LIDOCAINE HYDROCHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)

Available from:

Teligent Pharma, Inc.

INN (International Name):

Lidocaine Hydrochloride

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 40 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocaine Hydrochloride Topical Solution USP, 4% is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract. Lidocaine HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of Lidocaine Hydrochloride Topical Solution, 4%.

Product summary:

Lidocaine Hydrochloride Topical Solution USP, 4% is available in 50 mL screw cap glass bottles, individually cartoned. NOT FOR INJECTION. Lidocaine Hydrochloride Topical Solution USP, 4% 50 mL NDC 52565-009-50 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310 PI-009-00 Rev 11/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE SOLUTION
TELIGENT PHARMA, INC.
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LIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION USP, 4%
RX ONLY
DESCRIPTION
Lidocaine Hydrochloride Topical Solution USP, 4% contains a local
anesthetic agent and is
administered topically. See INDICATIONS for specific uses.
Lidocaine Hydrochloride Topical Solution USP, 4% contains lidocaine
HCl, which is chemically
designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-,
monohydrochloride and has the
following structural formula:
The 50 mL screw-cap bottle should not be autoclaved, because the
closure employed cannot withstand
autoclaving temperatures and pressures. Composition of Lidocaine
Hydrochloride Topical Solution
USP, 4%: Each mL contains lidocaine HCl, 40 mg, methylparaben,
purified water, and sodium
hydroxide to adjust pH to 6.0-7.0.
An aqueous solution. NOT FOR INJECTION.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Lidocaine HCl 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.
PHARMACOKINETICS AND METABOLISM
Lidocaine HCl may be absorbed following topical administration to
mucous membranes, its rate of
absorption and percent of dose absorbed depending 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 intratracheal administration.
Lidocaine HCl is well-absorbed from the gastrointestinal tract, but
little intact drug appears in the
circulation because of biotransformation in the liver.
Lidocaine HCl is metabolized rapidly by the liver, and metabolites and
unc