LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE- lidocaine hydrochloride anhydrous and epinephrine injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987), EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)

Available from:

McKesson Packaging Services Business Unit of McKesson Corporation

INN (International Name):

LIDOCAINE HYDROCHLORIDE ANHYDROUS

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL

Administration route:

INFILTRATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Product summary:

Lidocaine Hydrochloride 1% and Epinephrine 1:100,000 Injection, USP is supplied as: 1 vial packaged in a pouch NDC 63739-468-21 5 pouches (NDC 63739-468-21) packaged in a carton NDC 63739-468-05 Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, USP is supplied as: 1 vial packaged in a pouch NDC 63739-475-21 5 pouches (NDC 63739-475-21) packaged in a carton NDC 63739-475-05

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE- LIDOCAINE HYDROCHLORIDE
ANHYDROUS
AND EPINEPHRINE INJECTION, SOLUTION
MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION
----------
LIDOCAINE HYDROCHLORIDE 1% AND 2%
AND EPINEPHRINE 1:100,000 INJECTION, USP
_FOR INFILTRATION AND NERVE BLOCK._
MULTIPLE-DOSE FLIPTOP VIAL
PROTECT FROM LIGHT.
Rx only
REVISED: 06/2004
DESCRIPTION
Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile,
nonpyrogenic solution of
lidocaine hydrochloride and epinephrine in water for injection for
parenteral administration in
various concentrations with characteristics as follows:
CONCENTRATION
LIDOCAINE
HCL
EPINEPHRINE
LIDOCAINE
HCL
(ANHYD.)
MG/ML
EPINEPHRINE
MCG/ML
SODIUM
CHLORIDE
MG/ML
0.5%
1:200,000
5
5
8
1%
1:200,000
10
5
7
1.5%
1:200,000
15
5
6.5
2%
1:200,000
20
5
6
1%
1:100,000
10
10
7
2%
1:100,000
20
10
6
Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL
added as stabilizers. The
headspace of Lists 1209, and 3179 are carbon dioxide gassed and Lists
3177, 3178, 3181, 3182 and
3183 are nitrogen gassed. May contain sodium hydroxide and/or
hydrochloric acid to adjust pH; pH is
4.5 (3.3 to 5.5). See _HOW SUPPLIED_ section for various sizes and
strengths.
Multiple-dose vials contain methylparaben 1 mg/mL added as
preservative.
Single-dose ampuls and vials contain no bacteriostat or antimicrobial
agent. Discard unused portion.
Lidocaine is a local anesthetic of the amide type.
Lidocaine Hydrochloride, USP is chemically designated
2-(diethyl-amino)-2’,6’-acetoxylidide
monohydrochloride monohydrate, a white powder freely soluble in water.
It has the following
structural formula:
Epinephrine, USP is a sympathomimetic (adrenergic) agent designated
chemically as 4-[1-hydroxy-2
(methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline
powder. It has the following structural
formula:
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION: Lidocaine stabilizes the neuronal membrane by
inhibiting the ionic fluxes
required for the initiation and conduction of impulse