LIDOCAINE HYDROCHLORIDE AND DEXTROSE- lidocaine hydrochloride anhydrous and dextrose monohydrate injection, solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987), DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)

から入手可能:

A-S Medication Solutions

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

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.

製品概要:

Product: 50090-4559 NDC: 50090-4559-0 500 mL in a CONTAINER

認証ステータス:

New Drug Application

製品の特徴

LIDOCAINE HYDROCHLORIDE AND DEXTROSE- LIDOCAINE HYDROCHLORIDE
ANHYDROUS AND DEXTROSE MONOHYDRATE INJECTION, SOLUTION
A-S MEDICATION SOLUTIONS
----------
LIDOCAINE HYDROCHLORIDE AND
5% DEXTROSE INJECTION USP
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.
COMPOSITION - EACH 100 ML CONTAINS:
SOLUTION
LIDOCAINE
HYDROCHLORIDE
ANHYDROUS
USP
HYDROUS
DEXTROSE
USP
PH
CALCULATED
OSMOLARITY
MOSMOL/LITER
0.4%
Lidocaine
HCl and
5%
Dextrose
Injection
USP
0.4 g
5 g
4.4
(3.0–
7.0)
280
0.8%
Lidocaine
HCl and
5%
Dextrose
Injection
USP
0.8 g
5 g
4.2
(3.0–
7.0)
305
Water
for
Injection
USP qs
The formulas of the active ingredients are:
Lidocaine Hydrochloride Anhydrous USP
(M.W. 270.80)
Hydrous Dextrose USP
(M.W. 198.17)
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 pro