DIFFERIN - adapalene gel

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Galderma Laboratories, L.P.

Laluan pentadbiran:

TOPICAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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

Ringkasan produk:

DIFFERIN (adapalene gel) Gel, 0.1% is supplied in the following size: 45 g laminate tube - NDC 0299-5910-45 Store at controlled room temperature 68° - 77°F (20° - 25°C), excursions permitted between 59° and 86°F (15° - 30°C). Protect from freezing. Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USA Mfd. by: G Production Inc. Baie d’Urfe, QC, H9X 3S4 Canada Made in Canada.  GALDERMA is a registered trademark. P50045-1 Revised: April 2011

Status kebenaran:

New Drug Application

Ciri produk

DIFFERIN - ADAPALENE GEL
GALDERMA LABORATORIES, L.P.
----------
DIFFERIN
(ADAPALENE GEL)
GEL, 0.1%
RX ONLY
DESCRIPTION:
DIFFERIN Gel, containing adapalene, is used for the topical treatment
of acne vulgaris. Each gram of
DIFFERIN Gel contains adapalene 0.1% (1 mg) in a vehicle consisting of
carbomer 940, edetate
disodium, methylparaben, poloxamer 182, propylene glycol, purified
water and sodium hydroxide. May
contain hydrochloric acid to adjust pH.
The chemical name of adapalene is
6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. Adapalene
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:
Adapalene is a chemically stable, retinoid-like compound. 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 may normalize the differentiation of follicular
epithelial cells resulting in
decreased microcomedone formation.
_PHARMACOKINETICS:_
Absorption of adapalene through human skin is low. Only trace amounts
(<0.25 ng/mL) of parent
substance have been found in the plasma of acne patients following
chronic topical application of
adapalene in controlled clinical trials. Excretion appears to be
primarily by the biliary route.
INDICATIONS AND USAGE:
®
®
28
28
3
DIFFERIN Gel is indicated for the topical treatment of acne vulgaris.
CONTRAINDICATIONS:
DIFFERIN Gel should not be administered to individuals who are
hypersensitive to adapalene or any of
the components in the vehicle gel.