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Lidocaine and Dextrose (Lidocaine Hydrochloride) - Description and Clinical Pharmacology

 
 



Do not admix with other drugs.

DESCRIPTION

Lidocaine Hydrochloride and 5% Dextrose Injection USP is a sterile, nonpyrogenic solution prepared from lidocaine hydrochloride and dextrose in water for injection.

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 - Each 100 mL contains:
SolutionLidocaine
Hydrochloride
Anhydrous
USP
Hydrous
Dextrose
USP
pHCalculated
Osmolarity
mOsmol/liter
0.2% Lidocaine HCl and
5% Dextrose Injection USP
0.2 g5 g4.4 (3.0–7.0)265
0.4% Lidocaine HCl and
5% Dextrose Injection USP
0.4 g5 g4.4 (3.0–7.0)280
0.8% Lidocaine HCl and
5% Dextrose Injection USP
0.8 g5 g4.2 (3.0–7.0)305

Water for Injection USP qs

The formulas of the active ingredients are:


Lidocaine Hydrochloride Anhydrous USP
(M.W. 270.80)

Hydrous Dextrose USP
(M.W. 198.17)

The EXCEL Container is Latex-free; PVC-free; and DEHP-free.

The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

The closure system has two ports; the one for the administration set has a tamper evident plastic protector. Refer to the Directions for Use of the container.

CLINICAL PHARMACOLOGY

Lidocaine hydrochloride exerts an antiarrhythmic effect by increasing the electric 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 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.

This solution provides approximately 170 calories per liter.

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