LIDOCAINE HYDROCHLORIDE- lidocaine hydrochloride lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Stratus Pharamceuticals

INN (International Name):

Lidocaine Hydrochloride

Composition:

Lidocaine Hydrochloride 5.31 mL in 177 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness and discomfort due to pruritus ani, pruritus vulvae, hemorrhoids, anal fissures, and similar conditions of the skin and mucous membranes. Traumatized mucosa, secondary bacterial infection of the area of proposed application and known hypersensitivity to any of the components. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Product summary:

Lidocaine HCl 3% Lotion is supplied in the following size: KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F). Protect from freezing [See USP Controlled Room Temperature].

Authorization status:

unapproved drug other

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE LOTION
STRATUS PHARAMCEUTICALS
_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._
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LIDOCAINE HCL 3% LOTION
Topical Anesthetic
Rx only
DESCRIPTION
Contains lidocaine HCl 3%. Lidocaine is chemically designated as
acetamide, 2-(diethylamino)-N-(2,6-
dimethylphenyl), and has the following structure:
C
H N O MOL.WT.234 .34
Each gram of LIDOCAINE HCL 3% LOTION contains ACTIVE: Lidocaine HCl 30
mg in a lotion base of
INACTIVES: Aluminum sulfate, calcium acetate, cetyl alcohol,
glycerine, mineral oil, methyl paraben,
white petrolatum, glyceryl monostearate SE, propyl paraben, purified
water, sodium hydroxide, sorbitan
stearate, stearic acid and stearyl alcohol
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
LIDOCAINE HCL 3% LOTION releases lidocaine which stabilizes the
neuronal membrane by inhibiting the
ionic fluxes required for initiation and conduction of impulses,
thereby effecting local anesthetic
action.
PHARMACOKINETICS
Lidocaine may be absorbed following topical administration to mucous
membranes, 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 application
occurs most rapidly after intratracheal administration. Lidocaine is
also well-absorbed from the
gastrointestinal tract, but little intact drug appears in the
circulation because of biotransformation in the
liver.
Lidocaine is metabolized rapidly by the liver, and metabolites and
unchanged drug are excreted by the
kidneys. Biotransformation includes oxidative N-dealkylation, ring
hydroxylation, cleavage of the amide
linkage, and conjugation. N-dealkylation, a major pathway of
biotransformation, yields the metabolites
monoethylglycinexylidide and glycinexylidide. The pharmacological /
toxicological actions of t