XYLOCAINE lidocaine hydrochloride solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

APP Pharmaceuticals, LLC

INN (الاسم الدولي):

LIDOCAINE HYDROCHLORIDE

تركيب:

LIDOCAINE HYDROCHLORIDE 40 mg in 1 mL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الوضع إذن:

New Drug Application

خصائص المنتج

XYLOCAINE- LIDOCAINE HYDROCHLORIDE SOLUTION
APP PHARMACEUTICALS, LLC
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XYLOCAINE
Topical Solution
Rx only
DESCRIPTION
4% Xylocaine (lidocaine HCl) Topical Solution contains a local
anesthetic agent and is administered
topically. See INDICATIONS for specific uses.
4% Xylocaine Topical Solution contains lidocaine HCl, which is
chemically designated as acetamide,
2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has
the following structural formula:
The 50 mL screw-cap bottle should not be autoclaved, because the
closure employed cannot withstand
autoclaving temperatures and pressures. Composition of 4% Xylocaine
(lidocaine HCl) Topical
Solution: Each mL contains lidocaine HCl, 40 mg, methylparaben, and
sodium hydroxide and/or
hydrochloric acid to adjust pH to 6.0–7.0.
An aqueous solution. NOT FOR INJECTION.
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
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.
PHARMACOKINETICS AND METABOLISM
Lidocaine HCl may be absorbed following topical administration to
mucous membranes, its rate of
absorption and percent of dose absorbed depending upon concentration
and total dose administered, the
specific site of application and duration of exposure. In general, the
rate of absorption of local
anesthetic agents following topical application occurs most rapidly
after intratracheal administration.
Lidocaine HCl is well-absorbed from the gastrointestinal tract, but
little intact drug appears in the
circulation because of biotransformation in the liver.
circulation because of biotransformation in the liver.
Lidocaine HCl is metabolized rapidly by the liver, and metabolites