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:

REMEDYREPACK INC.

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:

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
REMEDYREPACK INC.
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XYLOCAINE
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 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
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.
14
22
2
9
13
3
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Lidocaine HCl stabilizes the neuronal membrane by inhibiting the ionic
fluxes required for the initiation
and conduction of impulses thereby effecting local anesthetic action.
HEMODYNAMICS
Excessive blood levels may cause changes in cardiac output, total