Adapalene

Registered South African indications: 

• Acne vulgaris of the face, chest and back where comedones, papules and pustules predominate

Registered South African contraindications

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

South African recommendations

Caution in the following patient groups

• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly

Excipient sensitivity (gel)

• Adapalene gel contains methyl parahydroxybenzoate (E218) which can cause allergic reactions (which can arise after the treatment is completed) and propylene glycol which can be irritating to the skin

Excipient sensitivity (cream)

• Adapalene cream contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which can cause allergic reactions (which can arise after the treatment is completed)

Sensitivity or severe irritation

• If a reaction suggesting sensitivity or severe irritation occurs, use of adapalene should be discontinued

Management of local irritation

• If the degree of local irritation warrants, patients should be directed to use the medication less frequently, to discontinue use temporarily, or to discontinue use altogether

Contact with sensitive areas

• Adapalene should not come into contact with the eyes, mouth, angles of the nose, or mucous membranes. If adapalene comes into contact with the eye, wash immediately with warm water

Application restrictions

• Adapalene should not be applied to broken skin (cuts and abrasions) or to eczematous skin

Severe acne and contraception

• Adapalene should not be used in patients with severe acne involving large areas of the body, especially in women of childbearing age who are not on effective contraception. Adapalene should not be used in patients with severe acne

Sunlight and UV exposure

• The safety of using adapalene during repeated exposure to sunlight or UV irradiation has not been established in either animals or man. Exposure to excessive sunlight or UV irradiation should therefore be avoided

Forms avail. in SA and covered in this monograph: cre, gel, jel

South African registered indications and dosages

Acne vulgaris of the face, chest and back where comedones, papules and pustules predominate

• Topical (cre, gel, jel): Apply small quantity to affected area(s), dly, after washing and before retiring

A thin film of the cream or gel should be applied avoiding the eyes, lips and mucous membranes. Adapalene cream and gel are not to be taken orally and is for cutaneous use only. If patients use cosmetics, these should be non-comedogenic and non-astringent

Clinical improvement is expected to be clearly evident after four to eight weeks of treatment with further improvement expected with continued use. With patients for whom it is necessary to reduce the frequency of application or to temporarily discontinue treatment, frequency of application may be restored or therapy resumed once it is judged that the patient can tolerate the treatment

Adapalene cream and gel should not be used in patients with severe acne

Not established for use in children below 12 years

Pregnancy

South African recommendations

• Contraindicated
• Adapalene cream and gel are contraindicated in pregnancy, or in women planning a pregnancy
• In case of unexpected pregnancy, treatment should be discontinued
• Animal studies by the oral route have shown teratogenicity

Breastfeeding

South African recommendations

• Caution; not recommended
• No study on animal or human milk transfer was conducted after cutaneous application of adapalene cream and differin gel. Safety in lactation has not been demonstrated
• Adapalene should not be used during breastfeeding

Fertility

South African recommendations

• Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result in low systemic exposure due to minimal dermal absorption. However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure

South African recommendations

• Caution; no dose adjustment recommended

South African recommendations

• Caution; no dose adjustment recommended

South African recommendations

• Caution; no dose adjustment recommended

Skin and Subcutaneous Tissue Disorders

• Dry skin
• Skin irritation
• Skin burning sensation
• Erythema
• Contact dermatitis
• Skin discomfort
• Sunburn
• Pruritus
• Skin exfoliation
• Acne
• Allergic dermatitis
• Pain of skin
• Skin swelling
• Eyelid irritation
• Eyelid erythema
• Eyelid pruritus
• Eyelid swelling

• Other retinoids
• Peeling agents, abrasive cleansers, strong drying agents, astringents or irritant products

None routine

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. 

Gel (per g) 1mg

• Dapta (Litha Pharma)
• Deriva (Glenmark)
• Differin (Galderma) originator

Cream (per g) 1mg

• Dapta (Litha Pharma)
• Differin (Galderma) originator

COMBINATION PREPARATION

Adapalene/ Benzoyl peroxide

Gel (per g) 1mg/25mg

• Epiduo (Galderma) originator