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

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:

PERINEURAL

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 All solutions should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Protect from light. The brand names mentioned in this document are the trademarks of their respective owners. PremierProRx ® is a registered trademark of Premier Healthcare Alliance, L.P., used under license.

Authorization status:

New Drug Application

Summary of Product characteristics

XYLOCAINE MPF- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
XYLOCAINE - LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
XYLOCAINE - LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE INJECTION,
SOLUTION
FRESENIUS KABI USA, LLC
----------
XYLOCAINE ®
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).
14
22
2
9
13
3
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:
MECHANI