Is it safe to use Daktar 2 per cent miconazole nitrate cream on fungal infection in a 2-month-old c

Fråga: Is it safe to use Daktar 2 per cent miconazole nitrate cream on fungal infection in a 2-month-old child with fungal infection on the skull, chest, grain and feet?

Sammanfattning: Information on the topical use of miconazole cream in infants is lacking. However, a few studies including older children indicate that miconazole cream is well tolerated. Miconazole cream could probably be tried in this patient, but clinical observation of the child is recommended due to the limited experience.

Svar: Information concerning the use of miconazole nitrate cream, an imidazole derivative, in neonates and children is lacking. The doses for topical application are recommended for adults (1). In neonates and children under two years of age, doses of miconazole oral gel for treatment of oral lesions have not been established, but should not exceed 5 ml per 24 hours (1). In general, children are rarely included in clinical trials.

In Medline only a few references concerning the topical use of two per cent miconazole cream were indexed with infants or children. In a randomised double-blind study including 54 patients comparing the topical use of one per cent clotrimazole and two per cent miconazole on cutaneous leishmaniasis, no side effects were observed (2). However, clotrimazole was more effective in early healing of lesions. The miconazole cream treatment was also well tolerated in another study on 83 dermatophytic and candidal infections. Only one case of sensitisation was observed (3). In a multi-centre study, the topical application of one per cent hydrocortisone plus two per cent miconazole cream for infected eczema and impetigo gave no systemic or local side effects (4). In the Swedish Catalogue of Approved Medical Products, local skin irritation is the only side effect mentioned. In addition, miconazole intravenously administered has been well tolerated in infants with systemic Candida albicans infections (5,6). 1 Dollery C Sir, editor. Therapeutic drugs. 2nd ed. Edinburgh: Churchill Livingstone; 1998. p 2 Larbi EB, al-Khawajah A, al-Gindan Y, Jain S, Abahusain A, al-Zayer A: A randomized, double-blind, clinical of topical clotrimazole versus miconazole for treatment of cutaneous leishmaniasis in the eastern province of Saudi Arabia. Am J Trop Med Hyg 1995; 52: 166-8 (Medline-abstract) 3 Degreef H, Verhoeve L, van Cutsen J: Miconazole nitrate in the treatment of dermatomycoses. Dermatologica 1975; 150: 103-10 (Medline-abstract) 4 Jaffe GV, Grimshaw JJ: A clinical trial of hydrocortisone/potassium hydroxyquinoline sulphate ("Quinocort") in the treatment of infected eczema and impetigo in general practice. Pharmatherapeutica 1986; 4: 628-36 (Medline-abstract) 5 Fisher TJ, Klein RB, Kershnar HE, Borut TC, Stiehm ER: Miconazole in the treatment of chronic mucocutaneous candidiasis: a preliminary report. J Pediatr1977; 91: 815-9 (Medline-abstract) 6 Tudehope DI, Rigby B: Neonatal systemic candidiasis treated with miconazole and ketoconazole. Med J Aust 1983; 1: 480-1 (Medline-abstract)