. . . . . . . . . "4.4\tZvl\u00E1\u0161tn\u00ED upozorn\u011Bn\u00ED a opat\u0159en\u00ED pro pou\u017Eit\u00ED"@cs . . "004.004" . . . . . . . . . . "Tinea capitis \nFlukonazol byl studov\u00E1n pro l\u00E9\u010Dbu tinea capitis u d\u011Bt\u00ED. Uk\u00E1zalo se, \u017Ee nen\u00ED lep\u0161\u00ED ne\u017E griseofulvin, celkov\u00E1 m\u00EDra klinick\u00E9 \u00FAsp\u011B\u0161nosti byla m\u00E9n\u011B ne\u017E 20 %. Z toho d\u016Fvodu se flukonazol nem\u00E1 u\u017E\u00EDvat k l\u00E9\u010Db\u011B t inea capitis. \nKryptokok\u00F3za \nPr\u016Fkaz \u00FA\u010Dinosti flukonazolu v l\u00E9\u010Db\u011B dal\u0161\u00EDch forem kryptokok\u00F3zy (nap\u0159. plicn\u00ED, ko\u017En\u00ED) je omezen\u00FD, co\u017E zamezuje doporu\u010Den\u00ED d\u00E1vkov\u00E1n\u00ED. \nSyst\u00E9mov\u00E9 endemick\u00E9 myk\u00F3zy \nPr\u016Fkaz \u00FA\u010Dinnosti flukonazolu v l\u00E9\u010Db\u011B dal\u0161\u00EDch forem endemick\u00E9 myk\u00F3zy jako jsou parakokcidioidomyk\u00F3za, lymfokut\u00E1nn\u00ED sporotrich\u00F3za a histoplazm\u00F3za jsou omezen\u00E9, co\u017E zamezuje doporu\u010Den\u00ED d\u00E1vkov\u00E1n\u00ED. \nRen\u00E1ln\u00ED syst\u00E9m \nPacient\u016Fm s ren\u00E1ln\u00ED dysfunkc\u00ED m\u00E1 b\u00FDt flukonazol pod\u00E1v\u00E1n s opatrnost\u00ED (viz tak\u00E9 4.2). \nHepatobili\u00E1rn\u00ED syst\u00E9m \nPacient\u016Fm s jatern\u00ED dysfunkc\u00ED m\u00E1 b\u00FDt flukonazol pod\u00E1v\u00E1n s opatrnost\u00ED. \nFluconazol je spojov\u00E1n se vz\u00E1cn\u00FDmi p\u0159\u00EDpady z\u00E1va\u017En\u00E9ho toxick\u00E9ho po\u0161kozen\u00ED jater s mo\u017En\u00FDm fat\u00E1ln\u00EDm zakon\u010Den\u00EDm, a to p\u0159edev\u0161\u00EDm u pacient\u016F v z\u00E1va\u017En\u00E9m stavu. V p\u0159\u00EDpadech flukonazolem navozen\u00E9 hepatotoxicity nebyla nalezena z\u00E1vislost na velikosti denn\u00ED d\u00E1vky, d\u00E9lce terapie, pohlav\u00ED nebo v\u011Bku. Flukonazolem navozen\u00E1 hepatotoxicita byla po vysazen\u00ED l\u00E9\u010Dby obvykle reverzibiln\u00ED. \nPacienti, u kter\u00FDch se objev\u00ED b\u011Bhem l\u00E9\u010Dby p\u0159\u00EDpravkem Apo-Fluconazol abnorm\u00E1ln\u00ED hodnoty jatern\u00EDch test\u016F, mus\u00ED b\u00FDt pe\u010Dliv\u011B sledov\u00E1ni z d\u016Fvodu mo\u017En\u00E9ho v\u00FDvoje z\u00E1va\u017En\u011Bj\u0161\u00EDho jatern\u00EDho po\u0161kozen\u00ED. \nPacient by m\u011Bl b\u00FDt informov\u00E1n o pr\u016Fvodn\u00EDch p\u0159\u00EDznac\u00EDch z\u00E1va\u017En\u00E9ho hepatick\u00E9ho \u00FA\u010Dinku (z\u00E1va\u017En\u00E1 astenie, anorexie, p\u0159etrv\u00E1vaj\u00EDc\u00ED nauzea, zvracen\u00ED a \u017Eloutenka). L\u00E9\u010Dbu flukonazolem je nutn\u00E9 okam\u017Eit\u011B p\u0159eru\u0161it a pacient m\u00E1 kontaktovat l\u00E9ka\u0159e. \nKardiovaskul\u00E1rn\u00ED syst\u00E9m \nN\u011Bkter\u00E9 azoly, v\u010Detn\u011B flukonazolu, b\u00FDvaj\u00ED spojov\u00E1ny s prodlou\u017Een\u00EDm QT intervalu na elektrokardiogramu. B\u011Bhem postmarketingov\u00E9ho sledov\u00E1n\u00ED se u pacient\u016F u\u017E\u00EDvaj\u00EDc\u00EDch flukonazol objevily velmi vz\u00E1cn\u00E9 p\u0159\u00EDpady prodlou\u017Een\u00ED QT intervalu a torsades de pointes. Tato hl\u00E1\u0161en\u00ED se t\u00FDkala pacient\u016F s \u010Detn\u00FDmi vz\u00E1jemn\u011B p\u016Fsob\u00EDc\u00EDmi rizikov\u00FDmi faktory, jako je srde\u010Dn\u00ED choroba organick\u00E9ho p\u016Fvodu, elektrolytov\u00E9 abnormality a sou\u010Dasn\u011B u\u017E\u00EDvan\u00E9 l\u00E9ky, kter\u00E9 mohou p\u0159isp\u00EDvat ke vzniku abnormalit. \nPacient\u016Fm s t\u011Bmito potenci\u00E1ln\u011B proarytmick\u00FDmi p\u0159edpoklady m\u00E1 b\u00FDt flukonazol pod\u00E1v\u00E1n s opatrnost\u00ED. Sou\u010Dasn\u00E9 pod\u00E1v\u00E1n\u00ED s dal\u0161\u00EDmi l\u00E9\u010Div\u00FDmi p\u0159\u00EDpravky, kter\u00E9 prodlu\u017Euj\u00ED QT interval a jsou metabolizov\u00E1ny prost\u0159ednictv\u00EDm cytochromu P450 (CYP) 3A4, je kontraindikov\u00E1no (viz body 4.3 a 4.5). \nHalofantrin\nHalofantrin je substr\u00E1tem CYP3A4 a je spojov\u00E1n s prodlou\u017Een\u00EDm QTc intervalu p\u0159i doporu\u010Den\u00FDch terapeutick\u00FDch d\u00E1vk\u00E1ch. Sou\u010Dasn\u00E9 pod\u00E1n\u00ED flukonazolu a halofantrinu se proto nedoporu\u010Duje (viz bod 4.5). \nDermatologick\u00E9 reakce \nZ\u0159\u00EDdka se b\u011Bhem l\u00E9\u010Dby flukonazolem mohou objevit exfoliativn\u00ED ko\u017En\u00ED reakce, jako je Stevens - Johnson\u016Fv syndrom a toxick\u00E1 epiderm\u00E1ln\u00ED nekrol\u00FDza. K z\u00E1va\u017En\u00FDm ko\u017En\u00EDm reakc\u00EDm na mnoh\u00E1 l\u00E9\u010Diva jsou n\u00E1chyln\u011Bj\u0161\u00ED pacienti s AIDS. Pokud se u pacient\u016F s povrchn\u00ED ko\u017En\u00ED myk\u00F3zou objev\u00ED exant\u00E9m, jeho\u017E p\u0159\u00ED\u010Dinou m\u016F\u017Ee b\u00FDt flukonazol, m\u00E1 b\u00FDt terapie t\u00EDmto p\u0159\u00EDpravkem p\u0159eru\u0161ena. Jestli\u017Ee se u pacient\u016F s invazivn\u00ED nebo syst\u00E9movou myk\u00F3zou objev\u00ED vyr\u00E1\u017Eka, je t\u0159eba je pe\u010Dliv\u011B sledovat a terapii flukonazolem p\u0159eru\u0161it, pokud se objev\u00ED bul\u00F3zn\u00ED l\u00E9ze nebo erythema multiforme. \nHypersensitivita \nVz\u00E1cn\u011B byly hl\u00E1\u0161eny p\u0159\u00EDpady anafylaxe (viz bod 4.3). \nCytochrom P450 \nFlukonazol je siln\u00FD inhibitor CYP2C9 a st\u0159edn\u011B siln\u00FD inhibitor CYP3A4. Flukonazol je rovn\u011B\u017E inhibitor CYP2C19. Pacienti l\u00E9\u010Den\u00ED flukonazolem, kte\u0159\u00ED jsou sou\u010Dasn\u011B l\u00E9\u010Deni l\u00E9ky s \u00FAzkou terapeutickou \u0161\u00ED\u0159\u00ED a metabolizovan\u00FDmi prost\u0159ednictv\u00EDm CYP2C9, CYP2C19 a CYP3A4, maj\u00ED b\u00FDt sledov\u00E1ni (viz bod 4.5). \nTerfenadin \nSou\u010Dasn\u00E9 pod\u00E1v\u00E1n\u00ED flukonazolu v d\u00E1vce do 400 mg spolu s terfenadinem je t\u0159eba pe\u010Dliv\u011B monitorovat (viz body 4.3 a 4.5). \nPomocn\u00E9 l\u00E1tky \nP\u0159\u00EDpravek Apo-Fluconazol tobolky obsahuje monohydr\u00E1t lakt\u00F3zy a nesm\u00ED se pod\u00E1vat pacient\u016Fm se vz\u00E1cn\u00FDmi d\u011Bdi\u010Dn\u00FDmi probl\u00E9my s intoleranc\u00ED galakt\u00F3zy, heredit\u00E1rn\u00ED deficienc\u00ED lakt\u00E1zy nebo malabsorpc\u00ED gluk\u00F3zy a galakt\u00F3zy.\n"@cs . . .