LIDOCAINE HCI AND DEXTROSE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)

Available from:

HF Acquisition Co LLC, DBA HealthFirst

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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.

Product summary:

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. 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.

Authorization status:

New Drug Application

Summary of Product characteristics

LIDOCAINE HCI AND DEXTROSE- LIDOCAINE HCI AND DEXTROSE INJECTION,
SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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LIDOCAINE HCI AND 5% DEXTROSE INJECTION USP, 2G (8MG/ML)
SPL UNCLASSIFIED
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.
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 t