"4.6\tT\u011Bhotenstv\u00ED a kojen\u00ED"@cs . . "Nedoporu\u010Duje se u\u017E\u00EDvat Amprilan H v prvn\u00EDm trimestru t\u011Bhotenstv\u00ED (viz bod 4.4) a u\u017E\u00EDv\u00E1n\u00ED ve druh\u00E9m a\u00A0t\u0159et\u00EDm trimestru t\u011Bhotenstv\u00ED je kontraindikov\u00E1no (viz bod 4.3). \nPokud jde o riziko teratogenity, epidemiologick\u00FD d\u016Fkaz po expozici ACE inhibitor\u016Fm b\u011Bhem prvn\u00EDho trimestru t\u011Bhotenstv\u00ED nebyl p\u0159esv\u011Bd\u010Div\u00FD, p\u0159esto nelze vylou\u010Dit mal\u00E9 zv\u00FD\u0161en\u00ED rizika. Pokud se pokra\u010Dov\u00E1n\u00ED l\u00E9\u010Dby ACE inhibitory nepova\u017Euje vysloven\u011B za nezbytn\u00E9, mus\u00ED b\u00FDt u pacientek pl\u00E1nuj\u00EDc\u00EDch ot\u011Bhotn\u011Bn\u00ED zm\u011Bn\u011Bna l\u00E9\u010Dba na alternativn\u00ED antihypertenzn\u00ED l\u00E9\u010Dbu s\u00A0prok\u00E1zan\u00FDm bezpe\u010Dnostn\u00EDm profilem pro pou\u017E\u00EDv\u00E1n\u00ED v\u00A0dob\u011B t\u011Bhotenstv\u00ED. Jestli\u017Ee se zjist\u00ED, \u017Ee je pacientka t\u011Bhotn\u00E1, mus\u00ED b\u00FDt l\u00E9\u010Dba ACE inhibitory okam\u017Eit\u011B ukon\u010Dena a, pokud je to vhodn\u00E9, mus\u00ED b\u00FDt zah\u00E1jena alternativn\u00ED l\u00E9\u010Dba.\nJe zn\u00E1mo, \u017Ee expozice l\u00E9\u010Db\u011B ACE inhibitorem / antagonistou receptoru pro angiotenzin II (AIIRA) v\u00A0dob\u011B druh\u00E9ho a t\u0159et\u00EDho trimestru zp\u016Fsobuje u lid\u00ED fetotoxicitu (sn\u00ED\u017Een\u00E1 funkce ledvin, oligohydramnion, retardovan\u00E1 osifikace lebky) a neonat\u00E1ln\u00ED toxicitu (selh\u00E1n\u00ED ledvin, hypotenze, hyperkal\u00E9mie) (viz tak\u00E9 bod 5.3 P\u0159edklinick\u00E9 \u00FAdaje vztahuj\u00EDc\u00ED se k bezpe\u010Dnosti). Dojde-li k\u00A0expozici ACE inhibitor\u016Fm od druh\u00E9ho trimestru, doporu\u010Duje se kontrola ledvin a lebky ultrazvukem. Novorozenci, jejich\u017E matky u\u017E\u00EDvaly ACE inhibitory, mus\u00ED b\u00FDt d\u016Fkladn\u011B sledov\u00E1ni, jestli se u nich nevyskytuje hypotenze, oligurie nebo hyperkal\u00E9mie (viz tak\u00E9 body 4.3 a 4.4).\nS\u00A0u\u017E\u00EDv\u00E1n\u00EDm hydrochlorothiazidu b\u011Bhem t\u011Bhotenstv\u00ED existuje omezen\u00E1 zku\u0161enost, zejm\u00E9na b\u011Bhem prvn\u00EDho trimestru. Studie proveden\u00E9 na zv\u00ED\u0159atech nejsou dostate\u010Dn\u00E9.\nHydrochlorothiazid proch\u00E1z\u00ED placentou. Podle farmakologick\u00E9ho mechanismu \u00FA\u010Dinku hydrochlorothiazidu m\u016F\u017Ee jeho pou\u017Eit\u00ED b\u011Bhem druh\u00E9ho a t\u0159et\u00EDho trimestru ohrozit fetoplacent\u00E1ln\u00ED perfuzi a zp\u016Fsobit fet\u00E1ln\u00ED nebo neonat\u00E1ln\u00ED vlivy jako ikterus, porucha rovnov\u00E1hy elektrolyt\u016F a trombocytopenie.\nHydrochlorothiazid nesm\u00ED b\u00FDt pou\u017E\u00EDv\u00E1n p\u0159i t\u011Bhotensk\u00E9m ed\u00E9mu, t\u011Bhotensk\u00E9 hypertenzi nebo preeklampsii kv\u016Fli riziku sn\u00ED\u017Een\u00E9ho plasmatick\u00E9ho objemu a placent\u00E1ln\u00ED hypoperfuze, bez prosp\u011B\u0161n\u00E9ho vlivu na pr\u016Fb\u011Bh onemocn\u011Bn\u00ED. Hydrochlorothiazid nesm\u00ED b\u00FDt pou\u017E\u00EDv\u00E1n p\u0159i esenci\u00E1ln\u00ED hypertenzi u t\u011Bhotn\u00FDch \u017Een s\u00A0vyj\u00EDmkou vz\u00E1cn\u00FDch situac\u00ED, kdy nem\u016F\u017Ee b\u00FDt pou\u017Eita jin\u00E1 l\u00E9\u010Dba.\nRamipril a hydrochlorothiazid jsou vylu\u010Dov\u00E1ny do mate\u0159sk\u00E9ho ml\u00E9ka v\u00A0takov\u00E9 m\u00ED\u0159e, \u017Ee \u00FA\u010Dinky u kojen\u00FDch d\u011Bt\u00ED jsou pravd\u011Bpodobn\u00E9, kdy\u017E se terapeutick\u00E1 d\u00E1vka ramiprilu a hydrochlorothiazidu pod\u00E1v\u00E1 koj\u00EDc\u00EDm matk\u00E1m. Nejsou k\u00A0dispozici dostate\u010Dn\u00E9 \u00FAdaje t\u00FDkaj\u00EDc\u00ED se u\u017E\u00EDv\u00E1n\u00ED ramiprilu b\u011Bhem kojen\u00ED a je preferov\u00E1na alternativn\u00ED l\u00E9\u010Dba s\u00A0l\u00E9pe stanoven\u00FDm bezpe\u010Dnostn\u00EDm profilem, zejm\u00E9na p\u0159i kojen\u00ED novorozenc\u016F nebo nedono\u0161en\u00FDch d\u011Bt\u00ED. Hydrochlorothiazid je vylu\u010Dov\u00E1n do mate\u0159sk\u00E9ho ml\u00E9ka. Thiazidy mohou u koj\u00EDc\u00EDch \u017Een zp\u016Fsobit pokles a\u017E potla\u010Den\u00ED tvorby ml\u00E9ka. Mohou se vyskytnout p\u0159\u00EDpady hypersenzitivity na sulfonamidov\u00E9 deriv\u00E1ty, hypokal\u00E9mie a j\u00E1drov\u00E9ho ikteru. Proto\u017Ee u obou l\u00E9\u010Div\u00FDch l\u00E1tek existuje mo\u017Enost z\u00E1va\u017En\u00FDch reakc\u00ED u kojen\u00FDch d\u011Bt\u00ED, je nutn\u00E9 se rozhodnout, zda p\u0159eru\u0161it kojen\u00ED nebo l\u00E9\u010Dbu, p\u0159i\u010Dem\u017E je t\u0159eba vz\u00EDt v\u00A0\u00FAvahu d\u016Fle\u017Eitost l\u00E9\u010Dby pro matku. \n"@cs . . . . . . . . "004.006" .