Adapalene

Q: Is Adapalene available over the counter?

Adapalene is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

Prescription

Brand names: Adapalene

Dosage Form

Topical

Route

TOPICAL

Manufacturer

E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC

About This Medication

DESCRIPTION: Adapalene cream, 0.1%, contains adapalene 0.1% in an aqueous cream emulsion consisting of carbomer 934P, cyclomethicone, edetate disodium, glycerin, methyl glucose sesquistearate, methylparaben, PEG-20 methyl glucose sesquistearate, phenoxyethanol, propylparaben, purified water, squalane, and trolamine. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It 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 28 H 28 O 3 and molecular weight is 412.52. Adapalene is represented by the following structural formula: Structural Formula

Active Ingredients

Ingredient	Strength
Adapalene	-

Indications & Usage

INDICATIONS AND USAGE: Adapalene cream is indicated for the topical treatment of acne vulgaris.

How It Works

Mechanism of Action: Adapalene acts on retinoid receptors. 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 normalizes the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.

Dosage & Administration

DOSAGE AND ADMINISTRATION: Adapalene cream should be applied to affected areas of the skin, once daily at nighttime. A thin film of the cream should be applied to the skin areas where acne lesions appear, using enough to cover the entire affected area lightly. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of adapalene cream.

Side Effects Overview

ADVERSE REACTIONS: In controlled clinical trials, local cutaneous irritation was monitored in 285 acne patients who used adapalene cream once daily for 12 weeks. The frequency and severity of erythema, scaling, dryness, pruritus and burning were assessed during these studies. The incidence of local cutaneous irritation with adapalene cream from the controlled clinical studies is provided in the following table: Incidence of Local Cutaneous Irritation with Adapalene Cream from Controlled Clinical Studies (N=285) None Mild Moderate Severe Erythema 52% (148) 38% (108) 10% (28) <1% (1) Scaling 58% (166) 35% (100) 6% (18) <1% (1) Dryness 48% (136) 42% (121) 9% (26) <1% (2) Pruritus (persistent) 74% (211) 21% (61) 4% (12) <1% (1) Burning/Stinging (persistent) 71% (202) 24% (69) 4% (12) <1% (2) Other reported local cutaneous adverse events in patients who used adapalene cream once daily included: sunburn (2%), skin discomfort-burning and stinging (1%) and skin irritation (1%). Events occurring in less than 1% of patients treated with adapalene cream included: acne flare, dermatitis and contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.

Contraindications

CONTRAINDICATIONS: Adapalene cream should not be administered to individuals who are hypersensitive to adapalene or any of the components in the cream vehicle.

Pharmacokinetics

Pharmacokinetics: Absorption of adapalene from adapalene cream through human skin is low. In a pharmacokinetic study with six acne patients treated once daily for 5 days with 2 grams of adapalene cream applied to 1000 cm 2 of acne involved skin, there were no quantifiable amounts (limit of quantification = 0.35 ng/mL) of adapalene in the plasma samples from any patient. Excretion appears to be primarily by the biliary route.

Frequently Asked Questions

INDICATIONS AND USAGE: Adapalene cream is indicated for the topical treatment of acne vulgaris.

DOSAGE AND ADMINISTRATION: Adapalene cream should be applied to affected areas of the skin, once daily at nighttime. A thin film of the cream should be applied to the skin areas where acne lesions appear, using enough to cover the entire affected area lightly. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of adapalene cream.

CONTRAINDICATIONS: Adapalene cream should not be administered to individuals who are hypersensitive to adapalene or any of the components in the cream vehicle.

Adapalene is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

References & Data Sources

• DailyMed — Adapalene drug label (National Library of Medicine)
• openFDA — Adapalene label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 313852 (NLM Normalized Drug Names)
• NDC Directory — Adapalene (FDA National Drug Code)

Medical Disclaimer

The information on this page is intended for educational purposes only and should not be used as a substitute for professional medical advice, diagnosis, or treatment.

Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication.

Data sources: DailyMed (NLM), openFDA, MFDS