Epiduo Forte

EPIDUO FORTE- adapalene and benzoyl peroxide gel
Galderma Laboratories, L.P.

45-gram-carton-image

1 INDICATIONS AND USAGE

EPIDUO FORTE 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. EPIDUO FORTE is not for oral, ophthalmic, or intravaginal use.
  • Apply a thin layer of EPIDUO FORTE 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 EPIDUO FORTE may bleach hair or colored fabrics.
  • Avoid the eyes, lips and mucous membranes.

3 DOSAGE FORMS AND STRENGTHS

Each gram of EPIDUO FORTE topical gel contains 3 mg (0.3%) adapalene and 25 mg (2.5%) benzoyl peroxide in a white to very pale yellow, opaque gel. EPIDUO FORTE is available in pumps containing 15 g, 30 g, 45 g, 60 g or 70 g.

4 CONTRAINDICATIONS

EPIDUO FORTE is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in EPIDUO FORTE.

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 EPIDUO FORTE immediately and initiate appropriate therapy.

5.2 Photosensitivity

Avoid exposure to sunlight, including sunlamps, during the use of EPIDUO FORTE. 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 EPIDUO FORTE.

5.3 Skin Irritation/Contact Dermatitis

Erythema, scaling, dryness, and stinging/burning may be experienced with use of EPIDUO FORTE. 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 EPIDUO FORTE, 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 EPIDUO FORTE.
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 EPIDUO FORTE. 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 EPIDUO FORTE and for which the rate with EPIDUO FORTE exceeded the rate for the vehicle are presented in Table 1:

Table 1. Adverse Reactions Occurring in ≥ 1% of Subjects with Acne Vulgaris in a 12-week Clinical Trial
EPIDUO FORTE (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.

Table 2. Incidence of Local Cutaneous Irritation in 12-week Clinical Trial in Subjects with Acne Vulgaris
Maximum SeverityDuring Treatment End of Treatment Severity(Final Score)
Moderate Severe Moderate Severe
EPIDUO FORTE (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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