XYLOCAINE-MPF lidocaine hydrochloride solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

קנה את זה

הורד מאפייני מוצר (SPC)
14-05-2018

מרכיב פעיל:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)

זמין מ:

APP Pharmaceuticals, LLC

INN (שם בינלאומי):

LIDOCAINE HYDROCHLORIDE

הרכב:

LIDOCAINE HYDROCHLORIDE 40 mg in 1 mL

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

New Drug Application

מאפייני מוצר

                                XYLOCAINE-MPF- LIDOCAINE HYDROCHLORIDE SOLUTION
APP PHARMACEUTICALS, LLC
----------
4% XYLOCAINE-MPF (LIDOCAINE HCL) STERILE SOLUTION
Rx only
DESCRIPTION
4% Xylocaine-MPF (lidocaine HCl) Sterile Solution (Methylparaben Free)
contains a local anesthetic
agent and is administered topically or by injection. See INDICATIONS
for specific uses.
4% Xylocaine-MPF Sterile Solution contains lidocaine HCl, which is
chemically designated as
acetamide, 2-(diethylamino)-N-(2,6- dimethylphenyl)-mono-hydrochloride
and has the following
structural formula:
4% Xylocaine-MPF Sterile Solution in 5 mL ampules may be autoclaved
repeatedly if necessary.
Composition of 4% Xylocaine-MPF Sterile Solution
Each mL contains lidocaine HCl, 40 mg, and sodium hydroxide and/or
hydrochloric acid to adjust pH to
5.0 to 7.0.
A sterile, aqueous solution.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Lidocaine stabilizes the neuronal membrane by inhibiting the ionic
fluxes required for the initiation and
conduction of impulses, thereby effecting local anesthetic action.
ONSET AND DURATION OF ANESTHESIA
The onset of action is rapid. For retrobulbar injection, 4 mL of 4%
Xylocaine-MPF Sterile Solution
provides an average duration of action of 1 to 1½ hours. This
duration may be extended for ophthalmic
surgery by the addition of epinephrine, the usual recommended dilution
being 1:50,000 to 1:100,000.
HEMODYNAMICS
Excessive blood levels may cause changes in cardiac output, total
peripheral resistance, and mean
arterial pressure. These changes may be attributable to a direct
depressant effect of the local anesthetic
agent on various components of the cardiovascular system. The net
effect is normally a modest
hypotension when the recommended dosages are not exceeded.
PHARMACOKINETICS AND METABOLISM
Information derived from other formulations, concentrations and usages
reveals that lidocaine is
completely absorbed following parenteral administration, its rate of
absorption depending, for example,
upon such factors such as the site of administration and the pre
                                
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