Adapalene/ Benzoyl Peroxide

Registered South African indications:

• Cutaneous treatment of acne vulgaris when comedones, papules and pustules are present

Registered contraindications in South Africa & other jurisdictions

• Hypersensitivity to the active ingredients or to any of the excipients
• Pregnancy
• Women planning a pregnancy

Cautions

• Breastfeeding 
• Eczematous skin
• Damaged or broken skin
• Contact with the eyes, mouth, nostrils or mucous membranes
• Sunlight or UV radiation

Forms avail. in SA and covered in this monograph: gel

South African registered indications and dosages

Cutaneous treatment of acne vulgaris when comedones, papules and pustules are present

Adapalene/ Benzoyl Peroxide
1mg/25mg (per g)
3mg/25mg (per g)

• Topical (gel): Apply a thin film to acne affected areas, dly in the evening on clean, dry skin; Treatment duration: Based on clinical condition, with early signs of improvement usually appearing after 1-4 weeks of treatment

For external cutaneous use only. A thin film of gel should be applied, with the fingertips, avoiding the eyes, lips and nostrils

If irritation occurs, the patient should be directed to apply non-comedogenic moisturisers, to use adapalene/ benzoyl peroxide less frequently (e.g. every other day), to suspend use temporarily, or to discontinue use altogether

If no improvement is observed after 4-8 weeks of treatment, the benefit of continued treatment should be reconsidered (0.3%/2.5% gel)

As there are 2 strengths of adapalene/ benzoyl peroxide, the lower strength can be considered in patients with moderate acne vulgaris, however, selection of either strength should be based on the presenting patient’s clinical condition and severity

Paed. forms avail. in SA and covered in this monograph: gel

South African registered indications and dosages

Cutaneous treatment of acne vulgaris when comedones, papules and pustules are present

Adapalene/ Benzoyl Peroxide
1mg/25mg (per g)

Younger than 9 years 

• Not established for use

9 years and older

• See adult dosage

The safety and effectiveness of adapalene/ benzoyl peroxide 1mg/25mg strength has not been studied in children below 9 years of age

3mg/25mg (per g)

Younger than 12 years 

• Not established for use

12 years and older 

• See adult dosage

The safety and effectiveness of adapalene/ benzoyl peroxide 3mg/25mg has not been studied in children below 12 years of age

Pregnancy

South African recommendations

• Contraindicated
• Adapalene/ benzoyl peroxide is contraindicated in pregnancy, or in women planning a pregnancy
• Safety in pregnancy has not been established. Animal studies by the oral route have shown reproductive toxicity at high systemic exposure
• If the patient becomes pregnant while taking this drug, treatment should be discontinued

Recommendations in other jurisdictions

• Contraindicated
• Adapalene/ benzoyl peroxide is contraindicated in pregnancy, or in women planning a pregnancy
• There are no or limited amount of data from the use of adapalene topically in pregnant women
• Animal studies by the oral route have shown reproductive toxicity at high systemic exposure. Clinical experience with locally applied adapalene and benzoyl peroxide in pregnancy is limited
• If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued

Breastfeeding

South African recommendations

• Caution; not recommended
• No study on animal or human milk transfer was conducted after cutaneous application of adapalene/ benzoyl peroxide gel
• Adapalene/ benzoyl peroxide should not be used during breastfeeding, especially in case of acne treatment requiring product application on the chest

Recommendations in other jurisdictions

• Caution
• No study on animal or human milk transfer was conducted after cutaneous application of adapalene/ benzoyl peroxide gel
• No effects on the suckling child are anticipated since the systemic exposure of the breastfeeding woman to adapalene/ benzoyl peroxide is negligible, therefore it can be used during breastfeeding
• To avoid contact exposure of the infant, application of adapalene/ benzoyl peroxide to the chest should be avoided when used during breastfeeding

Fertility

Recommendations below are applicable to South Africa and other jurisdictions

• No human fertility studies were conducted with adapalene/ benzoyl peroxide gel
• However, no effects of adapalene or benzoyl peroxide on fertility were found in rats in reproductive studies

• No dose adjustment recommended

• No dose adjustment recommended

• No dose adjustment recommended

Respiratory Disorders

• Throat tightness

Skin and Subcutaneous Tissue Disorders

• Dry skin
• Irritative contact dermatitis
• Skin irritation
• Burning skin sensation
• Erythema
• Skin exfoliation 
• Pruritus
• Sunburn
• Allergic contact dermatitis
• Swollen face
• Pain of skin
• Blisters
• Eyelid oedema

• Cosmetics with desquamative effects
• Other retinoids or benzoyl peroxide

None routine 

Benzoyl peroxide
Benzoyl peroxide releases free-radical oxygen which oxidizes bacterial proteins in the sebaceous follicles decreasing the number of anaerobic bacteria and decreasing free fatty acids.

Adapalene
Adapalene is a retinoid-like compound which is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris.

COMBINATION PREPARATIONS

Adapalene/ Benzoyl Peroxide

Gel (per g) 1mg/25mg

• Epiduo gel (Galderma) originator