Izinhlobo ezi-9 ezijwayelekile zeLyrica manje sezitholakala ngezindleko eziphansi zeziguli

Izindaba

Ngonyaka odlule, ILyrica (pregabalin) kwakuyisidakamizwa semithi yesibili esithengiswa kakhulu esidayisa imithi, i-Pfizer Inc. Imithi ihlukaniswa njengesidakamizwa se-antiepileptic, aka an anticonvulsant . Kepha kubekiwe futhi njenge- ukudambisa izinhlungu . Ukuthandwa kwayo ngabodokotela kungabangelwa ingxenye yokuthi imithi ingenye yezinketho ezimbalwa ezingezona i-opioid, ezingezona i-acetaminophen, ezingezona ze-NSAID zokuphumula kobuhlungu obungapheli. I-Pregabalin ihlukaniswa njenge- Uhlelo V into elawulwayo futhi itholakala ngomuthi kadokotela kuphela.

Uphatha ini uLyrica?

Ngo-2005, i-U.S.Food and Drug Administration (i-FDA) yavuma ukuthi imithi yokwelapha ubuhlungu be-neuropathic nomonakalo ngenxa yesifo sikashukela noma i-shingles, i-fibromyalgia (isimo esivezwa ubuhlungu obungapheli, obusakazeke kabanzi), ukulimala komgogodla nokuquleka. Kusukela lapho, kunqunyelwe okungaphezu kwe- Abantu abayizigidi eziyi-16 e-United States.

Kubiza malini uLyrica?

Kuyinani eliphakeme. Ngaphandle komshwalense, igama lomkhiqizo i-Lyrica libiza phakathi kuka- $ 460 kuya ku- $ 720 ngenyanga, kuya ngomthamo nobungako.

Ngabe uLyrica wavela nini ejwayelekile?

NgoJulayi 22, 2019, i-FDA ivume i-9 umuthi ojwayelekile izicelo zezinguqulo ze- pregabalin - uhlobo lomkhiqizo okungelona igama lomuthi. Ukugunyazwa kwezinhlobo ezijwayelekile zeLyrica kwanikezwa i-Alembic Pharmaceuticals, i-Alkem Laboratories, i-Amneal Pharmaceuticals, uDkt. Reddy's Laboratories, InvaGen Pharmaceuticals, MSN Laboratories Ltd., Rising Pharmaceuticals, Inc., iSciegen Pharmaceuticals Inc., neTeva Pharmaceuticals — ngethemba lokuthi ukudala izinhlobo ezijwayelekile zeLyrica kungathuthukisa ukufinyelela kweziguli kwezinye izindlela ezingabizi kumuthi.

Ibiza malini igeneral generic?

Amanani okuthengisa we-generic pregabalin aphakathi kuka- $ 140 no- $ 370 ngenyanga. I-copay yakho ingahle ibe ngaphansi kohlelo lwakho lomshuwalense noma ikhadi lesaphulelo somuthi, njengeOkufanayo.

Kungani i-generic Lyrica ibiza kancane?

Imayelana nokunikezwa nokufunwa. Ukutholakala kwemithi ejwayelekile kusiza ukudala ukuncintisana ezimakethe, okusiza ukwenza ukwelashwa kuthengeke kakhulu futhi kwandise ukufinyelela kwezokunakekelwa kwezempilo kweziguli eziningi, ngokusho kukaSandy Walsh, isikhulu sezindaba e-FDA.

Kepha inkampani eyodwa ingawusabalalisa kanjani umuthi ofanayo ngezindleko eziphansi bese izuza? Lokho konke kuyingxenye yenqubo yentuthuko, kuchaza uWalsh. Ukwenza umuthi kubiza imali eningi, uthi. Njengoba abenzi bemithi ejwayelekile bengaqali umuthi zisuka nje, izindleko zokuletha umuthi emakethe zincane. Kepha kumele bakhombise ukuthi umkhiqizo wabo usebenza ngendlela efanayo nomuthi wegama lomkhiqizo. Ngenkathi umuthi omusha, wegama lomkhiqizo uhamba ngenqubo ende yezicelo kanye nokuhlolwa kwemitholampilo ukuphepha nokusebenza kahle, umenzi ojwayelekile ufaka isicelo se-New Drug Application, noma Nina .

Futhi ngenkathi imiphumela emibi yeLyrica yaziwa kahle (futhi ivame ukumbozwa ezindabeni), i-FDA idinga ukuthi i-pregabalin ikhishwe umhlahlandlela wemithi yesiguli oqukethe imininingwane ebalulekile yezempilo kanye nezeluleko zezokwelapha mayelana nokusetshenziswa kwayo nezingozi.

Imiphumela emibi engaba khona ye-pregabalin ifaka phakathi ithuba lokungenwa i-angioedema (ukuvuvukala kobuso, umphimbo, ikhanda, nentamo, okungadala ukwehluleka kokuphefumula okusongela impilo okudinga ukwelashwa okuphuthumayo); ukusabela kwe-hypersensitivity okufana nesifuba, i-dyspnea (ukuphefumula kanzima), kanye nokushayana; kanye nobungozi obandayo bokuquleka uma umuthi unqanyulwa ngokushesha. Ngokwengeziwe, yonke imishanguzo yokulwa nesifo sokuwa njenge-pregabalin ibeka abasebenzisi engcupheni yemiphumela emibi yengqondo njengengozi eyengeziwe yemicabango yokuzibulala noma yokuziphatha. Kodwa-ke, imiphumela emibi kakhulu ebikiwe ngesikhathi sokusetshenziswa kweLyrica (kanye ne-generic yayo, pregabalin) yisiyezi, ukozela, umlomo owomile, ukuvuvukala, ukungaboni kahle, ukuzuza kwesisindo, nokucabanga okungavamile (ikakhulukazi ubunzima bokugxila / ukunakwa).

Izotholakala nini i-generic Lyrica?

IGeneric Lyrica iyatholakala ngemithi kadokotela e-U.S. Ngamandla ayisishiyagalombili (25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, no-300 mg). Iphinde itholakale ifomu eliketshezi. Ngokuzayo lapho ushayela ikhemisi yangakini ukugcwalisa umuthi waseLyrica, buza usokhemisi wakho ukuthi ungashintshela ku-pregabalin.