Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2063
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Lidocaine Hydrochloride (Spray)
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When Lidocaine Hydrochloride Topical Solution, USP is used
concomitantly with other products containing lidocaine, the total dose contributed
by all formulations must be kept in mind. The dosage
varies and depends upon the area to be anesthetized, vascularity of the tissues,
individual tolerance and the technique of anesthesia. The lowest dosage needed
to provide effective anesthesia should be administered. Dosages should be
reduced for children and for elderly and debilitated patients. Although
the incidence of adverse effects with Lidocaine Hydrochloride Topical Solution,
USP is quite low, caution should be exercised, particularly when employing
large volumes and concentrations of Lidocaine Hydrochloride Topical Solution,
USP since the incidence of adverse effects is directly proportional to the
total dose of local anesthetic agent administered. For specific techniques
and procedures refer to standard textbooks. The dosages
below are for normal, healthy adults. TOPICAL
APPLICATION: For laryngoscopy, bronchoscopy and endotracheal intubation,
the pharynx may be sprayed with 1���5 mL (40���200 mg of lidocaine
HCl), i.e., 0.6���3 mg/kg or 0.3���1.5 mg/lb body weight. For
local anesthesia by the transtracheal route, it may be occasionally necessary
to spray the pharynx by oropharyngeal spray to achieve complete analgesia. MAXIMUM RECOMMENDED DOSAGES Normal Healthy Adults: The maximum recommended
dose of Lidocaine Hydrochloride Topical Solution, USP should be such that
the dose of lidocaine HCl is kept below 300 mg and in any case should not
exceed 4.5 mg/kg (2 mg/lb) body weight. 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 of less than
ten years who have a normal lean body mass and normal body development, the
maximum dose may be determined by the application of one of the standard pediatric
drug formulas (e.g., Clark's rule). For example, in a child of five
years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed
75���100 mg when calculated according to Clark's rule. In any
case, the maximum dose of lidocaine with epinephrine should not exceed 7 mg/kg
(3.2 mg/lb) of body weight. When used without epinephrine, the amount of lidocaine
administered should be such that the dose of lidocaine is kept below 300 mg
and in any case should not exceed 4.5 mg/kg (2 mg/lb) of body weight. Directions for Use USE ASEPTIC TECHNIQUE IMPORTANT: Use of the kit requires strict observance
of precautions appropriate to use of topical anesthesia in the respiratory
tract. (See Drug Information Section) For
Use Prior to Intubation During Anesthesia Induction (Unconscious Patient): For Use in Endoscopic Procedures
to Supplement Initial Atomizer Spray of Local Anesthetic (Conscious Patient):
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The LTA Kits are sterile disposable kits for producing rapid,
effective topical anesthesia of the interior of the larynx and trachea. Each
kit contains (1) a sterile, anatomically-curved plastic cannula with attached
vial injector, and (2) a single-use vial prefilled with 4 mL of a 4% sterile
aqueous solution of Lidocaine Hydrochloride Topical Solution, USP for adults
or 5 mL of a 2% sterile aqueous solution for children. The
LTA 360 Kit is preattached and distributes anesthetic in a circumferential
spray pattern. The LTA II Kit and the Pediatric LTA Kit are not preattached
and distribute anesthetic in a longitudinal spray pattern. Contents of each
kit are sterile in intact unit package. The kit is designed for one-time use
only. After use, it should be discarded without disassembly. USE The kit is used
to instill a jet spray of lidocaine hydrochloride solution into the interior
of the larynx and trachea for local anesthesia in the unconscious patient
just prior to endotracheal intubation. This form of application also is effective
as a final stage of topical anesthesia in the conscious patient (after initial
use of an atomizer spray or other appropriate technique for applying topicalanesthetic to the pharynx and epiglottis) prior to laryngeal or tracheobronchial
endoscopic procedures. Drug
Information
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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. Onset and Duration
of Anesthesia: The onset of action is rapid. Hemodynamics: Excessive blood levels may cause
changes in cardiac output, total peripheral resistance, and mean arterial
pressure. These changes may be attributable to a direct depressant effect
of the local anesthetic agent on various components of the cardiovascular
system. The net effect is normally a modest hypotension when the recommended
dosages are not exceeded. Pharmacokinetics
and Metabolism: Information derived from other formulations, concentrations
and usages reveals that lidocaine is completely absorbed following parenteral
administration, its rate of absorption depending, for example, upon such factors
such as the site of administration and the presence or absence of a vasoconstrictor
agent. Lidocaine may be absorbed following topical administration to mucous
membranes, its rate and extent of absorption depending upon concentration
and total dose administered, the specific siteof application and duration
of exposure. In general, the rate of absorption of local anesthetic agents
following topical application occurs most rapidly after intratracheal administration.
Lidocaine is also well absorbed from the gastrointestinal tract, but littleintact drug appears in the circulation because of biotransformation by the
liver. 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. Studies
have shown that peak blood levels of lidocaine may occur as early as 5 and
as late as 30 minutes after endotracheal administration of a 4% lidocaine
HCl solution. 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. Studies
of lidocaine metabolism following intravenous bolus injections have shown
that the elimination half-life of this agent 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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The LTA Kits are supplied as follows: ���List 5648, Pediatric LTA Kit is not preattached and contains 5 mL of Lidocaine
Hydrochloride Topical Solution, USP 2% (20 mg/mL); ���List 4698, LTA 360 Kit is preattached and contains 4 mL of Lidocaine Hydrochloride
Topical Solution, USP 4% (40 mg/mL). ���List 1001,
LTA II Kit is not preattached and contains 4 mL of Lidocaine Hydrochloride
Topical Solution, USP 4% (40 mg/mL). Store at 20 to
25��C (68 to 77��F). [See USP Controlled Room Temperature.] 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.
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. 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 status. Lidocaine should also be used with caution in patients
with severe shock or heart block. 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 Hydrochloride Topical Solution should be used with
caution in patients with hepatic disease. Patients with
severe hepatic disease, because of their inability to metabolize local anesthetic
normally, are a greater risk of developing toxic plasma concentrations. Lidocaine
Hydrochloride Topical Solution 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
management 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 suspecttriggering agent(s) and institution of treatment, including
oxygen therapy, indicated supportive measures and dantrolene (consult dantrolene
sodium intravenous package insert before using). 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.<br/>Information for Patients:: When topical anesthetics are used in the mouth, the patient
should be aware that the production of topical anesthesia may impair swallowing
and thus enhance the danger of aspiration. For this reason, food should not
be ingested for 60 minutes following use of local anesthetic preparations
in the mouth or throat area. This is particularly important in children because
of their frequency of eating. Numbness of the tongue
or buccal mucosa may enhance the danger of unintentional biting trauma. Food
and chewing gum should not be taken while the mouth or throat area is anesthetized.<br/>Clinically Significant Drug Interactions:: The administration of local anesthetic solutions containing
epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors,
tricyclic antidepressants or phenothiazines may produce severe, prolonged
hypotension or hypertension. Concurrent use of these agents should generally
be avoided. In situations when concurrent therapy is necessary, careful patient
monitoring is essential.<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/>Use in 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:: Lidocaine is not contraindicated in labor and delivery. Should
Lidocaine Hydrochloride Topical Solution be used concomitantly with other
products containing lidocaine, the total dose contributed by all formulations
must be kept in mind.<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 children should be reduced, commensurate with
age and body weight. 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 solutions (see
ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS). Management of Local Anesthetic Emergencies: The
first consideration is prevention, best accomplished by careful and constant
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 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. 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
intravenous LDof lidocaine HCl in female mice is 26 (21���31)
mg/kg and the subcutaneous LDis 264 (203���304) mg/kg.
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Lidocaine Hydrochloride
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Lidocaine Hydrochloride (Spray)
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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 thefirst 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 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.
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LIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION 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 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. Lidocaine
Hydrochloride Topical Solution should be used with extreme caution if there
is sepsis or severely traumatized mucosa in the area of application, since
under such conditions there is the potential for rapid systemic absorption.
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Lidocaine Hydrochloride Topical Solution is
indicated for the production of topical anesthesia of the mucous membranes
of the respiratory tract.
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Lidocaine Hydrochloride
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