Epiduo Forte 0.3%/2.5%

Epiduo Forte 0.3%/2.5% (Epiduo Forte 0.3%/2.5% 0.3%/2.5%) gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

Benzoyl Peroxide (Epiduo Forte 0.3%/2.5% 0.3%/2.5%) has an antibacterial effect. It also has a mild drying effect, which allows excess oils and dirt to be easily washed away from the skin.

Adapalene (Epiduo Forte 0.3%/2.5%) is similar to vitamin A. It helps the skin renew itself.

Epiduo Forte 0.3%/2.5% (Epiduo Forte 0.3%/2.5% 0.3%/2.5%) topical (for the skin) is a combination medicine used to treat acne in adults and children who are at least 9 years old.

Epiduo Forte 0.3%/2.5% (Epiduo Forte 0.3%/2.5% 0.3%/2.5%) topical may also be used for purposes not listed in this medication guide.

For topical use only. Epiduo Forte 0.3%/2.5% gel is not for oral, ophthalmic, or intravaginal use.

Apply a thin layer of Epiduo Forte 0.3%/2.5% 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). Avoid the eyes, lips and mucous membranes.

How supplied

Dosage Forms And Strengths

Each gram of Epiduo Forte 0.3%/2.5% gel contains 3 mg (0.3%) Adapalene (Epiduo Forte 0.3%/2.5%) and 25 mg (2.5%) Benzoyl Peroxide (Epiduo Forte 0.3%/2.5% 0.3%/2.5%) in a white to very pale yellow, opaque gel. Epiduo Forte 0.3%/2.5% is available in pumps containing 15 g, 30 g, 45 g, 60 g or 70 g.

Epiduo Forte 0.3%/2.5% (Epiduo Forte 0.3%/2.5% (Epiduo Forte 0.3%/2.5% 0.3%/2.5%)) gel 0.3% / 2.5% is white to very pale yellow in color and opaque in appearance, and is supplied as follows:

15 gram pump NDC 0299-5906-15

30 gram pump NDC 0299-5906-30

45 gram pump NDC 0299-5906-45

60 gram pump NDC 0299-5906-60

70 gram pump NDC 0299-5906-70

Storage And Handling

• Store at controlled room temperature 20 – 25°C (68 – 77°F) with excursions permitted to 15° – 30°C (59° – 86°F).
• Protect from light.
• Keep out of reach of children.
• Keep away from heat.

Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177, USA. Revised: July 2015

See also:
What is the most important information I should know about Epiduo Forte 0.3%/2.5%?

Before using this medication, tell your doctor about all other medicated skin products you are using. Using more than one acne medication at a time could cause severe skin irritation.

Avoid getting this medication in your mouth, nose, or eyes, or on your lips. If it does get into any of these areas, rinse with water. Do not use Epiduo Forte 0.3%/2.5% (Epiduo Forte 0.3%/2.5% 0.3%/2.5%) topical on sunburned, windburned, dry, chapped, irritated, or broken skin. Also avoid using Epiduo Forte 0.3%/2.5% (Epiduo Forte 0.3%/2.5% 0.3%/2.5%) topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Avoid using skin products that can cause dryness or irritation, such as harsh soaps, shampoos, or skin cleansers, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

Do not use other medicated skin products unless your doctor has told you to.

Use Epiduo Forte 0.3%/2.5% (Epiduo Forte 0.3%/2.5% 0.3%/2.5%) gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Epiduo Forte 0.3%/2.5% (Epiduo Forte 0.3%/2.5% 0.3%/2.5%) gel. Talk to your pharmacist if you have questions about this information.
• Do not apply Epiduo Forte 0.3%/2.5% (Epiduo Forte 0.3%/2.5% 0.3%/2.5%) gel to eczema or to damaged or sunburned skin.
• Before applying Epiduo Forte 0.3%/2.5% (Epiduo Forte 0.3%/2.5% 0.3%/2.5%) gel, clean the area to be treated with mild soap or soapless cleanser and gently dry.
• Apply a thin film of Epiduo Forte 0.3%/2.5% (Epiduo Forte 0.3%/2.5% 0.3%/2.5%) gel to the affected skin and the surrounding area. Use a pea-sized amount for each area of the face (eg, forehead, chin, cheek) unless your doctor tells you otherwise. Rub in gently.
• Wash your hands right away after using Epiduo Forte 0.3%/2.5% (Epiduo Forte 0.3%/2.5% 0.3%/2.5%) gel.
• A mild sensation of warmth or slight stinging may occur shortly after using Epiduo Forte 0.3%/2.5% (Epiduo Forte 0.3%/2.5% 0.3%/2.5%) gel.
• If you miss a dose of Epiduo Forte 0.3%/2.5% (Epiduo Forte 0.3%/2.5% 0.3%/2.5%) gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. If several applications are missed, contact your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Epiduo Forte 0.3%/2.5% (Epiduo Forte 0.3%/2.5% 0.3%/2.5%) gel.

This medication is used on the skin to treat acne. This medication is a combination of Adapalene (Epiduo Forte 0.3%/2.5%) (a retinoid) and Benzoyl Peroxide (Epiduo Forte 0.3%/2.5% 0.3%/2.5%) (an antibiotic and skin-peeling agent). This product may decrease the number and severity of acne pimples and promote quick healing of pimples that do appear.

Adapalene (Epiduo Forte 0.3%/2.5%) works by affecting the growth of cells and decreasing swelling and inflammation. Benzoyl Peroxide (Epiduo Forte 0.3%/2.5% 0.3%/2.5%) works by reducing the amount of acne-causing bacteria and by causing the skin to dry and peel off..

How to use Epiduo Forte 0.3%/2.5% (Epiduo Forte 0.3%/2.5% 0.3%/2.5%) topical

Wash your hands before applying this medication. Gently clean the affected skin with a mild or soapless cleanser and pat dry. Apply a thin layer of this medication usually once daily or as directed by your doctor. Use your fingertips to apply a small amount of medication (about the size of a pea) to the affected areas of skin.

Use this medication on the skin only. Do not apply to the inner lip area, inside the nose/mouth, or on mucous membranes. Do not apply to cut, scraped, sunburned or eczema-affected skin.

Avoid getting this medication in your eyes. If this medication gets into your eyes, flush with large amounts of water. Call your doctor if eye irritation develops. Wash your hands after using the medication to avoid accidentally getting it in your eyes.

Your dosage and treatment plan is based on your medical condition and response to treatment.

During the first few weeks of using Adapalene (Epiduo Forte 0.3%/2.5%), your acne might appear worse because the medication is working on pimples forming inside the skin.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. Do not use a larger amount or use it more frequently than recommended. Your skin will not improve any faster, and it will increase the risk of developing redness, peeling, and pain.

Tell your doctor if your condition does not improve or if it worsens.

See also:
What other drugs will affect Epiduo Forte 0.3%/2.5%?

No formal drug-drug interaction studies were conducted with Epiduo Forte 0.3%/2.5% gel.

Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents.

See also:
What are the possible side effects of Epiduo Forte 0.3%/2.5%?

Clinical Studies Experience

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 clinical trials, 1401 subjects were exposed to Epiduo Forte 0.3%/2.5%. A total of 1036 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks to 12 months. Related adverse events reported within 12 weeks of treatment and in at least 1% of subjects treated with Epiduo Forte 0.3%/2.5% and those reported in subjects treated with the vehicle gel are presented in Table 1:

Local tolerability evaluations, presented in Table 2, were conducted at each study visit in clinical trials by assessment of erythema, scaling, dryness, burning, and stinging.

Analysis over the 12-week period showed that local tolerability scores for erythema, scaling, dryness, and stinging/burning peaked at Week 1 of therapy and decreased thereafter.

During a pediatric clinical trial, 285 children with acne vulgaris, 9 to 11 years of age were treated with Epiduo Forte 0.3%/2.5% or with the vehicle gel once daily for 12 weeks. Overall, the safety profile of Epiduo Forte 0.3%/2.5% in these subjects is comparable to the safety profile observed in older subjects 12 years of age and above, both in the nature and frequency of the observed adverse events.

Analysis of local tolerability evaluations shows similar incidence of treatment emergent signs and symptoms as in subjects 12 years of age and above, with local tolerability signs and symptoms peaking during the first week and decreasing over time.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Epiduo Forte 0.3%/2.5%: eyelid edema, sunburn, blister, pain of skin, pruritus, swelling face, conjunctivitis, skin discoloration, rash, eczema, throat tightness and allergic contact dermatitis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.