ADAPALENE cream

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

E. Fougera & Co. a division of Fougera Pharmaceuticals 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 0168-0424-46 Store at controlled room temperature 68° to 77°F (20° to 25°C). Excursions permitted between 59° and 86° F (15° and 30° C). Protect from freezing. I2424B R02/13 #187 E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

ADAPALENE- ADAPALENE CREAM
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
----------
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
28
28
3
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 rout