Terbinafine (Systemic)
Jeneng merek: LamISIL
Kelas obat:
Agen Antineoplastik
Panganggone Terbinafine (Systemic)
Onikomikosis
Pengobatan infeksi dermatofit ing kuku jempol utawa kuku (onikomikosis, tinea unguium) sing disebabake dening jamur sing rentan.
Wis efektif ing perawatan saka infèksi kuku disebabake paling galur Trichophyton rubrum lan T. mentagrophytes. Sanajan biasane aktif ing vitro nglawan Epidermophyton floccosum, Candida albicans, lan Scopulariopsis brevicaulis, khasiat kanggo perawatan onikomikosis sing disebabake dening organisme kasebut durung ditetepake ing studi sing nyukupi lan dikontrol.
Terbinafine bisa uga migunani utamane ing pasien sing ora bisa ngidinke antijamur azole (contone, itraconazole) utawa nalika ana keprihatinan babagan interaksi obat sing bisa ditindakake antarane azole lan obat liyane sing ditampa pasien. Nanging, gagal ati (kadhangkala nyebabake pati utawa transplantasi ati) jarang kedadeyan ing pasien sing duwe utawa tanpa penyakit ati sing wis ana sadurunge sing nampa terbinafine oral kanggo perawatan onikomikosis. (Deleng Hepatotoksisitas ing Cautions.)
Tinea Capitis
Pengobatan tinea capitis (kurap kulit sirah) sing disebabake dening dermatofit sing rentan (contone, Trichophyton, Microsporum).
Tinea capitis mbutuhake perawatan karo antijamur oral. Terapi topikal (umpamane, sampo sing ngemot selenium sulfida, povidone yodium, utawa ketoconazole; antijamur topikal) kadhangkala digunakake minangka tambahan kanggo antijamur oral lan bisa nyuda penularan jamur lan risiko transmisi utawa infeksi maneh.
Griseofulvin oral minangka obat pilihan biasa; alternatif kalebu flukonazol oral, itrakonazol, utawa terbinafine.
Terbinafine oral katon efektif kaya griseofulvin oral kanggo perawatan tinea capitis sing disebabake dening Trichophyton, lan mbutuhake wektu perawatan sing luwih cendhek sing bisa nambah kepatuhan. Nanging, ana sawetara bukti yen griseofulvin bisa luwih efektif tinimbang terbinafine nalika M. canis minangka agen penyebab.
Tinea Corporis utawa Tinea Cruris
Pengobatan tinea corporis† [off-label] (body ringworm) utawa tinea cruris† [off-label] (jock gatel).
Antijamur topikal biasane efektif kanggo perawatan tinea corporis sing ora rumit. Antifungal oral (griseofulvin, fluconazole, itraconazole, terbinafine) bisa uga dibutuhake yen tinea corporis ekstensif, Dermatophyte folliculitis ana, infeksi ora nanggapi terapi topikal, utawa pasien immunocompromised amarga penyakit sing ana bebarengan utawa terapi bebarengan.
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Carane nggunakake Terbinafine (Systemic)
Administrasi
Administrasi Lisan
Administrasi kanthi lisan.
Njupuk granula lisan karo panganan. Sprinkle isi paket siji-dosis ing spoonful saka puding utawa liyane alus, pangan non-asam (contone, mashed kentang); aja nggunakake saus apel utawa panganan sing adhedhasar woh-wohan. Ngulu kabeh sendok (tanpa ngunyah). Yen dosis mbutuhake 2 paket kanggo saben dosis, sprinkle isi loro paket ing siji sendok pangan non-asam utawa sprinkle isi paket ing 2 spoonfuls pangan nonacidic.
Dosis
Kasedhiya minangka terbinafine hidroklorida; dosis ditulis ing syarat-syarat terbinafine.
Pasien Anak
Tinea Capitis OralGranules ing bocah ≥4 taun: 125-250 mg sapisan dina suwene 6 minggu. Gunakake 125 mg sapisan dina ing wong sing bobote <25 kg, 187,5 mg sapisan dina kanggo sing bobote 25-35 kg, lan 250 mg sapisan dina kanggo sing bobote > 35 kg.
Sawetara bukti yen durasi luwih suwe perawatan (contone, 6-8 minggu) utawa dosis sing luwih dhuwur bisa uga dibutuhake nalika tinea capitis disebabake M. canis.
Dewasa
Onikomikosis Kuku Jari OralTablet: 250 mg saben dina diwenehi suwene 6 minggu. Pangobatan sing luwih dawa umume ora luwih efektif, sanajan sawetara pasien bisa entuk manfaat saka kursus terbinafine sing dawa lan / utawa bola-bali.
Infeksi kuku biasane dievaluasi maneh ≥18 minggu sawise rampung perawatan.
Kuku Jari OralTablet: 250 mg saben dina diwenehi suwene 12 minggu. Sawetara pasien sing ora nanggapi regimen awal 12 minggu bisa nanggapi kursus kaping pindho.
Infeksi kuku biasane dievaluasi maneh 6-9 sasi sawise terapi rampung.
Tinea Capitis OralButiran: 125-250 mg sapisan dina kanggo 6 minggu. Gunakake 187,5 mg sapisan dina kanggo sing bobote 25-35 kg lan 250 mg sapisan dina kanggo sing bobote > 35 kg.
Sawetara bukti yen perawatan luwih suwe (contone, 6-8 minggu) utawa dosis sing luwih dhuwur bisa uga dibutuhake yen tinea capitis disebabake dening M. canis.
Tinea Corporis† [off-label] utawa Tinea Cruris† [off-label] OralTablet: 250 mg saben dina kanggo 2-4 minggu wis digunakake.
Populasi Khusus
Gangguan Hepatik
Ora dianjurake kanggo pasien sing duwe penyakit ati sing wis ana (contone, sirosis). (Deleng Kerusakan Hepatik ing Ati-ati.)
Gangguan Ginjal
Ora dianjurake kanggo pasien kanthi gangguan ginjel (yaiku, Clcr ≤50 mL / menit) (Deleng Kerusakan Ginjal ing Ati-ati.)
Pènget
Kontraindikasi
Pènget/PanandhapPènget
Hepatotoksisitas
Hepatotoksisitas, kalebu tes fungsi ati sing ora normal lan hepatitis kolestatik abot, dilapurake ing sawetara pasien sing nampa terbinafine oral.
Gagal ati, kadhangkala nyebabake pati utawa transplantasi ati, arang kedadeyan ing pasien kanthi utawa tanpa penyakit ati sing wis ana sadurunge nampa terbinafine lisan kanggo perawatan onikomikosis. Umume pasien duwe kahanan sistemik sing serius; keruwetan lan asil saka hepatotoksisitas bisa dadi luwih elek ing pasien kanthi penyakit ati sing aktif utawa kronis.
Ora dianjurake kanggo pasien kanthi penyakit ati kronis utawa aktif.
Kaji fungsi hepatik (AST serum lan ALT) sadurunge miwiti terbinafine oral.
Nyetop terbinafine yen ana bukti biokimia utawa klinis ciloko ati, kalebu tambah konsentrasi ALT utawa AST, mual terus-terusan, anorexia, lemes, mutahke, nyeri weteng sisih ndhuwur tengen utawa jaundice, cipratan peteng, utawa bangkekan pucet.
Efek HematologiPenurunan sementara ing jumlah limfosit absolut (ALC) sing dilapurake; penting klinis ora dingerteni. Neutropenia abot kacarita arang; ditanggulangi kanthi utawa tanpa terapi dhukungan nalika terbinafine dihentikan.
Trombositopenia, agranulositosis, pansitopenia, lan anemia sing dilapurake sajrone pengawasan pasca pemasaran; hubungan sebab-akibat ora ditetepake.
Ing pasien sing dicurigai kurang imun, nimbang ngawasi CBC yen terbinafine oral diterusake nganti >6 minggu.
Yen tandha lan gejala klinis nuduhake infeksi sekunder, tindakake CBC. Yen jumlah neutrofil ≤1000 / mm3, mandhegake terbinafine lan miwiti terapi dhukungan.
Efek DermatologiReaksi kulit sing serius (contone, sindrom Stevens-Johnson, nekrolisis epidermis beracun) kacarita arang banget.
Erupsi psoriasis utawa eksaserbasi psoriasis lan pustulosis exanthematous akut sing umum dilapurake.
Yen ana ruam progresif, mandhegake terbinafine.
Lupus ErythematosusPresipitasi lan eksaserbasi lupus eritematosus kulit lan sistemik kacarita.
Yen pasien ngalami gejala klinis lan gejala sing nuduhake lupus erythematosus, mandhegake terbinafine.
Reaksi Sensitivitas
Reaksi HipersensitivitasAngioedema lan reaksi alergi, kalebu anafilaksis, jarang dilapurake.
Pancegahan Umum
Efek OkularGangguan visual, kalebu owah-owahan ing lensa okular lan retina, dilapurake sawise nggunakake tablet terbinafine oral kanggo perawatan onikomikosis ing wong diwasa; penting klinis ora dingerteni.
Sanajan ora ana sinyal safety ophthalmologic sing diidentifikasi ing uji klinis nggunakake granula lisan terbinafine, ana sawetara laporan owah-owahan ing ketajaman visual lan sawetara laporan kebingungan warna ing penilaian visi warna kuning-biru.
GI EfekGangguan rasa (kalebu mundhut rasa) bisa kedadeyan. Biasane rampung ing sawetara minggu sawise terbinafine mandheg, nanging gangguan rasa sing suwe (> 1 taun) wis dilaporake. Bisa uga cukup abot kanggo nyebabake nyuda intake panganan sing ndadékaké mundhut bobot sing ora dikarepake.
Pamilihan lan Panggunaan Antijamur kanggo OnikomikosisSadurungé administrasi terbinafine oral kanggo perawatan onikomikosis, spesimen kuku sing cocog kanggo studi mikrobiologis (contone, persiapan kalium hidroksida [KOH], kultur jamur, utawa biopsi kuku) kudu ditindakake. dipikolehi kanggo konfirmasi diagnosa.
Nalika milih antijamur kanggo perawatan onikomikosis, nimbang efek salabetipun kacarita lan risiko efek serius, perlu kanggo terapi dawa, biaya, lan risiko kambuh.
Infeksi kuku jempol umume mbutuhake terapi antijamur sing luwih dawa tinimbang infeksi kuku.
Efek klinis optimal terbinafine ing perawatan onikomikosis ora katon nganti pirang-pirang sasi sawise perawatan mikologis lan rampung perawatan, lan ana hubungane karo periode sing dibutuhake kanggo pertumbuhan kuku sing sehat.
Kemungkinan Kesalahan Resep lan DispensingMesthekake akurasi resep; podho ing ejaan lamotrigine (Lamictal) lan terbinafine (Lamisil) bisa nyebabake kasalahan.
Populasi Tertentu
KandhutanKategori B.
Tunda panggunaan terbinafine oral nganti sawise meteng rampung.
LaktasiDisebarake menyang susu. Gunakake ora dianjurake.
Panggunaan PediatrikAman lan khasiat tablet terbinafine sing ora ditetepake ing bocah-bocah <18 taun.
Aman lan khasiat granula lisan terbinafine sing ora ditetepake ing bocah-bocah <4 taun.
Panggunaan GeriatrikGula oral terbinafine sing ora diteliti ing pasien geriatrik.
Gangguan HepatikReresik bisa uga suda (udakara 50%) ing wong diwasa kanthi sirosis hepatik.
Ora dianjurake kanggo pasien kanthi penyakit ati kronis utawa aktif. (Deleng Hepatotoksisitas ing Ati-ati.)
Gagal GinjalReresik bisa suda banget (udakara 50%) ing wong diwasa kanthi gangguan ginjel (Clcr ≤50 mL/menit).
Ora ditliti kanthi cukup ing pasien kanthi Clcr ≤50 mL / menit; digunakake ing pasien kasebut ora dianjurake.
Efek Umum sing Sabar
Efek GI (diare, dyspepsia, mual, mutahke, nyeri weteng, gangguan rasa), sirah, mriyang, infèksi utawa gejala saluran napas ndhuwur (batuk, nasofaringitis, hidung tersumbat , nyeri pharyngolaryngeal, influenza), kelainan tes ati, efek dermatologis (ruam, urtikaria, pruritus).
Apa obatan liyane bakal mengaruhi Terbinafine (Systemic)
Nyandhet CYP2D6.
Obat sing dimetabolisme dening Enzim Mikrosomal Hepatik
Interaksi farmakokinetik bisa karo obat sing dadi substrat kanggo CYP2D6 (contone, antidepresan trisiklik, β-blocker, inhibitor reuptake serotonin selektif [SSRIs], monoamine oxidase inhibitor [MAO]); bisa uga penting sacara klinis yen obat kasebut nduweni jendela terapi sing sempit. Ngawasi kanthi teliti yen terbinafine digunakake bebarengan karo obat kasebut; dosis obat sing dimetabolisme dening CYP2D6 bisa uga kudu dikurangi.
Obat lan Panganan Spesifik
Obat utawa Pangan
Interaksi
Komentar
Agen antiaritmia (amiodarone, flecainide , propafenone)
Konsentrasi antiarrhythmic potensial tambah
Amiodarone: Kemungkinan konsentrasi terbinafine lan AUC tambah akeh
Monitor kanthi teliti; nyuda dosis antiarrhythmic bisa uga dibutuhake
Antidepresan
Penggunaan bebarengan terbinafine lan antidepresan sing dimetabolisme dening CYP2D6 (contone, trisiklik, SSRI, inhibitor MAO) bisa nyebabake konsentrasi antidepresan sing tambah
Desipramine: Tambah konsentrasi lan AUC saka desipramine; efek bisa tahan ≥4 minggu sawise mandheg saka terbinafine
Ngawasi kanthi teliti; nyuda dosis antidepresan trisiklik, SSRI, utawa MAO inhibitor bisa uga dibutuhake
Anti jamur, azoles
Fluconazole: Konsentrasi terbinafine lan AUC sing tambah akeh; efek ing farmakokinetik flukonazol ora dianggep penting sacara klinis
Ketoconazole: Kemungkinan konsentrasi terbinafine lan AUC tambah akeh
Benzodiazepine
Midazolam: Terbinafine ora mengaruhi farmakokinetik midazolam
p>
Triazolam: Terbinafine ora duwe efek klinis penting ing farmakokinetik triazolam
Kafein
Penurunan reresik kafein
Cimetidine
Penurunan reresik terbinafine
Cyclosporine
Peningkatan reresik saka cyclosporine; ora ana pengaruh ing reresik terbinafine
Peningkatan rasio dextromethorphan/dextromethorphan metabolit ing urine
Digoxin
Ora ana pengaruh ing reresik digoxin p>
Rifampisin
Reresik terbinafine meningkat sacara substansial
Sulfamethoxazole
Ora ana efek klinis penting ing farmakokinetik sulfametoksazol
Teofilin
Ora ana efek klinis penting ing teofilin farmakokinetik
Trimethoprim
Ora ana efek klinis sing penting ing farmakokinetik trimetoprim
Warfarin
Nambah utawa nyuda ing PT kacarita; hubungan sebab akibat ora ditetepake
Zidovudine
Ora ana efek klinis penting ing farmakokinetik zidovudine
Disclaimer
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