XYLOCAIN (LIDOCAINE HCL ) (xylocaine- lidocaine hcl injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)

Available from:

HF Acquisition Co LLC, DBA HealthFirst

Administration route:

INFILTRATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

NDC 51662-1587-2 XYLOCAINE® (LIDOCAINE HCl INJECTION, USP) 1% 500 mg/50 mL (10 mg/mL) 50mL VIAL IN A POUCH NDC 51662-1587-3 XYLOCAINE® (LIDOCAINE HCl INJECTION, USP) 1% 500 mg/50 mL (10 mg/mL) 50mL VIAL IN A POUCH, CASE OF 25 HF Acquisition Co LLC, DBA HealthFirst 11629 49th Pl W. Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms 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. www.fresenius-kabi.com/us 451175G Revised: August 2020

Authorization status:

New Drug Application

Summary of Product characteristics

XYLOCAIN (LIDOCAINE HCL )- XYLOCAINE (LIDOCAINE HCL ) INJECTION,
SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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XYLOCAINE® (LIDOCAINE HCL INJECTION, USP) 1% 500 MG/50 ML (10 MG/ML)
SPL UNCLASSIFIED
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 the