LIDOCAINE HYDROCHLORIDE solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

NuCare Pharmaceuticals,Inc.

INN (nume internaţional):

LIDOCAINE HYDROCHLORIDE ANHYDROUS

Compoziție:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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.

Rezumat produs:

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. NDC 66267-962-00 Bottles of 100mL The solution should be stored at controlled room temperature 15° - 30°C (59° - 86°F). SHAKE WELL BEFORE USE. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Made in U.S.A. Rev. 775:09 08/17

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE SOLUTION
NUCARE PHARMACEUTICALS,INC.
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LIDOCAINE HYDROCHLORIDE ORAL TOPICAL SOLUTION, USP (VISCOUS) 2%
A Topical Anesthetic for the Mucous Membranes of the Mouth and
Pharynx.
RX ONLY
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, methylparaben, natural
orange flavor, propylparaben,
purified water, and saccharin sodium. The pH is adjusted to 5.0 to 7.0
by means of hydrochloric acid
and/or sodium hydroxide.
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