XYLOCAINE- lidocaine hydrochloride jelly

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

Lidocaine hydrochloride (UNII: V13007Z41A) (lidocaine - UNII:98PI200987)

זמין מ:

Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)

INN (שם בינלאומי):

Lidocaine hydrochloride

הרכב:

Lidocaine hydrochloride 0.5 mg in 18 mL

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Xylocaine (lidocaine HCl) 2% Jelly is indicated for prevention and control of pain in procedures involving the male and female urethra, for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal). Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of Xylocaine 2% Jelly.

leaflet_short:

Xylocaine (lidocaine HCl) 2% Jelly is supplied as follows: NDC 76478-479-05           2% (20 mg/mL) 5 mL aluminum tube packed individually. NDC 76478-479-30           2% (20 mg/mL) 30 mL aluminum tube packed individually. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. AKORN Distributed by: Akorn, Inc. Lake Forest, IL 60045 OAK Mfd. for: Oak Pharmaceuticals, Inc. OPXY00N       Rev. 10/18

מצב אישור:

New Drug Application

מאפייני מוצר

XYLOCAINE- LIDOCAINE HYDROCHLORIDE JELLY
OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.)
----------
XYLOCAINE® 2% JELLY
(LIDOCAINE HYDROCHLORIDE)
Rx only
DESCRIPTION:
Xylocaine (lidocaine HCl) 2% Jelly is a sterile aqueous product that
contains a local anesthetic agent
and is administered topically (see INDICATIONS AND USAGE 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 to 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 gastr