Valsts: Armēnija
Valoda: angļu
Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ketoconazole
Arpimed LLC
D01AC08
ketoconazole
20mg/ml
shampoo
plastic container 90ml
OTC
Registered
2020-12-09
SUMMARY PRODUCT CHARACTERISTIC (SPC) KETOCONAZOLE 2% SHAMPOO BRAND NAME – Ketoconazole INTERNATIONAL NON-PROPERTY NAME – Ketoconazole COMPOSITION Each ml of shampoo contains: _ACTIVE INGREDIENT:_ ketoconazole – 20mg; _INACTIVE INGREDIENTS:_ cocamide DEA, cocamidopropyl betaine, sodium laureth sulfate, diazolidinyl urea, hydrochloric acid(conc), triethanolamine 98 %, sodium chloride, flavor apple,color red E-129, water deionized DOSAGE FORM Shampoo A red, transparent, viscous liquid. PHARMACOLOGICAL GROUP AND ATC CODE Antifungal; D01AC08. PHARMACOLOGICAL ACTION MECHANISM OF ACTION Ketoconazole usually is fungistatic in action, but may be fungicidal at high concentrations after prolonged incubation or against very susceptible organisms. Like other azole antifungal agents, ketoconazole presumably exerts its antifungal activity by altering and damaging cellular membranes, resulting in increased membrane permeability, secondary metabolic effects, and growth inhibition of fungal cells. Although the exact mechanism of action of ketoconazole has not been fully determined, it has been suggested that the fungistatic activity of the drug may result from interference with ergosterol synthesis, probably via inhibition of C-14 demethylation of sterol intermediates (e.g., lanosterol). The fungicidal activity of ketoconazole at high concentrations may result from a direct physiochemical effect of the drug on the fungal cell membrane. Ketoconazole 2% shampoo is an imidazole antifungal administered topically for scale washing. It is given in candidiasis and dermatophyte infections of the scalp for prophylaxis and treatment. It indicated for treatment of dandruff and seborrheic dermatitis. It has been given for the prophylaxis of fungal infections in immunocompromised patients, although fluconazole or itraconazole are usually preferred. It has been recommended that, because of its erratic absorption and slow therapeutic response, ketoconazole should not be used for the treatment of life- threatening fungal infections, includi Izlasiet visu dokumentu