ECONAZOLE ARROW 1%, Talcum Powder for local application, Mycosis, 30g bottle

1. NAME OF DRUG ECONAZOLE ARROW 1% powder for local application. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Econazole nitrate: 1g Per 100g of powder. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Powder for local application. 4. CLINICAL DATA 4.1. Therapeutic Indications Thrush: Skin candidiasis encountered in humans is usually due to Candida albicans. However, evidence of a candida on the skin can not in itself be an indication. Treatment: - intertrigos, notably genital-crural, anal and perianal, - Angular cheilitis - Vulvitis, balanitis. In some cases it is recommended to simultaneously treat the digestive tube. Treatment of onyxis and perionyxis Dermatomycosis: Treatment: - dermatomycosis on clean-shaven skin, - genital and crural intertrigos, - intertrigos in the toes (athlete’s foot), Treatment of sycosis and kerions: systematic anti-fungal treatment. Supplementary treatment: - ringworm, - hair follicule infection (Trichophyton rubrum.). Systematic anti-fungal treatment. Pityriasis versicolor. Erythrasm a. 4.2. Dosage and how to use Regular application until the area has healed. Apply the lotion onto the areas to be treated with the tips of your fingers, then small drops either onto the hand or directly onto the area. Gently massage in until the lotion has completely absorbed. 4.3. Contraindications Sensitive to imidazole derivatives or one of the other ingredients. 4.4. Special warnings and side effects Thrush: do not use an pH acid soap (this increases the Candida). 4.5. Interactions with other drugs Not applicable. 4.6. Pregnancy and breast feeding Not applicable. 4.7. Effects on the ability to drive and operate machinery Not applicable. 4.8. Side effects Because of the low level of resorption of econazole (0.5% -2%) on healthy skin, the risk of systemic effects can be virtually ruled out. However, on injured skin, a large area, and on an infant (due to the surface to weight ratio and the occlusal effect of the layers), attention must be paid to this possibility. Locally, rare manifestations of intolerance are burning sensations, or sometimes pruritus and redness of the skin. These manifestations rarely lead to discontinuation of treatment (about 1.7% of cases). 4.9. Overdose Not applicable. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties Pharmaco-therapeutic class: ANTI-FUNGAL A SYSTEMATIC USAGE, Code ATC: D01AC03. Econazole nitrate is an imidazole derivative endowed with anti-fungal and antibacterial activity. The anti-fungal activity has been demonstrated in vitro and is exerted on the agents responsible for mucocutaneous mycosis: · Dermatophytes (Trichophyton, Epidermophyton, Microsporum), · Candida and other yeasts, · Malassezzia furfur (agent of Pityriasis Capitis, of Pityriasis Versicolor), · Mould and other fungi. The antibacterial activity was demonstrated in vitro against Gram + bacteria. Its mechanism of action, different from that of antibiotics, is at several levels: membrane (increase in permeability), cytoplasmic (inhibition of oxidative processes in the mitochondria), nuclear (inhibition of A.R.N. synthesis). · Activity on Corynebacterium minutissimum (erythrasma). · Actinomycetes. 5.2. Pharmacokinetics properties In vivo experiments in healthy volunteers (with or without occlusive dressing) showed that econazole nitrate penetrated the deepest dermal cell layers. In the upper layers of the dermis and in the epidermis, econazole nitrate reaches fungicidal concentrations. Econazole nitrate accumulates in large quantities in the stratum corneum and remains there for 5 to 16 hours. The horny layer thus acts as a reservoir. The rate of systemic resorption is between about 0.5% and about 2% of the applied dose. The transcutaneous passage can be increased on injured skin. 5.3. Preclinical safety data Not applicable. 6. PHARMACEUTICAL DATA 6.1. List of dilutants Talc, anhydrous colloidal silica, zinc oxide. 6.2. Incompatibilities This medication must not be mixed with other medication. 6.3. Shelf life 3 years. 6.4. Storage precautions No specific storage precautions. 6.5. Nature and contents of outside packaging 30 g of powder in a bottle (PEBD) of 60ml with powdered tablet closed with a lid (polypropylene). 6.6. Precautions for handling and disposal No specific requirements. 7. THE MARKETING AUTHORISATION HOLDER ARROW GENERIQUES 26, avenue Tony Garnier 69007 LYON 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 383 108-4 or 34009 383 108 4 9: 30 g bottle with a lid. 9. START/RENEWEL DATE OF AUTHORISATION [To be completed by holder] 10. DATE OF UPDATE OF TEXT [To be completed by holder] 11. DOSIMETRY Not applicable. 12. INSTRUCTIONS FOR RADIOPHARMACEUTICAL PREPARATION Not applicable. PRESCRIPTION AND DELIVERY CONDITIONS Not applicable.