Exoderil BSS
Exoderil® 1%. Presentations. Cream: 1 g contains 10 mg naftifine hydrochloride and solution: 1 mL contains 10 mg naftifine hydrochloride. Indications: topical treatment of the following skin infections in adults: mycoses of the skin or skin folds (tinea corporis, tinea inguinalis) and interdigital mycoses (tinea manum, tinea pedum). It can be used as second line treatment in adults for the treatment of cutaneous candidiasis. The official guidelines and national recommendations on the appropriate use and prescription of antifungal agents are to be considered. Posology and method of administration. Cream or solution should be applied once daily to the cleaned and thoroughly dried affected skin and adjacent areas and should be gently massaged. Treatment should be continued for at least two weeks after clinical healing in order to avoid relapse. If no clinical improvement is observed within 4 weeks, the therapeutic approach should be reassessed. The safety and efficacy of naftifine in children and adolescents under 18 years are not yet established. No dosage adjustment is necessary in patients with impaired renal or hepatic function. No dose adjustment is necessary in older adults. No experience or very limited experience with the use of naftifine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. For precautionary reasons, Exoderil® 1% should be avoided during pregnancy and lactation. No studies have been conducted to investigate the effect of Exoderil® 1% on fertility. Contraindications. Hypersensitivity to the active substance or to any of the excipients. Special warnings and precaoutions for use. Exoderil® 1% must not come into contact with the eyes or mucous membranes. Exoderil® 1% cream contains cetyl and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). Interactions. No interaction studies have been performed. Undesirable effects. General disorders and administration conditions: sensation of dryness, reddening and burning (incidence can not be estimated from the available data). CDS Sept 2012.