LIDOCAINE HYDROCHLORIDE injection, solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

McKesson Corporation dba SKY Packaging

INN (International Name):

Lidocaine Hydrochloride

Sammensætning:

Lidocaine Hydrochloride 20 mg in 1 mL

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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.

Produkt oversigt:

Product: 63739-457 NDC: 63739-457-21 5 mL in a SYRINGE, PLASTIC / 5 in a BOX

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
MCKESSON CORPORATION DBA SKY PACKAGING
----------
LIDOCAINE
HYDROCHLORIDE
INJECTION, USP
_AQUEOUS SOLUTIONS FOR_
_ACUTE MANAGEMENT OF_
_VENTRICULAR ARRHYTHMIAS_
ANS YR 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:
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