Lidocaine Hydrochloride and Epinephrine Injection, USP

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987), EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)

Pieejams no:

A-S Medication Solutions

SNN (starptautisko nepatentēto nosaukumu):

LIDOCAINE HYDROCHLORIDE

Kompozīcija:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL

Ievadīšanas:

INFILTRATION

Receptes veids:

PRESCRIPTION DRUG

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE- LIDOCAINE HYDROCHLORIDE AND
EPINEPHRINE INJECTION, SOLUTION
A-S MEDICATION SOLUTIONS
----------
LIDOCAINE HYDROCHLORIDE
AND EPINEPHRINE
INJECTION, USP
For Infiltration and Nerve Block.
AMPUL
FLIPTOP VIAL
MULTIPLE-DOSE FLIPTOP VIAL
PROTECT FROM LIGHT.
Rx only
_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, 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 impulses, thereby
effecting local anesthetic action.
HEMODYNAMICS: Excessive blood levels may cause changes in cardiac
outp