Lidocaine Hydrochloride and Dextrose

LIDOCAINE HYDROCHLORIDE AND DEXTROSE- lidocaine hydrochloride and dextrose monohydrate injection, solution
A-S Medication Solutions

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:

Solution	LidocaineHydrochlorideAnhydrousUSP	HydrousDextroseUSP	pH	CalculatedOsmolaritymOsmol/liter
0.4% Lidocaine HCl and5% Dextrose Injection USP	0.4 g	5 g	4.4 (3.0–7.0)	280
0.8% Lidocaine HCl and5% Dextrose Injection USP	0.8 g	5 g	4.2 (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)

Not made with natural rubber latex, PVC or DEHP.

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.

INDICATIONS AND USAGE

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.

CONTRAINDICATIONS

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.

WARNINGS

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 or 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 pediatric patients is limited. Anaphylactic reactions may occur following administration of lidocaine hydrochloride. In the case of severe reaction, discontinue the use of the drug.

Because dosages of this drug are titrated to response (see DOSAGE AND ADMINISTRATION), no additives should be made to Lidocaine Hydrochloride and 5% Dextrose Injection USP.

PRECAUTIONS

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 (see CONTRAINDICATIONS and WARNINGS).

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 (see CONTRAINDICATIONS).

Most potent anesthetic agents, local anesthetics of the amide type which includes lidocaine, and muscle relaxants of both depolarizing and nondepolarizing 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 use plastic containers in series connection.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container.

These solutions are intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

Use only if solution is clear and container and seals are intact.