LIDOCAINE HYDROCHLORIDE cream

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)

から入手可能:

Seton Pharmaceuticals

投与経路:

TOPICAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Anesthetic for relief of 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. Reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place. Dosage in pediatric patients should be reduced commensurate with age, body weight and physical condition.

製品概要:

Lidocaine 3% Cream is supplied as a white cream in: 1 oz. (28.35 g) tubes, NDC 13925-159-01 3 oz. (85 g) tubes, NDC 13925-159-03

認証ステータス:

unapproved drug other

製品の特徴

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE CREAM
SETON PHARMACEUTICALS
_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 3% CREAM
RX ONLY
DESCRIPTION:
Lidocaine 3% Cream is a topical anesthetic indicated for the relief of
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.
ACTIVE INGREDIENT:
Each gram of Lidocaine 3% Cream contains lidocaine hydrochloride 3%
(30 mg).
INACTIVE INGREDIENTS:
aluminum sulfate, calcium acetate, cetyl alcohol, citric acid,
glyceryl stearate (and) PEG-
100 stearate, methylparaben, mineral oil, PEG-150 distearate,
petrolatum, polycarbophil,
propylene glycol, propylparaben, purified water, sodium citrate,
sodium hydroxide,
stearyl alcohol, xanthan gum.
CLINICAL PHARMACOLOGY:
MECHANISM OF ACTION:
Lidocaine 3% Cream releases lidocaine 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.
Lidocaine is chemically designated as acetamide, 2-
(diethylamino)-N-(2,6-
dimethylphenyl), and has the following structure.
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