XYLOCAINE lidocaine hydrochloride jelly

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

APP Pharmaceuticals, LLC

Designació comuna internacional (DCI):

LIDOCAINE HYDROCHLORIDE

Composición:

LIDOCAINE HYDROCHLORIDE 20 mg in 1 mL

tipo de receta:

PRESCRIPTION DRUG

Estat d'Autorització:

New Drug Application

Fitxa tècnica

XYLOCAINE- LIDOCAINE HYDROCHLORIDE JELLY
APP PHARMACEUTICALS, LLC
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XYLOCAINE JELLY
DESCRIPTION
Xylocaine (lidocaine HCl) 2% Jelly is a sterile aqueous product that
contains a local anesthetic agent
and is administered topically (see INDICATIONS for specific uses).
Xylocaine 2% Jelly contains lidocaine HCl which is chemically
designated as acetamide, 2-
(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the
following structural formula:
Xylocaine 2% Jelly also contains hypromellose, and the resulting
mixture maximizes contact with
mucosa and provides lubrication for instrumentation. The unused
portion should be discarded after
initial use.
Composition of Xylocaine 2% Jelly 30 mL and 5 mL tubes: Each mL
contains 20 mg of lidocaine HCl.
The formulation also contains methylparaben, propylparaben,
hypromellose, and sodium hydroxide
and/or hydrochloric acid to adjust pH to 6.0–7.0.
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 OF ACTION
The onset of action is 3 to 5 minutes. It is ineffective when applied
to intact skin.
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 may be absorbed following topical administration to mucous
membranes, its rate and extent of
absorption 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 is also well-absorbed from
the gastrointestinal tract, but little intact drug may appear in the
circulation because o