LIDOCAINE HYDROCHLORIDE- lidocaine injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)

Available from:

General Injectables & Vaccine, Inc

INN (International Name):

Lidocaine Hydrochloride

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocaine hydrochloride injection administered intravenously or intramuscularly, is specifically indicated in the acute management of ventricular arrhythmias such as those occurring in relation to acute myocardial infarction, or during cardiac manipulation, such as cardiac surgery. Lidocaine hydrochloride is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. Lidocaine hydrochloride should not be used in patients with Stokes-Adams syndrome, Wolff-Parkinson-White syndrome or with severe degrees of sinoatrial, atrioventricular or intraventricular block in the absence of an artificial pacemaker. Although specific studies have not been conducted, lidocaine HCl has been used clinically without evidence of abuse of this drug or of psychological or physical dependence as a result of its use.

Product summary:

Lidocaine Hydrochloride Injection, USP is supplied as follows: **Abboject® Unit of Use Syringe with Male Luer Lock Adapter and protected needle. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Distributed by: Hospira, Inc., Lake Forest, IL 60045 USA Abboject® is a trademark of the Abbott group of companies. LIFESHIELD® is the trademark of ICU Medical, Inc. and is used under license. LAB-1021-3.0 Revised: 04/2018

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE- LIDOCAINE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINE, INC
----------
LIDOCAINE HCL 1% 50 MG INJECTION, USP 5 ML ABBOJECT SYRINGE
DESCRIPTION
AQUEOUS SOLUTIONS FOR
ACUTE MANAGEMENT OF
VENTRICULAR ARRHYTHMIAS
Ansyr® Plastic Syringe
LifeShield® Abboject® Syringe
Rx only
Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic
solution of an
antiarrhythmic agent administered intravenously by either direct
injection or continuous
infusion. It is available in various concentrations with the following
characteristics:
May contain sodium hydroxide and/or hydrochloric acid for pH
adjustment. Injections
containing 10 mg/mL (1%) contain sodium chloride 7 mg and injections
containing 20
mg/mL (2%) lidocaine hydrochloride contain sodium chloride 6 mg to
adjust tonicity.
Single-dose solutions contain no preservative and unused portions must
be discarded
after use.
Lidocaine Hydrochloride, USP is chemically designated
2-(Diethylamino)-2’,6’-
acetoxylidide monohydrochloride monohydrate, a white powder freely
soluble in water.
The molecular formula is C14H22N2O• HCl •H2O. The molecular weight
is 288.82. It has
the following structural formula:
The semi-rigid vial used for the plastic vials is fabricated from a
specially formulated
polyolefin. It is a copolymer of ethylene and propylene. The safety of
the plastic has been
confirmed by tests in animals according to USP biological standards
for plastic
containers. The container requires no vapor barrier to maintain the
proper drug
concentration. The plastic syringe is molded from a specially
formulated polypropylene.
Water permeates from inside the container at an extremely slow rate
which will have an
insignificant effect on solution concentration over the expected shelf
life. Solutions in
contact with the plastic container may leach out certain chemical
components from the
plastic in very small amounts; however, biological testing was
supportive of the safety of
the syringe material.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION AND