LIDOCAINE HYDROCHLORIDE- lidocaine gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)

Available from:

Lake Erie Medical DBA Quality Care Products LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocaine Hydrochloride USP is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of LidoRx 3%. Do not use LidoRx 3% on traumatized mucosa or in the presence of secondary bacterial infection of the area of proposed application.

Product summary:

Lido Rx 3%(Lidocaine HCl USP 3%) 1.01 oz (28.5g) 30mL Airless Pump - NDC 35356-936-30 35356-936-90 Relabeled by: Quality Care Products, LLC Holland, OH 43528 Gensco Labratories, LLC 12741 Miramar Parkway Miramar, FL 33027

Authorization status:

unapproved drug other

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE- LIDOCAINE GEL
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
LIDORX (LIDOCAINE HCL USP) 3%
RX ONLY
DO NOT USE IN THE EYES.
DESCRIPTION
Lidocaine HCL USP, 3% contains a local anesthetic agent and is
administered topically. See
INDICATIONS AND USAGE for specific uses.
Lidocaine HCL USP, 3% contains lidocaine, which is chemically
designated as acetamide, 2-
(diethylamino)-_N_-(2,6-dimethylphenyl)-, and has the following
structural formula:
Composition of Lidocaine HCL USP, 3%: Each gram contains lidocaine
hydrocloride USP, 3% in a
water soluble base containing AQUA (DEIONIZED WATER), CARBOMER,
ISOPROPYL
ALCOHOL, PETROLATUM, POLYSORBATE-20, TRIETHANOLAMINE.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
LidoRx 3% releases Lidocaine Hydrochloride USP from a mild acidic
vehicle to stabilize the neuronal
membrane by inhibiting the ionic fluxes required for initiation and
conduction of impulses, thereby
effecting local anesthetic action. A mild acidic vehicle lowers pH to
increase protection against
alkaline irritations and to provide a favorable environment for
healing.
ONSET OF ANESTHESIA
LidoRx 3% effects local, topical anesthesia. The onset of action is
3-5 minutes.
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 Hydrochloride USP may be absorbed following topical
administration to mucous membranes
or open wounds, its rate and extent of absorption depending upon the
specific site of application,
duration of exposure, concentration, and total dosage. In general, the
rate of absorption of local
anesthetic agents following topical applicatio