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:

Medical Purchasing Solutions, LLC

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. For direct intravenous injection: Single-dose: 0409-1323-05 Ansyr ® Plastic Syringe 2% (20 mg/mL) 5 mL 100 0409-9137-05 Ansyr ® Plastic Syringe 1% (10 mg/mL) 5 mL 50 0409-4903-34 LifeShield ® Abboject ® Syringe with Male Luer Lock Adapter (20-Gauge protected needle)** 2% (20 mg/mL) 5 mL 100 0409-4904-34 LifeShield ® Abboject ® Syringe with Male Luer Lock Adapter (20-Gauge protected needle)** 1% (10 mg/mL) 5 mL 50 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
----------
LIDOCAINE
HYDROCHLORIDE
INJECTION, USP
_AQUEOUS SOLUTIONS FOR_
_ACUTE MANAGEMENT OF_
_VENTRICULAR ARRHYTHMIAS_
ANSYR PLASTIC SYRINGE
LIFESHIELD ABBOJECT SYRINGE
Rx only
DESCRIPTION
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:
VOLUME
(TOTAL LIDOCAINE HCL)
LIDOCAINE
HYDROCHLORIDE
(MG/ML)
PH
For Direct Intravenous Injection:
5 mL (100 mg)
20
5.0 to 7.0
Single-dose:
5 mL (50 mg)
10
5.0 to 7.0
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 C
H
N
O • HCl • H
O. The molecular weight is 288.82. It
has the following structural formula:
®
®
®
14
22
2
2
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
compon