Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4100
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Lidocaine Hydrochloride and Dextrose (Injection, Solution)
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dailymed-instance:dosage |
Therapy of
ventricular arrhythmias is often initiated with a single IV bolus of 50
to 100 mg of lidocaine hydrochloride injection. Following acute
treatment by bolus in patients in whom arrhythmias tend to recur and who
are incapable of receiving oral antiarrhythmic agents, intravenous
infusion of Lidocaine Hydrochloride and 5% Dextrose Injection, USP is
administered continuously at the rate of 1 to 4 mg/min (20 to 50
mcg/kg/min in the average 70 kg adult). The 0.4% solution (4 mg/mL) can
be given at a rate of 15 to 60 mL/hr (0.25 to 1 mL/min). The 0.8%
solution (8 mg/mL) can be given at a rate of 7.5 to 30 mL/hr (0.12 to
0.5 mL/min). Precise dose is determined by patient response. ���Pharmacokinetic
data indicate reduced elimination of lidocaine after prolonged infusion
(24 hours) with resultant prolongation of the half-life to approximately
three times that seen following a single administration. Failure to
adjust the rate of infusion in keeping with this altered ability to
eliminate lidocaine may result in toxic accumulation of the drug in the
patient's serum.��� Intravenous
infusions of lidocaine hydrochloride must be administered under constant
ECG monitoring to avoid potential overdosage and toxicity. Intravenous
infusion should be terminated as soon as the patient's basic cardiac
rhythm appears to be stable or at the earliest signs of toxicity. It
should rarely be necessary to continue intravenous infusions beyond 24
hours. Assoon as possible and when indicated, patients should be
changed to an oral antiarrhythmic agent for maintenance therapy. Caution: When administering lidocaine
hydrochloride by continuous infusion, it is advisable to closely monitor
the infusion rate. Administer Lidocaine Hydrochloride and 5% Dextrose
Injection, USP only with a calibrated infusion device. Pediatric: Although controlled clinical
studies to establish pediatric dosing schedules have not been conducted,
the American Heart Association's Standards and Guidelines recommends a
bolus dose of 1 mg/kg followed by an infusion rate of 30��g/kg/min. Lidocaine
hydrochloride should not be added to blood transfusion assemblies. Parenteral drug
products should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and container
permit. Use of a final filter is recommended during administration of
all parenteral solutions, where possible. All injections in
VIAFLEX Plus plastic containers are intended for intravenous
administration using sterile equipment. Because dosages of
this drug are titrated to response, no
additives should be made to Lidocaine Hydrochloride and 5% Dextrose
Injection, USP.
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dailymed-instance:descripti... |
Lidocaine
Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic
solution prepared from lidocaine hydrochloride and dextrose in water for
injection. It contains no antimicrobial agents. Lidocaine hydrochloride
is designated chemically as 2-(Diethylamino) - 2', 6' - acetoxylidide monohydrochloride. The solution serves as a cardiac antiarrhythmic agent
intended for intravenous use. Composition, osmolarity, pH and caloric
content are shown in Table 1. The pH is adjusted with sodium hydroxide. This VIAFLEX Plus
plastic container is fabricated from a specially formulated polyvinyl
chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the
presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic
container system utilizes the same container as the VIAFLEX plastic
container system. The amount of water that can permeate from inside the
container into the overwrap is insufficient to affect the solution
significantly. Solutions in contact with the plastic container can leach
out certain of its chemical components in very small amounts within the
expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in
tests in animals according to USP biological standards for plastic
containers as well as by tissue culture toxicity studies.
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dailymed-instance:clinicalP... |
Lidocaine
hydrochloride exerts an antiarrhythmic effect by increasing the
electrical stimulation threshold of the ventricle during diastole. In
usual therapeutic doses, lidocaine hydrochloride 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 via the kidneys. Lidocaine toxicity
is related to systemic 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 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% (See Drug
Interactions).
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Lidocaine
hydrochloride is contraindicated in patients with a known history of
hypersensitivity to local anesthetics of the amide type. Lidocaine
should not be used in patients with Stokes-Adams syndrome,
Wolff-Parkinson-White syndrome, or with severe degrees of sinoatrial,
atrioventricular, or intraventricular block. Solutions
containing dextrose may be contraindicated in patients with known
allergy to corn or corn products.
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dailymed-instance:supply |
Lidocaine
Hydrochloride and 5% Dextrose Injection, USP in VIAFLEX plastic container is available as follows: Exposure of
pharmaceutical products to heat should be minimized. Avoid excessive
heat. It is recommended the product be stored at room temperature
(25��C); brief exposure up to 40��C does not adversely affect the
product.
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dailymed-instance:precautio... |
General:: Caution
should be employed in the repeated use of lidocaine
hydrochloride in patients with severe liver or renal disease
because accumulation may occur and lead to toxic phenomena,
since lidocaine hydrochloride is metabolized mainly in the liver
and excreted by the kidneys. The drug should also be used with
caution in patients with hypovolemia and shock, and in all forms
of heart block . In patients
with sinus bradycardia or incomplete heart block, the
administration of lidocaine hydrochloride intravenously for the
elimination of ventricular ectopic beats without prior
acceleration in heart rate (e.g., by isoproterenol or by
electric pacing) may promote more frequent and serious
ventricular arrhythmias or complete heart block . Most potent
anesthetic agents, local anesthetics of the amide type, which
includes lidocaine, and muscle relaxants of both depolarizing
and non-depolarizing types, have been associated with malignant
hyperthermia. Care should
be taken in the administration of intravenous fluids in patients
with compromised myocardial function to avoid fluid overload or
disturbances of serum electrolyte concentrations which might
interfere with cardiac conduction or result in congestive heart
failure. Do not
administer unless solution is clear and seal is intact.<br/>Laboratory Tests:: 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.<br/>Drug Interactions:: Lidocaine should be used with caution in patients with digitalis toxicity
accompanied by atrioventricular block . Coadministration of propranolol or cimetidine 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 amiodarone, 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.<br/>Carcinogenesis,
Mutagenesis, Impairment of Fertility:: Long term
animal studies have not been performed to evaluate carcinogenic
potential, mutagenic potential or the effect on fertility of
lidocaine hydrochloride.<br/>Pregnancy::<br/>Teratogenic
Effects: Pregnancy Category B.: Reproduction studies have been performed in rats at
doses up to five times the maximum human dose and have
revealed no significant findings. There are, however, no
adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always
predictive of human response, lidocaine hydrochloride
should be used during pregnancy only if clearly
needed.<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 hydrochloride is administered to a nursing
woman.<br/>Pediatric Use: Safety and
effectiveness in pediatric patients have not been
established.<br/>Geriatric Use: Clinical
studies of Lidocaine Hydrochloride did not include sufficient
numbers of subjects aged 65 and over to determine whether they
respond differently from younger subjects. Other reported clinical experience has not identified differences in responses
between the elderly and younger patients. 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 hepatic, renal, or cardiac
function, and of concomitant disease or other drug
therapy.
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dailymed-instance:overdosag... |
Reported adverse
reactions are due to overdosage (see ADVERSE
REACTIONS).
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dailymed-instance:genericMe... |
Lidocaine Hydrochloride and Dextrose
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dailymed-instance:fullName |
Lidocaine Hydrochloride and Dextrose (Injection, Solution)
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dailymed-instance:adverseRe... |
Systemic reactions
of the following types have been reported: Central Nervous
System: Light-headedness; drowsiness; dizziness; apprehension; euphoria;
tinnitus; blurred or double vision; vomiting; sensation of heat, cold or
numbness; twitching; tremors; convulsions; unconsciousness; respiratory
depression and arrest. Cardiovascular System: Hypotension; cardiovascular arrest; and bradycardia which may
lead to cardiac arrest. Allergic reactions
may occur but are infrequent. There have been no reports of cross
sensitivity between lidocaine hydrochloride and procainamide or between
lidocaine hydrochloride and quinidine.<br/>Management of
Adverse Reactions:: In the case
of severe reaction, discontinue the use of the drug. Institute
emergency resuscitative procedures and administer the emergency drugs necessary to manage the severe reaction. For severe
convulsions, small increments of diazepam or an
ultrashort-acting barbiturate (thiopental or thiamylal) or if
those are not available, a short-acting barbiturate
(pentobarbital or secobarbital); or if the patient is under
anesthesia, a short-acting muscle relaxant (succinylcholine) may
be given intravenously. Muscle relaxants and intravenous
medications should only be used by those familiar with their
use. Patency of the airway and adequacy of ventilation must be
assured. Should
circulatory depression occur, vasopressors may be
used.
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dailymed-instance:warning |
Constant monitoring
with an electrocardiograph is essential to the proper administration of
lidocaine hydrochloride intravenously. Signs of excessive depression of
cardiac conductivity, such as prolongation of the PR interval, widening
of the QRS interval and the appearance or aggravation of arrhythmias,
should be followed by prompt cessation of the intravenous infusion of this agent. It is mandatory to have emergency resuscitative equipment
and drugs immediately available to manage adverse reactions involving
cardiovascular, respiratory, or central nervous systems. Occasional
acceleration of ventricular rate may occur when lidocaine hydrochloride
is administered to patients with atrial fibrillation. Evidence for
proper usage in children is limited. Administer
Lidocaine Hydrochloride and 5% Dextrose Injection, USP only with a
calibrated infusion device.
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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 manipulations, such as cardiac surgery and (2) life-threatening
arrhythmias which are ventricular in origin, such as occur during acute
myocardial infarction.
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Lidocaine Hydrochloride and Dextrose
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