Vonoprazan, Clarithromycin, and Amoxicillin
Jeneng merek: Voquezna
Kelas obat:
Agen Antineoplastik
Panganggone Vonoprazan, Clarithromycin, and Amoxicillin
Vonoprazan, clarithromycin, lan amoxicillin nduweni panggunaan ing ngisor iki:
Vonoprazan/clarithromycin/amoxicillin dituduhake kanggo perawatan infeksi Helicobacter pylori (H. pylori) ing wong diwasa.
Kanggo nyuda pangembangan bakteri sing tahan obat lan njaga efektifitas vonoprazan / clarithromycin / amoxicillin lan obat antibakteri liyane, persiapan kombinasi tetep kudu digunakake mung kanggo nambani utawa nyegah infeksi sing wis kabukten utawa dicurigai banget disebabake dening bakteri.
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Carane nggunakake Vonoprazan, Clarithromycin, and Amoxicillin
Umum
Kombinasi tetep vonoprazan/clarithromycin/amoxicillin kasedhiya ing wangun dosis lan kekuatan:
Karton 14 paket administrasi saben dina kanggo dosis esuk lan sore, saben ngemot telung produk obat:
Kapsul Amoxicillin 500 mg
Dosis
Penting kanggo labeling pabrikan kudu takon kanggo informasi sing luwih rinci babagan dosis lan administrasi obat iki. Ringkesan dosis:
Dewasa
Dosis lan AdministrasiRejimen dosis sing disaranake saka vonoprazan/clarithromycin/amoxicillin yaiku vonoprazan 20 mg plus amoxicillin 1.000 mg plus clarithromycin 500 mg, saben diwenehi kaping pindho saben dina (esuk lan sore, selisih 12 jam), kanthi utawa tanpa panganan, suwene 14 dina.
Pènget
Kontraindikasi
Pènget / PancegahanReaksi Hipersensitivitas
Reaksi hipersensitivitas sing serius lan kadhangkala fatal (contone, anafilaksis, kejut anafilaksis, ruam, eritema multiforme, lan Henoch-Schonlein purpura) wis dilapurake karo komponen vonoprazan/clarithromycin/amoxicillin.
Sadurunge miwiti terapi karo vonoprazan/clarithromycin/amoxicillin, priksa kanthi ati-ati babagan reaksi hipersensitivitas sadurunge kanggo penisilin, cephalosporin, obat antibakteri macrolide utawa alergen liyane. Mungkasi persiapan kombinasi tetep lan tindakake perawatan sing cocog yen ana hipersensitivitas.
Reaksi Saleh Kulit Parah
Reaksi salabetipun kulit abot (SCAR), kalebu sindrom Stevens-Johnson (SJS) lan necrolysis epidermal beracun (TEN) wis dilaporake karo komponen vonoprazan/clarithromycin/amoxicillin. Kajaba iku, reaksi obat karo eosinofilia lan gejala sistemik (DRESS), lan pustulosis exanthematous generalized akut (AGEP) wis dilaporake karo amoxicillin lan clarithromycin. SCAR utawa tandha hipersensitivitas liyane lan nimbang evaluasi luwih lanjut.
Clostridioides Difficile-related Diare
Clostridioides difficile-associated diare (CDAD) wis dilapurake kanthi nggunakake terapi suppressing asam lan meh kabeh agen antibakteri, kalebu amoxicillin lan clarithromycin, komponen persiapan kombinasi tetep , lan bisa uga ana ing keruwetan saka diare entheng nganti kolitis fatal. Pangobatan kanthi agen antibakteri ngowahi flora normal ing usus gedhe sing ndadékaké tuwuhing Clostridioides difficile (C. difficile).
C. difficile ngasilake racun A lan B sing nyumbang kanggo pangembangan CDAD. Galur C. difficile sing ngasilake hipertoksin nyebabake morbiditas lan mortalitas, amarga infèksi kasebut bisa tahan kanggo terapi antimikroba lan mbutuhake kolektomi. CDAD kudu dianggep ing kabeh pasien sing ngalami diare sawise nggunakake antibakteri. Riwayat medis sing ati-ati perlu amarga CDAD wis dilaporake kedadeyan luwih saka rong sasi sawise administrasi agen antibakteri.
Yen CDAD dikonfirmasi, vonoprazan/clarithromycin/amoxicillin kudu dilereni. Manajemen cairan lan elektrolit sing cocog, suplemen protein, perawatan antibakteri C. difficile, lan evaluasi bedah kudu ditindakake kaya sing dituduhake sacara klinis.
Rash ing Patients karo Mononucleosis
Persentase dhuwur saka patients karo mononucleosis sing nampa amoxicillin, komponèn saka preparation tetep-kombinasi ngembangaken ruam kulit erythematous. Aja nggunakake vonoprazan/clarithromycin/amoxicillin ing pasien mononukleosis.
Interaksi karo Investigasi Diagnostik kanggo Tumor Neuroendokrin
Kadar kromogranin A (CgA) serum mundhak sekunder amarga nyuda asam lambung amarga obat-obatan. Tingkat CgA sing tambah bisa nyebabake asil positif palsu ing investigasi diagnostik kanggo tumor neuroendokrin. Kaji tingkat CgA paling sethithik 14 dina sawise perawatan vonoprazan/clarithromycin/amoxicillin lan nimbang mbaleni tes yen tingkat CgA awal dhuwur.
Pengembangan Bakteri Tahan Narkoba
Preskripsi vonoprazan/clarithromycin/amoxicillin yen ora ana infèksi bakteri utawa indikasi profilaksis sing wis kabukten utawa dicurigai kuat ora bakal menehi keuntungan kanggo pasien, lan nambah risiko pangembangan bakteri tahan obat.
QT Prolongation
Clarithromycin wis digandhengake karo prolongation saka interval QT lan kasus arang aritmia. Kasus torsades de pointes wis dilaporake sacara spontan sajrone pengawasan pasca pemasaran ing pasien sing nampa clarithromycin. Pati wis dilaporake. Ngindhari vonoprazan/clarithromycin/amoxicillin ing pasien ing ngisor iki:
Pasien sing nampa obat sing dikenal bisa nambah interval QT (contone, pimozide).
Pasien tuwa bisa luwih rentan kanggo obat -efek digandhengake ing interval QT.
Hepatotoksisitas
Disfungsi hepatik, kalebu tambah enzim ati lan hepatoseluler lan/utawa hepatitis kolestatik, kanthi utawa tanpa jaundice, wis dilaporake karo clarithromycin, komponen saka persiapan kombinasi tetep. Disfungsi hepatik iki bisa uga abot lan biasane bisa dibalik. Ing sawetara kasus, gagal hepatik kanthi asil fatal wis dilaporake lan umume digandhengake karo penyakit serius lan / utawa obat-obatan sing ana gandhengane. Gejala hepatitis bisa kalebu anorexia, jaundice, cipratan peteng, pruritus, utawa weteng empuk.
Mateni langsung vonoprazan/clarithromycin/amoxicillin yen ana tandha lan gejala hepatitis.
Reaksi Saleh sing Serius Amarga Panganggone Clarithromycin kanthi Obat Liyane
Obat sing dimetabolisme dening CYP3A4: Reaksi saleh sing serius wis dilaporake ing pasien sing njupuk clarithromycin bebarengan karo substrat CYP3A4. Iki kalebu keracunan colchicine karo colchicine; tambah transaminase kanthi lomitapide; rhabdomyolysis karo simvastatin, lovastatin, lan atorvastatin; hipoglikemia lan aritmia jantung (contone, torsades de pointes) kanthi disopyramide; lan hipotensi lan ciloko ginjel akut kanthi blocker saluran kalsium sing dimetabolisme dening CYP3A4 (contone, verapamil, amlodipine, diltiazem, nifedipine). Umume laporan cedera ginjel akut kanthi blocker saluran kalsium sing dimetabolisme dening CYP3A4 melu pasien tuwa sing umure 65 taun utawa luwih
Colchicine: Interaksi obat sing ngancam nyawa lan fatal wis dilaporake ing pasien. diobati karo clarithromycin. Yen co-administrasi vonoprazan / clarithromycin / amoxicillin lan colchicine perlu ing pasien kanthi fungsi ginjel lan ati normal, nyuda dosis colchicine. Ngawasi pasien kanggo gejala klinis keracunan colchicine. Administrasi serentak saka vonoprazan / clarithromycin / amoxicillin lan colchicine dikontraindikasi ing pasien kanthi gangguan ginjel utawa ati.
Lomitapide: Panggunaan bebarengan saka vonoprazan/clarithromycin/amoxicillin karo lomitapide bisa nambah risiko elevasi ing transaminase amarga komponen clarithromycin. Panganggone persiapan kombinasi tetep karo lomitapide dikontraindikasi. Yen perawatan karo vonoprazan/clarithromycin/amoxicillin ora bisa dihindari, terapi karo lomitapide kudu dilereni sajrone perawatan.
HMG-CoA Reductase Inhibitors (statin): Panggunaan bebarengan Vonoprazan / clarithromycin / amoxicillin kanthi lovastatin utawa simvastatin bisa nambah konsentrasi plasma obat kasebut amarga komponen clarithromycin, sing bisa nambah risiko myopathy, kalebu rhabdomyolysis. Kasus rhabdomyolysis wis dilaporake ing pasien sing diobati kanthi clarithromycin lan lovastatin utawa simvastatin. Kontraindikasi nggunakake vonoprazan / clarithromycin / amoxicillin kanthi lovastatin utawa simvastatin. Yen perawatan karo persiapan kombinasi tetep ora bisa dihindari, terapi karo lovastatin utawa simvastatin kudu ditundha sajrone perawatan. Ati-ati nalika menehi resep vonoprazan/clarithromycin/amoxicillin karo atorvastatin utawa pravastatin.
Agen Hipoglikemik/Insulin: Panggunaan bebarengan karo vonoprazan/clarithromycin/amoxicillin lan agen hipoglikemik (kayata pioglitazonelinide, , repaglinide lan rosiglitazone) lan / utawa insulin bisa nyebabake hipoglikemia sing signifikan amarga komponen clarithromycin. Ngawasi tingkat glukosa kanthi ati-ati nalika obat kasebut digunakake bebarengan karo persiapan kombinasi tetep.
Quetiapine: Panggunaan bebarengan vonoprazan/clarithromycin/amoxicillin karo quetiapine bisa nyebabake ngantuk, hipotensi ortostatik, owah-owahan kesadaran, sindrom ganas neuroleptik, lan prolongation QT amarga clarithromycin. komponen. Deleng informasi resep quetiapine kanggo nyuda dosis sing disaranake yen digunakake bebarengan karo persiapan kombinasi tetep.
Warfarin: Ana risiko pendarahan serius lan peningkatan signifikan ing rasio normalisasi internasional (INR) lan wektu prothrombin nalika klaritromisin digunakake bebarengan karo warfarin. Ngawasi kaping INR lan prothrombin asring nalika warfarin digunakake bebarengan karo vonoprazan/clarithromycin/amoxicillin.
Benzodiazepines: Tambah sedasi lan prolongation saka sedasi wis kacarita karo administrasi concomitant clarithromycin lan triazolobenzodiaze , kayata triazolam lan midazolam. Ngawasi pasien kanthi rapet kanggo tandha-tandha utawa gejala efek sistem saraf pusat sing saya tambah utawa suwe nalika benzodiazepine kayata triazolam utawa midazolam digunakake bebarengan karo vonoprazan / clarithromycin / amoxicillin.
Toksisitas Embrio-Fetal
Adhedhasar temuan saka studi kewan lan studi pengamatan manungsa ing wanita ngandhut kanthi nggunakake clarithromycin, panggunaan vonoprazan/clarithromycin/amoxicillin ora dianjurake kanggo wanita ngandhut kajaba ing kahanan klinis. ora ana terapi alternatif sing cocok. Yen persiapan kombinasi tetep digunakake nalika meteng, utawa yen meteng ana nalika pasien njupuk obat iki, menehi saran marang pasien babagan risiko potensial kanggo janin. Clarithromycin nuduhake efek sing ora becik ing asil meteng lan / utawa perkembangan janin embrio, ing kewan sing ngandhut clarithromycin oral. Pasinaon pengamatan ing wanita ngandhut uga nuduhake efek sing ora becik tumrap asil meteng, kalebu risiko keguguran sing tambah lan ing sawetara panaliten nambah insiden malformasi janin.
Eksaserbasi Myasthenia Gravis
Eksaserbasi gejala myasthenia gravis lan gejala anyar saka sindrom myasthenia wis dilaporake ing pasien sing nampa terapi klaritromisin. Ngawasi pasien kanggo gejala.
Populasi Spesifik
KandhutanAdhedhasar temuan saka studi kewan lan studi observasional ing wanita ngandhut kanthi nggunakake clarithromycin, panggunaan vonoprazan/clarithromycin/amoxicillin ora dianjurake kanggo wanita ngandhut kajaba ing kahanan klinis sing ora ana alternatif. therapy cocok. Ora ana studi sing nyukupi lan dikontrol kanthi apik babagan persiapan kombinasi tetep ing wanita ngandhut kanggo ngevaluasi risiko sing gegandhengan karo obat saka cacat lair utama, keguguran, utawa asil ibu utawa janin liyane. Yen vonoprazan/clarithromycin/amoxicillin digunakake nalika meteng, menehi saran marang wanita ngandhut babagan risiko potensial kanggo janin.
Ora ana studi keracunan reproduksi lan perkembangan kanthi kombinasi vonoprazan, amoxicillin, lan/utawa clarithromycin sing ditindakake.
Clarithromycin: Panaliten observasional sing diterbitake ing wanita ngandhut wis nuduhake efek sing ora becik tumrap asil meteng, kalebu risiko keguguran sing tambah lan ing sawetara panaliten nambah insiden malformasi janin. Ing studi reproduksi kewan, administrasi clarithromycin oral kanggo tikus ngandhut, tikus, terwelu, lan kethek sajrone periode organogenesis ngasilake malformasi ing tikus (anomali kardiovaskular) lan tikus (sumbing langit-langit) ing dosis sing cocog sacara klinis. Efek janin ing tikus, tikus, lan kethek (contone, nyuda kaslametan janin, bobot awak, bobot awak) lan mundhut implantasi ing terwelu umume dianggep sekunder kanggo keracunan ibu.
Vonoprazan: Data sing kasedhiya saka laporan pharmacovigilance kanthi nggunakake vonoprazan ing wanita ngandhut ora cukup kanggo ngevaluasi risiko sing gegandhengan karo obat kanggo cacat lair utama, keguguran utawa asil sing ora becik kanggo ibu utawa janin. Ing tikus ngandhut, ora ana efek saleh sing dicathet sawise administrasi lisan vonoprazan sajrone organogenesis kira-kira 27 kaping dosis manungsa maksimal sing disaranake (MRHD) adhedhasar perbandingan paparan AUC. Ing studi pra-lan postnatal (PPND), anak kirik saka bendungan sing diwenehake kanthi lisan sajrone organogenesis lan liwat laktasi nuduhake owah-owahan warna ati, sing ing studi kewan mekanistik tindak lanjut digandhengake karo nekrosis, fibrosis lan pendarahan kanthi dosis kira-kira 22 kali. MRHD adhedhasar perbandingan AUC sing bisa uga disebabake paparan nalika laktasi. Efek kasebut ora diamati ing dosis ngisor sabanjure ing panliten iki, sing kira-kira padha karo MRHD adhedhasar perbandingan AUC, nanging katon ing eksposur sing relevan sacara klinis ing panaliten nemokake sawetara dosis ing tikus.
< b>Amoxicillin: Data sing kasedhiya saka studi epidemiologi sing diterbitake lan laporan kasus pharmacovigilance sajrone pirang-pirang dekade kanthi nggunakake amoxicillin durung nemtokake risiko cacat lair utama, keguguran, utawa asil ibu utawa janin sing ora becik. Pasinaon reproduksi karo amoxicillin wis ditindakake ing tikus lan tikus (5 lan 10 kaping dosis manungsa 2 g dosis manungsa kanggo tikus lan tikus, masing-masing, 3 lan 6 kaping dosis manungsa 3 g kanggo tikus lan tikus, masing-masing). Ora ana bukti mbebayani kanggo janin amarga amoxicillin.
Risiko latar mburi sing kira-kira saka cacat lair utama lan keguguran kanggo populasi sing dituduhake ora dingerteni. Kabeh meteng duwe risiko latar mburi cacat lair, mundhut, utawa asil salabetipun liyane. Ing populasi umum AS, kira-kira risiko latar mburi cacat lair utama lan keguguran ing kandhutan sing diakoni sacara klinis yaiku 2% nganti 4% lan 15% nganti 20%.
Lapokake meteng menyang Phathom Pharmaceuticals, Inc. Baris laporan Adverse Event ing 1-888-775-PHAT (7428) . Vonoprazan lan metabolité ana ing susu tikus. Cilaka ati dumadi ing turunan saka tikus ngandhut lan lactating sing diwenehi vonoprazan oral ing paparan AUC kira-kira padha karo lan luwih gedhe tinimbang MRHD. Nalika obat kasebut ana ing susu kewan, kemungkinan obat kasebut ana ing susu manungsa. Amarga risiko potensial efek ati sing saleh sing dituduhake ing studi kewan karo vonoprazan, wong wadon kudu ngompa lan mbuwang susu manungsa sajrone perawatan vonoprazan / clarithromycin / amoxicillin, lan sajrone 2 dina sawise terapi rampung, lan menehi susu bayi sing disimpen. (dikumpulake sadurunge terapi) utawa formula.
Adhedhasar data saka studi laktasi sing diterbitake, clarithromycin lan metabolit aktif 14-OH clarithromycin ana ing susu manungsa kurang saka 2% saka bobote ibu sing disetel. dosis. Ing panaliten pengamatan sing kapisah saka wanita lactating sing kena clarithromycin, nglaporake efek samping ing bocah-bocah sing nyusoni (ruam, diare, mundhut napsu, ngantuk) padha karo amoxicillin. Ora ana data sing kasedhiya kanggo netepake efek clarithromycin utawa 14-OH clarithromycin ing produksi susu.
Data saka studi laktasi klinis sing diterbitake nyatakake yen amoxicillin ana ing susu manungsa. Ora ana data babagan efek amoxicillin ing produksi susu.
Wanita lan Lanang Potensi ReproduksiAdhedhasar temuan studi kesuburan kewan kanggo clarithromycin, vonoprazan/clarithromycin/amoxicillin bisa ngrusak kesuburan lanang sing potensial reproduksi.
Panggunaan PediatrikAman lan efektifitas vonoprazan/clarithromycin/amoxicillin ing pasien pediatrik durung ditetepake.
Panggunaan GeriatrikAmoxicillin lan clarithromycin dikenal sacara substansial diekskresi dening ginjel, lan Resiko reaksi salabetipun kanggo obat kasebut bisa uga luwih gedhe ing pasien sing duwe fungsi ginjel cacat lan bisa uga migunani kanggo ngawasi fungsi ginjel.
Vonoprazan: Ana 218 pasien umur 65 taun lan luwih ing studi klinis vonoprazan/clarithromycin/amoxicillin kanggo perawatan infeksi H. pylori. Saka jumlah total subyek sing diobati vonoprazan (N=694), ana 153 (22.0%) pasien sing umure 65 taun lan luwih lawas lan 18 (2.6%) pasien umure 75 taun lan luwih. Ora ana bedane safety utawa efektifitas sakabèhé ing antarane pasien kasebut lan pasien diwasa sing luwih enom.
Amoxicillin: Analisis studi klinis amoxicillin ditindakake kanggo nemtokake manawa subyek umur 65 lan luwih. nanggapi beda karo subyek sing luwih enom. Analisis kasebut ora nemtokake bedane respon antarane pasien tuwa lan luwih enom, nanging sensitivitas sing luwih gedhe saka sawetara wong tuwa ora bisa ditolak. Obat iki dikenal sacara substansial diekskripsikake dening ginjel, lan risiko reaksi beracun kanggo obat iki bisa uga luwih gedhe ing pasien sing duwe fungsi ginjel cacat. Amarga pasien lansia luwih cenderung ngalami penurunan fungsi ginjel, bisa uga migunani kanggo ngawasi fungsi ginjel.
Clarithromycin: Ing studi steady-state ing ngendi subyek lansia sing sehat (65 taun nganti 81 taun) diwenehi 500 mg clarithromycin saben 12 jam, konsentrasi serum maksimal lan AUC saka clarithromycin lan 14-OH clarithromycin tambah dibandhingake karo sing diraih ing wong diwasa enom sing sehat. Owah-owahan ing farmakokinetik iki padha karo penurunan fungsi ginjel sing gegandhengan karo umur. Ing uji klinis, pasien tuwa ora ngalami kedadeyan reaksi salabetipun yen dibandhingake karo pasien sing luwih enom. Pasien tuwa bisa uga luwih rentan kanggo pangembangan aritmia torsades de pointe tinimbang pasien sing luwih enom. Umume laporan cedera ginjel akut kanthi nggunakake clarithromycin lan blocker saluran kalsium sing dimetabolisme dening CYP3A4 (contone, verapamil, amlodipine, diltiazem, nifedipine) melu pasien tuwa sing umure 65 taun utawa luwih. Utamane ing pasien tuwa, ana laporan babagan keracunan colchicine kanthi nggunakake clarithromycin lan colchicine bebarengan, sawetara sing kedadeyan ing pasien kanthi insufficiency ginjel. Pati wis dilaporake ing sawetara pasien.
Gagal ginjelOra ana pangaturan dosis saka vonoprazan/clarithromycin/amoxicillin sing disaranake ing pasien kanthi gangguan ginjel entheng nganti moderat (eGFR 30 nganti 89 mL/menit). Aja nggunakake persiapan kombinasi tetep ing pasien kanthi gangguan ginjel sing abot (eGFR <30 mL / min).
Gangguan HepatikOra ana pangaturan dosis saka vonoprazan/clarithromycin/amoxicillin sing disaranake ing pasien kanthi gangguan hepatik entheng (Child-Pugh A). Aja nggunakake persiapan kombinasi tetep ing pasien kanthi gangguan hepatik moderat nganti abot (Child-Pugh B utawa C).
Efek Sabar sing Umum
Reaksi salabetipun sing paling umum (≥ 2%) yaiku dysgeusia, diare, kandidiasis vulvovaginal, sirah, nyeri weteng, lan hipertensi.
Apa obatan liyane bakal mengaruhi Vonoprazan, Clarithromycin, and Amoxicillin
Obat Spesifik
Pancen penting panyedhiya label pabrikan kudu dikonsultasi kanggo informasi sing luwih rinci babagan interaksi karo obat iki, kalebu kemungkinan pangaturan dosis. Sorotan interaksi:
Komponèn vonoprazan/clarithromycin/amoxicillin duweni potensi interaksi obat sing penting sacara klinis. Deleng Informasi Resep Lengkap kanggo interaksi obat sing penting karo persiapan kombinasi tetep.
Disclaimer
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