DefinitionThis section has been translated automatically.
IndicationThis section has been translated automatically.
Bufexamac-containing Externa was withdrawn from the market in 2010 due to its high side effect potential!
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Dosage and method of useThis section has been translated automatically.
Apply 1-3 times/day to the affected skin areas.
Standard concentrationThis section has been translated automatically.
5% in water absorbing ointments (absorption bases), hydrophilic ointments, hydrophobic creams (W/O emulsion ointments), hydrophilic creams (O/W emulsion ointments) and hydrophilic gels.
Undesirable effectsThis section has been translated automatically.
Sensitization, allergic reactions up to erythema exsudativum multiforme, burning, scaling, deterioration of skin condition.
ContraindicationThis section has been translated automatically.
Pregnancy, use on the eye, hypersensitivity to the active ingredient.
Note(s)This section has been translated automatically.
- Sensitization potential: according to studies, sensitization is frequent with topical application, up to 50-60% according to studies. In 25% of the sensitized persons the application time was less than one week.
- Professional sensitizations are rare. In the case of non-occupational exposures a sensitization rate of 1-4% is present. The sensitization rate increases with age. The possibility of sensitization through therapy of occupational eczema should be considered.
- In patients with atopic eczema, sensitization to bufexamac is about 3 times more frequent than in non-atopic patients. This is due to the use of bufexamac in the therapy of atopic eczema.
- In children, Bufexamac is among the "Top Ten" of the most common allergens. Here too, the cause can be assumed to be the frequent use of bufexamac in the therapy of atopic eczema.
- Risk factors of a Bufexamac sensitization include further type IV sensitizations, anogenital localization, atopic eczema, eczema of the legs.
- In the meantime, the EMA is demanding that the Bufexamac-containing topicals be withdrawn from the market.
LiteratureThis section has been translated automatically.
- Weisshaar E et al (2008) Justification for the assessment of the effect of an allergy to bufexamac in the MdE assessment. Dermatol Occupation Environment 56: 31-33
- EMA (2010) www.EMA.europa. eu/pdfs/human/referral/bufexamac. Questions and answers:22.4.2010