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Differin (adapalene)

THERAPEUTIC CLASS

Naphthoic acid derivative (retinoid-like)

DEA CLASS

RX

INDICATIONS

Topical treatment of acne vulgaris in patients ≥12 yrs of age.

ADULT DOSAGE

Acne Vulgaris

Cre:
Apply a thin film qpm

0.1% Gel:
Apply a thin film qpm after washing

0.3% Gel:
Apply a thin film qpm after washing

Reevaluate if therapeutic results are not noticed after 12 weeks of treatment

Lot:
Apply a thin film (3-4 actuations of the pump) qd after washing

PEDIATRIC DOSAGE

Acne Vulgaris

≥12 Years:
Cre:
Apply a thin film qpm

0.1% Gel:
Apply a thin film qpm after washing

0.3% Gel:
Apply a thin film qpm after washing

Reevaluate if therapeutic results are not noticed after 12 weeks of treatment

Lot:
Apply a thin film (3-4 actuations of the pump) qd after washing

ADMINISTRATION

Topical route

Apply enough to cover the entire face or other affected areas completely and lightly

HOW SUPPLIED

Cre: 0.1% [45g]; Gel: 0.1% [45g], 0.3% [15g, 45g tube; 45g pump]; Lot: 0.1% [2 oz]

WARNINGS/PRECAUTIONS

Not for ophthalmic, oral, or intravaginal use. Avoid exposure to sunlight, including sunlamps; caution in patients with high levels of sun exposure and those with inherent sensitivity to sun. Extreme weather (eg, wind, cold) may cause irritation. Local skin irritation may be experienced; depending on severity, may use moisturizer, reduce frequency of application, or d/c use. (Cre/Gel) Apparent exacerbation of acne may occur. (Cre/0.1% Gel) D/C if reaction suggesting sensitivity or chemical irritation occurs. (Cre/0.3% Gel) A mild transitory sensation of warmth or slight stinging may occur shortly after application. (0.1% Gel) Avoid in patients with sunburn until fully recovered. (0.3% Gel) Reactions characterized by pruritus, face edema, eyelid edema, and lip swelling, requiring medical treatment reported; d/c use if experiencing allergic or anaphylactoid/anaphylactic reactions during therapy.

ADVERSE REACTIONS

Local cutaneous irritation. (0.3% Gel) Skin discomfort.

DRUG INTERACTIONS

Caution with preparations containing sulfur, resorcinol, or salicylic acid. (Cre/Gel) Do not start therapy until effects of such preparations in the skin have subsided. Caution with other potentially irritating topical products (medicated/abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime). (Lot) Caution with concomitant topical acne therapy, especially with peeling, desquamating, or abrasive agents. Avoid with other potentially irritating topical products.

PREGNANCY AND LACTATION

Category C, caution in nursing.

MECHANISM OF ACTION

Naphthoic acid derivative; not established. Binds to specific retinoic acid nuclear receptors and modulates cellular differentiation, keratinization, and inflammatory processes.

PHARMACOKINETICS

Absorption: (0.3% Gel, Day 10) Cmax=0.553ng/mL, AUC0-24hr=8.37ng•hr/mL. (Lot, Day 28) Adolescent: Cmax=0.128ng/mL, AUC0-24hr=3.07ng•hr/mL. Elimination: (Cre/Gel) Bile. (0.3% Gel) T1/2=17.2 hrs.

ASSESSMENT

Assess for excessive sun exposure, sun sensitivity, hypersensitivity to any of the components of the drug, pregnancy/nursing status, and for possible drug interactions. Assess for presence of cuts, abrasions, eczematous, or sunburned skin at the treatment site.

MONITORING

Monitor for sensitivity or chemical irritation, cutaneous signs/symptoms, and other adverse reactions.

PATIENT COUNSELING

Advise to cleanse area with mild or soapless cleanser before applying the medication. Instruct to avoid or minimize exposure to sunlight and sunlamps. Instruct to use sunscreen products and protective clothing when exposure cannot be avoided. Instruct not to use more than the recommended amount. Instruct to avoid contact with eyes, lips, angles of the nose, and mucous membranes. Advise not to apply medication to cuts, abrasions, eczematous, or sunburned skin. Counsel to avoid use of waxing as depilatory method. Advise to use moisturizers if necessary and to avoid products containing α-hydroxyl or glycolic acids. Instruct to use externally and ud. Inform that an apparent exacerbation of acne may occur during the early weeks of therapy and that it should not be considered a reason for discontinuation. Instruct to contact the physician if signs of allergy or hypersensitivity develop. (Cre/0.3% Gel/Lot) Avoid waxing as a depilatory method.

STORAGE

20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). Protect from freezing. (Lot) Do not refrigerate. Protect from light. Keep away from heat.

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