LIDOCAINE HYDROCHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)

Available from:

Akorn

INN (International Name):

LIDOCAINE HYDROCHLORIDE ANHYDROUS

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% 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 Hydrochloride Oral Topical Solution, USP (Viscous) 2% is a clear, viscous liquid with a very slight orange flavor available in 100 mL polyethylene squeeze bottles and in 15 mL unit dose in trays of ten cups. The solution should be stored at controlled room temperature 15° to 30°C (59° to 86°F). SHAKE WELL BEFORE USE. Distributed by: Akorn Operating Company LLC Gurnee, IL 60031 Made in U.S.A. Rev. 775:12 03/22

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE SOLUTION
AKORN
----------
LIDOCAINE HYDROCHLORIDE ORAL TOPICAL SOLUTION, USP (VISCOUS) 2%
RX ONLY
A Topical Anesthetic for the Mucous Membranes of the Mouth and
Pharynx.
FOR ORAL USE ONLY
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
Hydrochloride
Oral Topical Solution, USP (Viscous) 2% when it was not administered
in strict
adherence to the dosing and administration recommendations. In the
setting of
teething pain, Lidocaine Hydrochloride Oral Topical Solution, USP
(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
Hydrochloride
Oral Topical Solution, USP (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 Hydrochloride Oral Topical Solution, USP (Viscous) 2%
contains a local
anesthetic agent and is administered topically. Lidocaine
Hydrochloride Oral Topical
Solution, USP (Viscous) 2% contains lidocaine hydrochloride, which is
chemically
designated as acetamide, 2-(diethylamino)-N- (2,6 dimethylphenyl)-,
monohydrochloride
and has the following structural formula:
The molecular formula of lidocaine is C
H
N O. The molecular weight is 234.34.
COMPOSITION OF SOLUTION
Each mL contains 20 mg of lidocaine HCl. In addition each mL contains
the following
inactive ingredients: carboxymethylcellulose sodium USP, methylparaben
NF, natural
orange flavor, propylparaben NF, purified water USP, and saccharin
sodium USP. The pH
is adjusted to 5.0 to 7.0 by means of hydrochloric acid and/or sodium
hydroxide.
CLINICAL P