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:

General Injectables & Vaccines, Inc

INN (International Name):

Lidocaine Hydrochloride

Composition:

Lidocaine Hydrochloride 20 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocaine Hydrochloride Jelly USP, 2% 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%.

Product summary:

Lidocaine Hydrochloride Jelly USP, 2% Box of 25 In unit use packages containing one single use vial and a URO-JET vial injector. * CAUTION:  IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY. Store at controlled room temperature 15° to 30°C (59° to 86°F). Rx Only INTERNATIONAL MEDICATION SYSTEMS, LIMITED SOUTH EL MONTE, CA 91733, U.S.A. An Amphastar Pharmceuticals Company REV. 10-19

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE JELLY
GENERAL INJECTABLES & VACCINES, INC
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LIDOCAINE HYDROCHLORIDE JELLY USP, 2% A STERILE, WATER-SOLUBLE,
TOPICAL ANESTHETIC
DESCRIPTION
Lidocaine Hydrochloride Jelly USP, 2% 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% contains lidocaine hydrochloride
which is
chemically designated as acetamide,
2-(diethylamino)-N-(2,6-dimethylphenyl)-,
monohydrochloride and has the following structural formula:
Lidocaine Hydrochloride Jelly USP, 2% also contains hypromellose, and
the resulting
mixture maximizes contact with muscosa and provides lubrication for
instrumentation.
The unused portion should be discarded after initial use.
Composition of Lidocaine Hydrochloride Jelly USP, 2%: 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 between 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 3-5 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
varies
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 rapidl