ADAPALENE cream

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF)

Tillgänglig från:

Physicians Total Caer, Inc.

INN (International namn):

ADAPALENE

Sammansättning:

ADAPALENE 1 mg in 1 g

Administreringssätt:

TOPICAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Adapalene cream is indicated for the topical treatment of acne vulgaris. Adapalene cream should not be administered to individuals who are hypersensitive to adapalene or any of the components in the cream vehicle.

Produktsammanfattning:

Adapalene Cream, 0.1% is supplied in a 45 g tube - NDC 54868-6148-0 Store at controlled room temperature 68° to 77°F (20°-25°C), excursions permitted between 59° and 86° F (15° – 30° C). Protect from freezing. I2424 R8/08 #187 E. FOUGERA & CO. A division of Nycomed US Inc. Melville, New York 11747 Relabeling of "Additional Barcode Label" by: Physicians Total Care, Inc. Tulsa, OK      74146

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

ADAPALENE - ADAPALENE CREAM
PHYSICIANS TOTAL CAER, INC.
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ADAPALENE CREAM, 0.1%
RX ONLY
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE
DESCRIPTION:
Adapalene cream, 0.1%, contains adapalene 0.1% in an aqueous cream
emulsion consisting of carbomer
934P, cyclomethicone, edetate disodium, glycerin, methyl glucose
sesquistearate, methylparaben, PEG-
20 methyl glucose sesquistearate, phenoxyethanol, propylparaben,
purified water, squalane, and
trolamine.
The chemical name of adapalene is
6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white
to off-white powder which is soluble in tetrahydrofuran, sparingly
soluble in ethanol, and practically
insoluble in water. The molecular formula is C
H O and molecular weight is 412.52. Adapalene is
represented by the following structural formula
CLINICAL PHARMACOLOGY:
MECHANISM OF ACTION:
Adapalene acts on retinoid receptors. Biochemical and pharmacological
profile studies have
demonstrated that adapalene is a modulator of cellular
differentiation, keratinization, and inflammatory
processes all of which represent important features in the pathology
of acne vulgaris.
Mechanistically, adapalene binds to specific retinoic acid nuclear
receptors but does not bind to the
cytosolic receptor protein. Although the exact mode of action of
adapalene is unknown, it is suggested
that topical adapalene normalizes the differentiation of follicular
epithelial cells resulting in decreased
microcomedone formation.
PHARMACOKINETICS:
Absorption of adapalene from adapalene cream through human skin is
low. In a pharmacokinetic study
with six acne patients treated once daily for 5 days with 2 grams of
adapalene cream applied to 1000
cm of acne involved skin, there were no quantifiable amounts (limit of
quantification = 0.35 ng/mL) of
adapalene in the plasma samples from any patient. Excretion appears to
be primarily by the biliary route.
INDICATIONS AND USAGE:
Adapalene cream is indicated for the topical treatment of acne
vulgaris.
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CLINICAL STUDIES: