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    Vitasilk, 5 % gel

    Drug formSoft

    ATC categoryAgents for topical use. Dermatology

    ATC subcategoryAgents for acne treatment

    Brand nameVitasilk

    Generic nameBenzoyl peroxide

    Composition

    Each gram of Vitasilk (Benzoyl peroxide) gel contains:

    active ingredient: benzoyl peroxide – 50 mg;
    excipients: propylene glycol (20%), carbomer 940, sodium hydroxide, water purified.

    Pharmacological group and ATC code
    Anti-acne, topical; D10AE01.
    Pharmacology

    Benzoyl peroxide has mild keratolytic properties. Its antimicrobial action is probably due to its oxidising effect and activity has been reported against Staphylococcus epidermidis and Propionibacterium acnes.

    Pharmacokinetics
    Absorbed by the skin, where it is metabolized to benzoic acid and excreted as benzoate in the urine.
    Uses
    Vitasilk is used mainly in the treatment of acne.
    Dosage and administration
    Adults and Children 12 yr of age and olderAfter cleaning skin, smooth small amount over affected area every day or twice daily. Reduce dose frequency or concentration if bothersome dryness or peeling occurs. If excessive stinging or burning occurs after any single application, remove with mild soap and water, resuming use the next day.

    Contraindications and Precautions
    – Hypersensitivity to any component of this product.
    – Children up to 12 years of age.During the first 3 weeks patient is using Vitasilk, skin may become irritated. Also, acne may seem to get worse before it gets better. If skin problem has not improved within 4 to 6 weeks, patient should check with health care professional.

    Patient should not wash the areas of the skin treated with Vitasilk for at least 1 hour after application.

    Patient should avoid using any other topical medicine on the same area within 1 hour before or after using Vitasilk. Otherwise, benzoyl peroxide may not work properly.

    It is especially important to avoid using the following skin products on the same area as Vitasilk:

    • any other topical acne product or skin product containing a peeling agent (such as resorcinol, salicylic acid, sulfur, or tretinoin);
    • hair products that are irritating, such as permanents or hair removal products;
    • skin products that cause sensitivity to the sun, such as those containing lime or spices;
    • skin products containing a large amount of alcohol, such as astringents, shaving creams, or after-shave lotions; or
    • skin products that are too drying or abrasive, such as some cosmetics, soaps, or skin cleansers.

    Using these products along with Vitasilk may cause mild to severe irritation of the skin. Usually Vitasilk is applied at night so that it doesn’t cause a problem with any other topical products that you might use during the day.

    This medicine may bleach hair or colored fabrics.

    Adverse effects

    Topical application of benzoyl peroxide may produce skin irritation, particularly on beginning treatment. In some patients the irritation may require reduced frequency of application or temporary suspension of treatment. Skin dryness, peeling, rash, and transient local oedema may also occur. Contact sensitisation has been reported in some patients using preparations containing benzoyl peroxide. Caution is required when applying it near the eyes, the mouth and other mucous membranes, and to the neck and other sensitive areas. Patients should be alerted to benzoyl peroxide’s bleaching property.

    Drug interactions

    Tretinoin
    Concurrent use may cause severe skin irritation.

    Identification

    A white to off white homogenous gel with a specific odor.

    Presentation

    25 g of gel is filled into aluminum tubes (inside package).
    The tubes are packed and inserted with the leaflet into cardboard boxes (outer package).

    Expiry date

    3 years. Do not use after the expiration date.

    Prescription status

    To be dispensed without prescription.

    Storage conditions

    Store at a room temperature, in a dry place, out of the reach of children. Protect from light.