ADAPALENE- adapalene solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Allegis Pharmaceuticals, LLC

관리 경로:

TOPICAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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

제품 요약:

Adapalene Topical Solution 0.1% is supplied in the following size: 60mL glass bottle - NDC 28595-530-60 Store at 20' to 25'C (68' to 77'F). [See USP controlled room temperature] CAUTION: Federal law prohibits dispensing without prescription.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

ADAPALENE- ADAPALENE SOLUTION
ALLEGIS PHARMACEUTICALS, LLC
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ADAPALENE TOPICAL SOLUTION 0.1%
RX ONLY
DESCRIPTION
Adapalene Topical Solution 0.1%, containing adapalene is used for the
topical treatment of acne
vulgaris. Each ml of Adapalene Topical Solution, 0.1%, contains
adapalene 0.1% (1mg) in a vehicle
consisting of polyethylene glycol 400 and alcohol, denatured, 30%
(w/v).
The chemical name of adapalene is
6-[3-(l-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 is
unknown, IT is suggested that topical
adapalene may normalize the differentiation of follicular epithelial
cells resulting in decreased
microcomedone formation.
PHARMACOKINELICS
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 Topical Solution 0.1% is indicated for the topical treatment
of acne vulgaris.
CONTRAINDICATIONS
Adapalene Topical Solution 0.1% should not be administered to
individuals who are hypersensitive to
adapalene or any of the components in the vehicle solution.
WARNINGS
Use of Adapalene Topical Solution 0.1% sh