Adult Dosing

Acne Vulgaris

Children 9 yrs

• Apply a thin film to affected areas of the face and/or trunk qd after washing in the evening before bedtime; avoid the eyes, lips, and mucous membranes

Note:

• For topical use only; not indicated for oral, ophthalmic, or intravaginal use

Pediatric Dosing

Acne Vulgaris

Children >12 yrs

• Apply a thin film to affected areas of the face and/or trunk qd after washing in the evening before bedtime; avoid the eyes, lips, and mucous membranes

• Safety and effectiveness in pediatric patients <12 yrs have not been established
• For topical use only; not indicated for oral, ophthalmic, or intravaginal use

[Outline]

• Adult Dosing
• Pediatric Dosing

• Topical treatment of acne vulgaris in patients 9 yrs of age

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Minimize sunlight exposure, including sunlamps, during the use of adapalene/benzoyl peroxide gel. When exposure cannot be avoided, use of sunscreen products and protective apparel are recommended
• Weather extremes such as wind or cold may be irritating to patients receiving treatment with this product
• Mild to moderate local cutaneous reactions including erythema, scaling, dryness, stinging, and burning may occur during the first four weeks of treatment; these reactions usually lessen with continued use of the medication
• Irritant and allergic contact dermatitis may occur during therapy. Based on the severity of skin reactions, instruct patients to use a moisturizer, reduce the frequency of application, or discontinue use
• Avoid application of therapy to cuts, abrasions, eczematous or sunburned skin
• Avoid concomitant use of other potentially irritating topical products (abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes)
• Avoid use of waxing as a depilatory method on skin treated with adapalene/benzoyl peroxide gel

Caution: Use cautiously in

• Photosensitivity

Supplemental Patient Information

• Advise patients to cleanse the area to be treated with a mild or soapless cleanser
• Advise patients to minimize exposure to sunlight, including sunlamps

Pregnancy Category:C

Breastfeeding: Topical adapalene has not been studied during breastfeeding. Due to minimal systemic absorption following topical application and serum levels <0.25 mcg/L with long-term use, it is considered a low risk to the nursing infant. Application to the nipple area is not recommended. Care should be taken to ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. Apply only water-miscible cream or gel products to the breast as ointments may expose the infant to high levels of mineral paraffins via licking. Benzoyl peroxide: Not studied during breastfeeding. It is considered a low risk to the nursing infant since only about 5% is absorbed following topical application. Ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. Apply only water-miscible cream or gel products to the breast as ointments may expose the infant to high levels of mineral paraffins via licking. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 21 2011). Manufacturer advises caution.

• DERM: Dry skin, contact dermatitis, erythema, scaling, burning/stinging, photosensitivity
• LOCAL: Application site burning/irritation

Adapalene

• Retinoid (Anti-acne); exact mechanism of action unknown; binds to specific retinoic acid nuclear receptors and retinoid X receptors, which may normalize the differentiation of follicular epithelial cells resulting in decreased microcomedone formation
• Metabolized mainly by O-demethylation, hydroxylation and conjugation
• Excretion: Biliary route
• Half-life: Unknown

Benzoyl peroxide

• Antibacterial; releases active or free-radical oxygen capable of oxidizing bacterial proteins. Also, exhibits keratolytic effects
• Metabolized in the skin to benzoic acid
• Excreted in urine
• Half-life: Unknown

US Trade Name(s)

• Epiduo

US Availability

Epiduo (adapalene/benzoyl peroxide)

• GEL: 0.1%/2.5%

Canadian Trade Name(s)

• Tactuo

Canadian Availability

Tactuo (adapalene/benzoyl peroxide)

• GEL: 0.1%/2.5%

UK Trade Name(s)

• Epiduo

UK Availability

Epiduo (adapalene/benzoyl peroxide)

• GEL: 0.1%/2.5%

Australian Trade Name(s)

• Epiduo

Australian Availability

Epiduo (adapalene/benzoyl peroxide)

• GEL: 0.1%/2.5%

[Outline]

Dermatologic

Antiacne Agents

Retinoids

Pricing data from www.DrugStore.com in U.S.A.

• Epiduo 0.1-2.5 % GEL [Tube] (GALDERMA)
  45 % = $260
  135 % = $738.95

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.