RifAXIMin (Systemic)
Jeneng merek: Xifaxan
Kelas obat:
Agen Antineoplastik
Panganggone RifAXIMin (Systemic)
Ensefalopati Hepatik
Ngurangi risiko kambuh encephalopathy hepatik sing jelas ing wong diwasa.
Pandhuan umume nyaranake rifaximin minangka tambahan kanggo laktulosa kanggo nyegah kambuh ensefalopati hepatik ing pasien sing paling ora ngalami 1 episode encephalopathy hepatik sing jelas nalika nampa laktulosa piyambak.
Wis digunakake. ing perawatan hepatic encephalopathy† [off-label] kanggo nyuda konsentrasi amonia getih lan nyuda keruwetan manifestasi neurologis; ditetepake minangka obat yatim piatu dening FDA kanggo perawatan kondisi iki.
Informasi saka American Association for Study of Liver Diseases (AASLD) lan European Association for the Study of the Liver (EASL) babagan manajemen hepatik. encephalopathy, kalebu rekomendasi kanggo perawatan lan nyegah kambuh, kasedhiya ing [Web]. Pangobatan encephalopathy hepatic overt pisanan kalebu lactulose, nalika rifaximin dianjurake minangka terapi tambahan kanggo nyegah kambuh.
Sindrom Irritable Bowel with Diare
Pengobatan sindrom irritable bowel (IBS) karo diare ing wong diwasa. Pedoman kanggo IBS sing paling dominan diare umume kalebu panggunaan rifaximin kanggo ngobati gejala global. Rifaximin uga dianjurake kanggo perawatan maneh ing wong sing nanggepi rifaximin lan ngalami gejala sing terus-terusan.
Diare Pelancong
Pengobatan diare lelungan sing disebabake dening galur Escherichia coli non-invasif ing wong diwasa lan remaja ≥12 taun.
Ora efektif lan ora bisa digunakake kanggo perawatan diare sing rumit amarga demam utawa feces getih.
Ora efektif lan ora bisa digunakake kanggo perawatan diare sing dikenal utawa dicurigai disebabake dening patogen liyane saka E. coli (contone, Campylobacter jejuni, Shigella, Salmonella).
Diare wong sing lelungan sing disebabake dening bakteri bisa uga mandheg lan asring pulih sajrone 3-7 dina tanpa perawatan anti-infeksi. . Pedoman umume nganggep rifaximin minangka alternatif kanggo fluoroquinolones utawa azithromycin kanggo diare lelungan moderat nganti abot sing ora invasif.
Wis digunakake kanggo nyegah diare lelungan† [off-label]. CDC lan liya-liyane nyatakake yen profilaksis anti-infèksi kanggo nyegah diare lelungan ora dianjurake kanggo umume wong sing seneng lelungan.
Panganggone Liyane
Wis digunakake ing sawetara wong diwasa minangka perawatan kanggo nyegah kambuh sawise perawatan standar kanggo infeksi Clostridioides difficile (CDI) ing pasien kanthi pirang-pirang kambuh† [off-label].
Wis digunakake ing terapi kombinasi kanggo pasien karo pouchitis akut refrakter, † [off-label] sanajan safety lan khasiat durung ditetepake.
Wis digunakake kanggo perawatan saka overgrowth bakteri usus cilik, † [off-label] sanajan safety lan khasiat durung ditetepake.
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Carane nggunakake RifAXIMin (Systemic)
Umum
Pengawasan Pasien
Administrasi
Administrasi Lisan
Administrasi kanthi lisan tanpa nggatekake dhaharan.
Dosis
Pasien Anak
Pengobatan Diare Wisatawan OralRemaja ≥12 taun: 200 mg kaping telu saben dina suwene 3 dina.
Yen diare saya tambah parah utawa terus >24-48 jam sawise obat diwiwiti, mandheg lan nimbang alternatif anti-infèksi.
Dewasa
Hepatic Encephalopathy Ngurangi Resiko Kambuh saka Overt Hepatic Encephalopathy Oral550 mg kaping pindho saben dina.
Perawatan Hepatic Encephalopathy† Oral600-1200 mg saben dina (biasane ing 3 dosis dibagi) suwene 7-21 dina.
Sindrom Irritable Bowel with Diare Oral550 mg kaping telu saben dina suwene 14 dina.
Yen gejala kasebut kambuh, nganti 2 kursus tambahan bisa diwenehake kanthi nggunakake regimen 14 dina sing padha.
Pengobatan Diare Wisatawan Oral200 mg kaping telu saben dina suwene 3 dina.
Yen diare saya tambah parah utawa terus > 24-48 jam sawise obat diwiwiti, mandheg lan nimbang alternatif anti-infeksi.
Nyegah† Oral200-1100 mg saben dina, dibagi dadi 1-3 dosis.
p> Infeksi Clostridioides difficile - Patients Kanthi Multiple Kambuh† Oral400 mg kaping telu dina kanggo 20 dina utawa 400 mg kaping telu dina kanggo 14 dina, banjur 200 mg kaping telu dina kanggo tambahan 14 dina.
Pouchitis Akut Refraktori† Oral400 mg telu dina kanggo 4 minggu utawa 1 gram kaping pindho saben dina kanggo 15 dina.
Pertumbuhan Bakteri Usus Cilik† Oral400 mg kaping telu saben dina suwene 10 dina.
Populasi Khusus
Gangguan Hepatik
Panyesuaian dosis ora dibutuhake; Gunakake kanthi ati-ati ing wong sing duwe gangguan hepatik sing abot (kelas Anak-Pugh C).
Gangguan Ginjal
Ora ana rekomendasi dosis khusus ing wektu iki.
Panganggone Geriatri
Saiki ora ana rekomendasi dosis khusus.
Pènget
Kontraindikasi
Pènget / PancegahanDiare Pelancong Ora Disebabake Escherichia Coli
Aja digunakake kanggo perawatan diare sing rumit amarga demam utawa feces getih.
Aja nggunakake kanggo perawatan diare wong sing dikenal utawa dicurigai disebabake dening C. jejuni, Shigella, utawa Salmonella. Rifaximin ora efektif kanggo diare amarga patogen liyane saka E. coli.
Yen diare saya tambah parah utawa terus >24-48 jam sawise miwiti rifaximin, mandheg lan nimbang nggunakake anti-infektif liyane.
Clostridium difficile-associated Diare (CDAD)
Pengobatan kanthi anti-infèksi ngubah flora usus normal lan bisa ngidinake tuwuhing Clostridium difficile. CDI lan CDAD (uga dikenal minangka diare lan kolitis sing gegandhengan karo antibiotik utawa kolitis pseudomembranous) dilapurake kanthi meh kabeh anti-infeksi, kalebu rifaximin, lan bisa uga beda-beda saka diare entheng nganti kolitis fatal. C. difficile ngasilake racun A lan B, sing nyumbang kanggo pangembangan CDAD; galur C. difficile sing ngasilake hypertoxin digandhengake karo tambah morbiditas lan mortalitas amarga bisa uga refrakter kanggo anti-infèksi lan kolektomi bisa uga dibutuhake.
Coba CDAD yen diare berkembang sajrone utawa sawise terapi lan ngatur kanthi bener. Entuk riwayat medis sing ati-ati amarga CDAD bisa kedadeyan nganti ≥2 sasi sawise terapi anti-infektif mandheg.
Yen CDAD dicurigai utawa dikonfirmasi, mandhegake anti-infèksi sing ora ditujokake marang C. difficile yen bisa. Miwiti terapi dhukungan sing cocog, terapi anti-infektif sing ditujokake marang C. difficile, lan evaluasi bedah kaya sing dituduhake sacara klinis.
Pengembangan Bakteri Tahan Narkoba
Gunakake kanggo diare wong sing lelungan yen ora ana infeksi bakteri utawa indikasi profilaksis ora bisa menehi manfaat lan nambah risiko bakteri tahan obat.
Gangguan Hepatik Akut (Child-Pugh Kelas C)
Paparan sistemik mundhak ing gangguan ati sing abot. Ati-ati nalika menehi rifaximin kanggo pasien kanthi gangguan ati sing abot (Child-Pugh Kelas C).
Panganggone bebarengan karo inhibitor P-glikoprotein
Panganggone bebarengan karo inhibitor transportasi P-glikoprotein (P-gp) (contone, siklosporin) bisa nambah paparan sistemik rifaximin. Ing pasien kanthi gangguan hepatik, efek aditif potensial nyuda metabolisme hepatik lan panggunaan bebarengan karo inhibitor P-gp bisa nambah paparan rifaximin. Ati-ati.
Populasi Tertentu
KandhutanData ora kasedhiya babagan panggunaan ing wanita ngandhut. Efek teratogenik (contone, malformasi okular, lisan lan maxillofacial, jantung, lan tulang belakang lumbar) diamati ing studi reproduksi kewan ing tikus lan terwelu.
LaktasiOra dingerteni manawa disebarake menyang susu manungsa; efek ing produksi susu manungsa utawa efek ing bayi-disusun bayi ora dingerteni. uga nimbang potensial efek salabetipun ing anak sing disusui saka tamba utawa saka kondisi ibu sing ndasari.
Panggunaan PediatrikHepatic Encephalopathy: Safety lan khasiat ora ditetepake ing bocah lan remaja <18 taun.
p>IBS karo diare: Keamanan lan khasiat ora ditetepake ing bocah lan remaja <18 taun.
Diare lelungan: Keamanan lan khasiat ora ditetepake ing bocah-bocah <12 taun.
p> Panggunaan GeriatrikEncephalopathy hepatik: Ora ana bedane sakabèhé ing safety utawa efektifitas sing diamati antarane pasien ≥65 taun lan wong diwasa luwih enom.
IBS karo diare: Ora ana beda sakabèhé ing safety utawa efektifitas sing diamati antarane pasien ≥65 taun lan wong diwasa sing luwih enom.
Diare wong sing lelungan: Pengalaman ing umur ≥65 taun ora cukup kanggo nemtokake manawa reaksi kasebut beda karo pasien sing luwih enom.
Gangguan HepatikSanajan dosis pangaturan ora dibutuhake ing pasien kanthi gangguan hepatik, gangguan hepatik abot (kelas Anak-Pugh C) nyebabake tambah paparan sistemik rifaximin lan kesadaran tambahan lan pemantauan efek samping sing gegandhengan karo rifaximin bakal disaranake.
Encephalopathy hepatik: Uji klinis ora kalebu pasien kanthi skor MELD>25.
Gagal GinjalOra diteliti sacara khusus babagan gangguan ginjel.
Efek Sabar sing Umum
Encephalopathy hepatik: Efek sing ora becik (≥10%): edema perifer, mual, pusing, lemes, asites.
IBS karo diare: Efek saleh (≥2%): mual, konsentrasi ALT mundhak.
Diare wong sing lelungan: Efek saru (≥2%): sirah.
Apa obatan liyane bakal mengaruhi RifAXIMin (Systemic)
Substrat saka CYP3A4. Ora nyandhet CYP1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1, utawa 3A4 in vitro. Wis nyebabake CYP3A4 in vitro, nanging efek klinis penting ing usus utawa hepatik CYP3A4 ora mungkin.
Substrat transportasi P-gp in vitro. Nyandhet P-gp in vitro, nanging efek ing vivo ora dingerteni.
Substrat polipeptida transport anion organik (OATP) 1A2, 1B1, lan 1B3, nanging efek in vivo ora dingerteni. Ora substrat OATP2B1. Nyandhet OATP1B1, 1A2, lan 1B3 in vitro, nanging efek ing vivo ora dingerteni.
Obat sing kena pengaruh Enzim Mikrosomal Hepatik
Substrat CYP3A4: Interaksi farmakokinetik sing ora dikarepake ing pasien kanthi fungsi ati normal ; ora dikawruhi manawa interaksi dumadi ing wong sing duwe gangguan hepatik sing nyebabake tambah akeh paparan sistemik rifaximin.
Substrat CYP1A2, 2A6, 2B6, 2C9, 2C19, 2D6, lan 2E1: Interaksi farmakokinetik ora samesthine.
Obat sing Ngaruhi utawa Dipengaruhi Sistem Transportasi
Inhibitor P-gp: Eksposur rifaximin sing saya tambah akeh bisa kedadeyan. Ati-ati kanthi nggunakake bebarengan; fungsi hepatik sing cacat bisa nambah paparan rifaximin.
Substrat P-gp: Efek sing bisa ditindakake ing vivo ora dingerteni.
Obat Spesifik
Obat
Interaksi
Komentar
Cyclosporine
Konsentrasi rifaximin lan AUC sing saya tambah akeh
Fungsi hepatik sing rusak bisa nyebabake paparan aditif kanggo rifaximin
Klinis ora dingerteni pentinge; ati-ati
Kontrasepsi hormonal (etinil estradiol lan norgestimate)
Penurunan konsentrasi etinil estradiol lan norgestimate
Kepentingan klinis ora dingerteni
Midazolam
p>Ora ana owah-owahan substansial ing farmakokinetik midazolam utawa metabolit utama (1′-hydroxymidazolam)
Tingkat interaksi ora penting sacara klinis
Warfarin
Owah-owahan ing INR
Monitor PT lan INR; pangaturan dosis warfarin bisa uga dibutuhake
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