Israel - English - Ministry of Health
INTRAVENOUS INJECTION FOR CARDIAC ARRHYTHMIAS
Each ampoule of 10ml contains:
Lidocaine hydrochloride 1% or2% (Lignocaine hydrochloride)
in an isotonic sodiumchloride solution without preservatives.
Lidocaine controls ventricular arrhythmias by suppressing automaticityin the His-Purkinje system
and by suppressing spontaneous depolarization of the ventriclesduring diastole. These effects
occur at lidocaine concentrations (therapeuticdosage) that do not suppress automaticity of the
sinoatrial (SA) node. At therapeutic plasmaconcentrations, lidocainehas little effect on
atrioventricular (AV) node conduction and His-Purkinje conduction inthe normal heart. The
specialized conducting tissues of theatria are less sensitive to the effects of lidocaine than those of
ventricular tissues. Lidocaine hasa variable effect on the effective refractory period (ERP) of the
AV node; the drug shortens the ERP and the action potential duration of the His-Purkinje system.
Lidocaine does not appear to affectexcitability ofnormal cardiac tissue.
Lidocaine ismetabolizedin the liver and excreted via the kidneys.
Lidocaine plasmaconcentrations of approximately 1.5-6mcg base/ml are required to suppress
ventricular arrhythmias. Plasmalevels above 6 mcg/mlresult in increased toxicity.
Acute management of ventricular arrhythmias occurring during cardiac manipulation, such as in
cardiac surgery and in life-threatening arrhythmias which are ventricular in origin, i.e. as occur
during acute myocardial infarction.
Lidocaine hydrochloride is contraindicated in patients with a known historyof hypersensitivity to
local anesthetics of the amide type. It should not be used in patients with Stokes-Adams syndrome,
Wolf-Parkinson-White syndrome, orin severedegrees of sinoatrial,atrioventricular or
intraventricular block in the absence ofan artificial pacemaker.
This preparation is intended for use as a bolus injection by the intravenous route only. Prior dilution
is required when using this preparation for intravenous infusion (see Dosage and Administration).
In order to manage possible adverse reactions, resuscitative equipment and drugs, including
oxygen, should be immediately available when lidocaine hydrochloride injections are used. CNS
depression (sedation) or irritability (twitching) may progress tofrank convulsions accompanied by
respiratory depression and/or arrest.
Should convulsions persist despite ventilatorytherapy with oxygen, small increments of
anticonvulsant drugs may be administered intravenously. Such agents include diazepam, thiopental,
thiamylal or pentobarbital. Ifthe patient is under anesthesia,a short-acting relaxant (e.g.
succinylcholine) may be used. Longer-actingdrugs should be used only when recurrent
convulsions are evidenced. Shouldcirculatory depression occur,vasopressors may be used.
Constant electrocardiographic monitoring is essential to the proper administration of lidocaine
hydrochloride bolus injection. Signsof excessive depression of cardiacelectrical activity such as
sinus node dysfunction, prolongation of the P-R interval and QRS complex or the appearance or
aggravation of arrhythmias, should be followedby flow adjustment and if necessary, prompt
cessation of the intravenous infusionof this agent. Occasionally, acceleration of ventricular rate
may occur when lidocaine bolus injection is administered to patients with atrial flutter or
Prophylactic single dose lidocaine administered in a monitored environment does not appear to
affect mortality in the earliest phase ofacute MI,and may harmsomepatients who are later shown
not to have suffered an acute MI.
Use in Pregnancy
Safe use has not been established. Lidocaine hydrochloride should not be used in women of
childbearing potential, particularlyduring early pregnancy, unless, inthe opinion of the clinician,
the potential benefits outweigh the unknown hazards.
Use in Labor and Delivery
The effects on the mother and the fetus in the management of cardiac arrhythmias during labor and
delivery are not known. Lidocaine hydrochloride readily crosses the placental barrier.
Use in Breastfeeding
It is not known whether this drug is excretedin human milk. However, because many drugs are
excreted in human milk, it is recommended thatnursing be discontinued when lidocaine is
Use in Pediatrics
Safety of use of this drug inchildren has not been established.
Amide local anesthetic administration has beenassociated with acute onset of fulminant
hypermetabolismof skeletal muscle known as malignanthyperthermic crisis. Recognition of early
unexplained signs of tachycardia, tachypnea, labile blood pressure and metabolic acidosis may
precede temperature elevation. Successfuloutcomedepends on early diagnosis, prompt
discontinuance of the triggering agent and institution of treatment, including oxygen, supportive
measures and IV dantrolene sodium(see individual monograph).
The safety ofamide local anestheticsin patients with genetic predisposition of malignant
hyperthermia has not been fully assessed; use lidocaine with caution insuch patients. In hospitals
where triggering agents for malignant hyperthermia are administered, a standard protocol for
managementshould be available.
Constant ECG monitoring
Constant ECG monitoring is essential for the properadministration of IV lidocaine hydrochloride.
Signs of excessive depression of cardiac conductivity, such as prolongationof the PR and the QRS
complex and the appearance of arrhythmias, shouldlead to the prompt cessation of the IV infusion.
Emergency resuscitive equipment
It is mandatory to have emergency resuscitive equipment and drugs immediately available to
manage possible adverse reactionsinvolving the cardiovascular, respiratory or central nervous
Adverse reaction may result fromhigh plasmalevels caused by excessive dosage, or from
hypersensitivity, idiosyncrasy or diminished tolerance on the partof the patient. Serious adverse
experiences are generally systemic in nature. The following types are those commonly reported.
The CNS and cardiovascular adverse experiences are listed, in general, in aprogression frommild
Serious adverse reactions to lidocaine are uncommon. Adverse effects of the drug mainly involve
the CNS. They are usually ofshort duration and are dose related.
Central Nervous System
Manifested by drowsiness, dizziness, disorientation, confusion, lightheadedness, tremulousness,
psychosis, nervousness, apprehension, agitation, euphoria, tinnitus, visual disturbances including
blurred ordouble vision, nausea, vomiting, paresthesia, sensations of heat, cold ornumbness,
difficulty in swallowing, dyspnea and slurred speech. Muscle twitching or tremors, seizures,
unconsciousness, comaand respiratory depression and arrest may also occur.
Although usual doses of lidocainegenerally have no adverse cardiovascular effects, patients with
high plasmaconcentrations of the drug orwith myocardial conduction defects may develop
hypotension, arrhythmias, heart block, cardiovascular collapse andbradycardia which may lead to
Hypersensitivity to lidocaine israre and may be characterized by skin lesions, urticaria, edema and
anaphylactoid reactions. No cross-sensitivtyhas been reported between lidocaine and
procainamide or quinidine.
Caution should be taken with the repeated use oflidocaine hydrochloride in patients with severe
liver or kidney disease, in patients with hypovolemia, shock, or any formof heart block. In patients
with sinus bradycardia or incomplete heart block,the administration of lidocaine hydrochloride I.V.
or the elimination of ventricular ectopic beatswithout prior acceleration in heart rate (e.g. by,
atropine, isoproterenole or by electric pacing) may produce more frequent and serious ventricular
arrhythmias or complete heart block.
Lactation: In a single case report,lidocaine was excreted into breast milk at concentrations 40% of
serumlevels. At this level, an infant might ingest up to 1.5 mg, a very small amount that would not
be expected to lead to significant accumulation. However, exercise caution when administering to
a nursing woman.
Children:Safety and efficacy have not been established;reduce dosage. The IM autoinjector
device is not recommended in children < 50 kg (110 lbs).
Care should be observed in patients suffering from epilepsy.
Lidocaine/Anticonvulsants/or benzodiazepines/or barbiturates: May lower plasmalevels of
lidocaine when used concomitantly.
Lidocaine/Beta-adrenoreceptor blocking agents: Co-administration ofbeta-blockers may reduce
the plasmaclearance of lidocaine;possibly enhancing its toxicity.
Lidocaine/Cimetidine:Combined use results in increased plasmaconcentrations of lidocaine and,
thus, enhanced toxicity.
Lidocaine/Disopyramide: Very high doses of lidocaine and disopyramide were reported, in one
case to prolong the Q-T interval and to produce atrioventricular block andventricular fibrillation.
Lidocaine/Muscle relaxants: The neuro-blocking effect of succinylcholine is increased by high
I.V. doses of lidocaine.
Lidocaine/Phenytoin: Concurrent use yields a high incidence of CNS toxicity. Sino-atrial arrest
occurred in one case with heart block when both drugs were given intravenously.
Lidocaine/Procainamide/Quinidine: Concurrent use is synergistic.
Isoprenaline increases total bodyclearance of lidocaine. Noradrenaline has the opposite effect.
Because IM injection of lidocainemay increase serumcreatinine phosphokinase (CPK)
concentrations, isoenzyme separation is necessary when CPK determinations are usedin the
diagnosis of acute myocardial infarction in patients receiving the drug IM.
Dosage and Administration
Single Intravenous Injection (Bolus Injection)
The usual dose is 50-100mg administered INTRAVENOUSLY , under ECG monitoring, at a rate of
Sufficient timeshould be allowed toenable a slow circulation to carry the drug to itssite of action.
If the above initial injectionof 50-100mgdoes not produce a desired response, a second dose may
be repeated after 5 minutes.
NOTE: No more than 200-300mg oflidocaine hydrochloride shouldbe administered during a one-
Continuous Intravenus Infusion
The I.V. bolus is only used to establish rapid therapeutic levels. A I.V. continuous infusion is used
to maintain therapeutic levels. An infusion solution should be prepared using 5% dextrose in
water. This solution is stable for a minimum of 24 hours at roomtemperature.
Reactions due to overdosage are systemic and involve the central nervous and cardiovascular
systems. Nervousness, dizziness, blurred visionor tremors may occur followed by drowsiness,
convulsions, unconsciousness andpossibly respiratory arrest.
Reactions involving the cardiovascular systeminclude depression of the myocardium, hypotension,
bradycardia and even cardiac arrest.
In the treatment of CNS and cardiovascular reactions, generalphysiological supportive measures,
such as maintenance of an adequate airway,oxygen uptake and carbon dioxide removal should be
Administration of oxygen and assistedrespiration may be sufficientto control anoxia in patients
with convulsions, and avoids thehazards associated with the administration of CNS depressant
drugs. For control of severe convulsions, slow I.V.infusion of diazepam or an ultra-short or short-
acting barbiturate has been recommended. If these are not available, a short-acting muscle relaxant
(succinylcholine) together withoxygen may be used. If circulatory depression occurs, administer
vasopressors and, if necessary, institute CPR.
Lidocaine hydrochloride injections orsolutionsshould be stored at roomtemperature; freezing
should be avoided.
Esracain Injection 1%: 50 ampoules of 10ml.
Esracain Injection 2%: 50 ampoules of 10ml.
The formatandcontent ofthisdocument have beenapprovedbythe MinistryofHealthinNovember 2006.
Rafa Laboratories, POB 405, Jerusalem91003, tel: 02-5893939, fax: 02-5870282
AMPOULES FOR LOCAL ANESTHESIA
1% or 2% Lidocaine Hydrochloride (Lignocaine HCl) in an isotonic sodium chloride
solution. Contains no antibacterial preservatives.
Lidocaine hydrochloride stabilizes the neuronal membrane and prevents the initiation
and conduction of nerve impulses thereby effecting local anesthetic action. Lidocaine
hydrochloride is metabolized mainly in the liver and excreted via the kidneys, mainly
in the form of various metabolites.
Lidocaine hydrochloride solutions are indicated for the production of local or regional
anesthesia by infiltration techniques, including percutaneous and intravenous regional
anesthesia; by peripheral nerve block techniques, such as brachial plexus and
intercostal blocks; and by central neural techniques, including epidural and caudal
Lidocaine hydrochloride is contraindicated in patients with a known history of
hypersensitivity to local anesthetics of the amide type.
“Local anesthetics” are contraindicated in patients with myasthenia gravis, severe
shock or impaired cardiac conduction. Lidocaine hydrochloride is also
contraindicated by any route when the area or site of injection is infected or inflamed
and it should be used with extreme caution in patients with skin infections anywhere
on the body.
Contraindications to epidural (including caudal) anesthesia include serious diseases of
the CNS or of the spinal cord such as meningitis, spinal fluid block, cranial or spinal
hemorrhage, tumors, poliomyelitis, syphilis and tuberculosis.
Other contraindications include: spinal deformities, arteriosclerosis, occlusive arterial
disease, pernicious anemia with spinal cord involvement, severe anemia, cachexia or
moribund condition, septicemia, bowel obstruction, chronic backache, preoperative
headaches of long duration or history of migraine, high or low blood pressure and
emotional instability, hysteria or nervous tension.
Use in Pregnancy
Safe use in pregnancy has not been established. Lidocaine hydrochloride should not
be used during early pregnancy unless, in the opinion of the clinician, the potential
benefits outweigh the unknown hazards. This does not exclude the use of this drug at
term for obstetrical analgesia.
Use in Labor and Delivery
Local anesthetics rapidly cross the placenta and when used for epidural, paracervical,
pudendal or caudal block anesthesia, they can cause varying degrees of maternal, fetal
and neonatal toxicity. 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
Material 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.
Fetal bradycardia frequently follows paracervical block and may be associated with
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
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 monitoried during paracervical anesthesia. The physician
should weigh the possible advantages against risks when considering a 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.
Use in Breastfeeding
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.
Lidocaine 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 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,
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
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
Use in Pediatrics
Dosage in children should be reduced in accordance with age, body weight and
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 manifestations are usually depressant and are characterized by
bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac
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 the
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.
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; 3 percent for
shivering; and less than 1 percent each for peripheral nerve symptoms, nausea,
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 have 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.
The lowest dosage that results in effective anesthesia should be used. 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.
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.
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
Lidocaine solutions should be used with caution in patients with digitalis toxicity
accompanied by atrioventricular block.
Debilitated, elderly patients, acutely ill patients and children should be given reduced
doses, in accordance with their age and physical status.
Lidocaine hydrochloride should be used with caution in patients with severe shock or
impaired cardiac conduction.
Epidural anesthesia and caudal anesthesia should be used with extreme caution in
conditions such as those existing in neurological disease, spinal deformities,
septicemia, severe hypertension and in the extremely young.
Lidocaine hydrochloride should be used with caution in patients with known drug
sensitivity. Caution is recommended when local amide-anesthetics are used in patients
with malignant hyperthermia. 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).
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.
Local anesthetic procedures should be used with caution when there is inflammation
and/or sepsis in the region of the proposed injection. Patients with cardiac disease,
hyperthyroidism, or other endocrine diseases may be particularly susceptible to the
toxic effects of “local anesthetics”.
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 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. Dosage recommendations should not be exceeded. (See Dosage and
Vasopressor agents (administered for the treatment of hypotension related to caudal or
other epidural blocks) should be used with caution in the presence of oxytocic drugs,
as a severe persistent hypertension and even rupture of cerebral blood vessels may
Both the pharmacologic and toxic effects of Lidocaine hydrochloride may be
increased (e.g. dysphoric sensations, circumoral and digital paresthesias, lethargy,
The CNS toxicity (delirium) of both drugs may be increased.
The neuromuscular blocking effects of succinylcholine may be increased. Prolonged
respiratory depression with extended periods of apnea may occur. The effects of this
interaction are dependent upon the dose of Lidocaine HCl.
Lidocaine/Beta-adrenoreceptor blocking agents
: Co-administration of
may reduce the plasma clearence of lidocaine; possibly enhancing its toxicity.
Isoprenaline increases total body clearance of lidocaine. Noradrenaline has the
In one study serum creatinine phosphokinase was sevenfold elevated following IM
lidocaine administration in healthy subjects.
Dosage and Administration
Proper technique is inherent to the safe use of lidocaine hydrochloride. It should be
injected slowly and with frequent aspiration to guard against intravascular injection.
The injection should be terminated if toxic effects appear.
The following table summarizes the recommended volumes and concentrations of
lidocaine hydrochloride solutions for various types of anesthetic procedures.
The dosages suggested in this table are for normal, healthy adults and refer to
epinephrine free solutions. These recommended dosages serve only as a guide to the
amount of anesthetic required for most routine procedures.
The actual volume and concentrations to be used depend on a number of factors, such
as the type and extent of the surgical procedure, degree of muscular relaxation
required, duration of anesthesia required and the physical state of the patient. The
lowest concentration and smallest dose that will produce the desired result should be
The onset and duration of anesthesia and the degree of muscular relaxation (and
appearance of adverse reactions) are proportional to the volume and concentration of
local anesthetic injection used.
LIDOCAINE HCL (without epinephrine and bacteriostatic agents)
0.5 or 1.0
Peripheral Nerve Blocks
Pudental (each side)
Obstetrical analgesia (each side)
Sympathetic Nerve Block
Cervical (stillate ganglion)
Central Nerve Blocks
dose determined by number of dermatomes to be anesthetized (2-3 mg/dermatome)
Note: a test dose of 2 ml should be administered at least 5 minutes prior to injecting
the total required volume for central neural blocks (epidural or caudal anesthesia).
Maximum Recommended Dose for Normal Healthy Adults
The individual dose of a Lidocaine hydrochloride solution, when used without
epinephrine, should be such that it is kept below 300 mg and, in any case, should not
exceed 4.5 mg/kg body weight.
For continuous epidural or caudal anesthesia, the maximum recommended dosage
should not be administered at intervals of less than 90 minutes.
For paracervical block for obstetrical analgesia (including abortion), the maximum
recommended dosage (200mg) should not be administered at intervals of less than 90
For I.V. regional anesthesia in adults (using 0.5% lidocaine hydrochloride solution
without epinephrine), the dose should not exceed 4mg/kg of body weight.
Maximum Recommended Dose for Children
The maximum dose for children varies as a function of age and weight.
The amount of lidocaine hydrochloride solution should not exceed 4.5mg/kg of body
weight. The use of 0.5% or 1.0% solutions is recommended for most anesthetic
procedures. More dilute injections of 0.25-0.5% and total dosages not exceeding
3mg/kg are recommended for the induction of I.V. regional anesthesia in children.
Toxic cardiovascular reactions to local anesthetics are usually depressant in nature,
and are characterized by peripheral vasodilation, hypotension, myocardial depression,
bradycardia and possible cardiac arrest.
Treatment consists in assuring and maintaining a patent airway, supporting ventilation
with oxygen, and assisting or controlling respiration.
Should a convulsion persist, small increments of anticonvulsive agents may be
administered intravenously, (e.g. diazepam), ultra short-acting barbiturates (e.g.
thiopental or thiamylal) or a short acting barbiturate (e.g. pentobarbital or
Cardiovascular depression may require circulatory assistance (unit IV fluids and/or
vasopressors (e.g. ephedrine), as dictated by the clinical situation).
Lidocaine hydrochloride injections or solutions should be stored at room temperature.
Do not freeze.
Esracain Injection 1%: 50 ampoules of 10 ml or 5 ml.
Esracain Injection 2%: 50 ampoules of 10 ml or 5 ml.
Esracain Injection 1%:
019 20 21029 00
Esracain Injection 2%:
020 82 21028 00
Rafa Laboratories, POB 405, Jerusalem 91003,
The format and content of this document have been approved by the Ministry of Health in Junuary 2007.