ADAPALENE gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PruGen, Inc.

INN (International Name):

ADAPALENE

Composition:

ADAPALENE 45 g in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Adapalene gel, 0.1% is supplied in the following size: 45 g laminate tube NDC 42546-720-45 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ADAPALENE- ADAPALENE GEL
PRUGEN, INC.
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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.
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
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.
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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 of adapalene gel should be discontinued if