LIDOCAINE HYDROCHLORIDE AND DEXTROSE- lidocaine hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)

Available from:

Baxter Healthcare Corporation

INN (International Name):

LIDOCAINE HYDROCHLORIDE

Composition:

LIDOCAINE HYDROCHLORIDE 4 mg in 1 mL

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. 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.

Product summary:

Lidocaine Hydrochloride and 5% Dextrose Injection, USP in VIAFLEX plastic container is available as follows: 2B0972 250 0338-0409-02 Lidocaine Hydrochloride and 5% Dextrose 2B0973 500 0338-0409-03 Injection, USP (4 mg/mL) 2B0962 250 0338-0411-02 Lidocaine Hydrochloride and 5% Dextrose Injection, USP (8 mg/mL) 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.

Authorization status:

New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE AND DEXTROSE- LIDOCAINE HYDROCHLORIDE
INJECTION,
SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
LIDOCAINE HYDROCHLORIDE AND 5% DEXTROSE INJECTION, USP
IN PLASTIC CONTAINER
VIAFLEX PLUS CONTAINER
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.
TABLE 1
*
Composition
Osmolarity
(mOsmol/L)
(calc)
pH
Caloric
Content
(kcal/L)
**Lidocaine
Hydrochloride,
USP (mg/mL)
***Dextrose
Hydrous, USP (g/L)
0.4% Lidocaine
Hydrochloride
and 5%
Dextrose
Injection, USP
4
50
282
4.0
(3.0 to 7.0)
170
0.8% Lidocaine
Hydrochloride
and 5%
Dextrose
Injection, USP
8
50
311
4.0
(3.0 to 7.0)
170
This VIAFLEX Plus plastic container is fabricated from a specially
formulated polyvinyl chloride (PL
Normal physiologic osmolarity range is approximately 280 to 310
mOsmol/L. Administration of substantially
hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage.
*
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
container