LIDOCAINE HCI AND DEXTROSE (Page 2 of 2)

ADVERSE REACTIONS

Systemic reactions of the following types have been reported:

Central Nervous System: Light-headedness; drowsiness; dizziness; apprehension; euphoria; tinnitus; blurred or double vision; nausea and vomiting; sensation of heat, cold or numbness; twitching; tremors; convulsions; unconsciousness; respiratory depression and arrest.
Cardiovascular System: Hypotension; cardiovascular arrest; and bradycardia which may lead to cardiac arrest.
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 results in systemic toxicity (see ADVERSE REACTIONS).

DOSAGE & ADMINISTRATION

Therapy of ventricular arrhythmias is often initiated with a single IV bolus of 1 mg/kg of Lidocaine Hydrochloride Injection USP. 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.

Rate of Administration

Adults (20 to 50 mcg/kg/min):

DOSAGE
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Pediatric Patients (30 mcg/kg/min).1

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.2

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: Concentrated solutions of lidocaine hydrochloride (greater than 0.2%) should be administered by carefully calibrated infusion devices.

1
Standards and Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiac Care (ECC). American Heart Association, JAMA 244 (5):453–509, 1980.
2
LeLorier J, Grenon D, Latour Y, et al.: Pharmacokinetics of lidocaine after prolonged intravenous infusions in uncomplicated myocardial infarction. Ann Int Med 87:700–702, 1977.

Pediatric Use

Therapy should be initiated with a single IV bolus of 1 mg/kg of Lidocaine Hydrochloride Injection USP. A maintenance intravenous infusion of Lidocaine Hydrochloride and 5% Dextrose Injection USP administered at a recommended infusion rate of 30 mcg/kg/min may be given.1

Geriatric Use

Patients with reduced hepatic function or diminished hepatic blood flow (as in heart failure and after cardiac surgery), or those over 70 years of age should receive half the usual loading dose and also should be given lower maintenance levels of intravenous lidocaine. Patients over 65 years may benefit from dosing based upon body weight (see CLINICAL PHARMACOLOGY and PRECAUTIONS, GERIATRIC USE).

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.

HOW SUPPLIED

Lidocaine Hydrochloride and 5% Dextrose Injection USP is supplied sterile and nonpyrogenic in Full Fill 500 mL and 250 mL EXCEL® Containers packaged 24 per case.

HS
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Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.

SPL UNCLASSIFIED

Rx only

Revised: November 2019

EXCEL is a registered trademark of B. Braun Medical Inc.

DIRECTIONS FOR USE OF EXCEL® CONTAINER

Do not admix with other drugs.

Caution: Do not use plastic containers in series connection.

To Open

Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired.

NOTE: Before use, perform the following checks:

Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.

Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter.
Any container which is suspect should not be used.

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

Preparation for Administration

Remove plastic protector from sterile set port at bottom of container.
Attach administration set. Refer to complete directions accompanying set.

SPL UNCLASSIFIED

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y36-003-016 LD-236-8

PRINCIPAL DISPLAY PANEL — 51662-1565-1 250 mL CONTAINER (BAG) — LABEL AND SERIALIZED LABELING

51662-1565-1

LIDOCAINE HCI AND 5% DEXTROSE INJECTION USP, 2g (8mg/mL) 250mL BAG

BAG
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SERIALIZED
(click image for full-size original)
LIDOCAINE HCI AND DEXTROSE
lidocaine hci and dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1565(NDC:0264-9598)
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 5 g in 100 mL
LIDOCAINE HYDROCHLORIDE ANHYDROUS (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 0.8 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51662-1565-1 250 mL in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019830 07/17/2021
Labeler — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Registrant — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Establishment
Name Address ID/FEI Operations
HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel (51662-1565)

Revised: 07/2021 HF Acquisition Co LLC, DBA HealthFirst

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