. Anesthesia 1.5 15 to 20 225 to 300 The oral LD50 of lidocaine HCl in non-fasted “epinephrine response” within 45 seconds, con- female rats is 459 (346 to 773) mg/kg (as the sisting of an increase in heart rate and systolic 2 10 to 15 200 to 300 Neurologic salt) and 214 (159 to 324) mg/kg (as the salt) in blood pressure, circumoral pallor, palpitations Caudal The incidences of adverse reactions associated fasted female rats. and nervousness in the unsedated patient. The Obstetrical analgesia 1 20 to 30 200 to 300 with the use of local anesthetics may be related sedated patient may exhibit only a pulse rate Surgical anesthesia 1.5 15 to 20 225 to 300 to the total dose of local anesthetic administered DOSAGE AND ADMINISTRATION: increase of 20 or more beats per minute for 15 and are also dependent upon the particular drug Table 1 (Recommended Dosages) summarizes or more seconds. Patients on beta blockers may *Dose determined by number of dermatomes to be anesthetized (2 to 3 mL/dermatome). used, the route of administration and the physi- the recommended volumes and concentrations not manifest changes in heart rate, but blood cal status of the patient. In a prospective review of Xylocaine Injection for various types of anes- pressure monitoring can detect an evanescent THE ABOVE SUGGESTED CONCENTRATIONS have been related to incidents of swelling and of 10,440 patients who received lidocaine HCl thetic procedures. The dosages suggested in rise in systolic blood pressure. Adequate time AND VOLUMES SERVE ONLY AS A GUIDE. edema. When chemical disinfection of multi- for spinal anesthesia, the incidences of adverse this table are for normal healthy adults and refer should be allowed for onset of anesthesia after OTHER VOLUMES AND CONCENTRATIONS dose vials is desired, either isopropyl alcohol reactions were reported to be about 3 percent to the use of epinephrine-free solutions. When administration of each test dose. The rapid MAY BE USED PROVIDED THE TOTAL (91%) or ethyl alcohol (70%) is recommended. each for positional headaches, hypotension larger volumes are required, only solutions con- injection of a large volume of Xylocaine Injec- MAXIMUM RECOMMENDED DOSE IS NOT Many commercially available brands of rubbing and backache; 2 percent for shivering; and taining epinephrine should be used except in tion through the catheter should be avoided, EXCEEDED. alcohol, as well as solutions of ethyl alcohol less than 1 percent each for peripheral nerve those cases where vasopressor drugs may be and, when feasible, fractional doses should be not of USP grade, contain denaturants which symptoms, nausea, respiratory inadequacy and contraindicated. administered. STERILIZATION, STORAGE AND TECHNICAL are injurious to rubber and therefore are not double vision. Many of these observations may There have been adverse event reports In the event of the known injection of a large PROCEDURES: to be used. be related to local anesthetic techniques, with or of chondrolysis in patients receiving intra- volume of local anesthetic solution into the sub- Disinfecting agents containing heavy metals, without a contribution from the local anesthetic. articular infusions of local anesthetics fol- arachnoid space, after suitable resuscitation and which cause release of respective ions (mer- Dosage forms listed as Xylocaine-MPF indi- In the practice of caudal or lumbar epidural lowing arthroscopic and other surgical pro- if the catheter is in place, consider attempting cury, zinc, copper, etc) should not be used for cate single dose solutions that are Methyl block, occasional unintentional penetration of cedures. Xylocaine is not approved for this the recovery of drug by draining a moderate skin or mucous membrane disinfection as they Paraben Free (MPF). the subarachnoid space by the catheter may use (see WARNINGS and DOSAGE AND amount of cerebrospinal fluid (such as 10 mL) occur. Subsequent adverse effects may depend ADMINISTRATION). through the epidural catheter. HOW SUPPLIED: partially on the amount of drug administered These recommended doses serve only as a Xylocaine-MPF Xylocaine subdurally. These may include spinal block of guide to the amount of anesthetic required for MAXIMUM RECOMMENDED DOSAGES: varying magnitude (including total spinal block), most routine procedures. The actual volumes Adults Plastic Multiple hypotension secondary to spinal block, loss of and concentrations to be used depend on a For normal healthy adults, the individual Ampule Dose bladder and bowel control, and loss of perineal number of factors such as type and extent of maximum recommended dose of lidocaine HCl Ampules (mL) (mL) Single Dose Vials (mL) Vials (mL) with epinephrine should not exceed 7 mg/kg sensation and sexual function. Persistent motor, surgical procedure, depth of anesthesia and Xylocaine Epinephrine sensory and/or autonomic (sphincter control) degree of muscular relaxation required, dura- (3.5 mg/lb) of body weight, and in general it is recommended that the maximum total dose not (lidocaine HCl) Dilution deficit of some lower spinal segments with tion of anesthesia required, and the physical Concentration (if present) 2 5 20 30 10 20 2 5 10 20 30 50 10 20 50 slow recovery (several months) or incomplete exceed 500 mg. When used without epinephrine condition of the patient. In all cases the low- 0.5% X X recovery have been reported in rare instances est concentration and smallest dose that will the maximum individual dose should not exceed when caudal or lumbar epidural block has been produce the desired result should be given. 4.5 mg/kg (2 mg/lb) of body weight, and in gen- 0.5% 1:200,000 X eral it is recommended that the maximum total attempted. Backache and headache have also Dosages should be reduced for children and for 1% X X X X X X X X X X been noted following use of these anesthetic the elderly and debilitated patients and patients dose does not exceed 300 mg. For continuous procedures. with cardiac and/or liver disease. epidural or caudal anesthesia, the maximum 1% 1:100,000 X X X There have been reported cases of perma- The onset of anesthesia, the duration of anes- recommended dosage should not be adminis- 1% 1:200,000 X X X nent injury to extraocular muscles requiring sur- thesia and the degree of muscular relaxation tered at intervals of less than 90 minutes. When gical repair following retrobulbar administration. are proportional to the volume and concentra- continuous lumbar or caudal epidural anesthe- 1.5% X X tion (ie, total dose) of local anesthetic used. sia is used for non-obstetrical procedures, more 1.5% 1:200,000 X X X X Hematologic drug may be administered if required to produce Thus, an increase in volume and concentration 2% X X X X X X X Methemoglobinemia. of Xylocaine Injection will decrease the onset adequate anesthesia. The maximum recommended dose per 90 2% 1:100,000 X X OVERDOSAGE: of anesthesia, prolong the duration of anes- thesia, provide a greater degree of muscular minute period of lidocaine hydrochloride for Acute emergencies from local anesthetics are paracervical block in obstetrical patients and 2% 1:200,000 X X X generally related to high plasma levels encoun- relaxation and increase the segmental spread of anesthesia. However, increasing the volume non-obstetrical patients is 200 mg total. One tered during therapeutic use of local anesthet- half of the total dose is usually administered to ics or to unintended subarachnoid injection of and concentration of Xylocaine Injection may All solutions should be stored at 20° to 25°C result in a more profound fall in blood pressure each side. Inject slowly, five minutes between local anesthetic solution (see ADVERSE REAC- sides (see also discussion of paracervical block (68° to 77°F) [see USP Controlled Room TIONS, WARNINGS, and PRECAUTIONS). when used in epidural anesthesia. Although Temperature]. the incidence of side effects with lidocaine HCl in PRECAUTIONS). For intravenous regional anesthesia, the dose Protect from light. Management of Local Anesthetic is quite low, caution should be exercised when employing large volumes and concentrations, administered should not exceed 4 mg/kg in Emergencies adults. All trademarks are the property of The first consideration is prevention, best since the incidence of side effects is directly Fresenius Kabi USA, LLC. accomplished by careful and constant moni- proportional to the total dose of local anesthetic Children toring of cardiovascular and respiratory vital agent injected. It is difficult to recommend a maximum dose of signs and the patient’s state of consciousness For intravenous regional anesthesia, only the any drug for children, since this varies as a func- after each local anesthetic injection. At the first 50 mL single dose vial containing Xylocaine tion of age and weight. For children over 3 years sign of change, oxygen should be administered. (lidocaine HCl) 0.5% Injection should be used. of age who have a normal lean body mass and The first step in the management of convul- Epidural Anesthesia normal body development, the maximum dose sions, as well as underventilation or apnea due For epidural anesthesia, only the following dosage is determined by the child’s age and weight. to unintended subarachnoid injection of drug forms of Xylocaine Injection are recommended: For example, in a child of 5 years weighing 50 lbs solution, consists of immediate attention to the the dose of lidocaine HCl should not exceed maintenance of a patent airway and assisted or 1% without epinephrine 10 mL Plastic Ampule 75 to 100 mg (1.5 to 2 mg/lb). The use of even controlled ventilation with oxygen and a delivery 1% without epinephrine 30 mL single dose more dilute solutions (ie, 0.25 to 0.5%) and total solutions dosages not to exceed 3 mg/kg (1.4 mg/lb) system capable of permitting immediate positive Fresenius Kabi USA, LLC airway pressure by mask. Immediately after the 1% with epinephrine 30 mL single dose are recommended for induction of intravenous institution of these ventilatory measures, the 1:200,000 solutions regional anesthesia in children. Lake Zurich, IL 60047 adequacy of the circulation should be evalu- In order to guard against systemic toxicity, 1.5% without epinephrine 10 mL Plastic Ampule ated,Reference keeping in mind thatID: drugs 4199967 used to treat the lowest effective concentration and lowest 451175D convulsions sometimes depress the circulation 1.5% without epinephrine 20 mL Plastic Ampule effective dose should be used at all times. In Revised: November 2014