LIDOCAINE HYDROCHLORIDE solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

DIRECT RX

INN (국제 이름):

LIDOCAINE HYDROCHLORIDE ANHYDROUS

구성:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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.

제품 요약:

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° - 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. 775:07 03/15

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE SOLUTION
DIRECT RX
----------
LIDOCAINE ORAL TOPICAL SOLUTION
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.
A Topical Anesthetic for the Mucous Membranes of the Mouth and
Pharynx.
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:
[Chemical Structure]
The molecular formula of lidocaine is C14H22N2O. The molecular weight
is 234.34.
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.
Mechanism of Action:
Lidocaine stabilizes the neuronal membrane by inhibiting the ionic
fluxes