I-Zulresso (i-brexanolone)

-Delile

• Yini iZulresso?
• Ukusebenza ngempumelelo
• Ukuvunyelwa kwe-FDA
• Ingabe iZulresso yinto elawulwayo?
• I-Zulresso ejwayelekile
• Izindleko zeZulresso
• Usizo lwezezimali nolomshuwalense
• Imiphumela emibi ye-Zulresso
• Imiphumela emibi ejwayelekile
• Imiphumela emibi kakhulu
• Imininingwane yomphumela oseceleni
• Ukusabela okweqile
• Ukuhlala nokulahlekelwa ukwazi
• I-Zulresso yokudangala kwangemva kokubeletha
• Isilinganiso seZulresso
• Amafomu wezidakamizwa namandla
• Isilinganiso sokucindezeleka kwangemva kokubeletha (PPD)
• Ngabe kuzodingeka ngisebenzise lesi sidakamizwa isikhathi eside?
• UZulresso notshwala
• Ukusebenzisana kweZulresso
• I-Zulresso neminye imithi
• I-Zulresso nama-opioid
• I-Zulresso nemithi ethile yokukhathazeka
• I-Zulresso nemithi ethile yokulala
• I-Zulresso kanye ne-anti-depressants
• Ezinye izindlela zeZulresso
• I-Zulresso vs. iZoloft
• Isebenzisa
• Amafomu wezidakamizwa nokuphathwa
• Imiphumela emibi kanye nezingozi
• Imiphumela emibi ejwayelekile
• Imiphumela emibi kakhulu
• Ukusebenza ngempumelelo
• Izindleko
• I-Zulresso vs. iLexapro
• Isebenzisa
• Amafomu wezidakamizwa nokuphathwa
• Imiphumela emibi kanye nezingozi
• Imiphumela emibi ejwayelekile
• Imiphumela emibi kakhulu
• Ukusebenza ngempumelelo
• Izindleko
• Inikezwa kanjani iZulresso
• Lapho iZulresso inikezwa
• Ukuthatha iZulresso ngokudla
• Isebenza kanjani iZulresso
• Mayelana ne-PPD
• I-Zulresso ingasiza kanjani
• Kuthatha isikhathi esingakanani ukusebenza?
• I-Zulresso nokukhulelwa
• I-Zulresso nokuncelisa
• Imibuzo ejwayelekile ngeZulresso
• Ngabe iZulresso ingazelapha ezinye izinhlobo zokudangala ngaphandle kokudangala kwangemva kokubeletha?
• Kungani iZulresso itholakala kuphela esikhungweni esiqinisekiswe yi-REMS?
• Ngabe ngisazodinga ukuthatha imishanguzo yomlomo ngemuva kokwelashwa kweZulresso?
• Ngabe abesilisa bangathola yini ukucindezeleka kwangemva kokubeletha? Uma kunjalo, bangayisebenzisa iZulresso?
• Ngabe iZulresso ingelapha ukwelashwa kwangemva kokubeletha?
• Ngabe iZulresso ingalapha ukucindezeleka kwangemva kokubeletha kwentsha?
• Ukuqapha kweZulresso
• Isexwayiso se-FDA: Ukudonswa ngokweqile nokulahleka okungazelelwe komuzwa
• Ezinye izexwayiso
• Imininingwane yobuchwepheshe yeZulresso
• Izinkomba
• Indlela yokusebenza
• I-Pharmacokinetics ne-metabolism
• Izimo
• Ukuhlukumeza nokuncika
• Isitoreji

Yini iZulresso?

I-Zulresso ngumuthi kadokotela obizwa ngegama lomuthi onqunyelwe ukucindezeleka kwangemva kokubeletha (PPD) kubantu abadala. I-PPD ukucindezeleka okuvame ukuqala kungakapheli amasonto ambalwa ubelethile. Kwabanye, akuqali kuze kube yizinyanga ngemuva kokuba nomntwana.

IZulresso ayilaphi i-PPD, kepha ingasiza ekunciphiseni izimpawu ze-PPD. Lokhu kungabandakanya ukuzizwa udabuke ngokweqile, ukhathazekile futhi ukhungathekile. I-PPD ingakuvimbela ukuthi ukwazi ukunakekela ingane yakho, futhi ingaba nemiphumela emibi kakhulu kuwe nasemndenini wakho.

I-Zulresso iqukethe i-brexanolone yezidakamizwa. Kunikezwa njengokufakwa okufakwa emthanjeni (IV), okungena emthanjeni wakho. Uzothola ukumnika esikhathini esingamahora angama-60 (izinsuku ezingu-2,5). Uzohlala esikhungweni sokunakekelwa kwezempilo esiqinisekiswe ngokukhethekile ngenkathi uthola iZulresso. (Okwamanje, akwaziwa ukuthi ukwelashwa okungaphezu kweyodwa nge-Zulresso kuphephile noma kuyasebenza.)

Ukusebenza ngempumelelo

Ezifundweni zokwelashwa, iZulresso ikhulule izimpawu ze-PPD ngaphezu kwe-placebo (ukwelashwa ngaphandle kwesidakamizwa esisebenzayo). Lezi zifundo zisebenzise isikali sokuqina kokucindezeleka esinamaphuzu aphezulu angama-52. Ngokuya ngocwaningo, i-PPD elinganisiwe itholakala inamaphuzu angama-20 kuye kwangama-25. I-PPD enamandla itholakala inamaphuzu angama-26 noma ngaphezulu.

Ucwaningo olulodwa lwabandakanya abesifazane abane-PPD enamandla. Ngemuva kokufakwa kwe-Zulresso kwamahora angama-60, izikolo zokucindezeleka zalabo besifazane zithuthukiswe ngamaphuzu angaphezu kuka-3.7 kuya ku-5.5 kunamanani abesifazane athatha i-placebo.

Ocwaningweni olubandakanya abesifazane abane-PPD elinganiselayo, iZulresso ithuthukise izikolo zokucindezeleka ngamaphoyinti angu-2,5 ngaphezulu kwe-placebo ngemuva kokufakwa kwehora lama-60.

Ukuvunyelwa kwe-FDA

I-Zulresso yamukelwa yi-Food and Drug Administration (i-FDA) ngo-Mashi 2019. Yisidakamizwa sokuqala futhi kuphela i-FDA esivume ukwelapha ngqo i-PPD. Kodwa-ke, ayikatholakali ukusetshenziswa (bheka "Ingabe iZulresso yinto elawulwayo?" Ngezansi).

Ingabe iZulresso yinto elawulwayo?

Yebo, iZulresso yinto elawulwayo, okusho ukuthi ukusetshenziswa kwayo kuhlolwe kakhulu nguhulumeni wesifundazwe. Into ngayinye elawulwayo inikezwa ishejuli ngokususelwa ekusetshenzisweni kwayo kwezokwelapha, uma ikhona, namandla ayo okusetshenziswa kabi. I-Zulresso ihlukaniswa njengesidakamizwa seshejuli 4 (IV).

IZulresso kulindeleke ukuthi itholakale ngasekupheleni kukaJuni 2019.

Uhulumeni usungule imithetho ekhethekile yokuthi isigaba ngasinye semithi ehleliwe singabekwa futhi sikhishwe kanjani. Udokotela wakho kanye nosokhemisi bangakutshela kabanzi ngale mithetho.

I-Zulresso ejwayelekile

I-Zulresso itholakala kuphela njengomuthi wegama lomkhiqizo. Okwamanje ayitholakali ngendlela ejwayelekile.

I-Zulresso iqukethe isithako sezidakamizwa esisebenzayo i-brexanolone.

Izindleko zeZulresso

Njengayo yonke imithi, izindleko zeZulresso zingahluka. AbakwaSage Therapeutics, abakhiqizi beZulresso, bathi embikweni wayo wekota ngayinye ukuthi intengo yohlu ingama- $ 7,450 ngesitsha esisodwa. Ukwelashwa kudinga isilinganiso sezitsha ezingama-4.5, ngakho-ke izindleko eziphelele zizoba cishe ngama- $ 34,000 ngaphambi kwezaphulelo. Intengo yangempela ozoyikhokha incike ohlelweni lwakho lomshuwalense.

Usizo lwezezimali nolomshuwalense

Uma udinga uxhaso lwezezimali ukukhokhela iZulresso, usizo lusendleleni. AbakwaSage Therapeutics, abenza iZulresso, bamemezele ukuthi bazonikela ngezinhlelo zosizo lwezezimali kwabesifazane abafanelekile.

Ukuze uthole olunye ulwazi, thinta iSage Therapeutics ku-617-299-8380. Ungahlola futhi imininingwane ebuyekeziwe kuwebhusayithi yenkampani.

Imiphumela emibi ye-Zulresso

I-Zulresso ingadala imiphumela emibi noma emibi. Uhlu olulandelayo luqukethe eminye yemiphumela emibi engaba khona ngenkathi uthatha iZulresso. Lezi zinhlu azibandakanyi yonke imiphumela emibi engaba khona.

Ukuthola eminye imininingwane ngemiphumela engemihle yeZulresso, khuluma nodokotela wakho noma usokhemisi. Bangakunika amathiphu okuthi ungabhekana kanjani nanoma yimiphi imiphumela emibi engase ikukhathaze.

Imiphumela emibi ejwayelekile

Imiphumela emibi ejwayelekile yeZulresso ingafaka:

• i-sedation (ukulala, ukukhathazeka ngokucabanga kahle, ukungakwazi ukushayela noma ukusebenzisa imishini esindayo)
• isiyezi noma i-vertigo (uzizwa sengathi uhamba lapho ungekho)
• uzizwe sengathi uzoquleka
• umlomo owomile
• ukuqhuma isikhumba (ubomvu nokuzwa ukufudumala esikhunjeni sakho)

Iningi lalemiphumela emibi ingahle ihambe ezinsukwini ezimbalwa noma emasontweni ambalwa. Uma zinzima kakhulu noma zingahambi, khuluma nodokotela wakho noma usokhemisi.

Imiphumela emibi kakhulu

Imiphumela emibi kakhulu evela kuZulresso ingenzeka. Shayela udokotela wakho ngokushesha uma unemiphumela emibi kakhulu ngemuva kokuphuma esikhungweni sokunakekelwa kwezempilo lapho uthole khona umthamo wakho. Shayela u-911 uma izimpawu zakho zizizwa zisongela impilo noma uma ucabanga ukuthi unezimo eziphuthumayo zezokwelapha.

Imiphumela emibi kanye nezimpawu zayo zingafaka okulandelayo:

• Ukulahlekelwa ukwazi. Izimpawu zingafaka:
• Imicabango yokuzibulala nokuziphatha kubantu abadala (abangaphansi kweminyaka engama-25 ubudala). * Izimpawu zingafaka:

* Le miphumela ingenzeka nasezinganeni. Lesi sidakamizwa asivunyelwe ukusetshenziswa ezinganeni.

Imininingwane yomphumela oseceleni

Ungase uzibuze ukuthi kaningi kangakanani imiphumela emibi ethile eba khona ngalo muthi. Nayi imininingwane ngemiphumela ethile eseceleni engadalwa yilesi sidakamizwa.

Ukusabela okweqile

Njengezidakamizwa eziningi, abanye abantu bangaba nokungezwani komzimba ngemuva kokuthatha iZulresso. Izimpawu zokuphendula okuncane komzimba zingabandakanya:

• ukuqubuka kwesikhumba
• ukulunywa
• ukuqhuma (ukufudumala nokubomvu esikhunjeni sakho)

Ukusabela okweqile okwedlulele akuvamile kodwa kungenzeka. Izimpawu zokuphendula okweqile kakhulu zingabandakanya:

• i-angioedema (ukuvuvukala ngaphansi kwesikhumba sakho, imvamisa ezinkalweni zakho, izindebe, izandla, noma izinyawo)
• ukuvuvukala kolimi lwakho, umlomo, noma umphimbo
• inkinga yokuphefumula

Shayela udokotela wakho ngokushesha uma une-allergies enamandla kakhulu ku-Zulresso ngemuva kokuphuma esikhungweni sokunakekelwa kwezempilo. Shayela u-911 uma izimpawu zakho zizizwa zisongela impilo noma uma ucabanga ukuthi unezimo eziphuthumayo zezokwelapha.

Ukuhlala nokulahlekelwa ukwazi

I-sedation ingumphumela ohlangothini ovamile neZulresso. Izimpawu zifaka ukulala nokukhathazeka ukucabanga kahle. Kwezinye izimo, ukuthambeka kungaba nzima, okuholele ekulaleni ngokweqile nasekulahlekelweni ukwazi.

Ezifundweni zomtholampilo, u-5% wabantu ubenesidudla esinzima esidinga ukumiswa okwesikhashana noma ushintsho ekwelashweni. Kubantu abathatha i-placebo (ukwelashwa okungenawo umuthi osebenzayo), akekho owaba nomphumela ofanayo.

Ukulahlekelwa ukwazi kusho ukuquleka noma ukubonakala ngathi ulele. Ngalesi sikhathi, awukwazi ukuphendula umsindo noma ukuthinta. Ezifundweni zokwelashwa, abantu abangu-4% abathathe iZulresso balahlekelwa ukwazi. Akekho noyedwa kubantu abathathe i-placebo onomphumela.

Kumuntu ngamunye owaquleka ezifundweni, ukwelashwa kwamiswa. Ngamunye walaba bantu wabuyela emumva kwemizuzu eyi-15 kuya kwengu-60 ngemuva kokuyeka ukwelashwa.

Lapho uthola iZulresso, udokotela wakho uzokuqapha ngokulahlekelwa ukwazi. Bazokwenza lokhu njalo emahoreni amabili ngezikhathi zokungalali. (Uzolandela uhlelo olujwayelekile lokulala ngesikhathi sokwelashwa kwakho.)

Kokubili ukudonswa ngamandla nokulahlekelwa ukwazi kungaholela emazingeni aphansi e-oxygen (hypoxia). Uma uhlala phansi noma ulahlekelwa ukwazi, ukuphefumula kwakho kungahle kuhamba kancane. Uma lokhu kwenzeka, umzimba wakho uthatha umoya-mpilo omncane. I-oxygen encane kakhulu kumaseli nezicubu zakho ingadala umonakalo ebuchosheni bakho, esibindini nakwezinye izitho zomzimba.

Ngalesi sizathu, udokotela wakho uzoqapha amazinga e-oxygen egazini lakho kulo lonke ukwelashwa kwakho.Uma ulahlekelwa ukwazi noma unamazinga aphansi oksijini egazini lakho, udokotela wakho uzomisa ukwelashwa kweZulresso okwesikhashana. Uma benquma ukuqala kabusha ukwelashwa kweZulresso, bangasebenzisa umthamo ophansi.

Ngenxa yengozi yokulahlekelwa ukwazi, iZulresso inikezwa kuphela ngabasebenzi bezempilo abaqinisekisiwe ukuthi banikeza le ndlela yokwelashwa.

[Ukukhiqizwa: Sicela ufake iwijethi yokuvimbela ukuzibulala ye-Pros-Cons]

I-Zulresso yokudangala kwangemva kokubeletha

Ukuphathwa Kwezokudla Nezidakamizwa (i-FDA) kuvumela imishanguzo kadokotela efana neZulresso ukwelapha izimo ezithile.

I-Zulresso ivunyelwe yi-FDA ukwelapha abantu abadala abane-postpartum depression (PPD). Lesi simo siyindlela ebucayi yokudangala okukhulu okwenzeka kungakapheli amasonto kuya ezinyangeni zokubeletha. Kunzima kakhulu kune "baby blues" abesifazane abaningi abanayo ngemuva nje kokubeletha. I-PPD engalashwa ingenza umama angakwazi ukunakekela ingane yakhe.

I-PPD ingabangelwa yizinto eziningana, kufaka phakathi:

• izinguquko kumazinga wakho we-hormone
• ukukhathala (ukungabi namandla)
• ukudla okungenampilo noma okungajwayelekile
• izinguquko empilweni yakho yezenhlalo noma yobungcweti (njengokuhlala ekhaya kakhulu kunakuqala)
• isimiso sokulala esibi noma esingajwayelekile
• ngizizwa ngikhishwa inyumbazane

Izimpawu zokudangala kwangemva kokubeletha zingabandakanya:

• ukukhathala
• ukukhathazeka
• ukushintsha kwemizwelo okukhulu
• uzizwe sengathi "ungumama omubi"
• unenkinga yokulala noma yokudla
• ukwesaba ngokuzilimaza wena noma abanye
• imicabango yokuzibulala noma isimilo

Ezifundweni zokwelashwa, iZulresso ikhulule izimpawu ze-PPD ngaphezu kwe-placebo (ukwelashwa ngaphandle kwesidakamizwa esisebenzayo). Lezi zifundo zisebenzise isilinganiso sokulinganisa ukukala ukuthi ukucindezeleka komuntu ngamunye kwakukubi kangakanani ngaphambi nangemva kokunikezwa iZulresso. Isilinganiso sokulinganisa sinamaphuzu aphezulu angama-52 amaphuzu, ngezikolo eziphakeme eziphakamisa ukucindezeleka okukhulu. Ngokuya ngocwaningo, i-PPD elinganisiwe itholakala inamaphuzu angama-20 kuye kwangama-25. I-PPD enamandla itholakala inamaphuzu angama-26 noma ngaphezulu.

Ucwaningo olulodwa lwabandakanya abesifazane abane-PPD enamandla. Ngemuva kokufakwa kwe-Zulresso kwamahora angama-60, izikolo zokucindezeleka zalabo besifazane zithuthukiswe ngamaphuzu angaphezu kuka-3.7 kuya ku-5.5 kunamanani abesifazane athatha i-placebo. Ocwaningweni olubandakanya abesifazane abane-PPD elinganiselayo, iZulresso ithuthukise izikolo zokucindezeleka ngamaphoyinti angu-2,5 ngaphezulu kwe-placebo ngemuva kokufakwa kwehora lama-60.

Isilinganiso seZulresso

Isilinganiso seZulresso udokotela wakho asinqumelayo sizoxhomeka ekutheni umzimba wakho uphendula kanjani kuZulresso.

Udokotela wakho uzokuqala ngomthamo ophansi futhi awukhulise ngaphezu kwamahora amaningana. Bazoyilungisa ngokuhamba kwesikhathi ukuze bafinyelele inani elibekezelelwa ngumzimba wakho ngaphandle kwemiphumela emibi kakhulu. Emahoreni ambalwa okugcina okwelashwa, bazokwehlisa umthamo futhi.

Imininingwane elandelayo ichaza imithamo esetshenziswa kakhulu noma enconyiwe. Udokotela wakho uzonquma isilinganiso esihle kakhulu ukulingana nezidingo zakho.

Amafomu wezidakamizwa namandla

I-Zulresso iza njengesisombululo esinikezwa njenge-infravenous (IV) infusion, engena emthanjeni wakho. Uzothola ukumnika esikhathini esingamahora angama-60 (izinsuku ezingu-2,5). Uzohlala esikhungweni sokunakekelwa kwezempilo ngalo lonke ukumnika.

Isilinganiso sokucindezeleka kwangemva kokubeletha (PPD)

Udokotela wakho uzonquma isilinganiso sakho ngokuya ngesisindo sakho. Ikhilogremu elilingana namakhilogremu angu-2.2.

Umthamo onconywayo weZulresso we-PPD ngu:

• Ukuqala kokumnika ngehora lesi-3: 30 mcg / kg ngehora
• Amahora 4–23: 60 mcg / kg ngehora
• Amahora angu-24–51: 90 mcg / kg ngehora
• Amahora 52-55: 60 mcg / kg ngehora
• Amahora 56-60: 30 mcg / kg ngehora

Uma unemiphumela emibi kakhulu ngesikhathi sokumnika, udokotela wakho angaphazamisa ukwelashwa noma anciphise umthamo weZulresso. Bazoqala kabusha ukwelashwa noma balondoloze umthamo uma benquma ukuthi kuphephile kuwe ukuqhubeka nokuthola iZulresso.

Ngabe kuzodingeka ngisebenzise lesi sidakamizwa isikhathi eside?

I-Zulresso ayenzelwe ukuthi isetshenziswe njengokwelashwa kwesikhathi eside. Ngemuva kokuthola i-Zulresso, wena nodokotela wakho ningaxoxa ngemithi ephephile nephumelelayo ye-anti-depressant ongayithatha isikhathi eside uma kudingeka.

UZulresso notshwala

Akufanele uphuze utshwala ngokushesha ngaphambi noma ngesikhathi sokwelashwa kwakho kweZulresso. Utshwala bungakhuphula ubungozi bokuhlala ngokukhululeka (ukulala, ukukhathazeka ngokucabanga kahle) uma kuphuzwa neZulresso. Kungakhuphula nengozi yokulahlekelwa ukwazi (ukungakwazi ukuphendula umsindo noma ukuthinta).

Uma ukhathazekile ngokwazi ukugwema utshwala eduze nesikhathi sokwelashwa kwakho, khuluma nodokotela wakho. Ungakhuluma futhi nokuthi ukuphuza utshwala kuphephile yini kuwe ngemuva kokwelashwa kwakho.

Ukusebenzisana kweZulresso

I-Zulresso ingaxhumana neminye imithi eminingana.

Ukuxhumana okuhlukile kungadala imiphumela ehlukile. Isibonelo, ukuxhumana okuthile kungaphazamisa ukusebenza kwesidakamizwa. Okunye ukuxhumana kungakhuphula imiphumela emibi noma kuyenze ibe nzima kakhulu.

I-Zulresso neminye imithi

Ngezansi kunohlu lwemithi engasebenzisana neZulresso. Lolu hlu aluqukethe zonke izidakamizwa ezingasebenzisana neZulresso.

Ngaphambi kokuthatha iZulresso, khuluma nodokotela wakho nosokhemisi. Batshele ngayo yonke imishanguzo oyinikezwa ngudokotela, i-counter-counter, nezinye izidakamizwa oziphuzayo. Batshele futhi nganoma yimaphi amavithamini, amakhambi, nezithako ozisebenzisayo. Ukwabelana ngalolu lwazi kungakusiza ugweme ukuhlangana okungenzeka.

Uma unemibuzo mayelana nokuhlangana kwezidakamizwa okungakuthinta, buza udokotela wakho noma usokhemisi.

I-Zulresso nama-opioid

Ukuthatha imishanguzo yobuhlungu efana nama-opioid ngaphambi noma ngesikhathi sokwelashwa kweZulresso kungakhuphula ubungozi bemiphumela emibi kakhulu. Ukuthatha i-Zulresso ngama-opioid kungakhuphula ubungozi be-sedation enzima (ukulala, ukukhathazeka ngokucabanga kahle, nokungakwazi ukushayela noma ukusebenzisa imishini esindayo). Kungakhuphula nobungozi bokulahlekelwa ukwazi (ukungakwazi ukuphendula umsindo noma ukuthinta).

Izibonelo zama-opioid ezingakhuphula ubungozi bokudonswa komzimba nokulahlekelwa ukwazi uma zithathwa ngeZulresso zifaka:

• i-hydrocodone (Hysingla, Zohydro)
• i-oxycodone (i-Oxycontin, i-Roxicodone, i-Xtampza ER)
• ikhodi
• i-morphine (i-Kadian, i-MS Contin)
• i-fentanyl (Abstral, Actiq, Duragesic, abanye)
• i-methadone (i-Dolophine, i-Methadose)

Imithi eminingi yezinhlungu iqukethe inhlanganisela yama-opioid nezinye izidakamizwa. Qiniseka ukuthi utshela udokotela wakho ngayo yonke imithi oyiphuzayo. Uma uthatha umuthi wezinhlungu, bangancoma ukuthi ungawuthathi ngokushesha ngaphambi nangesikhathi sokwelashwa kweZulresso. Lokhu kuzosiza ekunciphiseni ubungozi bokuhlala ngokukhululeka nokulahlekelwa ukwazi.

I-Zulresso nemithi ethile yokukhathazeka

Ukuthatha i-Zulresso nge-benzodiazepines (imithi esetshenziselwa ukwelapha ukukhathazeka) kungakhuphula ubungozi bemiphumela emibi kakhulu. Ukuthatha i-Zulresso nge-benzodiazepine kungakhuphula ubungozi be-sedation enamandla (ukulala, ukukhathazeka ngokucabanga kahle, ukungakwazi ukushayela noma ukusebenzisa imishini esindayo). Kungakhuphula nobungozi bokulahlekelwa ukwazi (ukungakwazi ukuphendula umsindo noma ukuthinta).

Izibonelo ze-benzodiazepines ezingakhuphula ubungozi bokudonswa komzimba nokulahlekelwa ukwazi uma zithathwa ngeZulresso zifaka:

• i-alprazolam (Xanax, Xanax XR)
• i-diazepam (Valium)
• I-lorazepam (Ativan)
• i-temazepam (Restoril)
• i-triazolam (Halcion)

I-Zulresso nemithi ethile yokulala

Ukuthatha i-Zulresso ngemithi ethile yokuqwasha (ukunenkinga yokulala) kungakhuphula ubungozi bokudonswa kanzima. Izimpawu ze-sedation zingabandakanya ukulala, ukukhathazeka ngokucabanga kahle, nokungakwazi ukushayela noma ukusebenzisa imishini esindayo. Zingabandakanya nokulahlekelwa ukwazi (ukungakwazi ukuphendula umsindo noma ukuthinta).

Izibonelo zemithi yokuqwasha engakhuphula ubungozi bokudonswa komzimba nokulahlekelwa ukwazi uma ithathwa neZulresso ifaka:

• eszopiclone (Lunesta)
• i-zaleplon (Sonata)
• i-zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist)

I-Zulresso kanye ne-anti-depressants

Ukuthatha i-Zulresso neminye imishanguzo ye-anti-depressant kungakhuphula ingozi yemiphumela emibi kakhulu, efana nokuthamba okunamandla (ukulala, ukukhathazeka ngokucabanga kahle, ukungakwazi ukushayela noma ukusebenzisa imishini esindayo. Kungadala nokulahlekelwa ukwazi (ukungakwazi ukuphendula umsindo noma ukuthinta).

Izibonelo ze-anti-depressants ezingakhuphula ubungozi bokuhlala phansi nokulahleka kokwazi kufaka phakathi:

• i-fluoxetine (Prozac, Sarafem, Selfemra)
• i-sertraline (Zoloft)
• I-citalopram (Celexa)
• i-escitalopram (Lexapro)
• i-paroxetine (Brisdelle, Paxil, Pexeva)
• i-venlafaxine (i-Effexor XR)
• i-duloxetine (iCymbalta)

Ezinye izindlela zeZulresso

Ezinye izidakamizwa ezisetshenziselwa ukucindezeleka zingasiza ekwelapheni ukucindezeleka kwangemva kokubeletha (PPD). Ngayinye yalezi zidakamizwa ehlukile isetshenziswa ngaphandle kwelebula ukwelapha i-PPD. Ukusetshenziswa okungekho kwelebula kulapho umuthi ovunyelwe ukusetshenziswa kokunye unqunyelwe okunye ukusetshenziswa.

Eminye yale mithi ingakulungela kangcono kunabanye. Uma unentshisekelo yokuthola enye indlela yeZulresso, khuluma nodokotela wakho. Bangakutshela ngeminye imithi engakusebenzela kahle.

Izibonelo zezinye izidakamizwa ezingasetshenziswa ngaphandle kwelebula ukwelapha i-PPD zifaka:

• i-fluoxetine (Prozac, Sarafem, Selfemra)
• i-paroxetine (Brisdelle, Paxil, Pexeva)
• i-sertraline (Zoloft)
• i-nortriptyline (Pamelor)
• amithole
• i-bupropion (i-Wellbutrin SR, i-Wellbutrin XL, i-Zyban)
• esketamine (Spravato)

I-Zulresso vs. iZoloft

Ungase uzibuze ukuthi iZulresso iqhathanisa kanjani neminye imithi enqunyelwe ukusetshenziswa okufanayo. Lapha sibheka ukuthi iZulresso neZoloft zifana kanjani futhi zehlukile.

Isebenzisa

I-Zulresso ne-Zoloft zivunyelwe yi-Food and Drug Administration (FDA) ukwelapha izimo ezahlukahlukene.

I-Zulresso igunyazwe yi-FDA ukwelapha ukucindezeleka kwangemva kokubeletha (PPD) kubantu abadala.

I-Zoloft ivunyelwe yi-FDA ukuphatha abantu abadala ngezimo ezilandelayo:

• ukucindezeleka okukhulu
• ukuphazamiseka kwesifo
• ukucindezeleka kwangemva kwenhlekelele
• ukuphazamiseka kwangaphambi kokuya esikhathini
• ukuphazamiseka kokukhathazeka komphakathi

IZoloft nayo ivunyelwe ukwelapha abantu abaneminyaka engu-6 nangaphezulu abanesifo sokucindezela ngokweqile. I-Zoloft isetshenziswa ngaphandle kwelebula ukwelapha i-PPD.

I-Zulresso iqukethe i-brexanolone yezidakamizwa. I-Zoloft iqukethe i-sertraline yezidakamizwa.

Amafomu wezidakamizwa nokuphathwa

I-Zulresso iza njengesisombululo esinikezwa njenge-infravenous (IV) infusion, engena emthanjeni wakho. Uzothola ukumnika esikhungweni sokunakekelwa kwezempilo esikhathini esingamahora angama-60 (izinsuku ezingu-2,5).

I-Zoloft iza njengethebhulethi noma isisombululo esithathwa ngomlomo. Kuthathwa kanye ngosuku.

Imiphumela emibi kanye nezingozi

IZulresso neZoloft ziqukethe izidakamizwa ezahlukahlukene. Ngakho-ke, imishanguzo ingadala imiphumela emibi kakhulu. Ngezansi kunezibonelo zale miphumela emibi.

Imiphumela emibi ejwayelekile

Lezi zinhlu ziqukethe izibonelo zemiphumela emibi ejwayelekile engenzeka ngeZulresso kanye neZoloft.

• Kungenzeka ngeZulresso:
  • i-sedation (ukulala, ukukhathazeka ngokucabanga kahle, ukungakwazi ukushayela noma ukusebenzisa imishini esindayo)
  • isiyezi noma i-vertigo (uzizwa sengathi uhamba lapho ungekho)
  • uzizwe sengathi uzoquleka
  • umlomo owomile
  • ukuqhuma isikhumba (ukubomvu nokuzwa okufudumele esikhunjeni)
• Kungenzeka ngeZoloft:
  • isicanucanu
  • uhudo noma indle evulekile
  • isisu esibuhlungu
  • ukulahlekelwa isifiso sokudla
  • ukujuluka okweqile
  • ukuthuthumela (ukunyakaza okungalawuleki kwezingxenye zomzimba wakho)
  • ukungakwazi ukukhipha umjovo
  • yehlise i-libido (idrayivu encane noma engekho nhlobo yocansi)

Imiphumela emibi kakhulu

Lezi zinhlu ziqukethe izibonelo zemiphumela emibi kakhulu engenzeka ngeZulresso, neZoloft, noma ngazo zombili izidakamizwa (uma zithathwa ngazodwana).

• Kungenzeka ngeZulresso:
  • ukulalisa kanzima
  • ukulahlekelwa ukwazi (ukungakwazi ukuphendula umsindo noma ukuthinta)
• Kungenzeka ngeZoloft:
  • i-serotonin syndrome (i-serotonin eningi kakhulu emzimbeni)
  • ingozi eyengeziwe yokopha
  • i-hyponatremia (amazinga aphansi e-sodium)
  • isigqi senhliziyo esingajwayelekile
  • ukuhoxa
  • ngenxa yokumisa i-glaucoma yokuvalwa kwe-Zoloftangle (ukucindezela okwandisiwe esweni lakho)
• Kungenzeka ngeZulresso kanye neZoloft:
  • imicabango yokuzibulala nokuziphatha kubantu abadala (abangaphansi kweminyaka engama-25 ubudala)

Ukusebenza ngempumelelo

I-Zulresso ne-Zoloft zinokusetshenziswa okwehlukile okuvunyelwe yi-FDA, kodwa zombili zisetshenziselwa ukwelapha i-PPD. Lokhu ukusetshenziswa okungekho kwelebula kweZoloft. Ungasebenzisi i-Zoloft ukwelapha i-PPD ngaphandle kokukhuluma nodokotela wakho kuqala.

Le mithi ayikaze iqhathaniswe ngqo ezifundweni zomtholampilo, kepha izifundo zithole ukuthi iZulresso iyasebenza ekwelapheni i-PPD.

Ukubuyekezwa kwezifundo zokwelashwa eziningana kuthole ukuthi iZoloft ibisebenza ekwelapheni i-PPD kwezinye izifundo kepha hhayi kwezinye.

Izindleko

I-Zulresso ne-Zoloft yizidakamizwa ezibizwa ngegama lomkhiqizo. Okwamanje azikho izinhlobo ezijwayelekile zeZulresso, kepha kukhona uhlobo olujwayelekile lweZoloft olubizwa nge-sertraline. Imithi enegama lomkhiqizo ivame ukubiza ngaphezu kwama-generic.

Intengo yohlu lweZulresso ingamaphesenti acishe abe ngama- $ 34,000 we-infusion ngaphambi kwezaphulelo, ngokusho kombiko wekota lomkhiqizi. Ngokususelwa kuleyo ntengo nentengo elinganiselwayo yeZoloft evela kwaGoodRx, iZulresso ibiza kakhulu. Inani langempela ozolikhokhela noma yisiphi isidakamizwa lizoya ngohlelo lwakho lomshuwalense.

I-Zulresso vs. iLexapro

I-Zulresso neLexapro inqunyelwe ukusetshenziswa okufanayo. Ngezansi kunemininingwane yokuthi le mithi ifana kanjani futhi yehlukile kanjani.

Isebenzisa

I-Zulresso neLexapro zivunyelwe yi-Food and Drug Administration (FDA) ukwelapha izimo ezahlukahlukene.

IZulresso ivunyelwe ukwelapha ukucindezeleka kwangemva kokubeletha (PPD) kubantu abadala.

ILexapro ivunyelwe ukwelapha ukukhathazeka okukhulu kokudangala kubantu abaneminyaka eyi-12 nangaphezulu. Futhi kuvunyelwe ukwelapha ukukhathazeka okujwayelekile kubantu abadala. ILexapro isetshenziswa ngaphandle kwelebula ukwelapha i-PPD.

I-Zulresso iqukethe i-brexanolone yezidakamizwa. ILexapro iqukethe i-escitalopram yezidakamizwa.

Amafomu wezidakamizwa nokuphathwa

I-Zulresso iza njengesisombululo esinikezwa njenge-infravenous (IV) infusion, engena emthanjeni wakho. Uzothola ukumnika esikhungweni sokunakekelwa kwezempilo esikhathini esingamahora angama-60 (izinsuku ezingu-2,5).

ILexapro iza njengethebhulethi nesisombululo. Noma iyiphi ifomu ithathwa ngomlomo kanye nsuku zonke.

Imiphumela emibi kanye nezingozi

I-Zulresso neLexapro ziqukethe izidakamizwa ezahlukahlukene. Ngakho-ke, zingadala imiphumela emibi ehluke kakhulu. Ngezansi kunezibonelo zale miphumela emibi.

Imiphumela emibi ejwayelekile

Lezi zinhlu ziqukethe izibonelo zemiphumela emibi ejwayelekile engenzeka ngeZulresso, neLexapro, noma ngazo zombili izidakamizwa (uma zithathwa ngazodwana).

• Kungenzeka ngeZulresso:
  • isiyezi noma i-vertigo (uzizwa sengathi uhamba lapho ungekho)
  • uzizwe sengathi uzoquleka
  • umlomo owomile
  • ukuqhuma isikhumba (ukubomvu nokuzwa okufudumele esikhunjeni sakho)
• Kungenzeka ngeLexapro:
  • ukuqwasha (kunzima ukulala)
  • isicanucanu
  • ukujuluka
  • ukukhathala (ukungabi namandla)
  • kunciphise i-libido (idrayivu encane noma engekho sex)
  • ukungakwazi ukuba ne-orgasm
  • ukubambezeleka kokubambezeleka
• Kungenzeka ngeZulresso kanye neLexapro:
  • i-sedation (ukulala, ukukhathazeka ngokucabanga kahle, ukungakwazi ukushayela noma ukusebenzisa imishini esindayo)

Imiphumela emibi kakhulu

Lezi zinhlu ziqukethe izibonelo zemiphumela emibi engaba khona neZulresso, neLexapro, noma ngazo zombili izidakamizwa (uma zithathwa ngazodwana).

• Kungenzeka ngeZulresso:
  • ukulalisa kanzima
  • ukulahlekelwa ukwazi
• Kungenzeka ngeLexapro:
  • i-serotonin syndrome (i-serotonin eningi kakhulu emzimbeni)
  • i-hyponatremia (amazinga aphansi e-sodium)
  • ingozi eyengeziwe yokopha
  • ukuhoxa ngenxa yokumisa iLexapro
  • ukuvalwa kwe-angle glaucoma (ingcindezi eyengeziwe esweni)
• Kungenzeka ngeZulresso kanye neLexapro:
  • imicabango yokuzibulala nokuziphatha kubantu abadala (abangaphansi kweminyaka engama-25 ubudala)

Ukusebenza ngempumelelo

I-Zulresso neLexapro zinokusetshenziswa okwehlukile okuvunyelwe yi-FDA, kodwa zombili zisetshenziselwa ukwelapha i-PPD. Lokhu ukusetshenziswa okungekho kwelebula kweLexapro. Ungasebenzisi i-Lexapro ukwelapha i-PPD ngaphandle kokukhuluma nodokotela wakho kuqala.

Le mithi ayikaze iqhathaniswe ngqo ezifundweni zokwelashwa. Kodwa-ke, izifundo zithole ukuthi iZulresso iyasebenza ekwelapheni i-PPD. Futhi ukubuyekezwa kwezifundo kuchaze isifundo esathola ukuthi iLexapro ingasebenza ekwelapheni i-PPD.

Izindleko

I-Zulresso neLexapro zombili izidakamizwa zomuthi. Okwamanje azikho izinhlobo ezejwayelekile zeZulresso, kepha kukhona uhlobo olujwayelekile lweLexapro olubizwa ngokuthi i-escitalopram. Imithi enegama lomkhiqizo ivame ukubiza ngaphezu kwama-generic.

Intengo yohlu lweZulresso ingamaphesenti acishe abe ngama- $ 34,000 we-infusion ngaphambi kwezaphulelo, ngokusho kombiko wekota lomkhiqizi. Ngokususelwa kuleyo ntengo nentengo elinganiselwayo yeLexapro evela kwaGoodRx, iZulresso ibiza kakhulu. Inani langempela ozolikhokhela noma yisiphi isidakamizwa lizoya ngohlelo lwakho lomshuwalense.

Inikezwa kanjani iZulresso

Uzonikezwa iZulresso ngudokotela wakho esikhungweni sokunakekelwa kwezempilo. Uzokuthola njengokufakwa okufakwa emthanjeni (IV), okungena emthanjeni wakho. Ukumnika umjovo ohlala isikhathi esithile. Ukufakwa kweZulresso kuzohlala cishe amahora angama-60 (izinsuku ezi-2,5).

Ngalesi sikhathi, uzohlala esikhungweni sokunakekelwa kwezempilo. Lokhu kuzovumela udokotela wakho ukuthi alungise isilinganiso esihleliwe. Futhi kuzobavumela ukuthi bakubheke ngemiphumela emibi kakhulu, efana nokuhlala phansi nokulahlekelwa ukwazi.

Uma unemiphumela emibi kakhulu, njengokulahlekelwa ukwazi, udokotela wakho uzophazamisa ukumnika. Bazokwelapha imiphumela yakho emibi ngaphambi kokuqalisa kabusha ukumnika. Esimweni esingavamile udokotela wakho anquma ukuthi akuphephile ukuthi uqhubeke nokuthola iZulresso, bazokuyeka ukwelashwa.

Lapho iZulresso inikezwa

I-Zulresso inikezwa njengokufakwa ngaphakathi kwamahora angama-60 (izinsuku ezi-2,5). Ngalesi sikhathi, uzohlala esikhungweni sokunakekelwa kwezempilo. Uzolandela uhlelo olujwayelekile lokudla nokulala ngesikhathi sokwelashwa kwakho. Ungachitha isikhathi nezivakashi, kufaka phakathi ingane yakho (noma izingane).

Udokotela wakho uzoqala ukwelashwa ekuseni. Lokhu kubenza bakwazi ukukuqapha ngemiphumela emibi emini, lapho kungenzeka uvuke khona.

Ukuthatha iZulresso ngokudla

Ukufakwa kweZulresso kuhlala amahora angama-60 (izinsuku ezi-2,5), ngakho-ke uzodla ukudla ngaleso sikhathi. Indawo yokunakekelwa kwezempilo izokunikeza ukudla ngesikhathi uhlala khona.

Isebenza kanjani iZulresso

Akwaziwa kahle ukuthi iZulresso isiza kanjani ekwelapheni ukucindezeleka kwangemva kokubeletha (PPD).

Mayelana ne-PPD

I-PPD idalwa ngokwengxenye ukungalingani komsebenzi wama-neurosteroids nama-hormone okucindezela, kanye nohlelo lwakho lonke lwezinzwa. Ama-Neurosteroids angama-steroids atholakala ngokwemvelo emzimbeni. Lezi zinto zidlala indima ekulawuleni umsebenzi wesistimu yakho yezinzwa.

I-Zulresso ingasiza kanjani

I-Zulresso inguqulo eyenziwe ngumuntu ye-allopregnanolone, i-neurosteroid. Kucatshangwa ukuthi kubuyisela ibhalansi ohlelweni lwakho lwezinzwa namahomoni okucindezeleka. Ikwenza lokhu ngokwandisa ukusebenza kwama-neurotransmitter athile (amakhemikhali athumela imiyalezo phakathi kwamangqamuzana ezinzwa).

Ngokuqondile, iZulresso inyusa umsebenzi we-gamma aminobutyric acid (GABA), i-neurotransmitter esiza ukukhiqiza umphumela wokuthula. Umsebenzi owandisiwe we-GABA ungasiza ekunciphiseni izimpawu ze-PPD.

Kuthatha isikhathi esingakanani ukusebenza?

Uzobona ukwehla kwezimpawu zakho ze-PPD kungakapheli amahora ambalwa uqale ukumnika kwakho.

Ezifundweni zomtholampilo, iZulresso ikhulule izimpawu zabantu kungakapheli amahora amabili aqale umuthi.

I-Zulresso nokukhulelwa

I-Zulresso ayenzelwe ukuthi isetshenziswe ngesikhathi sokukhulelwa. Kuvunyelwe yi-Food and Drug Administration (FDA) ukuthi isetshenziswe ngesikhathi "sokubeletha", esenzeka ngemuva kokubeletha.

Azikho izifundo zeZulresso ezisetshenziswa kubantu ngesikhathi sokukhulelwa. Ezifundweni zezilwane, iZulresso yadala ingozi kumbungu lapho umama ethola umuthi. Kodwa-ke, izifundo zezilwane azihlali zibikezela ukuthi kuzokwenzekani kubantu.

Ngaphambi kokuthatha iZulresso, tshela udokotela wakho uma kunethuba lokuthi ungakhulelwa. Bazoxoxa nawe ngobungozi kanye nezinzuzo zokusetshenziswa kweZulresso ngesikhathi sokukhulelwa.

Uma uthola iZulresso ngenkathi ukhulelwe, cabanga ukubhalisa kwirejista yokukhulelwa. Ukubhaliswa kokukhulelwa kuqoqa imininingwane ngokusetshenziswa kwezidakamizwa ngesikhathi sokukhulelwa ukusiza odokotela ukuthi bafunde kabanzi ngokuphepha komuthi. Ungabhalisa ku-National Pregnancy Registry for Antidepressants noma ngokushayela u-844-405-6185.

I-Zulresso nokuncelisa

Ukuncelisa ibele ngesikhathi sokwelashwa kweZulresso kungenzeka kuphephile. Ucwaningo oluncane ebantwini luthole ukuthi iZulresso idlulela ebisini lwebele. Kodwa-ke, itholakala emazingeni aphansi kakhulu obisini lwebele.

Ngokwengeziwe, uma ingane igwinya ubisi lwebele oluqukethe iZulresso, lesi sidakamizwa ngeke sibe nomthelela omncane kuzo. Lokho kungenxa yokuthi iZulresso idiliziwe futhi ayisebenzi esiswini sengane. Ngakho-ke, izingane ezinceliswa ibele zizothola kuphela amanani amancane kakhulu eZulresso esebenzayo.

Khuluma nodokotela wakho mayelana nokuthi ukuncelisa ibele ngesikhathi sokwelashwa kweZulresso kuyindlela enhle kuwe.

Imibuzo ejwayelekile ngeZulresso

Nazi izimpendulo zemibuzo ebuzwa njalo mayelana neZulresso.

Ngabe iZulresso ingazelapha ezinye izinhlobo zokudangala ngaphandle kokudangala kwangemva kokubeletha?

Ngalesi sikhathi, akwaziwa ukuthi iZulresso ingazelapha yini ezinye izinhlobo zokudangala. I-Zulresso ihlolwe kuphela ukuphepha nokusebenza kwabesifazane abanokucindezeleka kwangemva kokubeletha (PPD).

Uma unemibuzo mayelana nokuthi iZulresso ikulungele yini, khuluma nodokotela wakho.

Kungani iZulresso itholakala kuphela esikhungweni esiqinisekiswe yi-REMS?

I-Zulresso itholakala kuphela esikhungweni esiqinisekiswe yi-REMS ngenxa yokuthi imiphumela emibi ingaba mibi kangakanani. I-REMS (Amasu Wokuhlola Ubungozi kanye Namasu Okunciphisa) uhlelo oludalwe yi-Food and Drug Administration (FDA). Kuyasiza ukwenza isiqiniseko sokuthi izidakamizwa zisetshenziswa ngokuphepha futhi zinikezwa ochwepheshe bezempilo abaqeqeshwe ngokukhethekile.

I-Zulresso ingadala imiphumela emibi kakhulu, njenge-sedation enzima. Izimpawu zingafaka ukulala ngokweqile, ukukhathazeka ngokucabanga kahle, nokungakwazi ukushayela noma ukusebenzisa imishini esindayo. I-Zulresso nayo ingadala ukulahleka okungazelelwe kokuqonda (ukungakwazi ukuphendula umsindo noma ukuthinta).

Ngenxa yokuthi le miphumela emibi ingaba mibi kangakanani, iZulresso inikezwa kuphela ezindaweni ezithile zokunakekelwa kwezempilo. Lezi zikhungo zinodokotela abaqeqeshwe ngokukhethekile ukuqapha nokwelapha imiphumela emibi yeZulresso. Lokhu kusiza ukuqinisekisa ukuthi uthola iZulresso ngokuphepha.

Ngabe ngisazodinga ukuthatha imishanguzo yomlomo ngemuva kokwelashwa kweZulresso?

Ungahle. Njengoba nje izidambisi-mkhuba zingazelaphi ezinye izinhlobo zokudangala (zisiza kuphela ekunciphiseni izimpawu), iZulresso ayilaphi i-PPD. Ngakho-ke, ungadinga umuthi oqhubekayo wokudangala kwakho ngemuva kokwelashwa kwakho neZulresso.

Ngemuva kokuthola ukwelashwa kweZulresso, wena nodokotela wakho nizoqhubeka nokusebenza ndawonye ukuthola amasu amahle kakhulu okwelapha ukukusiza uzizwe ungcono kakhulu. Ungayeki ukuthatha imishanguzo yakho yomlomo ngaphandle uma udokotela ekutshela ukuthi wenze kanjalo.

Ngabe abesilisa bangathola yini ukucindezeleka kwangemva kokubeletha? Uma kunjalo, bangayisebenzisa iZulresso?

Kucatshangwa ukuthi nabesilisa bangahlushwa yi-PPD. Ukuhlaziywa kuhlanganiswe imiphumela evela ezifundweni emazweni ahlukene angama-22 afaka amadoda angaphezu kwama-40,000. Lokhu kuhlaziywa kutholakale ukuthi cishe u-8% wamadoda ocwaningweni abenokudangala ngemuva kokuzalwa kwengane yabo. Amadoda amaningi abike ukuthi azizwa ecindezelekile ezinyangeni ezintathu kuya kweziyisithupha ingane izelwe, uma kuqhathaniswa nezinye izinkathi zesikhathi.

Kodwa-ke, akwaziwa ukuthi iZulresso iyasebenza yini ekwelapheni i-PPD emadodeni. Ucwaningo lwezokwelapha lweZulresso lufake kuphela abesifazane abane-PPD.

Ngabe iZulresso ingelapha ukwelashwa kwangemva kokubeletha?

Hhayi ngalesi sikhathi. I-Zulresso ayivunyelwe yi-FDA ukwelapha i-postpartum psychosis. Ukuhlolwa kwemitholampilo kweZulresso akubandakanyi abesifazane abane-psychosis yangemva kokubeletha. Ngakho-ke, akwaziwa ukuthi iZulresso iphephile futhi iyasebenza yini ekwelapheni lesi simo.

I-Postpartum psychosis ibangela ukuthi owesifazane abe nezimpawu ezingabandakanya:

• ukuzwa amazwi
• ukubona izinto ezingekho ngempela lapho
• ukuba nemizwa eyeqile yokudabuka nokukhathazeka

Lezi zimpawu zinzima. Uma uhlangabezana nazo, shayela ku-911.

Ngabe iZulresso ingalapha ukucindezeleka kwangemva kokubeletha kwentsha?

I-Zulresso ivunyelwe yi-FDA ukwelapha i-PPD kwabesifazane abaneminyaka engu-18 nangaphezulu. Izifundo zomtholampilo azibandakanyi abesifazane abangaphansi kweminyaka engu-18. Akukaziwa ukuthi iZulresso iphephile noma iyasebenza yini ekwelapheni intsha esencane nge-PPD.

Ukuqapha kweZulresso

Lesi sidakamizwa siza nezixwayiso eziningana.

Isexwayiso se-FDA: Ukudonswa ngokweqile nokulahleka okungazelelwe komuzwa

Lesi sidakamizwa sinesixwayiso esibhakeleni. Isexwayiso esibhakeleni yisixwayiso esibi kakhulu esivela ku-Food and Drug Administration (FDA). Kwazisa odokotela neziguli ngemiphumela yezidakamizwa engaba yingozi.

I-Zulresso ingadala ukulalisa kanzima. Izimpawu zingafaka ukulala, ukukhathazeka ngokucabanga kahle, nokungakwazi ukushayela noma ukusebenzisa imishini esindayo. I-Zulresso nayo ingadala ukulahleka okungazelelwe kokuqonda (ukungakwazi ukuphendula umsindo noma ukuthinta).

I-Zulresso itholakala kuphela ngezikhungo eziqinisekisiwe. Udokotela wakho uzokuqapha eduze kwakho konke ukwelashwa kwakho kweZulresso. Bazobakhona futhi uma unengane yakho (noma izingane) uma kwenzeka ulahlekelwa ukwazi.

Ezinye izexwayiso

Ngaphambi kokuthatha iZulresso, khuluma nodokotela wakho ngomlando wakho wezempilo. I-Zulresso kungenzeka ingakulungeli uma unezimo ezithile zezokwelapha. Lokhu kufaka phakathi:

• Isifo sezinso sokugcina. Akwaziwa ukuthi iZulresso iphephile yini kubantu abanesifo sezinso (renal) sokugcina. Uma unesifo sezinso sokugcina futhi udinga iZulresso, khuluma nodokotela wakho ngezingozi nezinzuzo. Bangase bakunikeze umuthi ohlukile.

Qaphela: Ukuthola eminye imininingwane ngemiphumela emibi engaba khona yeZulresso, bheka isigaba esithi "Imiphumela emibi ye-Zulresso" ngenhla.

Imininingwane yobuchwepheshe yeZulresso

Imininingwane elandelayo inikezwa odokotela nabanye ochwepheshe bezempilo.

Izinkomba

I-Zulresso (i-brexanolone) yamukelwa yi-Food and Drug Administration (i-FDA) ukwelapha ukucindezeleka kwangemva kokubeletha (PPD) kubantu abadala. Yisidakamizwa sokuqala futhi okuwukuphela kwaso i-FDA esivume ukwelapha ngqo i-PPD.

Indlela yokusebenza

I-Zulresso iyi-analog yokwenziwa ye-allopregnanolone. Indlela eqondile yokusebenza kweZulresso ayaziwa, kepha imiphumela yayo ku-PPD kucatshangwa ukuthi ihlotshaniswa nokuqiniswa komsebenzi we-gamma aminobutyric acid (GABA) ngokusebenzisa ukuguquguquka okuhle kwe-allosteric. Ukushintshashintsha kwe-Allosteric kwenzeka lapho iZulresso ibopha isiza esingeyona i-GABA receptor futhi ikhulisa umphumela we-GABA obophezela kwi-receptor yayo. Kucatshangwa ukuthi ukuthuthukiswa komsebenzi we-GABA kulawula ukusayinwa kwengcindezi ku-hypothalamic-pituitary-adrenal axis (HPA). Umsebenzi we-HPA ongasebenzi kahle udlala indima ku-PPD.

I-Pharmacokinetics ne-metabolism

I-Zulresso ibonisa i-pharmacokinetics elingana nedosi. Kunokusatshalaliswa okubanzi kwezicubu kanye nokubopha okungaphezu kwamaphesenti angama-99% e-plasma protein.

I-Zulresso ihlanganiswa ngezindlela ezingezona ze-CYP kuma-metabolites angasebenzi. Impilo yokuqeda isigamu sempilo cishe amahora ayisishiyagalolunye. Emgqonyeni, ama-47% eZulresso akhishwa, kanti emchameni kukhishwe u-42%.

Imiphumela yesifo sezinso sesigaba sokugcina ku-Zulresso pharmacokinetics aziwa; Ukusetshenziswa kweZulresso kufanele kugwenywe kulesi sibalo.

Izimo

Akukho ukuphikisana nokusetshenziswa kweZulresso.

Ukuhlukumeza nokuncika

I-Zulresso yinto elawulwayo, futhi ihlukaniswa njengesidakamizwa seshejuli 4 (IV).

Isitoreji

I-Zulresso kufanele igcinwe esiqandisini ku-36⁰F – 46⁰F (2⁰C – 7⁰C). Vikela izimbiza ekukhanyeni futhi ungafrizi.

Ngemuva kokuhlanjululwa, iZulresso ingagcinwa esikhwameni sokumnika kuze kube ngamahora ayi-12 ekamelweni lokushisa. Uma ingasetshenziswanga ngokushesha ngemuva kokuhlanjululwa, ingagcinwa kuze kufike emahoreni angama-96 esiqandisini.

Ukuzikhulula: I-Healthline yenze yonke imizamo yokuqinisekisa ukuthi lonke ulwazi luyiqiniso, luphelele futhi lusesikhathini. Kodwa-ke, le ndatshana akufanele isetshenziswe njengokungena esikhundleni solwazi nobungoti bochwepheshe bezokunakekelwa kwezempilo onelayisense. Kufanele uhlale uthintana nodokotela wakho noma omunye uchwepheshe wezokunakekelwa kwempilo ngaphambi kokuthatha noma imuphi umuthi. Imininingwane yezidakamizwa equkethwe lapha ingashintsha futhi ayihloselwe ukumboza konke ukusetshenziswa okungaba khona, izinkomba, izixwayiso, izexwayiso, ukuxhumana kwezidakamizwa, ukungezwani komzimba, noma imiphumela emibi. Ukungabikho kwezixwayiso noma olunye ulwazi lomuthi othile awukhombisi ukuthi inhlanganisela yezidakamizwa noma yezidakamizwa iphephile, iyasebenza, noma ilungele zonke iziguli noma konke ukusetshenziswa okuthile.