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Adapalene (Monograph)

Brand name: Differin
Drug class: Skin and Mucous Membrane Agents, Miscellaneous
VA class: DE752
Chemical name: 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid
Molecular formula: C28H28O3
CAS number: 106685-40-9

Medically reviewed by Drugs.com on Jan 22, 2024. Written by ASHP.

Introduction

Retinoid; synthetic naphthoic acid-derivative.

Uses for Adapalene

Acne Vulgaris

Treatment of acne vulgaris.

Adapalene Dosage and Administration

Administration

Topical Administration

Apply a thin film to skin as a cream, gel, or solution.

Cleanse and dry the affected areas prior to application.

Do not apply to eye(s), lips, angles of nose, or mucous membranes.

A transient feeling of pruritus or burning may occur immediately after application. If increased sensitivity or irritation occurs, reduce frequency of application or, depending on the severity, discontinue use.

Apparent exacerbation of acne that may occur during early weeks of therapy is attributable to the drug’s action on previously unseen lesions; do not discontinue.

Excessive use does not increase therapeutic effects and may produce marked erythema, peeling, and discomfort.

Pledgets

Remove single-use pledget applicators from foil immediately before use, use once, and then discard; do not use if seal is broken.

Dosage

Pediatric Patients

Acne Vulgaris
Topical

Children and adolescents ≥12 years of age: Apply once daily in the evening at bedtime.

Improvement usually detectable within 8–12 weeks.

Adults

Acne Vulgaris
Topical

Apply once daily in the evening at bedtime.

Improvement usually detectable within 8–12 weeks.

Prescribing Limits

Pediatric Patients

Acne Vulgaris
Topical

Children and adolescents ≥12 years of age: most reported experience to date has been for treatment periods that did not exceed 12 weeks.

Adults

Acne Vulgaris
Topical

Most reported experience to date has been for treatment periods that did not exceed 12 weeks.

Cautions for Adapalene

Contraindications

Warnings/Precautions

Sensitivity Reactions

Photosensitivity

Increased risk for sunburn; minimize exposure to sunlight or artificial UV irradiation sources (e.g., sunlamps).

Use caution in patients subjected to considerable occupational sun exposure or with inherent sun sensitivity; use of sunscreen products (SPF 15 or greater) and protective clothing over treated areas recommended when exposure cannot be avoided.

Avoid concomitant use of photosensitizing agents. (See Interactions.)

Use not recommended in patients with sunburn until full recovery occurs.

Other Sensitivity Reactions

Discontinue therapy if sensitivity reaction or chemical irritation occurs.

General Precautions

Dermatologic Effects

Erythema, dryness, scaling, burning, or pruritus may occur. If increased sensitivity or irritation occurs, use less frequently or, depending on the severity of the reaction, discontinue.

Do not apply to cuts, abrasions, or eczematous or sunburned skin. (See Photosensitivity under Cautions.)

Facial Cleansing

Use of mild or soapless cleanser is recommended; use medicated or drying soaps and abrasive soaps and cleansers with caution.

Cosmetic Agents or Processes

Avoid use of irritating cosmetics, other preparations, or processes (e.g., electrolysis) that might dry or irritate the skin. (See Interactions.)

Environmental Stimuli

Possible increased skin irritation in patients exposed to environmental extremes (e.g., wind, cold).

Dry Skin

Use moisturizers if necessary; avoid preparations containing alpha hydroxy or glycolic acids.

Specific Populations

Pregnancy

Category C.

Lactation

Not known whether adapalene is distributed into milk. Use caution.

Pediatric Use

Safety and efficacy not established in children <12 years of age.

Geriatric Use

Insufficient experience in controlled clinical studies in patients ≥65 years of age to determine whether geriatric patients respond differently to adapalene than younger adults. However, clinical experience generally has not revealed age-related differences.

Common Adverse Effects

Erythema, scaling, dryness, pruritus, burning/stinging.

Drug Interactions

Specific Drugs

Drug

Interaction

Comments

Keratolytic agents (e.g., resorcinol, salicylic acid, sulfur)

Possible additive effects

Allow sufficient time for the effects of the keratolytic agent to subside before initiating adapalene

Photosensitizing agents (e.g., fluoroquinolone anti-infectives, phenothiazines, sulfonamides, thiazide diuretics)

Possible increased phototoxicity

Avoid concomitant use

Other Topical Preparations

Potential pharmacodynamic interaction (increased skin irritation). Avoid concurrent use of topical preparations with high concentrations of alcohol, menthol, spices, or lime (e.g., lotions, astringents, perfume); irritating cosmetics (e.g., toners, peeling [desquamating] agents); permanent wave solutions; or hair depilatories or waxes.

Adapalene Pharmacokinetics

Absorption

Bioavailability

Minimally absorbed following topical application.

Elimination

Elimination Route

Eliminated principally by biliary excretion.

Stability

Storage

Topical

Cream, Gel, Solution

20–25°C.

Protect cream from freezing.

Store solution upright in tight container.

Actions

Advice to Patients

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Adapalene

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

0.1%

Differin (with parabens)

Galderma

Gel

0.1%

Differin (with methylparaben and propylene glycol)

Galderma

Pledgets (saturated with solution)

0.1%

Differin (with SD alcohol 40-B 30% w/v)

Galderma

Solution

0.1%

Differin (with SD alcohol 40-B 30% w/v)

Galderma

AHFS DI Essentials™. © Copyright 2024, Selected Revisions February 1, 2005. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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