Adapalene and Benzoyl Peroxide
ADAPALENE AND BENZOYL PEROXIDE — adapalene and benzoyl peroxide gel
Viona Pharmaceuticals Inc
1 INDICATIONS AND USAGE
Adapalene and benzoyl peroxide topical gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.
2 DOSAGE AND ADMINISTRATION
- For topical use only. Adapalene and benzoyl peroxide topical gel is not for oral, ophthalmic, or intravaginal use.
- Apply a thin layer of adapalene and benzoyl peroxide topical gel to affected areas of the face and/or trunk once daily after washing.
- Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek).
- Wash hands after application as adapalene and benzoyl peroxide topical gel may bleach hair or colored fabrics.
- Avoid the eyes, lips and mucous membranes.
3 DOSAGE FORMS AND STRENGTHS
Each gram of adapalene and benzoyl peroxide topical gel contains 3 mg (0.3%) adapalene, USP and 25 mg (2.5%) benzoyl peroxide, USP in a white to very pale yellow opaque gel. Adapalene and benzoyl peroxide topical gel is available in pumps containing 45 g or 60 g.
4 CONTRAINDICATIONS
Adapalene and benzoyl peroxide topical gel is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in adapalene and benzoyl peroxide topical gel.
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported with the use of benzoyl peroxide products. If a serious hypersensitivity reaction occurs, discontinue adapalene and benzoyl peroxide topical gel immediately and initiate appropriate therapy.
5.2 Photosensitivity
Avoid exposure to sunlight, including sunlamps, during the use of adapalene and benzoyl peroxide topical gel. Patients with high levels of sun exposure and those with inherent sensitivity to sun should exercise particular caution. Use of broad spectrum sunscreen products and protective apparel (e.g., hat) are recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, may be irritating to patients under treatment with adapalene and benzoyl peroxide topical gel.
5.3 Skin Irritation/Contact Dermatitis
Erythema, scaling, dryness and stinging/burning may be experienced with use of adapalene and benzoyl peroxide topical gel. These are most likely to occur during the first four weeks of treatment, are mostly mild to moderate in intensity and usually lessen with continued use of the medication. Irritant and allergic contact dermatitis may occur. Depending upon the severity of these adverse reactions, patients should be instructed to use a moisturizer, reduce the frequency of the application of adapalene and benzoyl peroxide topical gel or discontinue use. The product should not be applied to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of “waxing” as a depilatory method should be avoided on skin treated with adapalene and benzoyl peroxide topical gel.
Avoid concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices or limes).
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
The following adverse reactions are discussed in greater detail elsewhere in the labeling:
- Hypersensitivity [see Warnings and Precautions (5.1)]
- Skin Irritation/Contact Dermatitis [see Warnings and Precautions (5.3)]
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
During the randomized, double-blind, vehicle- and active-controlled clinical trial, 217 subjects were exposed to adapalene and benzoyl peroxide topical gel. A total of 197 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks. Adverse reactions reported within 12 weeks of treatment in at least 1% of subjects treated with adapalene and benzoyl peroxide topical gel and for which the rate with adapalene and benzoyl peroxide topical gel exceeded the rate for the vehicle are presented in Table 1:
| Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% (N=217) | Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% (N=217) | Vehicle (N=69) | |
| Skin irritation | 4% | < 1% | 0% |
| Eczema | 1% | 0% | 0% |
| Dermatitis atopic | 1% | 0% | 0% |
| Skin burning sensation | 1% | 0% | 0% |
Local tolerability evaluations presented in Table 2, were conducted at each trial visit in the clinical trial by assessment of erythema, scaling, dryness and stinging/burning, which peaked at Week 1 of therapy and decreased thereafter.
| Maximum Severity During Treatment | End of Treatment Severity (Final Score) | |||
| Moderate | Severe | Moderate | Severe | |
| Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% (N=213) | ||||
| Erythema | 20% | 1% | 4% | < 1% |
| Scaling | 17% | 1% | 1% | < 1% |
| Dryness | 15% | 2% | 3% | < 1% |
| Stinging/burning | 19% | 6% | 1% | 1% |
| Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% (N=212) | ||||
| Erythema | 15% | 1% | 2% | < 1% |
| Scaling | 12% | < 1% | 2% | 0% |
| Dryness | 13% | 1% | 2% | 0% |
| Stinging/burning | 14% | 9% | 3% | 0% |
| Vehicle (N=68) | ||||
| Erythema | 6% | 1% | 1% | 0% |
| Scaling | 6% | 0% | 1% | 0% |
| Dryness | 4% | 1% | 1% | 0% |
| Stinging/burning | 3% | 1% | 0% | 0% |
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