ANESTACON- lidocaine hydrochloride jelly

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hi-Tech Pharmacal Co., Inc.

INN (International Name):

Lidocaine hydrochloride

Composition:

Lidocaine Hydrochloride Anhydrous 20 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocaine hydrochloride jelly USP, 2% (Anestacon® ) 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 hydrochloride jelly USP, 2% (Anestacon® ).

Product summary:

Lidocaine Hydrochloride Jelly USP, 2% (Anestacon® ) is supplied in 15 mL unit-dose disposable container for SINGLE PATIENT USE. Store at control room temperature 20° to 25°C (68° to 77°F) [see USP].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ANESTACON- LIDOCAINE HYDROCHLORIDE JELLY
HI-TECH PHARMACAL CO., INC.
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LIDOCAINE HYDROCHLORIDE JELLY USP, 2%
(ANES TACON )
RX ONLY
DESCRIPTION
Lidocaine Hydrochloride Jelly USP, 2% (Anestacon ) is a sterile
aqueous product that contains a local
anesthetic agent and is administered topically. (See INDICATIONS AND
USAGE for specific uses.)
Lidocaine Hydrochloride Jelly USP, 2% (Anestacon ) contains lidocaine
HCl which is chemically
designated as acetamide, 2- (diethyl-amino)-N-(2,6-dimethylphenyl)-,
monohydrochloride and has the
following structural formula:
Lidocaine Hydrochloride Jelly USP, 2% (Anestacon ) also contains
hydroxypropyl methylcellulose,
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 Hydrochloride Jelly USP, 2% (Anestacon ) 15
mL bottle: Each mL contains
20 mg of lidocaine HCl. The formulation also contains benzalkonium
chloride, hydroxypropyl
methylcellulose, purified water, sodium chloride, 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 3–5 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
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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