Label: LIDOCAINE HYDROCHLORIDE AND DEXTROSE- lidocaine hydrochloride injection, solution

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.

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.

Hypersensitivity reactions, including anaphylactic reactions, have been reported with lidocaine. Lidocaine hydrochloride is contraindicated in patients with a history of hypersensitivity to local anesthetics of the amide type.

Lidocaine is contraindicated in patients with Stokes-Adams syndrome, Wolff-Parkinson-White syndrome, or with severe degrees of sinoatrial, atrioventricular, or intraventricular block.

Constant monitoring with an electrocardiograph is essential to the 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. Central nervous system adverse reactions are associated with venous plasma levels above 6.0 μg free base per mL (see ADVERSE REACTIONS).

Hypersensitivity, including anaphylaxis, has been reported with lidocaine-containing solutions. Stop the infusion immediately if signs of hypersensitivity develop.

Acceleration of ventricular rate may occur in patients with atrial fibrillation or flutter treated with lidocaine.

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 r ate (e.g., by isoproterenol or by electric pacing) may promote more frequent and serious ventricular arrhythmias or complete heart block (see Contraindications).

Because lidocaine is metabolized mainly in the liver and excreted by the kidneys, patients with renal or hepatic insufficiency may be at increased risk for toxicity.

Systemic reactions of the following types have been reported:

Nervous System Disorders: 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; agitation; confused state; paresthesia; dysarthria.

Cardiovascular System: cardiovascular arrest; bradycardia which may lead to cardiac arrest; hypotension, Ventricular fibrillation, Ventricular tachycardia, Ventricular arrhythmia, Asystole.

Gastrointestinal Disorders: Hypoesthesia oral, Nausea,

Hematologic Effects: methemoglobinemia.

Psychiatric Disorders: Disorientation

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.

Signs and symptoms of overdose may include:

•

Central nervous system effects, e.g., coma, loss of consciousness, CNS depression, seizure, tonic-clonic muscle jerks, tremor, nystagmus, tingling of tongue and lips, tinnitus, drowsiness, disorientation, and lightheadedness.

•

Cardiorespiratory effects, e.g., cardiovascular collapse and cardiorespiratory arrest (sometimes fatal), respiratory depression and arrest, hypotension, myocardial depression, arrhythmias, including asystole, heart block, ventricular arrhythmias, tachycardia, and bradycardia.

Discontinue lidocaine administration in the event of an overdose.

There is no specific antidote for overdose of lidocaine. The risk of overdose can be minimized by close monitoring during treatment.

Emergency procedures should include appropriate corrective, resuscitative, and other supportive measures (See WARNINGS).

Therapy of ventricular arrhythmias is often initiated with a single IV bolus of 1.0 to 1.5 mg/kg at a rate of 25 to 50 mg/min. 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 (0.020 to 0.050 mg/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 dosage regimen is determined by patient characteristics and response.

Infusion rate should be reduced by approximately one-half to compensate for decreased rate of clearance after prolonged infusion (24 hours) (see Clinical Pharmacology). 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 (see OVERDOSAGE). 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: Clinical studies to establish pediatric dosing schedules have not been conducted. The usual dosage is a bolus dose of 1 mg/kg followed by an infusion rate of 20 mcg to 50 mcg/kg/min. The bolus dose should be repeated if infusion is not initiated within 15 minutes of the initial bolus dose.

Hepatic impairment is likely to decrease clearance and increase exposure level of lidocaine. Administer lidocaine at lower maintenance infusion rate with close monitoring of toxicity in patients with hepatic impairment.

Renal Impairment: In patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2), administer lidocaine at lower maintenance infusion rate with close monitoring of toxicity.

Lidocaine is incompatible with the following due to precipitate formation (includes but is not limited to):

•

Amphotericin

•

Cephazolin sodium

•

Phenytoin sodium

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless solution is clear, the seal is intact, and the container is undamaged. Some opacity of the container plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect solution quality or safety. The opacity will diminish gradually. Use of a final filter is recommended during administration of all parenteral solutions, where possible.

Lidocaine must not be infused simultaneously through the same tubing with other medicinal products without first verifying their compatibility.

Set the vent to the close position on a vented intravenous administration set to prevent air embolism.

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.

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.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Printed in USA

07-19-76-975

Rev. February 2017

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

Container

Container

LOT

EXP

NDC 0338-0411-02

Lidocaine

Lidocaine Hydrochloride and
5% Dextrose Injection USP

2g per 250 mL
(8 mg/mL)

250 mL STERILE SINGLE
DOSE CONTAINER EACH
100 mL CONTAINS 800 mg
LIDOCAINE HCI USP AND 5 g
DEXTROSE HYDROUS USP pH
4.0 (3.0 TO 7.0) OSMOLARITY
311 mOsmol/L (CALC) USUAL
DOSAGE SEE INSERTDO
NOT ADD SUPPLEMENTARY
MEDICATION FOR USE ONLY WITH
A CALIBRATED INFUSION DEVICE
STORE IN MOISTURE BARRIER
OVERWRAP AT ROOM TEMPERATURE
(77°F OR25°C) UNTIL READY TO
USE RX ONLY

Baxter
USA 2B0962

50
100
150
200

Container

Container

LOTEXP

NDC 0338-0409-03

Lidocaine

Lidocaine Hydrochloride and 5% Dextrose Injection USP

2g per 500 mL
(4 mg/mL)

500 mL STERILE SINGLE DOSE CONTAINER
EACH 100 mL CONTAINS 400 mg LIDOCAINE HCI
USP AND 5 g DEXTROSE HYDROUS USP
pH 4.0 (3.0 TO 7.0) OSMOLARITY 282
mOsmol/L (CALC) USUAL DOSAGE SEE INSERT
DO NOT ADD SUPPLEMENTARY MEDICATION
FOR USE ONLY WITH A CALIBRATED INFUSION DEVICE
STORE IN MOISTURE BARRIER OVERWRAP AT ROOM
TEMPERATURE (77°F OR25°C) UNTIL READY TO
USE RX ONLY

Baxter Logo
USA 2B0973

1

2

3

4