Levothyroxine Izidakamizwa Njenga-Synthroid Kwakudinga Ukubonisa Ukuzinza, Ukuvumelana
NgoSeptemba ka-1997, isimemezelo sagubha isigulane segciwane lesigulane. Ingakumbi, yabathintela abo gulane ababethabatha enye yeziyobisi ze-hormone zengxubevange ezithatha indawo ezifana ne-Synthroid, Levoxyl kunye nabanye-ngokusekelwe kwi-levothyroxine sodium.
NgokweSaziso soBhaliso seSithili kwilo xesha,
... akukho okwangoku kuthengiswa ngomlomo nge-levothyroxine umkhiqizo we-sodium uye waboniswa ukubonakalisa amandla okuzinza kunye nokuzinza, ngoko ke, akukho mveliso ekhoyo ngokuthengiswa ngomlomo nge-levothyroxine yemveliso ye-sodium ngokuqhelekileyo ibonwa njengekhuselekile kwaye isebenzayo.
Ngelo xesha, urhulumente wayefumene ukuba i-levothyroxine izidakamizwa ze-sodium yayingahlali zihlala ngamandla ngexesha lokuphela kwayo, kwaye amacwecwe enamandla okulinganisa okufanayo evela kumvelisi ofanayo atholakala ukuba ahluke kwi-lotency kwiqashiso ukuya kwinqanaba ngokwemali yokusebenza isithako esikhoyo. Ukuntuleka kozinzo kunye nokusebenza okusemgangathweni kwakunokubangela ukuba imiphumo emibi yezempilo kulabo bathatha la mayeza.
I-Levothyroxine sodium yaqala ukufakwa kwiimarike ngaphambi kowe-1962, ngaphandle kwesicelo seMvume entsha yeDrug (i-NDA) evumelekileyo, ngokucacileyo inkolelo yokuba akusiyo isiza esitsha.
Ukususela kulo xesha, phantse wonke umenzi weemveliso ze-levothyroxine ze-sodium, ezibandakanya i-Synthroid, wayedlala ngokukhumbula ukuba kwakungenxa yeengxaki ze-potency okanye zokuzinza.
Kwezinye iimeko, iingxaki zibangelwa kukuba i- levothyroxine sodium ayizinzile phambi kokukhanya, ukushisa, umoya kunye nomswakama.
Ngexesha eliphakathi kuka-1991 no-1997, kwakungekho ngaphantsi kwe-10 okukhumbulayo i-levothyroxine iipilisi ze-sodium ezibandakanya amaqela angama-150 kunye namaphilisi angaphezu kwezigidi ezili-100. Kuzo zonke iimeko, enye ikhunjulwa iqalelwa kuba iipilisi zafunyanwa zingekho phantsi okanye ngenxa yeeplatelet zabo ze-levothyroxine zazilahleka ngaphambi kokuba ziphelelwe ixesha.
Ukukhunjulwa okusele kwaqaliswa umkhiqizo ofunyenwe ukuba unamandla kakhulu. Ngeli xesha, i-FDA ikhuphe izilumkiso kumenzi wezinto eziphathelene ne- levothyroxine yemveliso ye-sodium elahlekelwe ngamandla xa igcinwe kwisiphezulu esiphakamileyo sobushushu obucetywayo, kunye neyodwa enefuthe ukusuka kuma-74.7 ukuya kwi-90.4, endaweni ye-90% ukuya kwi-110 ipesenti ezifunekayo ngelo xesha.
Iingxaki nazo zivela kwiinguqulelo zokuqulunqa. Ngenxa yokuba le mveliso yayithengiswa ngaphandle kwe-NDA, abavelisi bebengenakufakela imvume ye-FDA rhoqo xa beguqulela imveliso ye-sovothyroxine ye-sodium. Abavelisi batshintshe izithako ezingasebenziyo, uhlobo lwezinto ezibonakalayo zemibala kunye neminye imiba yomkhiqizo, okubangelwa utshintsho olukhulu kwiimeko ezithile, kwezinye iimeko zanda okanye zinciphisa amandla angama-30 ekhulwini. Ngenxa yoko, kwezinye iimeko, abantu abafumana isilinganiselo esifanayo seminyaka baba yityhefu kwaye bagxininiswa - okanye bangaphantsi - kwimizuzu efanayo. Kwakukho ubungqina bokuba abavelisi baqhubeka nokwenza ezi ntlobo zenguqu zenguqu ezithintekayo.
Emva koko, iminyaka engama-35 emva kokusungulwa kwawo, i-US Food and Drug Administration (i-FDA) yase-United States yakhupha isaziso (i- Federal Register , ngo-Agasti 14, 1997) ukuba iimveliso zonyango ezilawulwa ngomlomo ezine-levothyroxine sodium zafakwa ngokwasemthethweni ngokuthi "amatsha amachiza" kwaye kufuneka Inkqubo ye-NDA ngenxa yeengxaki zokuzinza neengxaki eziye zabonakala.
Ukuze uqhubeke nokuthengisa ezo zonyango, abavelisi kufuneka bahambise i-NDA ngobungqina obubhaliweyo bokuthi imveliso nganye yenkampani ikhuselekile, isebenzayo, kwaye iyenziwa ngendlela yokuqinisekisa ukuba i-potency eqhubekayo. Ngenxa yokuba izidakamizwa ziyimfuneko kwizigidi zabantu baseMerika, i-FDA ivumele abakhiqizi ukuba baqhube ukuthengisa iimveliso ngaphandle kwe-NDA evunyiweyo kude kube ngu-Agasti 14, 2000, ukwenzela ukuba banike iinkampani ithuba elifanelekileyo lokuqhuba izifundo ezahlukeneyo zophando kunye nokuhambisa ii-NDA zabo.
Impembelelo yezigulane
Ziziphi iimpembelelo ezi zenzeke kwizigulane ezithatha i-levothyroxine ye-thyroid hormone?
- Ngaphandle kokuba ugqirha wachaza ngokukodwa uhlobo oluthile lwe-levothyroxine sodium, ngokugqitywa kwemithi ngayinye, izigulane zigijimela i-RISK yokufumana imveliso ehlukileyo kwi-dose ekhoyo.
- Ukuba isilwanyana esifumene sasingenamandla, izigulane zaba yi-HYPOTHYROID kunye neempawu ezinokubandezeleka, ukukhathala, ukufumana ubunzima, ukunyamezela, ukunyamezela, ukuvuvukala, nobunzima bokugxila.
- Ukuba isilwanyana esifumene sisisigxina, izigulane zinokufumana iimpawu ezinzulu ze-HYPERTHYROIDISM ezinjengeentlungu zentliziyo, iintlungu zentliziyo, okanye i-cordiac arrhythmias. Kwizigulane ezinesifo senhliziyo, nokuba ukwanda okwenyuka kwi-levothyroxine sodium kungaba yingozi. Kwaye uphando lubonisa ukuba i-levothyroxine sodium encinci efana neyobangela ukuba i-potency yanda iyakwandisa umngcipheko we-osteoporosis ngokubangela i-subclinical hyperthyroidism.
- Ukutshintshwa kwendlela yokwenza i-potency kungenza ukuba isilinganisi esifanelekileyo singenakwenzeka. I-Levothyroxine iipilisi ze-sodium zifika ezinamandla ezilingana ezihluka ngexabiso elincinci, ezivumela ugqirha wakho ukuba akufumanise ngokuchanekileyo ncam. Kodwa xa inani leziyobisi ezisetyenziswayo kwi-dosage ethile lihluka, oko kwenza ukuba ufumane kwaye ulondoloze umthamo ochanekileyo kuwe ubunzima obuninzi.
QAPHELA: Abavelisi beziyobisi baye bafaka i-NDAs ye-levothyroxine, kwaye i-levothyroxine, ngo-2017, isicatshulwa esivumelekileyo se-FDA.