ADAPALENE gel

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Physicians Total Care, Inc.

INN (국제 이름):

ADAPALENE

구성:

ADAPALENE 1 mg in 1 g

관리 경로:

TOPICAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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.

제품 요약:

Adapalene Gel, 0.1% is supplied in the following size: 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 Sellersville, PA 18960 Iss. 1/2010 Relabeling of "Additional Barcode" by: Physicians Total Care, Inc. Tulsa, OK     74146

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

ADAPALENE - ADAPALENE GEL
PHYSICIANS TOTAL CARE, INC.
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ADAPALENE GEL, 0.1%
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 WEIG HT: 4 12.52
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
Adapalene gel should not be administered to individuals who are
hypersensitive to adapalene or any of
the components in the vehicle gel.
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WARNINGS
Use of adapalene gel should be discon