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FertilityThere are no data on the effect of topical benzoyl peroxide on fertility.
PregnancyThere 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 (see section 5.3.). No effects during pregnancy are anticipated since systemic exposure to benzoyl peroxide is very limited. However, Brevoxyl should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus.
LactationPercutaneous absorption of benzoyl peroxide is very limited; however, it is not known whether benzoyl peroxide is excreted in human milk after topical application. Brevoxyl should be used during lactation only if the expected benefit justifies the potential risk to the infant.If used during lactation, Brevoxyl should not be applied to the breast area to avoid accidental ingestion by the infant.
|Immune System Disorders|
|Not known:||Allergic reactions, including application site hypersensitivity and anaphylaxis|
|Skin and subcutaneous tissue disorders|
|Very Common:||Peeling, application site erythema|
|Common:||Dryness, pruritus and contact sensitisation reactions|
|Not known:||Application site rash|
|General Disorders and Administration Site Conditions|
|Not known:||Application site discoloration and application site reactions such as irritation and pain|
Mechanism of actionBenzoyl peroxide is a highly lipophilic, oxidising agent with keratolytic and bacteriocidal effects.Pharmacodynamic effects The effectiveness of benzoyl peroxide in the treatment of acne vulgaris is primarily attributable to its antibacterial activity, especially with respect to Propionibacterium acnes. The antibacterial activity of benzoyl peroxide is due to the release of active or free-radical oxygen capable of oxidising bacterial proteins. Benzoyl peroxide is also believed to be effective in the treatment of acne on account of its anti-inflammatory and mild keratolytic properties.