Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/707
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Lidocaine Hydrochloride and Epinephrine (Injection, Solution)
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Table I (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, USP 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, USP 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. Epidural Anesthesia For an epidural test dose, only the following available specific product of Lidocaine Hydrochloride
and Epinephrine Injection, USP by Hospira is recommended: 1.5%
with epinephrine 1:200,000������������������������������������������������..5
mL single-dose ampuls For epidural anesthesia, only
the following available specific
products of Lidocaine Hydrochloride and Epinephrine Injection, USP by Hospira
are recommended: 1% with epinephrine 1:200,000������������������������������������������������...30
mL single-dose ampuls 30 mL single-dose vials 1.5% with epinephrine
1:200,000������������������������������������������������30
mL single-dose ampuls 30 mL single-dose vials 2% with epinephrine
1:200,000���������������������������������������������������...20
mL single-dose vials 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 injection 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 and Epinephrine Injection, USP
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 solution 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 Adults: For normal healthy adults, the individual
maximum dose of Lidocaine Hydrochloride and Epinephrine Injection, USP 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 per 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). Pediatric Population: It is difficult to recommend
a maximum dose of any drug for pediatric patients, since this varies as a
function of age and weight. For pediatric patients 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). 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. FOR EPIDURAL USE ONLY. NOTE:
Parenteral drug products should be inspected visually for particulate matter
and discoloration prior to administration whenever the solution and container
permit. Do not use the injection if its color is pinkish or darker than slightly
yellow or if it contains a precipitate. *Dose determined by number of dermatomes to be anesthetized
(2 to 3 mL/ dermatome). 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 whichare injurious to rubber and, therefore, are not to be used.
It is recommended that chemical disinfection be accomplished by wiping the
vial stopper or ampul thoroughly with cotton or gauze that has been moistened
with the recommended alcohol just prior to use. Do not autoclave.
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Lidocaine Hydrochloride and Epinephrine Injection, USP is
a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine
in water for injection for parenteral administration in various concentrations
with characteristics as follows: Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous
0.2 mg/mL added as stabilizers. The headspace of Lists 1209, and 3179 are
carbon dioxide gassed and Lists 3177, 3178, 3181, 3182 and 3183 are nitrogen
gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH;
pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose
vials contain methylparaben 1 mg/mL added as preservative. Single-dose
ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused
portion. Lidocaine is a local anesthetic of the amide
type. Lidocaine Hydrochloride, USP is chemically designated
2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate,
a white powder freely soluble in water. It has the following structural formula: Epinephrine,
USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2
(methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It
has the following structural formula:
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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 and Epinephrine Injection, USP is
supplied in single-dose and multiple-dose containers as shown below: Store at controlled room temperature 15��to 30��C
(59��to 86��F) [See USP.] Protect
from light. June, 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 injection 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 a 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). Injections containing
epinephrine or other vasoconstrictors should not be used for intravenous regional
anesthesia. Lidocaine should be used with caution in
persons with known drug sensitivities. Patients allergic to para-amino-benzoic
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 oxytocic 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 arenot 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 ofobstetrical
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 possible advantages 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 under-ventilation 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,
small increments 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. Endotrachealintubation, 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 and Epinephrine
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Lidocaine Hydrochloride and Epinephrine (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, to bisulfites 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 fromthe 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 AND EPINEPHRINE INJECTION, USP 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 AVAILABILITY OF 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. Lidocaine Hydrochloride
and Epinephrine Injection contains sodium metabisulfite, a sulfite that may
cause allergic-type reactions including anaphylactic symptoms and life-threatening
or less severe asthmatic episodes in certain susceptible people. The overall
prevalence of sulfite sensitivity in the general population is unknown and
probably low. Sulfite sensitivity is seen more frequently in asthmatic than
in nonasthmatic people.
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Lidocaine Hydrochloride and Epinephrine Injection, USP is
indicated for production of local or regional anesthesia by infiltration techniques
such as percutaneous injection, by peripheral nerve block techniques such
as brachial plexus and intercostal and by central neural techniques such as
lumbar andcaudal epidural blocks, when the accepted procedures for these
techniques as described in standard textbooks are observed.
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Lidocaine Hydrochloride and Epinephrine
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