Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/889
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Lidocaine Hydrochloride (Injection, Solution)
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Table 1 (Recommended Dosages) summarizes the recommended
volumes and concentrations of Lidocaine Hydrochloride Injection, USP for various
types of anesthetic procedures. The dosages suggested in this table are for
normal healthy adults and refer to the use of epinephrine-free solutions.
When larger volumes are required only solutions containing epinephrine should
be used, except in those cases where vasopressor drugs may be contraindicated. These
recommended doses serve only as a guide to the amount of anesthetic required
for most routine procedures. The actual volumes and concentrations to be used
depend on a number of factors such as type and extent of surgical procedure,
depth of anesthesia and degree of muscular relaxation required, duration of
anesthesia required, and the physical condition of the patient. In all cases
the lowest concentration and smallest dose that will produce the desired result
should be given. Dosages should be reduced for children and for elderly and
debilitated patients and patients with cardiac and/or liver disease. The
onset of anesthesia, the duration of anesthesia and the degree of muscular
relaxation are proportional to the volume and concentration (i.e., total dose)
of local anesthetic used. Thus, an increase in volume and concentration of
Lidocaine Hydrochloride Injection will decrease the onset of anesthesia, prolong
the duration of anesthesia, provide a greater degree of muscular relaxation
and increase the segmental spread of anesthesia. However, increasing the volume
and concentration of Lidocaine Hydrochloride Injection may result in a more
profound fall in blood pressure when used in epidural anesthesia. Although
the incidence of side effects with lidocaine is quite low, caution should
be exercised when employing large volumes and concentrations, since the incidence
of side effects is directly proportional to the total dose of local anesthetic
agent injected. For intravenous regional anesthesia,
only the 50 mL single-dose vial containing 0.5% Lidocaine Hydrochloride Injection,
USP should be used. Epidural
Anesthesia For epidural anesthesia, only the
following available specific products
of Lidocaine Hydrochloride Injection by Hospira are recommended: 1%.
. . . . . . . . . . . . . . . . . . . 30 mL single-dose teartop vials 1.5%.
. . . . . . . . . . . . . . . . . . . . . . 20 mL single-dose ampuls 2%.
. . . . . . . . . . . . . . . . . . . . . . . .10 mL single-dose ampuls Although
these solutions are intended specifically for epidural anesthesia, they may
also be used for infiltration and peripheral nerve block provided they are
employed as single dose units. These solutions contain no bacteriostatic agent.
In epidural anesthesia, the dosage varies with the number of dermatomes to
be anesthetized (generally 2���3 mL of the indicated concentration per
dermatome). Caudal and Lumbar
Epidural Block: As a precaution against the adverse experiences
sometimes observed following unintentional penetration of the subarachnoid
space, a test dose such as 2���3 mL of 1.5% lidocaine hydrochloride should
be administered at least 5 minutes prior to injecting the total volume required
for a lumbar or caudal epidural block. The test dose should be repeated if
the patient is moved in a manner that may have displaced the catheter. Epinephrine,
if contained in the test dose (10���15��g have been suggested),
may serve as a warning of unintentional intravascular injection. If injected
into a blood vessel, this amount of epinephrine is likely to produce a transient
"epinephrine response" within 45 seconds, consisting of an increase in heart
rate and systolic blood pressure, circumoral pallor, palpitations and nervousness
in the unsedated patient. The sedated patient may exhibit only a pulse rate
increase of 20 or more beats per minute for 15 or more seconds. Patients on
beta-blockers may not manifest changes in heart rate, but blood pressure monitoring
can detect an evanescent rise in systolic blood pressure. Adequate time should
be allowed for onset of anesthesia after administration of each test dose.
The rapid injection of a large volume of Lidocaine Hydrochloride Injection
through the catheter should be avoided, and, when feasible, fractional doses
should be administered. In the event of the known injection
of a large volume of local anesthetic solutions into the subarachnoid space,
after suitable resuscitation and if the catheter is in place, consider attempting
the recovery of drug by draining a moderate amount of cerebrospinal fluid
(such as 10 mL) through the epidural catheter. Maximum Recommended Dosages NOTE: The products accompanying this insert do not contain
epinephrine. Adults: For normal healthy adults, the individual maximum recommended
dose of lidocaine HCl with epinephrine should not exceed 7 mg/kg (3.5 mg/lb)
of body weight and in general it is recommended that the maximum total dose
not exceed 500 mg. When used without epinephrine, the maximum individual dose
should not exceed 4.5 mg/kg (2 mg/lb) of body weight and in general it is
recommended that the maximum total dose does not exceed 300 mg. For continuous
epidural or caudal anesthesia, the maximum recommended dosage should not be
administered at intervals of less than 90 minutes. When continuous lumbar
or caudal epidural anesthesia is used for non-obstetrical procedures, more
drug may be administered if required to produce adequate anesthesia. The
maximum recommended dose per 90 minute period of lidocaine hydrochloride for
paracervical block in obstetrical patients and non-obstetrical patients is
200 mg total. One-half of the total dose is usually administered to each side.
Inject slowly five minutes between sides. (See also discussion of paracervical
block in PRECAUTIONS). For intravenous regional anesthesia,
the dose administered should not exceed 4 mg/kg in adults. Children: It is difficult to recommend a maximum
dose of any drug for children, since this varies as a function of age and
weight. For children over 3 years of age who have a normal lean body mass
and normal body development, the maximum dose is determined by the child's
age and weight. For example, in a child of 5 years weighing 50 lbs., the dose
of lidocaine HCl should not exceed 75���100 mg (1.5���2 mg/lb).
The use of even more dilute solutions (i.e., 0.25���0.5%) and total
dosages not to exceed 3 mg/kg (1.4 mg/lb) are recommended for induction of
intravenous regional anesthesia in children. In order
to guard against systemic toxicity, the lowest effective concentration and
lowest effective dose should be used at all times. In some cases it will be
necessary to dilute available concentrations with 0.9% sodium chloride injection
in order to obtain the required final concentration. Parenteral
drug products should be inspected visually for particulate matter and discoloration
prior to administration whenever the solution and container permit. Solutions
that are discolored and/or contain particulate matter should not be used. THE ABOVE SUGGESTED CONCENTRATIONS AND VOLUMES SERVE ONLY
AS A GUIDE. OTHER VOLUMES AND CONCENTRATIONS MAY BE USED PROVIDED THE TOTAL
MAXIMUM RECOMMENDED DOSE IS NOT EXCEEDED. Sterilization,
Storage and Technical Procedures: Disinfecting agents containing
heavy metals, which cause release of respective ions (mercury, zinc, copper,
etc.) should not be used for skin or mucous membrane disinfection as they
have been related to incidence of swelling and edema. When chemical disinfection
of multi-dose vials is desired, either isopropyl alcohol (91%) or 70% ethyl
alcohol is recommended. Many commercially available brands of rubbing alcohol,
as well as solutions of ethyl alcohol not of USP grade, contain denaturants
which are injurious to rubber and, therefore, are not to be used. It is recommended
that chemical disinfection be accomplished by wiping the vial stopper thoroughly
with cotton or gauze that has been moistened with the recommended alcohol
just prior to use.
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Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic
solution of lidocaine hydrochloride in water for injection for parenteral
administration in various concentrations with characteristics as follows: Multiple-dose vials contain 0.1% of methylparaben added
as preservative. May contain sodium hydroxide and/or hydrochloric acid for
pH adjustment. The pH is 6.5 (5.0 to 7.0). See HOW SUPPLIED section for various
sizes and strengths. Lidocaine is a local anesthetic
of the amide type. Lidocaine Hydrochloride, USP is chemically
designated 2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride
monohydrate, a white powder freely soluble in water. The molecular weight
is 288.82. It has the following structural formula: The
semi-rigid vial used for the plastic vials is fabricated from a specially
formulated polyolefin. It is a copolymer of ethylene and propylene. The safety
of the plastic has been confirmed by tests in animals according to USP biological
standards for plastic containers. The container requires no vapor barrier
to maintain the proper drug concentration.
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Mechanism of action: Lidocaine
stabilizes the neuronal membrane by inhibiting the ionic fluxes required for
the initiation and conduction of impulses, thereby effecting local anesthetic
action. Hemodynamics: Excessive
blood levels may cause changes in cardiac output, total peripheral resistance,
and mean arterial pressure. With central neural blockade these changes may
be attributable to block of autonomic fibers, a direct depressant effect of
the local anesthetic agent on various components of the cardiovascular system
and/or the beta-adrenergic receptor stimulating action of epinephrine when
present. The net effect is normally a modest hypotension when the recommended
dosages are not exceeded. Pharmacokinetics
and metabolism: Information derived from diverse formulations, concentrations
and usages reveals that lidocaine is completely absorbed following parenteral
administration, its rate of absorption depending, for example, upon various
factors such as the site of administration and the presence or absence of
a vasoconstrictor agent. Except for intravascular administration, the highest
blood levels are obtained following intercostal nerve block and the lowest
after subcutaneous administration. The plasma binding
of lidocaine is dependent on drug concentration, and the fraction bound decreases
with increasing concentration. At concentrations of 1 to 4��g of free
base per mL, 60 to 80 percent of lidocaine is protein bound. Binding is also
dependent on the plasma concentration of the alpha-1-acid glycoprotein. Lidocaine
crosses the blood-brain and placental barriers, presumably by passive diffusion. Lidocaine
is metabolized rapidly by the liver, and metabolites and unchanged drug are
excreted by the kidneys. Biotransformation includes oxidative N-dealkylation,
ring hydroxylation, cleavage of the amide linkage, and conjugation. N-dealkylation,
a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide
and glycinexylidide. The pharmacological/toxicological actions of these metabolites
are similar to, but less potent than, those of lidocaine. Approximately 90%
of lidocaine administered is excreted in the form of various metabolites,
and less than 10% is excreted unchanged. The primary metabolite in urine is
a conjugate of 4-hydroxy-2, 6-dimethylaniline. The elimination
half-life of lidocaine following an intravenous bolus injection is typically
1.5 to 2.0 hours. Because of the rapid rate at which lidocaine is metabolized,
any condition that affects liver function may alter lidocaine kinetics. The
half-life may be prolonged two-fold or more in patients with liver dysfunction.
Renal dysfunction does not affect lidocaine kinetics but may increase the
accumulation of metabolites. Factors such as acidosis
and the use of CNS stimulants and depressants affect the CNS levels of lidocaine
required to produce overt systemic effects. Objective adverse manifestations
become increasingly apparent with increasing venous plasma levels above 6.0��g free base per mL. In the rhesus monkey arterial blood levels of 18-21��g/mL have been shown to be threshold for convulsive activity.
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Lidocaine is contraindicated in patients with a known history
of hypersensitivity to local anesthetics of the amide type.
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Lidocaine Hydrochloride Injection, USP is supplied as follows: Single-dose products are preservative-free. Store
at 20 to 25��C (68 to 77��F). [See USP Controlled Room Temperature.] Lidocaine
Hydrochloride Injection, USP solutions packaged in ampuls and glass teartop
vials may be autoclaved one time only. Autoclave at 15 pounds pressure, 121��C
(250��F) for 15 minutes. DO NOT AUTOCLAVE PRODUCT
IN PLASTIC VIALS. July, 2004 HOSPIRA, INC., LAKE FOREST,
IL 60045, USA
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General:: The safety and effectiveness of lidocaine depend on proper
dosage, correct technique, adequate precautions, and readiness for emergencies.
Standard textbooks should be consulted for specific techniques and precautions
for various regional anesthetic procedures. Resuscitative
equipment, oxygen, and other resuscitative drugs should be available for immediate
use. (See WARNINGS and ADVERSE REACTIONS). The lowest dosage that results
in effective anesthesia should be used to avoid high plasma levels and serious
adverse effects. Syringe aspirations should also be performed before and during
each supplemental injection when using indwelling catheter techniques. During
the administration of epidural anesthesia, it is recommended that a test dose
be administered initially and that the patient be monitored for central nervous
system toxicity and cardiovascular toxicity, as well as for signs of unintended
intrathecal administration before proceeding. When clinical conditions permit,
consideration should be given to employing local anesthetic solutions that
contain epinephrine for the test dose because circulatory changes compatible
with epinephrine may also serve as a warning sign of unintended intravascular
injection. An intravascular injection is still possible even if aspirations
for blood are negative. Repeated doses of lidocaine may cause significant
increases in blood levels with each repeated dose because of slow accumulation
of the drug or its metabolites. Tolerance to elevated blood levels varies
with the status of the patient. Debilitated, elderly patients, acutely ill
patients and children should be given reduced doses commensurate with their
age and physical condition. Lidocaine should also be used with caution in
patients with severe shock or heart block. Lumbar and caudal epidural anesthesia
should be used with extreme caution in persons with the following conditions:
existing neurological disease, spinal deformities, septicemia and severe hypertension. Local
anesthetic solutions containing a vasoconstrictor should be used cautiously
and in carefully circumscribed quantities in areas of the body supplied by
end arteries or having otherwise compromised blood supply. Patients with peripheral
vascular disease and those with hypertensive vascular disease may exhibit
exaggerated vasoconstrictor response. Ischemic injury or necrosis may result.
Preparations containing a vasoconstrictor should be used with caution in patients
during or following the administration of potent general anesthetic agents,
since cardiac arrhythmias may occur under such conditions. Careful
and constant monitoring of cardiovascular and respiratory (adequacy of ventilation)
vital signs and the patient's state of consciousness should be accomplished
after each local anesthetic injection. It should be kept in mind at such times
that restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors,
depression or drowsiness may be early warning signs of central nervous system
toxicity. Since amide-type local anesthetics are metabolized
by the liver, lidocaine should be used with caution in patients with hepatic
disease. Patients with severe hepatic disease, because of their inability
to metabolize local anesthetics normally, are at greater risk of developing
toxic plasma concentrations. Lidocaine should also be used with caution in
patients with impaired cardiovascular function since they may be less able
to compensate for functional changes associated with the prolongation of A-V
conduction produced by these drugs. Many drugs used during the conduct of
anesthesia are considered potential triggering agents for familial malignant
hyperthermia. Since it is not known whether amide-type local anesthetics may
trigger this reaction and since the need for supplemental general anesthesia
cannot be predicted in advance, it is suggested that a standard protocol for
the management of malignant hyperthermia should be available. Early unexplained
signs of tachycardia, tachypnea, labile blood pressure and metabolic acidosis
may precede temperature elevation. Successful outcome is dependent on early
diagnosis, prompt discontinuance of the suspect triggering agent(s) and institution
of treatment, including oxygen therapy, indicated supportive measures and
dantrolene (consult dantrolene sodium intravenous package insert before using). Proper
tourniquet technique, as described in publications and standard textbooks,
is essential in the performance of intravenous regional anesthesia. Solutions
containing epinephrine or other vasoconstrictors should not be used for this
technique. Lidocaine should be used with caution in
persons with known drug sensitivities. Patients allergic to para-aminobenzoic
acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross
sensitivity to lidocaine. Use
in the Head and Neck Area: Small doses of local anesthetics injected
into the head and neck area, including retrobulbar, dental and stellate ganglion
blocks, may produce adverse reactions similar to systemic toxicity seen with
unintentional intravascular injections of larger doses. Confusion, convulsions,
respiratory depression and/or respiratory arrest and cardiovascular stimulation
or depression have been reported. These reactions may be due to intra-arterial
injections of the local anesthetic with retrograde flow to the cerebral circulation.
Patients receiving these blocks should have their circulation and respiration
monitored and be constantly observed. Resuscitative equipment and personnel
for treating adverse reactions should be immediately available. Dosage recommendations
should not be exceeded. (See DOSAGE AND ADMINISTRATION).<br/>Information for Patients:: When appropriate, patients should be informed in advance
that they may experience temporary loss of sensation and motor activity, usually
in the lower half of the body following proper administration of epidural
anesthesia.<br/>Clinically Significant Drug Interactions:: The administration of local anesthetic solutions containing
epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors
or tricyclic antidepressants may produce severe prolonged hypertension. Phenothiazines
and butyrophenones may reduce or reverse the pressor effect of epinephrine. Concurrent
use of these agents should generally be avoided. In situations when concurrent
therapy is necessary, careful patient monitoring is essential. Concurrent
administration of vasopressor drugs (for the treatment of hypotension related
to obstetric blocks) and ergot-type oxytoxic drugs may cause severe persistent
hypertension or cerebrovascular accidents.<br/>Drug Laboratory Test Interactions:: The intramuscular injection of lidocaine may result in an
increase in creatine phosphokinase levels. Thus, the use of this enzyme determination
without isoenzyme separation as a diagnostic test for the presence of acute
myocardial infarction may be compromised by the intramuscular injection of
lidocaine.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:: Studies of lidocaine in animals to evaluate the carcinogenic
and mutagenic potential or the effect on fertility have not been conducted.<br/>Pregnancy:: Teratogenic Effects. Pregnancy
Category B. Reproduction studies have been performed in rats at
doses up to 6.6 times the human dose and have revealed no evidence of harm
to the fetus caused by lidocaine. There are, however, no adequate and well-controlled
studies in pregnant women. Animal reproduction studies are not always predictive
of human response. General consideration should be given to this fact before
administering lidocaine to women of childbearing potential, especially during
early pregnancy when maximum organogenesis takes place.<br/>Labor and Delivery:: Local anesthetics rapidly cross the placenta and when used
for epidural, paracervical, pudendal or caudal block anesthesia, can cause
varying degrees of maternal, fetal and neonatal toxicity (See CLINICAL PHARMACOLOGY���Pharmacokinetics).
The potential for toxicity depends upon the procedure performed, the type
and amount of drug used, and the technique of drug administration. Adverse
reactions in the parturient, fetus and neonate involve alterations of the
central nervous system peripheral vascular tone and cardiac function. Maternal
hypotension has resulted from regional anesthesia. Local anesthetics produce
vasodilation by blocking sympathetic nerves. Elevating the patient's
legs and positioning her on her left side will help prevent decreases in blood
pressure. The fetal heart rate also should be monitored continuously, and
electronic fetal monitoring is highly advisable. Epidural,
spinal, paracervical, or pudendal anesthesia may alter the forces of parturition
through changes in uterine contractility or maternal expulsive efforts. In
one study, paracervical block anesthesia was associated with a decrease in
the mean duration of first stage labor and facilitation of cervical dilation.
However, spinal and epidural anesthesia have also been reported to prolong
the second stage of labor 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 of some local anesthetic drug products during labor and delivery may be
followed by diminished muscle strength and tone for the first day or two of
life. The long-term significance of these observations is unknown. Fetal bradycardia
may occur in 20 to 30 percent of patients receiving paracervical nerve block
anesthesia with the amide-type local anesthetics and may be associated with
fetal acidosis. Fetal heart rate should always be monitored during paracervical
anesthesia. The physician should weigh the possibleadvantages against risks
when considering paracervical block in prematurity, toxemia of pregnancy and
fetal distress. Careful adherence to recommended dosage is of the utmost importance
in obstetrical paracervical block. Failure to achieve adequate analgesia with
recommended doses should arouse suspicion of intravascular or fetal intracranial
injection. Cases compatible with unintended fetal intracranial injection of
local anesthetic solution have been reported following intended paracervical
or pudendal block or both. Babies so affected present with unexplained neonatal
depression at birth, which correlates with high local anesthetic serum levels,
and often manifest seizures within six hours. Prompt use of supportive measures
combined with forced urinary excretion of the local anesthetic has been used
successfully to manage this complication. Case reports
of maternal convulsions and cardiovascular collapse following use of some
local anesthetics for paracervical block in early pregnancy (as anesthesia
for elective abortion) suggest that systemic absorption under these circumstances
may be rapid. The recommended maximum dose of each drug should not be exceeded.
Injection should be made slowly and with frequent aspiration. Allow a 5-minute
interval between sides.<br/>Nursing Mothers:: It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised
when lidocaine is administered to a nursing woman.<br/>Pediatric Use:: Dosages in pediatric patients should be reduced, commensurate
with age, body weight and physical condition. See DOSAGE AND ADMINISTRATION.
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Acute emergencies from local anesthetics are generally related
to high plasma levels encountered during therapeutic use of local anesthetics
or to unintended subarachnoid injection of local anesthetic solution (see
ADVERSE REACTIONS, WARNINGS and PRECAUTIONS). Management of Local Anesthetic Emergencies: The
first consideration is prevention, best accomplished by careful monitoring
of cardiovascular and respiratory vital signs and the patient's state
of consciousness after each local anesthetic injection. At the first sign
of change, oxygen should be administered. The first
step in the management of convulsions, as well as underventilation or apnea
due to unintended subarachnoid injection of drug solution, consists of immediate
attention to the maintenance of a patent airway and assisted or controlled
ventilation with oxygen and a delivery system capable of permitting immediate
positive airway pressure by mask. Immediately after the institution of these
ventilatory measures, the adequacy of the circulation should be evaluated,
keeping in mind that drugs used to treat convulsions sometimes depress the
circulation when administered intravenously. Should convulsions persist despite
adequate respiratory support, and if the status of the circulation permits,
smallincrements of an ultra-short acting barbiturate (such as thiopental
or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously.
The clinician should be familiar, prior to use of local anesthetics, with
these anticonvulsant drugs. Supportive treatment of circulatory depression
may require administration of intravenous fluids and, when appropriate, a
vasopressor as directed by the clinical situation (e.g., ephedrine). If
not treated immediately, both convulsions and cardiovascular depression can
result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest.
Underventilation or apnea due to unintentional subarachnoid injection of local
anesthetic solution may produce these same signs and also lead to cardiac
arrest if ventilatory support is not instituted. If cardiac arrest should
occur standard cardiopulmonary resuscitative measures should be instituted. Endotracheal
intubation, employing drugs and techniques familiar to the clinician, may
be indicated, after initial administration of oxygen by mask, if difficulty
is encountered in the maintenance of a patent airway or if prolonged ventilatory
support (assisted or controlled) is indicated. Dialysis
is of negligible value in the treatment of acute overdosage with lidocaine. The
oral LDof lidocaine HCl in non-fasted female rats is 459 (346���773)
mg/kg (as the salt) and 214 (159���324) mg/kg (as the salt) in fasted
female rats.
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Lidocaine Hydrochloride
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Lidocaine Hydrochloride (Injection, Solution)
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Systemic: Adverse experiences
following the administration of lidocaine are similar in nature to those observed
with other amide local anesthetic agents. These adverse experiences are, in
general, dose-related and may result from high plasma levels caused by excessive
dosage, rapid absorption or inadvertent intravascular injection, or may result
from a hypersensitivity, idiosyncrasy or diminished tolerance on the part
of the patient. Serious adverse experiences are generally systemic in nature.
The following types are those most commonly reported: Central Nervous System: CNS manifestations are
excitatory and/or depressant and may be characterized by lightheadedness,
nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus,
blurred or double vision, vomiting, sensations of heat, cold or numbness,
twitching, tremors, convulsions, unconsciousness, respiratory depression and
arrest. The excitatory manifestations may be very brief or may not occur at
all, in which case the first manifestation of toxicity may be drowsiness merging
into unconsciousness and respiratory arrest. Drowsiness
following the administration of lidocaine is usually an early sign of a high
blood level of the drug and may occur as a consequence of rapid absorption. Cardiovascular System: Cardiovascular manifestations
are usually depressant and are characterized by bradycardia, hypotension,
and cardiovascular collapse, which may lead to cardiac arrest. Allergic: Allergic reactions are characterized
by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic
reactions may occur as a result of sensitivity either to local anesthetic
agents or to the methylparaben used as a preservative in multiple dose vials.
Allergic reactions as a result of sensitivity to lidocaine are extremely rare
and, if they occur, should be managed by conventional means. The detection
of sensitivity by skin testing is of doubtful value. Neurologic: The incidences of adverse 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.
In a prospective review of 10,440 patients who received lidocaine for spinal
anesthesia, the incidences of adverse reactions were reported to be about
3 percent each for positional headaches, hypotension and backache; 2 percent
for shivering; and less than 1 percent each for peripheral nerve symptoms,
nausea, respiratory inadequacy and double vision. Many of these observations
may be related to local anesthetic techniques, with or without a contribution
from the local anesthetic. In the practice of caudal
or lumbar epidural block, occasional unintentional penetration of the subarachnoid
space by the catheter may occur. Subsequent adverse effects may depend partially
on the amount of drug administered subdurally. These
may include spinal block of varying magnitude (including total spinal block),
hypotension secondary to spinal block, loss of bladder and bowel control,
and loss of perineal sensation and sexual function. Persistent motor, sensory
and/or autonomic (sphincter control) deficit of some lower spinal segments
with slow recovery(several months) or incomplete recovery have been reported
in rare instances when caudal or lumbar epidural block has been attempted.
Backache and headache have also been noted following use of these anesthetic
procedures. There have been reported cases of permanent
injury to extraocular muscles requiring surgical repair following retrobulbar
administration.
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LIDOCAINE HYDROCHLORIDE INJECTION, FOR INFILTRATION AND NERVE
BLOCK, SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS
AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES THAT MIGHT
ARISE FROM THE BLOCK TO BE EMPLOYED AND THEN ONLY AFTER ENSURING THE IMMEDIATE AVAILABILITYOF OXYGEN, OTHER RESUSCITATIVE
DRUGS, CARDIOPULMONARY EQUIPMENT, AND THE PERSONNEL NEEDED FOR PROPER MANAGEMENT
OF TOXIC REACTIONS AND RELATED EMERGENCIES (See also ADVERSE REACTIONS and
PRECAUTIONS). DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION
FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS,
CARDIAC ARREST AND, POSSIBLY, DEATH. To avoid intravascular
injection, aspiration should be performed before the local anesthetic solution
is injected. The needle must be repositioned until no return of blood can
be elicited by aspiration. Note, however, that the absence of blood in the
syringe does not guarantee that intravascular injection has been avoided. Local
anesthetic solutions containing antimicrobial preservatives (e.g., methylparaben)
should not be used for epidural or spinal anesthesia because the safety of
these agents has not been established with regard to intrathecal injection,
either intentional or accidental.
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Lidocaine Hydrochloride Injection, USP is indicated for production
of local or regional anesthesia by infiltration techniques such as percutaneous
injection and intravenous regional anesthesia by peripheral nerve block techniques
such as brachial plexus and intercostal and by central neural techniques such
as lumbar and caudal epidural blocks, when the accepted procedures for these
techniques as described in standard textbooks are observed.
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Lidocaine Hydrochloride
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