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Adapalene

Pronunciation

Pronunciation

(a DAP a leen)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External:

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Differin: 0.1% (45 g)

Generic: 0.1% (45 g)

Gel, External:

Differin: 0.1% (45 g)

Differin: 0.3% (45 g) [contains edetate disodium, methylparaben, propylene glycol]

Generic: 0.1% (45 g); 0.3% (45 g)

Lotion, External:

Differin: 0.1% (59 mL) [contains methylparaben, propylene glycol, propylparaben]

Generic: 0.1% (59 mL)

Brand Names: U.S.

  • Differin

Pharmacologic Category

  • Acne Products
  • Topical Skin Product, Acne

Pharmacology

Retinoid-like compound which is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris

Absorption

Topical: Minimal; only trace amounts have been measured in serum after chronic application

Excretion

Bile

Onset of Action

8 to 12 weeks

Half-Life Elimination

Terminal: 7 to 51 hours (gel)

Use: Labeled Indications

Acne vulgaris: Treatment of acne vulgaris.

Contraindications

Hypersensitivity to adapalene or any component of the formulation.

Lotion: There are no contraindications listed in the manufacturer's labeling.

Documentation of allergenic cross-reactivity for retinoids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosage

Acne vulgaris: Children ≥12 years, Adolescents, and Adults: Topical: Apply once daily; use cream and gel in the evening before bedtime

Dosage adjustment in renal impairment: There are no dosage adjustments provided in manufacturer’s labeling; however, systemic absorption is not extensive, making the need for a dose adjustment unlikely.

Dosage adjustment in hepatic impairment: There are no dosage adjustments provided in manufacturer’s labeling; however, systemic absorption is not extensive, making the need for a dose adjustment unlikely.

Administration

For topical use only; not for oral, ophthalmic, or intravaginal use. Avoid contact with abraded, broken, eczematous, or sunburned skin, mucous membranes, eyes, lips, and angles of the nose. Moisturizers may be used if necessary; avoid alpha hydroxy or glycolic acid-containing products. A mild transitory sensation of warmth or slight stinging may occur shortly after application.

Cream/gel: Apply a thin film to clean/dry skin in the evening before bedtime; apply enough to cover entire affected area

Lotion: Apply after washing gently with a mild or soapless cleanser and then pat dry; dispense a nickel size amount (3 to 4 pump actuations) to cover entire face

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F); do not freeze. Protect from light.

Lotion: Protect from light and heat; do not refrigerate.

Drug Interactions

Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Multivitamins/Minerals (with AE, No Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Monitor therapy

Adverse Reactions

>10%: Dermatologic: Dryness (≤45%), scaling (≤44%), erythema (≤38%), burning/stinging (≤29%)

1% to 10%: Dermatologic: Skin discomfort (1% to 6%), desquamation (2%), pruritus (≤2%), skin irritation (1% to 2%), sunburn (1% to 2%)

≤1% (Limited to important or life-threatening): Acne flares, angioedema (gel), application site pain (gel), conjunctivitis, contact dermatitis, dermatitis, eczema, eyelid edema, facial edema (gel), lip swelling (gel), rash (cream/gel), skin discoloration

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Reactions such as pruritus, face edema, eyelid edema, and swelling have been reported. Discontinue use immediately if allergic or anaphylactoid/anaphylactic reactions occur.

• Photosensitivity: Use is associated with increased susceptibility/sensitivity to UV light; avoid sunlamps or excessive sunlight exposure. Daily sunscreen use and other protective measures are recommended. Patients with sunburn should discontinue use until sunburn has healed.

• Skin irritation: Certain cutaneous signs and symptoms such as erythema, dryness, scaling, stinging/burning, or pruritus may occur during treatment; these are most likely to occur during the first 2 to 4 weeks and will usually lessen with continued use. Treatment can increase skin sensitivity to weather extremes of wind or cold. Concomitant topical medications (eg, medicated or abrasive soaps and cleansers, or cosmetics with a strong drying effect, products with high concentrations of alcohol, astringents, spices or limes) should be avoided due to increased skin irritation. Depending on the severity of irritation, use moisturizer, reduce the frequency of application, or discontinue use.

Other warnings/precautions:

• Appropriate use: For external use only; avoid contact with abraded, broken, eczematous, or sunburned skin, mucous membranes, eyes, lips, and angles of the nose. Wax depilation is not recommended.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse effects were observed in animal reproduction studies. Retinoids may cause harm when administered during pregnancy. A case report described maternal use of adapalene 1 month prior to pregnancy and through 13 weeks gestation; cerebral and ocular malformations were reported in the exposed fetus which resulted in termination of pregnancy (Autret, 1997). In clinical trials, women of childbearing potential were required to have a negative pregnancy test prior to therapy.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience sensation of warmth or xeroderma. Have patient report immediately to prescriber severe skin irritation or edema (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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