LIDOCAINE VISCOUS- lidocaine hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

LIDOCAINE HYDROCHLORIDE

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocaine is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type, or to other components of the solution.

Product summary:

Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution, USP) The 2% oral topical solution is supplied as a clear, colorless, viscous solution . NDC 0054-0548-44: Squeeze Bottle of 20 mL NDC 0054-3500-49: Squeeze Bottle of 100 mL Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a child-resistant container as defined in the USP/NF. SHAKE WELL BEFORE USE. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000710/01 Revised May 2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE VISCOUS- LIDOCAINE HYDROCHLORIDE SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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LIDOCAINE VISCOUS 2% (LIDOCAINE HYDROCHLORIDE ORAL TOPICAL SOLUTION,
USP)
RX ONLY
A topical anesthetic for the mucous membranes of the mouth and
pharynx.
WARNING: LIFE-THREATENING AND FATAL EVENTS IN INFANTS AND YOUNG
CHILDREN
Postmarketing cases of seizures, cardiopulmonary arrest, and death in
patients
under the age of 3 years have been reported with use of Lidocaine
Viscous 2%
when it was not administered in strict adherence to the dosing and
administration
recommendations. In the setting of teething pain, Lidocaine Viscous 2%
should
generally not be used. For other conditions, the use of the product in
patients less
than 3 years of age should be limited to those situations where safer
alternatives
are not available or have been tried but failed.
To decrease the risk of serious adverse events with use of Lidocaine
Viscous 2%,
instruct caregivers to strictly adhere to the prescribed dose and
frequency of
administration and store the prescription bottle safely out of reach
of children.
DESCRIPTION
Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution,
USP) contains a
local anesthetic agent and is administered topically. Lidocaine
Viscous 2% (Lidocaine
Hydrochloride Oral Topical Solution, USP) contains lidocaine
hydrochloride, which is
chemically designated as acetamide,
2-(diethylamino)-_N_-(2,6-dimethylphenyl)-
,monohydrochloride, monohydrate and has the following structural
formula:
The molecular formula of lidocaine is C
H
N O • HCl • H O. The molecular weight is
288.81.
14
22
2
2
COMPOSITION OF SOLUTION:
Each mL contains 20 mg (2%) of lidocaine hydrochloride, USP and the
following inactive
ingredients: carboxymethylcellulose sodium, flavoring, methylparaben,
propylparaben,
purified water and saccharin sodium.
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 lo