XYLOCAINE- lidocaine hydrochloride and epinephrine injection, solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Osta kohe

Laadi alla Toote omadused (SPC)
22-12-2022

Toimeaine:

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

Saadav alates:

General Injectables & Vaccines, Inc

INN (Rahvusvaheline Nimetus):

LIDOCAINE HYDROCHLORIDE ANHYDROUS

Koostis:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL

Manustamisviis:

INFILTRATION

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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.

Toote kokkuvõte:

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 APP Pharmaceuticals, LLC. APP APP Pharmaceuticals, LLC Schaumburg, IL 60173 451175B Revised: March 2010

Volitamisolek:

New Drug Application

Toote omadused

                                XYLOCAINE- LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
----------
XYLOCAINE
(LIDOCAINE HCL INJECTION, USP)
XYLOCAINE
(LIDOCAINE HCL AND EPINEPHRINE INJECTION, USP)
FOR INFILTRATION AND NERVE BLOCK
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.
14
22
2
9
13
3
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 stabilizes the neuronal membrane by inhibiting the ionic
fluxes required for
the initiation and conduction of imp
                                
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