LIDOCAINE HYDROCHLORIDE solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Chartwell RX, LLC

Uygulama yolu:

OROPHARYNGEAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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.

Ürün özeti:

Lidocaine Hydrochloride Oral Topical Solution, USP, 2% (Viscous) (NDC 62135-712-42) is a clear, viscous and pale yellow liquid with wild cherry flavor, available in 100 mL polyethylene squeeze bottles. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71559 Rev. 06/2023

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE SOLUTION
CHARTWELL RX, LLC
----------
LIDOCAINE HYDROCHLORIDE ORAL TOPICAL SOLUTION, USP, 2% (VISCOUS)
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
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.
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)- _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, wild 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.
14
22
2
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
Lidocaine stabilizes the neuronal membrane by inhibiting t