Aphoria (adapalene/benzoyl peroxide/niacinamide)
Acne Products Topical Gel (Gram)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Adapalene is a synthetic, naphthoic acid-derivative retinoid.
Adapalene is a synthetic, naphthoic acid-derivative retinoid analog. Adapalene has pharmacologic actions similar to those of other retinoids (e.g., tretinoin, isotretinoin) but has demonstrated more potent anti-inflammatory activity in vitro and in vivo. Unlike tretinoin and isotretinoin but like tazarotene, adapalene has relatively selective affinity for specific nuclear retinoic acid receptor (RAR) proteins (e.g., RARbeta, RARgamma) that appear to enhance gene transcription.
RARgamma is the predominant RAR species expressed in human epidermis and therefore may be the primary molecular target of retinoid action in adult human skin. Adapalene does not interact with retinoid X receptors (RXRs), which work in conjunction with RARs but appear to affect a variety of hormonal pathways and therefore may be involved in producing adverse effects of retinoid therapy. In addition, adapalene does not bind to cytosolic retinoic acid-binding proteins (CRABP).
The exact mechanism of action of topically applied adapalene in the treatment of acne vulgaris has not been fully elucidated. Adapalene appears to affect expression of genes that modulate follicular keratinization, and cell (e.g., epithelial) differentiation, which result in inhibition of corneocyte accumulation and cohesion and a reduction in inflammatory and noninflammatory acne lesions.
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information.
The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Generic name: adapalene/benzoyl peroxide/niacinamide
Drug class: Acne Products
Therapeutic class: Dermatological
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Aphoria
Indications
No indications are available for this drug.
Dosing
The manufacturer states that safety and efficacy of adapalene in children younger than 12 years of age have not been established.
For the topical treatment of acne vulgaris, a thin film of adapalene 0.1% cream or 0.1% gel should be applied to the cleansed affected area once daily in the evening at bedtime. During the early weeks of therapy with adapalene, an apparent exacerbation of acne may occur. This effect is attributable to the action of the drug on previously unseen lesions and should not be considered a reason to discontinue therapy. Improvement usually is detectable within 8-12 weeks of initiating topical therapy with the drug. Most reported experience to date has been for treatment periods that did not exceed 12 weeks.
Adapalene is applied topically to the skin as a 0.1% cream or 0.1% gel.
Prior to application of the cream or gel, the affected areas should be cleansed and dried. A transient feeling of pruritus or burning may occur immediately after application of adapalene cream or gel. If increased sensitivity or irritation occurs, patients should be instructed to reduce the frequency of application or, depending on the severity of the reaction, discontinue use of the drug.
Patients should be advised not to use adapalene cream or gel in amounts larger than instructed or more often than instructed, since such use of the drug will not lead to more rapid or better results but may result in marked erythema, peeling, or discomfort.
Care should be taken not to get adapalene cream or gel into the eyes. In addition, contact of the drug with the lips, mouth, angles of the nose, and mucous membranes should be avoided. If contact with the eye(s) occurs, the eye(s) should be washed with large amounts of water; patients should consult a clinician if ocular irritation persists.
Patients receiving topical adapalene therapy should be cautioned to minimize exposure to sunlight or other UV rays, including sunlamps, unless deemed medically necessary; in such cases, exposure should be minimized during the use of adapalene. Patients with sunburn should not use adapalene until full recovery occurs. In addition, patients should be cautioned to inform their clinician if they are using other drugs that potentially could increase the sensitivity of their skin to sunlight (e.g., fluoroquinolone anti-infectives, thiazide diuretics, sulfonamides, phenothiazines). Patients who may be subjected to considerable sun exposure because of their occupation and those with inherent sensitivity to the sun should be especially cautious; when exposure cannot be avoided, use of sunscreens and protective clothing over treated areas may be prudent. Weather extremes (e.g., wind, cold) may be irritating to patients receiving topical adapalene therapy. Moisturizers may be used if necessary; however, products containing alpha-hydroxy or glycolic acids should be avoided. The manufacturer states that adapalene cream, gel, or solution should not be applied to abraded, eczematous, or sunburned skin.
Patients should be advised that use of adapalene with other topical medications that have a strong skin-drying effect should be undertaken with caution. In patients who have used such agents, sufficient time should elapse for the effects of these drugs to subside before initiating adapalene therapy. Use of topical preparations with high concentrations of alcohol, menthol, spices, or lime rind, such as shaving lotions, astringents, and perfume, also should be used with caution or avoided if possible. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with adapalene cream, gel, or solution. Patients also should avoid the use of irritating cosmetics (e.g., toners, peeling (desquamating) agents), permanent wave solutions, electrolysis, hair depilatories, or other preparations or processes that might dry or irritate the skin during topical therapy with adapalene.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
There is no enhanced messaging for this drug.
- Pregnancy
- Exfoliative dermatitis
- Skin photosensitivity
- No disease contraindications
Adverse reactions
There is no enhanced messaging for this drug.
Less Frequent
- Skin irritation
Rare or Very Rare
- Anaphylaxis
- Anaphylaxis
- Angioedema
- Angioedema
- Dermatitis due to topical drug
- Dyspnea
- Eczema
- Eyelid edema
- Facial edema
- Hypersensitivity drug reaction
- Periorbital edema
- Pharyngeal edema
- Pruritus of skin
- Skin rash
- Syncope
- Throat constriction
- Urticaria
More Frequent
- Dry skin
- Erythema
- Pruritus of skin
- Skin scaling
- Stinging of skin
Less Frequent
- Abnormal desquamation
- Atopic dermatitis
- Dry skin
- Erythema
- Sensation of warmth
- Skin irritation
- Stinging of skin
Rare or Very Rare
- Conjunctivitis
- Contact dermatitis
- Dyschromia
- Dyschromia
- Lip swelling
- Skin inflammation
- Skin photosensitivity
Precautions
No enhanced messaging available.
No enhanced messaging available.
No enhanced messaging available.
No enhanced messaging available.
No enhanced messaging available.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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