LIDOCAINE HYDROCHLORIDE- lidocaine hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (International Name):

LIDOCAINE HYDROCHLORIDE

Composition:

LIDOCAINE HYDROCHLORIDE 20 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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. 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. 775:04 11/08

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE SOLUTION
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
----------
LIDOCAINE HYDROCHLORIDE ORAL TOPICAL SOLUTION, USP (VISCOUS) 2%
A Topical Anesthetic for the Mucous Membranes of the Mouth and
Pharynx.
FOR ORAL USE ONLY.
RX ONLY
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 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, saccharin sodium. The pH is adjusted to 5.0 to 7.0 by
means of hydrochloric acid and/or
sodium hydroxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
Lidocaine stabilizes the neuronal membrane by inhibiting the ionic
fluxes required for the initiation and
conduction of impulses, thereby effecting local anesthetic action.
HEMODYNAMICS :
Excessive blood levels may cause changes in cardiac output, total
peripheral resistance, and mean
arterial pressure. These changes may be attributable to a direct
depressant effect of the local anesthetic
agent on various components of the cardiovascular system. The net
effect is normally a modest
hypotension when the recommended dosages are not exceeded.
PHARMACOKINETICS AND METABOLISM:
Lidocaine is absorbed following topical administration to mucous
membranes, its rate and extent of
absorption being dependent upon concentration and total dose
administered, the specific site of
application, and duration of exposure. In general, the rate of
absorption of local anesthetic agents
following topical application occurs most rapidly after intratr