Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3294
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Lidocaine Hydrochloride and Dextrose (Injection, Solution)
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A 0.4% or 0.8% solution of Lidocaine Hydrochloride and 5%
Dextrose Injection, USP is not suitable for bolus administration and is to
be used only for infusion following appropriate bolus administration. IN
THE ADULT PATIENT, DOSAGE SHOULD BE LIMITED TO NO MORE THAN 200 TO 300
MG OF LIDOCAINE ADMINISTERED DURING A ONE-HOUR PERIOD. Patients
with reduced hepatic function or diminished hepatic blood flow (as in heart
failure and after cardiac surgery), or those over 70 years of age, should
receive half the usual loading dose and also should be given lower maintenance
levels of intravenous lidocaine. Patients over 65 years may benefit from dosing
based upon body weight. For continuous intravenous infusion, in patients whose arrhythmia tends to recur following a temporary response to a single or once repeated direct injection and who are incapable of receiving oral antiarrhythmic therapy, lidocaine hydrochloride may be infused continuously in a concentration of 0.4% (4 mg/mL) or 0.8% (8 mg/mL) at a rate of 1 to 4 mg (0.25 to 1 mL of 0.4% or 0.125 to0.5 mL of 0.8%) per minute (20 to 50 micrograms/kg/minute) in the average 70 kg adult. I.V. infusion of the drug must be administered under constant ECG monitoring to avoid potential overdosage and toxicity. I.V. infusion should be terminated as soon as the patient's basic cardiac rhythm appears to be stable or at the earliest signs of toxicity. As soon as possible, and when indicated, patients should be changed to an oral antiarrhythmic agent for maintenance therapy. Prolonged (24 hour) infusion
of the drug also appears to result in a longer half-life and reduced rate
of clearance (even in patients without cardiac or hepatic failure) that may
result in toxic accumulation of lidocaine in the plasma. After the first
24 hours, the rate of infusion of lidocaine should be reduced by about one-half
to compensate for the drop in the rate of elimination of the drug. When
administering lidocaine hydrochloride (or any potent medication) by continuous
intravenous infusion, it is advisable to use a precision volume control I.V.
set. Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to administration, whenever
solution and container permit. See PRECAUTIONS.
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| dailymed-instance:descripti... |
0.4% and 0.8% Lidocaine Hydrochloride and 5% Dextrose Injection,
USP are sterile, nonpyrogenic solutions of lidocaine hydrochloride and 5%
Dextrose Injection, USP for use in the management of ventricular arrhythmias. Each
100 mL contains lidocaine hydrochloride, anhydrous 400 mg (4 mg/mL) or 800
mg (8 mg/mL) and dextrose hydrous 5 g in water for injection. The osmolarity
of the solutions is 282 and 311 mOsmol/liter (calc.) respectively. May
contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH 4.0
(3.0���5.5). The solution contains no bacteriostatic,
antimicrobial agent or added buffer (except for pH adjustment) and is intended
only for use as a single-dose administration. When smaller doses are required,
the unused portion should be discarded. Lidocaine administered
intravenously is a cardiac antiarrhythmic agent. Lidocaine
Hydrochloride, USP is chemically designated 2(diethylamino)2', 6'-acetoxylidide
monohydrochloride monohydrate, a white powder freely soluble in water. It
has the following structural formula: Dextrose,
USP is chemically designated D-glucose monohydrate (CHO���HO), a hexose sugar freely soluble in water. It has the following
structural formula: Water for Injection, USP is chemically
designated HO. The flexible plastic container
is fabricated from a specially formulated polyvinylchloride. Water can permeate
from inside the container into the overwrap but not in amounts sufficient
to affect the solution significantly. Solutions inside the plastic container
also can leach out certain of its chemical components in very small amounts
before the expiration period is attained. However, the safety of the plastic
has been confirmed by tests in animals according to USP biological standards
for plastic containers.
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Intravenous injection of lidocaine hydrochloride produces
very rapid antiarrhythmic actions. The antiarrhythmic effect quickly decreases
once the infusion is stopped. Thus, ventricular ectopic activity can be titrated
from one moment to the next. Lidocaine reportedly exerts
a cardiac antiarrhythmic effect by increasing the electrical stimulation threshold
of the ventricle during diastole. At usual doses, lidocaine produces no change
in myocardial contractility, in systemic arterial pressure or in absolute
refractory period. About 90% of an administered dose
of the drug is metabolized in the liver. The remaining 10% is excreted unchanged
in the urine. Toxicity is related to lidocaine blood
levels. The decreased clearance and longer half-life of lidocaine should be
taken into consideration with prolonged (24 hour) infusions. Constant rate
of infusion may result in toxic accumulation of lidocaine. Infusion should
be reduced to approximately one half to compensate for decreased rate of clearance
and concomitant or prior administration of propranolol may further increase
blood concentrations by as much as 30% in patients without cardiac or hepatic
failure. In clinical studies, patients over 65 years showed decreased lidocaine
clearance. This was partly due to the tendency of elderly patients to have
lower body weight and the increased risk of cardiac failure in these patients. Solutions
containing carbohydrate in the form of dextrose restore blood glucose levels
and provide calories. Carbohydrate in the form of dextrose may aid in minimizing
liver glycogen depletion and exerts a protein-sparing action. Dextrose injected
parenterally undergoes oxidation to carbon dioxide and water. Water
is an essential constituent of all body tissues and accounts for approximately
70% of total body weight. Average normal adult daily requirements range from
two to three liters (1 to 1.5 liters each for insensible water loss by perspiration
and urine production). Water balance is maintained by
various regulatory mechanisms. Water distribution depends primarily on the
concentration of electrolytes in the body compartments and sodium (Na)
plays a major role in maintaining physiologic equilibrium.
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Lidocaine is contraindicated in patients with a known hypersensitivity
to local anesthetics of the amide type. Administration of lidocaine is contraindicated
in patients with Adams-Stokes syndrome or with severe degrees of sinoatrial,
atrioventricular or intraventricular heart block. Dextrose
solutions without electrolytes should not be administered simultaneously with
blood through the same infusion set because of the possibility that pseudoagglutination
of red cells may occur.
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0.4% Lidocaine Hydrochloride and 5% Dextrose Injection, USP
(List No. 7931) is supplied in single-dose 250 and 500 mL flexible containers.
0.8% Lidocaine Hydrochloride and 5% Dextrose Injection, USP (List No. 7939)
is supplied in single-dose 250 mL flexible containers. Exposure
of pharmaceutical products to heat should be minimized. Avoid excessive heat.
Protect from freezing. It is recommended that the product be stored at room
temperature (25��C); however, brief exposure up to 40��C does not
adversely affect the product. Revised: September, 2004 HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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The safe use of lidocaine requires careful electrocardiographic
(ECG) observation in an environment and by persons capable of resuscitation. Caution
should be exercised with repeated use of lidocaine in patients with severe
liver or renal disease because accumulation may lead to toxic phenomena, since
the drug is metabolized mainly in the liver and partially excreted unchanged
by the kidney. In patients with cardiac or hepatic failure, the rate of lidocaine
clearance may be decreased. Prolonged (24 hour) infusion of the drug also
appears to result in a longer half-life and reduced rate of clearance (even
in patients without cardiac or hepatic failure) that may resultin toxic accumulation
of lidocaine in the plasma. After the first 24 hours, the rate of infusion
of lidocaine should be reduced by about one-half to compensate for the drop
in the rate of elimination of the drug. Miscellaneous: Amide local anesthetic administration may be associated with acute
onset of fulminant hypermetabolism of skeletal muscle known as malignant hyperthermic
crisis. Key to successful outcome of fulminant hypermetabolism is early recognition
of premonitory signs, i.e., tachycardia and increased metabolic rate as evidenced
by respiratory and/or metabolic acidosis. Treatment includes administration
of oxygen and discontinuation of infusion and, where necessary, intravenous
administration of dantrolene sodium. For additional information on management
see prescribing information of dantrolene sodium. In
patients with sinus bradycardia the intravenous administration of lidocaine
for the elimination of ventricular ectopic beats without prior acceleration
in heart rate (e.g., by isoproterenol or by electric pacing) may provoke more
frequent and serious ventricular arrhythmias. Clinical
evaluation and periodic laboratory determinations are necessary to monitor
changes in fluid balance, electrolyte concentrations and acid-base balance
during prolonged parenteral therapy or whenever the condition of the patient
warrants such evaluation. Solutions containing dextrose
should be used with caution in patients with known subclinical or overt diabetes
mellitus. Do not administer unless solution is clear
and container is undamaged. Discard unused portion.<br/>Pregnancy Category B.: Reproduction studies have been performed in rats at doses
up to 5 times the human dose and have revealed no evidence of impaired fertility
or harm to the fetus due to lidocaine hydrochloride. There are, however, no
adequate well-controlled studies in pregnant women. Because animal reproduction
studies are not always predictive of human response, this drug should be used
during pregnancy only if clearly needed.<br/>Pediatric Use:: The safety and effectiveness of lidocaine has not been established
in pediatric patients (neonates to adolescents).<br/>Geriatric Use:: Clinical studies of Lidocaine HCl did not include sufficient
numbers of subjects aged 65 and over to determine whether they respond differently
from younger subjects. Lidocaine is substantially excreted by the kidney and
clearance of lidocaine is decreased in the elderly (see CLINICAL PHARMACOLOGY).
In general, dose selection for an elderly patient should be cautious, usually
starting at the low end of the dosing range, reflecting the greater frequency
of decreased renal or cardiac function, and of concomitant disease or other
drug therapy.<br/>Drug Interactions: Lidocaine should be used with caution in patients with digitalis
toxicity accompanied by atrioventricular block. Coadministration of propranolol
with lidocaine has been reported to reduce the clearance of lidocaine from
the plasma and may result in toxic accumulation of the drug. When
lidocaine is administered with other antiarrhythmic drugs such as phenytoin,
procainamide, propranolol or quinidine, the cardiac effects may be additive
or antagonistic and toxic effects may be additive. Phenytoin may stimulate
the hepatic metabolism of lidocaine, but the clinical significance of this
effect is not known.
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Reported adverse reactions are due to drug overdosage. SeeADVERSE REACTIONS section. For management of overdosage, see MANAGEMENT OF
ADVERSE REACTIONS section.
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Lidocaine Hydrochloride and Dextrose
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Lidocaine Hydrochloride and Dextrose (Injection, Solution)
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Adverse reactions are the result of systemic toxicity which
affects primarily the central nervous system and the cardiovascular system. Systemic
reactions of the following types have been reported: Allergic reactions are rare and may occur as a result of
sensitivity to lidocaine and are characterized by cutaneous lesions of delayed
onset, urticaria, edema or anaphylactoid symptoms. The detection of sensitivity
by skin testing is of limited value. There have been
no reports of cross-sensitivity between lidocaine and procainamide or between
lidocaine and quinidine. Other reactions which may occur
because of the solutions or technique of administration include febrile response
(see PRECAUTIONS section on hyperthermia), infection at the site of injection,
venous thrombosis or phlebitis extending from the site of injection, extravasation
and hypervolemia. MANAGEMENT
OF ADVERSE REACTIONS In case of severe reaction,
discontinue use of the drug. Treatment of a patient
with toxic manifestations consists of assuring and maintaining a patent airway
and supporting ventilation with oxygen and assisted or controlled respiration
as required. This usually will be sufficient in the management of most reactions.
Should a convulsion persist despite oxygen therapy, smallincrements of an
anticonvulsive agent may be given intravenously, such as a benzodiazepine
(e.g., diazepam) or ultrashort-acting barbiturate (thiopental or thiamylal)
or a short-acting barbiturate (pentobarbital or secobarbital). Should
circulatory depression occur, vasopressors, such as epinephrine, ephedrine
or metaraminol, and intravenous fluids may be used and, when necessary, standard
methods of cardiopulmonary resuscitation should be employed. Allergic
reactions should be managed by conventional means.
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Constant monitoring with an electrocardiograph is essential
for proper administration of lidocaine. Signs of excessive depression of cardiac
conductivity, such as prolongation of PR interval and QRS complex and appearance
or aggravation of arrhythmias, should be followed by prompt cessation of intravenous
infusion of this agent. It is mandatory to have emergency equipment and drugs
immediately available to manage possible adverse reactions involving the cardiovascular,
respiratory or central nervous systems. Excess administration
of potassium-free solutions may result in significant hypokalemia. The
intravenous administration of these solutions can cause fluid and/or solute
overloading resulting in dilution of serum electrolyte concentrations, overhydration,
congested states or pulmonary edema. As the dosage of
dilute solutions of lidocaine must be titrated to individual patient response,
additive medications should not be delivered via this solution. See PRECAUTIONS. Overt
or relative toxicity may result in evidence of central nervous system depression
(sedation) or irritability (twitching) which may progress to frank convulsions
accompanied by respiratory depression and/or arrest. Early recognition of
premonitory signs, assurance of adequate oxygenation and where necessary,
establishment of artificial airway with ventilatory support are essential
to management of this problem. Should convulsions persist despite ventilatory
therapy, small increments of anticonvulsant drugs may be used intravenously.
Examples of such agents include benzodiazepines (e.g., diazepam), and ultrashort-acting
barbiturate (e.g., thiopental or thiamylal). If the patient is under anesthesia,
a short-acting muscle relaxant (succinylcholine) may be used. Longer acting
drugs should be used only when recurrent convulsions are evidenced.
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| dailymed-instance:indicatio... |
Lidocaine Hydrochloride administered intravenously is specifically
indicated in the acute management of (1) ventricular arrhythmias occurring
during cardiac manipulation, such as cardiac surgery; and (2) life-threatening
arrhythmias, particularly those which are ventricular in origin, such as occur
during acute myocardial infarction.
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Lidocaine Hydrochloride and Dextrose
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