Classes
DEA Class; Rx, OTC
Common Brand Names; Differin
- Acne Agents, Topical
Description
Topical agent for the tx of acne vulgaris; causes less skin irritation and is more effective than the highest concentration of tretinoin gel (0.025%).
Indications
Indicated for the treatment of acne vulgaris.
Contraindications
Hypersensitivity to adapalene or any of its components
Adverse Effects
- Dryness (1-45%)
- Scaling (1-44%)
- Burning/stinging (4-29%)
- Erythema (0.5-26%)
- Skin discomfort (6%)
- Pruritus (2%)
- Desquamation (2%)
- Sunburn (1%)
- <1%
- Acne flare
- Conjunctivitis
- Contact dermatitis
- Eczema
- Erythema
- Eyelid edema
- Rash
- Skin discoloration
Warnings
Avoid eyes, lips, and mucous membranes
For external use only
Minimize UV light exposure; use sunscreen and protective clothing
Extreme weather (eg, wind, cold) may cause skin irritation
Adverse reaction risk higher during first month of treatment; generally subsides with use
Do not apply product to abrasions or cuts or to eczematous or sunburned skin
Skin irritation: Apply moisturizer, reduce application frequency, or discontinue
Do not wax treated area or apply topical products that may further irritate skin (eg, astringents, abrasive soaps, and cleansers, exfoliants, sulfur, resorcinol, salicylic acid)
Anaphylaxis, angioedema, urticaria, face edema, eyelid edema, lip swelling, and pruritus sometimes requiring medical treatment have been reported during postmarketing use of adapalene; advise patients to stop using medication and seek medical attention if experiencing allergic or anaphylactoid/anaphylactic reactions during treatment
Pregnancy and Lactation
Available data from clinical trials with DIFFERIN Lotion use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes
There are no data on presence of topical adapalene lotion or metabolite in human milk, effects on breastfed infant, or on milk production
Maximum Dosage
Maximum dosage information is not available.
Maximum dosage information is not available.
Maximum dosage information is not available.
Safe and effective use has not been established.
How supplied
Adapalene
topical cream
- 0.1% (Rx)
topical gel
- 0.1% (OTC)
- 0.3% (Rx)
topical lotion
- 0.1% (Rx)