XYLOCAINE- lidocaine hydrochloride and epinephrine injection, solution

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987), EPINEPHRINE BITARTRATE (UNII: 30Q7KI53AK) (EPINEPHRINE - UNII:YKH834O4BH)

Disponibbli minn:

General Injectables & Vaccines, Inc

INN (Isem Internazzjonali):

Lidocaine Hydrochloride

Kompożizzjoni:

Lidocaine Hydrochloride 10 mg in 1 mL

Rotta amministrattiva:

INFILTRATION

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia 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 HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Sommarju tal-prodott:

For single-dose vials and ampules: Discard unused portion. All solutions should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. All trademarks are the property of Fresenius Kabi USA, LLC. Fresenius Kabi Logo www.fresenius-kabi.com/us 451175G Revised: August 2020

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Karatteristiċi tal-prodott

XYLOCAINE- LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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XYLOCAINE 1% (LIDOCAINE HCL AND EPINEPHRINE 1:100,000) USP
For Infiltration and Nerve Block
Rx only
DESCRIPTION
Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic,
aqueous solutions that
contain a local anesthetic agent with or without epinephrine and are
administered
parenterally by injection. See INDICATIONS AND USAGE section for
specific uses.
Xylocaine solutions contain lidocaine HCl, which is chemically
designated as acetamide, 2-
(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the
molecular wt.
270.8. Lidocaine HCl (C14H22N2O • HCl) has the following structural
formula:
Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl
alcohol and has the
molecular wt. 183.21. Epinephrine (C9H13NO3) has the following
structural formula:
Dosage forms listed as Xylocaine-MPF indicate single dose solutions
that are Methyl
Paraben Free (MPF).
Xylocaine MPF is a sterile, nonpyrogenic, isotonic solution containing
sodium chloride.
Xylocaine in multiple dose vials: Each mL also contains 1 mg
methylparaben as antiseptic
preservative. The pH of these solutions is adjusted to approximately
6.5 (5.0 to 7.0) with
sodium hydroxide and/or hydrochloric acid.
Xylocaine MPF with Epinephrine is a sterile, nonpyrogenic, isotonic
solution containing
sodium chloride. Each mL contains lidocaine hydrochloride and
epinephrine, with 0.5 mg
sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a
stabilizer. Xylocaine
with Epinephrine in multiple dose vials: Each mL also contains 1 mg
methylparaben as
antiseptic preservative. The pH of these solutions is adjusted to
approximately 4.5 (3.3
to 5.5) with sodium hydroxide and/or hydrochloric acid. Filled under
nitrogen.
CLINICAL PHARMACOLOGY
Mechanism of Action
Lidocaine HCl stabilizes the neuronal membrane by inhibiting the ionic
fluxes required for
the initiation and conduction of impulses thereby effecting local
anesthetic ac