LIDOCAINE HYDROCHLORIDE solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Unit Dose Services

Vía de administración:

OROPHARYNGEAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Lidocaine hydrochloride oral topical solution USP, 2% (viscous) 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.

Resumen del producto:

NDC:50436-1827-1 in a BOTTLE of 100 SOLUTIONS Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE SOLUTION
UNIT DOSE SERVICES
----------
LIDOCAINE HYDROCHLORIDE ORAL TOPICAL SOLUTION USP, 2% (VISCOUS)
RX ONLY
A Topical Anesthetic for the Mucous Membranes of the Mouth and
Pharynx.
Post marketing 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 2% (viscous)
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 2% (viscous) 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. WARNING: LIFE-THREATENING AND FATAL EVENTS IN
INFANTS AND YOUNG CHILDREN
To decrease the risk of serious adverse events with use of lidocaine
hydrochloride oral topical
solution 2% (viscous), 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, 2% (viscous)
contains a local anesthetic agent and
is administered topically. Lidocaine hydrochloride oral topical
solution USP, 2% (viscous) contains
lidocaine HCl, which is chemically designated as acetamide,
2-(diethylamino)- -(2,6-dimethylphenyl)-,
monohydrochloride and has the following structural formula: _N_
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, artificial cherry flavor,
methylparaben, propylparaben,
saccharin sodium, sodium carboxymethylcellulose, and sodium hydroxide
in purified water. The pH is
adjusted to 5.0 to 7.0 with hydrochloric acid and/or sodium hydroxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
14222
Lidocaine stabilizes the neuronal membrane by inhibiti