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Epiduo Forte (0.3% adapalene and 2.5% benzoyl peroxide) gel

Summary about Epiduo Forte

Epiduo Forte (adapalene and benzoyl peroxide) gel, 0.3%/2.5% is a once-a-day prescription medication, with two powerful ingredients that treat tough acne now and helps prevent recurring acne from forming by unclogging pores and killing bacteria. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. Epiduo Forte Gel treats tough acne and reduces inflammatory lesions (blemishes), and the risk of acne scars.

It contains the highest concentration of the retinoid adapalene to reduce the inflammation associated with moderate to severe acne. If left untreated, inflammatory acne can lead to permanent scarring.

Epiduo Forte Gel is an antibiotic-free and comes in a convenient, easy-to-use pump. In clinical trials, many patients with hard-to-treat acne saw their breakouts visibly improve and continue to get better with regular treatment.

Epiduo Forte Gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

The most commonly reported adverse reactions (≥1%) in patients treated with Epiduo Forte Gel are skin irritation, eczema, atopic dermatitis and skin burning sensation.

Patients using Epiduo Forte Gel should avoid exposure to sunlight and sunlamps and wear sunscreen when sun exposure cannot be avoided. Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of Epiduo Forte Gel and may necessitate discontinuation. When applying Epiduo Forte Gel, care should be taken to avoid the eyes, lips and mucous membranes.

 

 

Epiduo Forte (0.3% adapalene and 2.5% benzoyl peroxide)

Active Ingredient

Adapalene and benzoyl peroxide

Administration Route

Gel for topical use

Alcohol Warning

In general, alcohol should be avoided during Epiduo Forte use. As it can enhance side effects of this product such as redness and itching.

Available Strength

Gel – 0.3% adapalene and 2.5% benzoyl peroxide

Breastfeeding Warning

Caution is recommended.

This drug should be applied in areas away from the chest to prevent accidental contact with the infant’s skin.

Risk to the nursing infant is considered low, as only a negligible amount is absorbed after topical application.

Excreted into human milk: Unknown
Excreted into animal milk: Yes (adapalene); Unknown (benzoyl peroxide)

Clinical Pharmacology

Pharmacodynamics

Adapalene is a chemically stable retinoid-like compound. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes all of which represent important features in the pathology of acne vulgaris.

Benzoyl peroxide acts as an antibacterial, irritant, keratolytic, comedolytic, and anti-inflammatory agent when applied topically to the human epithelium.

Pharmacokinetics

A pharmacokinetic study was conducted in 26 adult and adolescent subjects (12 to 33 years of age) with severe acne vulgaris who were treated with once-daily applications during a 4-week period with, on average, 2.3 grams/day (range 1.6-3.1 grams/day) of EPIDUO FORTE gel applied as a thin layer to the face, shoulders, upper chest, and upper back.

After a 4-week treatment, 16 subjects (62%) had quantifiable adapalene plasma concentrations above the limit of quantification of 0.1 ng/mL, with a mean Cmax of 0.16 ± 0.08 ng/mL and a mean AUC0-24hrof 2.49 ± 1.21 ng.h/mL. The most exposed subject had adapalene Cmax and AUC0-24hr of 0.35 ng/mL and 6.41 ng.h/mL, respectively. Excretion of adapalene appears to be primarily by the biliary route.

Benzoyl peroxide is absorbed by the skin where it is converted to benzoic acid and eliminated in the urine.

Cost

Approximate Price

from  https://www.drugs.com/price-guide/epiduo-forte

topical gel:

45g: from $587.14

Dosage Form

Topical gel 0.3%/2 5% in 15-g, 30-g, 45-g, 60-g and 70-g pumps

Dose Schedule

Apply a thin layer of EPIDUO FORTE 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.

Drug Class

Benzoyl peroxide:

D10AE — Peroxides

Adapalene:

D10AD — Retinoids for topical use in acne

Drug Unit

mg/g; %

Food Warning

There are no specific foods that you must exclude from your diet when receiving Epiduo Forte.

Included In
Health Insurance Plan

In general, Medicare plans do not cover this drug.

Interacting Drugs

No formal drug-drug interaction studies were conducted with EPIDUO FORTE 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.

Is Available Generically

No. There is currently no therapeutically equivalent version of Epiduo Forte available in the United States.

Is Proprietary

Yes

Label Details

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207917Orig1s000Lbl.pdf

Legal Status

Legal.

Is not subject to the Controlled Substances Act.

Manufacturer

Galderma Laboratories

Maximum Intake

Once daily should be applied in a thin layer on acne affected skin

Mechanism of Action

Anastrozole selectively inhibits aromatase. The principal source of circulating estrogen (primarily estradiol) is conversion of adrenally-generated androstenedione to estrone by aromatase in peripheral tissues. Therefore, aromatase inhibition leads to a decrease in serum and tumor concentration of estrogen, leading to a decreased tumor mass or delayed progression of tumor growth in some women. Anastrozole has no detectable effect on synthesis of adrenal corticosteroids, aldosterone, and thyroid hormone.

Non Proprietary Name

Adapalene and benzoyl peroxide

Overdosage

If overdosed there is an increased risk of side effects such as dry skin, contact dermatitis, application site burning, application site irritation and skin irritation

Pregnancy Category


AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Pregnancy Warning

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

Patients who become pregnant during treatment should consider discontinuation of this drug.

Animal studies have not been reported. There are no controlled data in human pregnancy.

Prescribing Info

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207917Orig1s000Lbl.pdf

Prescription Status

Prescription drug

Proprietary Name

Epiduo Forte

Related Drugs

doxycycline, clindamycin topical, erythromycin topical, minocycline, tetracycline topical,

RxCUI

1663747

Warning


Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided.Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of EPIDUO FORTE gel and may necessitate discontinuation.

 

Links:

https://www.epiduoforte.com
https://www.drugs.com/cdi/epiduo-forte.html
https://www.drugbank.ca/drugs/DB00210
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4e5d381-098a-4c93-9ff0-002cae46daac

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