DESCRIPTION

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.

CLINICAL PHARMACOLOGY

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).

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 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.

Anaphylactic reactions may occur following administration of lidocaine hydrochloride. (See ADVERSE REACTIONS).

In the case of severe reaction, discontinue the use of the drug.

Administer Lidocaine Hydrochloride and 5% Dextrose Injection, USP only with a calibrated infusion device.

PRECAUTIONS

ADVERSE REACTIONS

Systemic reactions of the following types have been reported:

Central Nervous System: respiratory depression and arrest; unconsciousness; convulsions; tremors; twitching; vomiting; blurred or double vision; drowsiness; dizziness; light-headedness; tinnitus; sensation of heat, cold or numbness; euphoria; apprehension.

Cardiovascular System: cardiovascular arrest; bradycardia which may lead to cardiac arrest; hypotension.

Hematologic Effects: methemoglobinemia.

Allergic reactions, including anaphylactic 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.

OVERDOSAGE

Overdosage may result in severe systemic toxicity (see Warnings and Precautions and Adverse Reactions).

DOSAGE AND ADMINISTRATION

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.” 1

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. As soon 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 µg/kg/min.2

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.

1

LeLorier, et al., Pharmacokinetics of lidocaine after prolonged intravenous infusions in uncomplicated myocardial infarction, Ann Int. Med. 87:700-702.

2

American Heart Association, Standards and Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiac Care (ECC), JAMA Vol. 244. No. 5: 453-509.

HOW SUPPLIED

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.

DIRECTIONS FOR USE OF VIAFLEX PLUS PLASTIC CONTAINER

WARNING: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA

*Bar Code Position Only
071968966

07-19-68-966

Rev. April 2012

BAXTER, VIAFLEX, and PL 146 are trademarks of Baxter International Inc.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

250 mL Container Label

LOT

EXP

2B0962      NDC 0338-0411-02

2g

Lidocaine
(8 mg/mL)

0.8% Lidocaine Hydrochloride
and 5% Dextrose Injection USP

250 mL

EACH 100 mL CONTAINS 800 mg
LIDOCAINE HYDROCHLORIDE USP 5 g
DEXTROSE HYDROUS USP pH
ADJUSTED WITH SODIUM HYDROXIDE
pH 4.0 (3.0 TO 7.0) OSMOLARITY
311 mOsmol/L (CALC) STERILE
NONPYROGENIC SINGLE DOSE
CONTAINER DOSAGE AS DIRECTED BY
A PHYSICIAN ADMINISTER
INTRAVENOUSLY USING A CALIBRATED
INFUSION DEVICE SEE DIRECTIONS
CAUTIONS SQUEEZE AND INSPECT
INNER BAG WHICH MAINTAINS PRODUCT
STERILITY DISCARD IF LEAKS ARE
FOUND DO NOT ADD SUPPLEMENTARY
MEDICATION MUST NOT BE USED IN
SERIES CONNECTIONS DO NOT
ADMINISTER SIMULTANEOUSLY WITH
BLOOD DO NOT USE UNLESS
SOLUTION IS CLEAR RX ONLY STORE
UNIT IN MOISTURE BARRIER OVERWRAP
AT ROOM TEMPERATURE (25°C) UNTIL
READY TO USE AVOID EXCESSIVE
HEAT SEE INSERT

VIAFLEX PLUS CONTAINER          PL 146 PLASTIC

Baxter
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

BAXTER VIAFLEX AND
PL 146 ARE TRADEMARKS OF
BAXTER INTERNATIONAL INC

FOR PRODUCT INFORMATION
1-800-933-0303

250 mL Carton Label

Lot: XXXX

Exp: XXXXX

QTY: 24-250mL

Code: 2B0962

NDC: 0338-0411-02

0.8% LIDOCAINE HYDROCHLORIDE
AND 5% DEXTROSE INJECTION

(17)XXXXX00(10)XXXX

(01) 50303380411028