LIDOCAINE HYDROCHLORIDE solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Asclemed USA, Inc.

Administreringssätt:

OROPHARYNGEAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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.

Produktsammanfattning:

Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) (NDC 76420-190-10 relabeled from NDC 0527-6002-74) is available in 100 mL polyethylene squeeze bottles. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE SOLUTION
ASCLEMED USA, INC.
----------
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.
14
22
2
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:
Lidocaine stabilizes the neuronal membrane by inhibit