Benzac AC 2.5% and Benzac AC 5% are topical water-base gel containing benzoyl peroxide 2.5% and 5%, respectively.
Excipients/Inactive Ingredients: Acrylates copolymer, glycerol, sodium hydroxide, poloxamer 182, carbomer 940, disodium edetate, dioctyl sodium sulfosuccinate, propylene glycol, colloidal anhydrous silica and purified water.
Pharmacology: Pharmacodynamics: Benzoyl peroxide has been shown to have potent broad spectrum antimicrobial activity, particularly against Cutibacterium acnes (C. acnes) which is abnormally present in acne affected hair follicles. Benzoyl peroxide can kill 94% of C. acnes after one week*.
Additionally benzoyl peroxide has demonstrated exfoliative and comedolytic activities both of which are beneficial in treatment of acne.
*study 1.CG.03.SUM.0325: Once daily application of BENZAC AC 5 gel.
Pharmacokinetics: The percutaneous penetration of benzoyl peroxide in rat, rabbit, monkey and man is low. The majority of the penetrated benzoyl peroxide is converted into benzoic acid which after absorption in the systemic circulation is rapidly eliminated by the kidney. There is no evidence of any tissue accumulation. There is no evidence that cutaneous application of the proposed clinical doses of BENZAC preparations should be associated with any systemic adverse reaction in humans.
Toxicology: Preclinical safety data: In animal studies by the cutaneous route, benzoyl peroxide is associated with a minimal to moderate skin irritation potential. The low systemic exposure and rapid elimination of the major degradation product of benzoyl peroxide, benzoic acid assure that no acute or chronic systemic toxicity occurs.
Topical treatment of acne vulgaris.
Before each application, the skin should be cleaned and dried carefully. It is recommended to initiate the treatment with benzoyl peroxide 2.5 or 5% gel. The gel is applied on a thin layer to cover the affected areas, once or twice daily. Persons with sensitive skin should be directed to apply the gel once daily before going to bed.
Benzoyl peroxide gels are preparations indicated for topical treatment only. If the medication is applied excessively, no more rapid or better results will be obtained and severe irritation might develop. In this event, treatment must be discontinued and appropriate symptomatic therapy should be instituted.
BENZAC preparations are contraindicated in patients who have shown hypersensitivity to any of their components.
A mild burning sensation will probably be felt on first application and some reddening and peeling of the skin will occur within a few days. During the first weeks of treatment a sudden increase in peeling will occur in most patients. This is not harmful and will normally subside within a day or two if treatment is temporarily discontinued. If severe irritation occurs, patients should be directed to use the medication less frequently, to temporarily discontinue use or to discontinue use altogether. Benzoyl peroxide may cause swelling and blistering of the skin, if any of these symptoms occur, medication has to be discontinued.
Benzoyl peroxide gel should not come into contact with the eyes, mouth, angles of the nose or mucous membranes. If the preparation enters the eye, wash thoroughly with water. Caution should be exercised when applying the drug to the neck and other sensitive areas.
Repeated exposure to sunlight or UV radiation should be avoided.
Contact with any coloured material including hair and dyed fabrics may result in bleaching or discoloration.
Due to the risk of sensitisation, benzoyl peroxide gel should not be applied on damaged skin.
Effects on ability to drive and use machines: Based on the pharmacodynamic profile and extensive clinical experience, performance related to driving and using machines should not be affected during treatment with benzoyl peroxide.
There is no safety concern relating to the effects of cutaneously applied benzoyl peroxide on reproductive function, fertility, teratogenicity, embryotoxicity, or peri- and post- natal development from animal data. 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 in humans.
Benzoyl peroxide gel should only be used by a pregnant woman if clearly needed.
It is not known whether benzoyl peroxide is excreted in animal or human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide gel is administered to a nursing woman and the preparation should not be applied on the chest to avoid accidental transfer to the infant.
The adverse reactions resulting from clinical trials are all skin disorders. They are reversible when treatment is reduced in frequency or discontinued. The following categories are used to indicate the frequency of occurence of adverse effects: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (</10,000); unknown (frequency not assessable based on the available data).
They are presented in the table as follows: See table.
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Swelling face and allergic reactions, including application site hypersensitivity and anaphylaxis (unknown frequency) have been reported during post-marketing surveillance.
There are no known interaction with other medications which might be used cutaneously and concurrently with benzoyl peroxide gel; however, drugs with desquamative, irritant and drying effects should not be used concurrently with benzoyl peroxide gel.
Incompatibilities: As a result of the oxidating effect of benzoyl peroxide, agents sensitive to oxidation should not be used simultaneously.
D10AE01 - benzoyl peroxide ; Belongs to the class of topical peroxide preparations used in the treatment of acne.
Benzac AC topical gel 2.5%
(water-based) 15 g x 1's; (water-based) 60 g x 1's
Benzac AC topical gel 5%
(water-based) 15 g x 1's; (water-based) 60 g x 1's
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