CNASRegulated (List II)CUTACNYL

GALDERMA
Identification
- Active ingredient (INN)
- PEROXYDE DE BENZOYLE
- Internal code
- 07 B 013
- Country of Origin
- France
- Pharmaceutical form
- Dermal Gel
- Prescription List
- Regulated (List II)
- Packaging
- t/40g

CNASDAWA Clinical Workbench v2.0
Information may not be accurate. Always consult a physician, pharmacist, or specialist before acting on any data shown here.
Description
Benzoyl peroxide is a commonly used drug in topical treatments for acne. 7, 9, 10, 11, 12 It has been formulated as products with either a single active ingredient, 7, 11 or with erythromycin, 9 clindamycin, 10 or adapalene.
After administration, the peroxide bond is cleaved, allowing benzoyloxy radicals to nonspecifically interact with proteins. 1, 2 This treatment decreases keratin and sebum around follicles, as well as increasing turnover of epithelial cells. 3, 4, 5 Benzoyl peroxide, in combination with erythromycin, was granted FDA approval on 26 October 1984.
Indications
Benzoyl peroxide is formulated with antibiotics such as erythromycin and clindamycin for the treatment of acne vulgaris.
Benzoyl peroxide is formulated as a number of topical products for the treatment of acne. 7, 11 Benzoyl peroxide is also indicated in combination with tretinoin for the treatment of acne vulgaris in patients aged nine years and older.
A triple-combination therapy including both clindamycin and adapalene is also available and indicated for the treatment of acne vulgaris in patients ≥12 years of age.
Topical benzoyl peroxide is also indicated for the treatment of inflammatory lesions of rosacea in adults.
Pharmacodynamics
Benzoyl peroxide is a topical treatment for acne that generates free radicals to break down comedones and increase the rate of epithelial cell turnover. 1, 3, 4, 5, 9, 10, 11, 12 It has a short duration of action as its active free radical metabolites quickly react to form inactive metabolites.
The therapeutic index is wide, as overdoses are rare, however patients may still experience skin peeling. 9, 10, 11, 12 Patients should be counselled regarding increased risks of skin irritation, dryness, and sunburn. 9, 10, 11, 12.
Mechanism of Action
Acne vulgaris is caused by inflammation in the pilosebaceous gland.
Acne is generally caused by increased excretion of sebum from pilosebaceous glands, endocrine factors such as androgenic hormones, keratin developing around follicles, bacterial growth, and inflammation.
These factors contribute to the formation of comedones (whiteheads and blackheads).
The peroxide bond of benzoyl peroxide is cleaved to form 2 benzoyloxy radicals.
These radicals interact nonspecifically with bacterial proteins, interfering with their function, and survival of the bacteria.
Over time, free radical interactions with bacterial proteins lead to decreased keratin and sebum around follicles. 3, 4 Benzoyl peroxide can also increase the turnover rate of epithelial cells, leading to skin peeling, and breaking down comedones.
Target Actions Organism U Catalase inhibitor Humans U Glutathione peroxidase inhibitor U Antizyme inhibitor 2 activator Humans U Protein kinase C inhibitor Humans U Superoxide Dismutases inhibitor Humans.
Absorption
In a sample of excised skin, 1.9% of a radiolabelled topical dose fully penetrates the skin, and 2.6% remains in the skin. 2, 6 The radiolabelled dose that fully penetrates the skin is recovered as benzoic acid, while the dose in the skin is approximately half benzoic acid and half benzoyl peroxide. 6 95.5% of a radiolabelled dose is not absorbed or metabolized after 8 hours.
Metabolism
The peroxide bond of benzoyl peroxide is cleaved to form 2 benzoyloxy radicals.
The benzyoyloxy radicals may interact with other molecules, forming benzoic acid; alternatively, benzoyloxy radicals can break down further to release carbon dioxide and a phenyl radical.
Hover over products below to view reaction partners Benzoyl peroxide Benzoyloxyl radical Carbon dioxide + Phenyl Radical Benzoic acid.
Route of Elimination
Benzoyl peroxide's metabolite benzoic acid, is eliminated in the urine.
Data regarding fecal elimination is not readily available.
Adverse Effects
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Toxicity
Data regarding overdoses of benzoyl peroxide are not readily available. 7, 9, 10, 11, 12 During an overdose patients may experience and increased risk or severity of adverse effects such as skin itching, burning, peeling, inflammation, and erythema. 9, 10, 11, 12 The oral LD in rats is 490 mg/kg.