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

 
 



AQUEOUS SOLUTIONS FOR ACUTE MANAGEMENT OF CARDIAC ARRHYTHMIAS|
Flexible Plastic Container

Rx only

Do not admix with other drugs

DESCRIPTION

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 (C6H12O6•H2O), a hexose sugar freely soluble in water. It has the following structural formula:

Water for Injection, USP is chemically designated H2O.

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.

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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