XYLOCAINE MPF- lidocaine hydrochloride injection, solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

REMEDYREPACK INC.

Vartojimo būdas:

INFILTRATION

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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.

Produkto santrauka:

Xylocaine® (lidocaine HCl Injection, USP) 20mg/2mL (10mg/mL) NDC: 70518-2876-00 NDC: 70518-2876-01 PACKAGING: 25 in 1 CARTON PACKAGING: 2 mL in 1 VIAL, SINGLE DOSE TYPE 0 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Autorizacija statusas:

New Drug Application

Prekės savybės

XYLOCAINE MPF- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
REMEDYREPACK INC.
----------
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
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
14
22
2
9
13
3
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 stabilizes the neuronal membrane by inhibiting the ionic
fluxes required for
the initiation and conduction of impulses thereby effe