LIDOCAINE- lidocaine hydrochloride jelly

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)

Tillgänglig från:

Akorn

Administreringssätt:

TOPICAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 Lidocaine HCl 2% Jelly.

Produktsammanfattning:

Lidocaine HCl 2% Jelly is supplied in the listed dosage forms. A detachable applicator cone and a key for expressing the contents are included in the 30 mL carton. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. AKORN Manufactured by: Akorn, Inc. Lake Forest, IL 60045 LD00N       Rev. 02/20

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

LIDOCAINE- LIDOCAINE HYDROCHLORIDE JELLY
AKORN
----------
LIDOCAINE HYDROCHLORIDE JELLY USP, 2%
RX ONLY
DESCRIPTION
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).
Lidocaine HCl 2% Jelly contains lidocaine HCl which is chemically
designated as
acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride
and has the
following structural formula:
Its molecular formula is C
H
N O • HCl and its molecular weight is 270.80.
Lidocaine HCl 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 Lidocaine HCl 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