ADAPALENE gel

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Glenmark Pharmaceuticals Inc., USA

INN (इंटरनेशनल नाम):

ADAPALENE

रचना:

ADAPALENE 1 mg in 1 g

प्रशासन का मार्ग:

TOPICAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Adapalene gel, 0.1% is indicated for the topical treatment of acne vulgaris. Adapalene gel should not be administered to individuals who are hypersensitive to adapalene or any of the components in the vehicle gel.

उत्पाद समीक्षा:

Adapalene gel, 0.1% is supplied in the following size: 45 g laminate tube NDC 68462-403-55 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

ADAPALENE- ADAPALENE GEL
GLENMARK PHARMACEUTICALS INC., USA
----------
ADAPALENE GEL, 0.1%
RX ONLY
DESCRIPTION:
Adapalene Gel, 0.1%, containing adapalene, USP is used for the topical
treatment of
acne vulgaris. Each gram of adapalene gel, 0.1% contains adapalene,
USP 0.1% (1 mg)
in a vehicle consisting of carbomer homopolymer, edetate disodium,
methylparaben,
poloxamer 182, propylene glycol, purified water and sodium hydroxide.
The chemical name of adapalene, USP is
6-[3-(1-adamantyl)-4-methoxyphenyl]-2-
naphthoic acid. Adapalene, USP is a white to off-white powder which is
sparingly soluble
in tetrahydrofuran, very slightly soluble in diethyl ether. The
molecular formula is
C
H
O and molecular weight is 412.52 g/mol. Adapalene, USP 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:
28
28
3
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:
Adapalene gel, 0.1% is indicated for the topical treatment of acne
vulgaris.
CONTRAINDICATIONS:
Adapalene gel should not be administered to individuals who are
hypersensitive to
adapalene or any of the components in the vehicle gel.
WARNINGS:
Use o