The safety and effectiveness of lidocaine depend on proper dosage, correct technique, adequate
precautions and readiness for emergencies. Consult standard textbooks 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. Repeated doses of lidocaine may cause significant increases in blood levels
with each repeated dose due to 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.
If sedatives are employed to reduce patient apprehension, reduced doses should be used since local
anesthetic agents, like sedatives, are central nervous system depressants which in combination may have
an additive effect. Young children should be given minimal doses of each agent.
Lidocaine should be used with caution in patients with severe shock or heart block. Lidocaine should
also be used with caution in patients with impaired cardiovascular function. Local anesthetic solutions
containing a vasoconstrictor should be used with caution 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
(such as exfoliating or ulcerating lesions) 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.
Cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient's state of
consciousness should be monitored after each local anesthetic injection. Restlessness, anxiety tinnitus,
dizziness, blurred vision, tremors, depression or drowsiness should alert the practitioner to the
possibility of central nervous system toxicity. Signs and symptoms of depressed cardiovascular
function may commonly result from a vasovagal reaction, particularly if the patient is in an upright
position : placing the patient in the recumbent position is recommended when an adverse response is
noted after injection of a local anesthetic (See ADVERSE REACTIONS - Cardiovascular
System ).Vasovagal reactions may elicit a range of clinical manifestations, from pre-syncope (e.g.,
lightheadedness, pallor, nausea, sweating, visual disturbances, weakness) to brief loss of consciousness
Lidocaine should be used with caution in patients with hepatic disease, since amide-type local
anesthetics are metabolized by the liver. Patients with severe hepatic disease, because of their inability
to metabolize local anesthetics normally, are at greater risk of developing toxic plasma concentrations.
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 suspected
triggering agent (s) and prompt treatment, including oxygen therapy, dantrolene (consult dantrolene
sodium intravenous package insert before using) and other supportive measures.
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 injeced 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, respiratony depression
and/or respiratory arrest, and cardiovascular stimulation or depression have been reported. These
reactions may be due to intra-arterial injection of the local anesthetic with retrograde 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).
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.
Concurrent administration of vasopressor drugs and ergot-type oxytocic drugs may cause severe,
persistent hypertension or cerebrovascular accidents.
As the LIGNOSPAN STANDARD and the LIGNOSPAN FORTE solutions both contain a
vasoconstrictor (epinephrine), concurrent use of either with a Beta-adrenergic blocking agent
(propranolol, timolol, etc.) may result in dose-dependent hypertension and bradycardia with possible
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.
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
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.
Dosages in pediatric population should be reduced, commensurate with age, body weight and physical
condition (See DOSAGE AND ADMINISTRATION).