Brivaracetam
Jeneng merek: Briviact
Kelas obat:
Agen Antineoplastik , Agen Antineoplastik
Panganggone Brivaracetam
Gangguan Kejang
Manajemen (kanthi kombinasi karo antikonvulsan liyane) saka serangan sebagean ing wong diwasa lan remaja ≥16 taun.
Related obat
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Carane nggunakake Brivaracetam
Umum
Administrasi
Administrasi oral (minangka tablet utawa solusi). Bisa ditrapake IV nalika administrasi oral sauntara ora bisa ditindakake; pabrikan nyatakake pengalaman klinis kanthi nggunakake IV diwatesi nganti 4 dina berturut-turut perawatan.
Tablet brivaracetam sing kasedhiya ing komersial, solusi oral, lan injeksi IV bisa digunakake bebarengan.
Administrasi Oral h4>
Wonten tablet utawa larutan oral kaping pindho saben dina tanpa preduli panganan.
Aja ngunyah utawa ngremuk tablet.
Atur solusi oral tanpa diencerake maneh.
Gunakake piranti ukur sing dikalibrasi kanggo ngukur lan ngatur dosis larutan oral; aja nganggo sendok teh utawa sendok.
NG TubeYen perlu, bisa menehi solusi oral liwat nasogastric utawa tabung feeding lambung.
IV Administration
Administrasi kaping pindho saben dina minangka injeksi langsung ("bolus") IV utawa infus liwat 2-15 menit; bisa ditindakake tanpa diencerake maneh utawa bisa diencerake nganggo solusi sing kompatibel. (Deleng Kompatibilitas ing Stabilitas.)
Ora ana pengawet; Mbuwang bokor sing sebagian digunakake.
Dosis
Bisa miwiti terapi kanthi administrasi oral utawa IV.
Titrasi dosis bertahap ora dibutuhake nalika miwiti terapi.
Pasien Anak
Gangguan Kejang Kejang Parsial OralRemaja ≥16 taun: 50 mg kaping pindho saben dina (total dosis saben dina 100 mg) minangka tablet utawa solusi lisan. Bisa nyuda nganti 25 mg kaping pindho saben dina utawa nambah dadi 100 mg kaping pindho saben dina adhedhasar respon pasien lan toleransi individu.
IVRemaja ≥16 taun: 50 mg kaping pindho saben dina (total dosis saben dina 100 mg). Bisa mudhun nganti 25 mg kaping pindho saben dina utawa nambah dadi 100 mg kaping pindho saben dina adhedhasar respon lan toleransi pasien individu.
Pengalaman klinis kanthi administrasi IV diwatesi nganti 4 dina perawatan berturut-turut.
Wong diwasa
Gangguan Kejang Kejang Parsial Oral50 mg kaping pindho saben dina (total dosis saben dina 100 mg) minangka tablet utawa solusi oral. Bisa nyuda dadi 25 mg kaping pindho saben dina utawa nambah dadi 100 mg kaping pindho saben dina adhedhasar respon pasien lan toleransi individu.
IV50 mg kaping pindho saben dina (total dosis saben dina 100 mg). Bisa mudhun nganti 25 mg kaping pindho saben dina utawa nambah dadi 100 mg kaping pindho saben dina adhedhasar respon lan toleransi pasien individu.
Pengalaman klinis kanthi administrasi IV diwatesi nganti 4 dina perawatan berturut-turut.
Populasi Khusus
Gangguan Hepatik
Pasien kanthi tingkat gangguan hepatik: Kaping pisanan, 25 mg kaping pindho saben dina. Aja ngluwihi 75 mg kaping pindho saben dina. (Deleng Cacat Hepatik ing Awas.)
Gangguan Ginjal
Ora ana pangaturan dosis sing dibutuhake. (Deleng Gagal Ginjal ing Ati-ati.)
Pasien Geriatrik
Ora ana rekomendasi dosis khusus. (Waca Panggunaan Geriatrik ing Ati-ati.)
Metabolisme CYP2C19 sing Miskin
Mungkin perlu nyuda dosis. (Waca Metabolizers CYP2C19 Miskin ing Ati-ati.)
Pènget
Contraindications
Pènget/PanandhapPanegahan Umum
Resiko Suicidality
Tambah risiko suicidality (prilaku bunuh diri utawa ideation) diamati ing analisis pasinaon nggunakake macem-macem anticonvulsants ing pasien karo epilepsi, kelainan psikiatri (contone, kelainan bipolar, depresi, kuatir) , lan kahanan liyane (contone, migren, nyeri neuropatik); Resiko ing pasien sing nampa antikonvulsan (0,43%) kira-kira kaping pindho tinimbang pasien sing nampa plasebo (0,24%). Tambah risiko suicidality diamati ≥1 minggu sawise miwiti terapi anticonvulsant lan terus nganti 24 minggu. Resiko luwih dhuwur kanggo pasien epilepsi dibandhingake karo sing nampa anticonvulsant kanggo kondisi liyane.
Ngawasi kanthi rapet kabeh pasien sing saiki nampa utawa miwiti terapi anticonvulsant kanggo owah-owahan prilaku sing bisa nuduhake muncule utawa elek pikirane utawa prilaku utawa depresi. Kuatir, agitasi, permusuhan, insomnia, lan mania bisa dadi prekursor kanggo suicidality sing muncul.
Imbangi risiko suicidality karo risiko penyakit sing ora diobati. Epilepsi lan penyakit liyane sing diobati karo anticonvulsant dhewe ana gandhengane karo morbiditas lan mortalitas lan tambah risiko suicidality. Yen pikirane utawa prilaku bunuh diri muncul sajrone terapi antikonvulsan, pikirake manawa gejala kasebut ana gandhengane karo penyakit kasebut. (Deleng Saran kanggo Pasien.)
Efek NeurologisEfek neurologis sing ora becik bisa kedadeyan; pusing, gangguan ing gait utawa koordinasi (contone, vertigo, nistagmus, gangguan keseimbangan, ataxia, koordinasi abnormal), ngantuk, lan kelelahan dilaporake. Umume diamati ing awal perawatan nanging bisa kedadeyan kapan wae sajrone terapi.
Ngawasi pasien kanggo efek neurologis sing saleh lan menehi saran supaya pasien ora nyopir utawa ngoperasikake mesin nganti efek obat kasebut dingerteni. (Deleng Saran kanggo Pasien.)
Efek PsikiatriEfek kejiwaan sing ala bisa kedadeyan, kalebu gejala nonpsikotik (contone, irritability, kuatir, gugup, agresi, perang, nesu, agitasi, gelisah, depresi, nangis, apatis, swasana ati sing diowahi, pengaruh labil, hiperaktivitas psikomotor, prilaku abnormal, kelainan penyesuaian) lan gejala psikotik (contone, gangguan psikotik, halusinasi, paranoia, psikosis akut).
Pantau pasien kanggo efek psikiatri sing saleh.
Reaksi SensitivitasReaksi hipersensitivitas (yaiku, bronkospasme, angioedema) dilaporake; langsung mandheg yen pasien ngalami reaksi hipersensitivitas.
Penghentian TerapiPenolakan antikonvulsan sing tiba-tiba bisa nambah frekuensi kejang lan risiko status epileptikus. Umumé, mundur alon-alon dianjurake; Nanging, pabrikan nyatakake yen mundur cepet bisa uga dianggep yen mandhegake brivaracetam perlu amarga efek saleh sing serius.
Potensi Penyalahgunaan lan KetergantunganBrivaracetam tundhuk kontrol minangka obat jadwal V (C-V). Efek sedative lan euphoric dilaporake kurang kerep tinimbang karo alprazolam (obat jadwal IV) ing dosis terapeutik sing disaranake; Nanging, efek kasebut padha karo sing diprodhuksi dening alprazolam nalika brivaracetam diwenehake ing dosis supratherapeutic.
Ora ana bukti katergantungan fisik utawa gejala mundur.
Populasi Spesifik
KandhutanKategori C.
Registry Kehamilan Obat Antiepileptik Amerika Utara (NAAED) (kanggo pasien) ing 888-233-2334 utawa [Web].
LaktasiOra dingerteni manawa disebarake menyang susu manungsa; nyebar menyang susu ing tikus. Mungkasi nyusoni utawa obat.
Panggunaan PediatrikKeamanan lan khasiat ora ditetepake ing pasien pediatrik <16 taun.
Panggunaan GeriatrikPengalaman sing ora cukup ing pasien geriatrik ≥65 taun kanggo netepake khasiat. Coba frekuensi sing luwih akeh nyuda fungsi ati, ginjel, lan / utawa jantung lan penyakit bebarengan lan terapi obat liyane nalika milih dosis ing pasien geriatrik. (Deleng Eliminasi: Populasi Khusus, miturut Farmakokinetik.)
Gangguan HepatikPaparan sistemik saka brivaracetam mundhak ing pasien kanthi gangguan hepatik. (Deleng Gangguan Hepatik ing Dosis lan Administrasi, lan uga ndeleng Penyerapan: Populasi Khusus, miturut Farmakokinetik.)
Gagal GinjalFarmakokinetik sing ora kena pengaruh kanthi signifikan dening gangguan ginjel. (Deleng Gangguan Renal ing Dosis lan Administrasi, lan uga ndeleng Penyerapan: Populasi Khusus, miturut Farmakokinetik.)
Ora diteliti ing pasien sing ngalami dialisis; panggunaan ora dianjurake.
Metabolizer CYP2C19 sing ora apikKonsentrasi plasma sing tambah ing pasien sing kurang metabolisme CYP2C19. (Deleng Metabolizer CYP2C19 sing Miskin miturut Dosis lan Administrasi, lan uga deleng Penyerapan: Populasi Khusus, miturut Farmakokinetik.)
Efek Sabar sing Umum
Somnolence/sedasi, pusing, kesel, mual/muntah, diare, sirah, insomnia, nasofaringitis.
Apa obatan liyane bakal mengaruhi Brivaracetam
Metabolisme nganti sawetara dening CYP2C19 lan CYP2C9.
Inhibitor CYP2C19 sing lemah; ora samesthine dadi klinis penting. Nyandhet hidrolase epoksida ing vitro. Ora nyandhet CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, utawa 3A4, uga ora ngindhuksi CYP1A2, 2B6, 2C9, 2C19, 3A4, utawa hidrolase epoksida.
Bukan substrat saka (P-glycoprotein) -gp) utawa multidrug resistance proteins (MRP) 1 lan MRP2. Ora nyandhet P-gp, protein tahan kanker payudara (BCRP), pompa ekspor garam empedu (BSEP), pengangkut ekstrusi multidrug lan racun (MATE) 1 lan MATE2/K, MRP2, pengangkut anion organik (OAT) 1 lan OAT3, organik transporter kation (OCT) 1 lan OCT2, utawa protein transport anion organik (OATP) 1B1 lan OATP1B3.
Obat sing Ngaruhi utawa Dimetabolisme dening Enzim Mikrosomal Hepatik
Inhibitor CYP2C19: Potensi tambah konsentrasi brivaracetam .
Interaksi farmakokinetik ora mungkin karo obat sing nyandhet isoenzim CYP liyane.
Inducer CYP2C19: Potensi nyuda konsentrasi brivaracetam.
Obat Spesifik
Obat
Interaksi
Komentar
Alkohol
Efek aditif ing gangguan psikomotor, perhatian, lan memori
Konsentrasi brivaracetam plasma mudhun nganti 26%
Tambah paparan metabolit aktif carbamazepine-epoxide ; paparan carbamazepine ora kena pengaruh
Coba ngurangi dosis carbamazepine yen panggunaan bebarengan ora ditrima
Kontrasepsi, oral
Brivaracetam ing kaping pindho dosis maksimum saben dina sing disaranake nyuda AUC estrogen lan komponen progestin kontrasepsi oral kanthi 27 lan 23%, masing-masing; ora ana pengaruh kanggo nyegah ovulasi
Brivaracetam ing dosis sing disaranake ora mengaruhi farmakokinetik obat kasebut
Interaksi sing ora dikarepake sacara klinis penting
Gemfibrozil
p>Farmakokinetik Brivaracetam ora kena pengaruh
Lacosamide
Ora ana pengaruh ing konsentrasi plasma lacosamide
Panyesuaian dosis brivaracetam ora perlu
Lamotrigine
Ora ana pengaruh ing konsentrasi plasma saka brivaracetam utawa lamotrigine
Panyesuaian dosis saka brivaracetam ora perlu
Levetiracetam
Ora ana manfaat terapeutik tambahan nalika brivaracetam ditambahake ing levetiracetam
Ora ana interaksi farmakokinetik sing diamati
Panyesuaian dosis brivaracetam ora perlu
Oxcarbazepine
Ora ana pengaruh ing konsentrasi plasma brivaracetam utawa metabolit monohidroksi aktif oxcarbazepine (MHD)
Panyesuaian dosis saka brivaracetam ora perlu
Phenobarbital
Konsentrasi brivaracetam plasma suda nganti 19%; konsentrasi fenobarbital ora kena
Panyesuaian dosis brivaracetam ora perlu
Phenytoin
Konsentrasi brivaracetam plasma mudhun nganti 21%; Konsentrasi fenitoin plasma tambah nganti 20% (kaping pindho dosis sing disaranake saka brivaracetam)
Panyesuaian dosis saka brivaracetam ora perlu
Ngawasi konsentrasi fenitoin nalika terapi brivaracetam diwiwiti utawa dihentikan
Pregabalin
Ora ana pengaruh ing konsentrasi plasma pregabalin
Panyesuaian dosis brivaracetam ora perlu
p>Rifampisin
Ngurangi paparan sistemik kanggo brivaracetam nganti 45%
Tambah dosis brivaracetam (nganti kaping pindho)
Topiramate
Ora ana pengaruh ing konsentrasi plasma brivaracetam utawa topiramate
Ora perlu pangaturan dosis brivaracetam
Asam valproat
Ora ana pengaruh ing konsentrasi plasma brivaracetam utawa asam valproat
Panyesuaian dosis brivaracetam ora perlu
Zonisamide
Ora ana pengaruh ing konsentrasi plasma zonisamide
Panyesuaian dosis brivaracetam ora perlu
Disclaimer
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