XYLOCAINE(R) -MPF- LIDOCAINE HCI AND EPINEPHRINE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

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:

XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE INJECTION, USP) is supplied in the following dosage forms. NDC 51662-1405-1 XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE INJECTION, USP) WITH EPINEPHRINE 1:200,000 1% 300mg per 30mL (10mg per mL) 30mL VIAL NDC 51662-1405-2 XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE INJECTION, USP) WITH EPINEPHRINE 1:200,000 1% 300mg per 30mL (10mg per mL) 30mL VIAL, 1 VIAL/POUCH NDC 51662-1405-3 XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE INJECTION, USP) WITH EPINEPHRINE 1:200,000 1% 300mg per 30mL (10mg per mL) 30mL VIAL, 1 VIAL/POUCH, 25 POUCHES/CASE HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms 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 4 5 1 1 7 5 F Revised: March 2019

Authorization status:

New Drug Application

Summary of Product characteristics

XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)- XYLOCAINE(R) -MPF
(LIDOCAINE HCI AND EPINEPHRINE) INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE INJECTION, USP)
WITH EPINEPHRINE 1:200,000 1% 300MG PER 30ML (10MG PER ML) 30ML VIAL
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 & 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 14H 22N 2O • 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 9H 13NO 3) 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 stabili