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

Fresenius Kabi USA, LLC

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:

Product Code Unit of Sale Strength Each 491297 NDC 63323-492-97 Unit of 5 1% (100 mg per 10 mL) (10 mg per mL) NDC 63323-492-08 10 mL Plastic Ampule 491397 NDC 63323-493-97 Unit of 5 1.5% (150 mg per 10 mL) (15 mg per mL) NDC 63323-493-03 10 mL Plastic Ampule 491391 NDC 63323-493-91 Unit of 5 1.5% (300 mg per 20 mL) (15 mg per mL) NDC 63323-493-01 20 mL Plastic Ampule 491697 NDC 63323-496-97 Unit of 5 2% (200 mg per 10 mL) (20 mg per mL) NDC 63323-496-03 10 mL Plastic Ampule 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.

Authorization status:

New Drug Application

Summary of Product characteristics

XYLOCAINE MPF - LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
XYLOCAINE MPF- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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XYLOCAINE MPF (LIDOCAINE HCL INJECTION USP)
XYLOCAINE MPF (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
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
14
22
2
9
13
3
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