ADAPALENE gel

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Teva Pharmaceuticals USA, Inc.

INN (इंटरनेशनल नाम):

ADAPALENE

रचना:

ADAPALENE 1 mg in 1 g

प्रशासन का मार्ग:

TOPICAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Adapalene Gel 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 0093-6301-95 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from Freezing. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured in Croatia By: PLIVA Hrvatska d.o.o. Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. A 12/2015

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

ADAPALENE- ADAPALENE GEL
TEVA PHARMACEUTICALS USA, INC.
----------
ADAPALENE GEL, 0.1%
RX ONLY
6301
DESCRIPTION
Adapalene Gel, containing adapalene, is used for the topical treatment
of acne vulgaris. Each gram of
Adapalene Gel contains adapalene 0.1% (1 mg) in a vehicle consisting
of carbomer homopolymer type
C, disodium edetate, 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. Adapalene is represented by the
following structural formula:
C
H O Molecular Weight: 412.52
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
Adapalene Gel is indicated for the topical treatment of acne vulgaris.
CONTRAINDICATIONS
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28
3
Adapalene gel should not be administered to individuals who are
hypersensitive to adapalene or any of
the components in the vehicle gel.
WARNINGS
Use of adapalene gel sho