Benzoyl Peroxide

Registered South African indications:

• Acne vulgaris

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Excessive application
• Contact with eyes, mouth, angles of the nose, neck, hair or mucous membranes
• Application to damaged skin
• Exposure to sunlight or sunlamps

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

Acne vulgaris

• Topical (gel): Apply to affected area(s), 12-24hrly

Should be applied after washing with a mild cleanser

• Topical (liq): Apply to affected area(s) and rinse off with water after 30 seconds, 12-24hrly

Contact with eyes and mucous membranes should be avoided

Not established for use in children below 12 years

Pregnancy

• Caution
• There are limited data on the use of topical benzoyl peroxide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. No effects during pregnancy are anticipated since systemic exposure to benzoyl peroxide is very limited. In widespread clinical use for the cutaneous treatment of acne vulgaris, at concentrations up to 10% w/w for several decades, benzoyl peroxide has never been associated with such effects. Benzoyl peroxide should be used by a pregnant woman only if clearly needed

Breastfeeding

• Caution
• It is unknown whether benzoyl peroxide/metabolites are excreted in human milk. A risk to the new-borns/infants cannot be excluded. Caution should be exercised when benzoyl peroxide is administered to a nursing woman and the preparation should not be applied on the chest to avoid accidental transfer to the infant

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Skin and Subcutaneous Tissue Disorders

• Dry skin
• Erythema
• Skin exfoliation
• Skin burning sensation
• Pruritus
• Skin pain
• Contact dermatitis

Immune, Blood and Lymphatic System Disorders

• Swollen face

• Topical acne therapy
• Agents with desquamative, irritant and drying effects

None routine

Benzoyl peroxide is an established and effective keratolytic agent with antibacterial properties. It has been shown to be effective in reducing the local population of Propionibacterium acnes leading to a reduction in the production of irritant fatty acids in the sebaceous glands.

Benzoyl peroxide is available in several formulations. Please note the list below gives examples of products which are available and is not necessarily comprehensive. The listing of a product does not constitute endorsement of the product by EMGuidance; likewise, failure to list a product does not imply that EMGuidance disapproves of the product. This information is put together on the basis of the National Government's Medicines Price Registry at the time of publication

Gel (per 100g) 5g

• Benzac AC 5 (Galderma)

Wash (per 100g) 5g

• Benzac AC 5 (Gladerma)