XYLOCAINE MPF- lidocaine hydrochloride injection, solution XYLOCAINE- lidocaine hydrochloride injection, solution XYLOCAINE MP

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

LIDOCAINE HYDROCHLORIDE ANHYDROUS

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL

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:

Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® -MPF (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:100,000 Xylocaine® (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000 Xylocaine® -MPF (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000 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

XYLOCAINE MPF- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
XYLOCAINE - LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
XYLOCAINE MPF- LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
INJECTION, SOLUTION
XYLOCAINE - LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE INJECTION,
SOLUTION
FRESENIUS KABI USA, LLC
----------
XYLOCAINE®
(LIDOCAINE HCL INJECTION, USP)
XYLOCAINE®
(LIDOCAINE HCL AND EPINEPHRINE INJECTION, 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 (C
H
N O • HCl)
has the following structural formula:
Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl
alcohol and has the molecular wt. 183.21.
Epinephrine (C H
NO ) 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 methyl​paraben 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.