Econazole - Talcum powder - Mycosis treatment - Viatris - 30g

1. NAME OF DRUG ECONAZOLE MYLAN 1%, powder for skin use. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Econazole nitrate: 1.000 g Quantity of econazole base: 0.860 g Per 100g of powder. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Powder for skin use. 4. CLINICAL DATA 4.1. Therapeutic Indications 1- Thrush Thrush encountered in humans is usually due to Candida albicans. However, evidence of candida on the skin can not in itself be an indication; - Treatment: *Intertrigo particularly genito-crural, anal and perianal, *Angular cheilitis, *Vumvitis, Balanitis. For some cases it is recommended to simultaneously treat the digestive tube. - Treatment ofonyxis and perionyxis: 2- Dermatophytosis - Treatment: *Dermatophytosis of clean-shaven skin, *Genito and crural intertrigos, *Toe intertrigos (athletes foots), *Sycosis and kerion: systematic anti-fungal treatment. - Additional Treatment: *Ringworm, * Folliculitis Systematic anti-fungal treatment. 3- Pityriasis versicolor 4- Erythrasma 4.2. Dosage and how to use Dosage: Regular daily application until the injuries have disappeared. How to use: Powder the areas to be treated twice per day after washing and drying the skin. Length of treatment is 2-4 weeks for mycosis, it can be extended if necessary. 4.3. Contraindications: Intolerance and sensitivity risk from the imidazole derivatives or one of the other ingredients. 4.4. Special warnings and side effects Thrush: it is not recommended to use a soap with a pH acid in as this worsens the infection). 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% to 2%) on healthy skin, the risk of systemic effects can be virtually ruled out. However, on damaged skin, a large surface, and in the infant (due to the ratio / weight and occlusal effect of the layers), attention must be paid to this possibility. · Locally, the rare manifestations of intolerance are burning sensations, or sometimes pruritus and redness of the skin; these manifestations rarely result in cessation of treatment (approximately 1.7% of cases). 4.9. Overdose Not applicable. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties ANTI6FUNGAL (D: dermatological medication) The anti-fungal activity has been demonstrated in vitro and is exerted on the agents responsible for mucocutaneous mycosis: - Dermatophyte (Trichophyton, Epidermophyton, Microsporum), - Thrush or other yeast, - Malassezia furfur (Pityriasis Capitis, Pityriasis Versicolor), - Moistness and other fungus. The antibacterial activity was demonstrated in vitro against Gram + bacteria. Its action mechanism, 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 cornea 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 (AEROSIL 300), light zinc oxide. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 3 years. 6.4. Storage precautions Store in a place below 25°C, away from heat and humidity. 6.5. Nature and contents of outside packaging 30 g bottle of powder (polyethylene, 66ml), 1 box. 6.6. Precautions for handling and disposal No specific requirements. 7. THE MARKETING AUTHORISATION HOLDER MYLAN SAS 117, allee des Parcs 69800 SAINT PRIEST 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 379 373-9 or 34009 379 373 9 9: 30 g bottle of powder (polyethylene, 66ml), 1 box. 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 Drug not subjected to prescription.