LIDOCAINE HYDROCHLORIDE- 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 ANHYDROUS 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. In unit use packages containing one single use vial and a URO-JET® AC (Anatomically Constricted) vial injector. Box of 25 Syringe Assembly Directions USE ASEPTIC TECHNIQUE Do not assemble until ready to use. *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 Pharmaceuticals Company REV. 10-10

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE - LIDOCAINE HYDROCHLORIDE JELLY
GENERAL INJECTABLES & VACCINES, INC
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LIDOCAINE HCL JELLY, USP, 2% 20 MG/ML 10 ML STERILE PAK URO-JET
DES CRIPTION
Lidocaine Hydrochloride Jelly USP, 2% is a sterile aqueous product
that contains a local anesthetic
agent and is administered topically. See INDICATIONS 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:
Composition of Lidocaine Hydrochloride Jelly USP, 2%
Each mL contains 20 mg of lidocaine hydrochloride, and sodium
carboxymethylcellulose as a
viscosity-increasing agent. Sodium hydroxide may have been added to
adjust pH to meet USP limits of 6
to 7. Carboxymethylcellulose sodium adjusts the resulting mixture to a
suitable consistency, to enhance
contact with mucosa and provide lubrication for instrumentation. This
product contains no preservative
and any unused portion should be discarded after initial use.
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 mos