Sandimmun Neoral 100mg Novartis anti-transplantasi sawise transplantasi organ, transplantasi sel induk, sumsum tulang (5 blister x 10 tablet)

Bentuk sediaan Kothak 10 blister x 5 tablet
Spesifikasi Siklosporin

Komposisi

Informasi komposisi	Isi
Siklosporin	100 mg

Migunakake

indikasi

Obat neoral Sandimmun dituduhake ing kasus ing ngisor iki:

dituduhake ing transplantasi organ

Transplantasi organ khusus

Nyegah mbusak potongan sawise transplantasi padhet. Perawatan transplantasi sel ing pasien wis nggunakake obat imunosupresif liyane.

Transplantasi sumsum balung

Nyegah pembuangan teka-teki sawise transplantasi sumsum balung lan transplantasi sel induk. Nyegah utawa nambani potongan nglawan host (GVHD).

dituduhake ing penyakit non-transplantasi

inflamasi endogen

Perawatan ancaman uveitis intermediate utawa post-threatening kanggo sesanti lan asal ora infèksius ing pasien sing perawatan normal gagal utawa nyebabake efek samping sing ora bisa ditampa.

Perawatan Behcet sing digali kanthi inflamasi bola-bali mengaruhi pasien tanpa manifestasi neurologis. Sindrom nefrotik gumantung marang steroid lan resistensi steroid amarga penyakit glomerular kayata penyakit ginjel minimal, fibrosis glomerular lokal utawa glomerulonefritis. Sandimmun Neooral bisa digunakake kanggo nggawe efek relief lan njaga penyakit sing stabil. Uga bisa digunakake kanggo njaga remisi amarga perawatan steroid, ngidini steroid mandheg.

atritis reumatoid

Perawatan atritis reumatoid abot, aktif.

Psoriasis

Perawatan psoriasis abot ing pasien kanthi perawatan normal ora cocog utawa ora efektif.

Dermatitis atopik

Sandimmun Neooral dituduhake kanggo pasien sing nandhang dermatitis atopik abot nalika kudu ngobati sistemik.

Pharmacokic

cyclosporin (uga dikenal minangka Ciclosporin A) yaiku polipeptida cincin saka 11 asam amino. Inhibitor kekebalan sing sah ing kéwan sing ngluwihi wektu kaslametané potongan spesies sing padha ing kulit, jantung, ginjel, pankreas, sumsum balung, usus cilik lan paru-paru. Riset nuduhake yen ciclosporin nyandhet wutah saka intermediaries, kalebu kakebalan transplantasi karo spesies individu liyane, sensitivitas alon ing kulit, eksperimen encephalitis alergi, atritis disebabake ton freund, penyakit korupsi marang inang (GVHD) lan produksi antibodi gumantung ing sel. (TCGF). Ciclosporin katon ditutup dening limfosit sing digedhekake ing fase GO utawa G saka siklus sel lan nyandhet sekresi limfolin sing disebabake dening antigen.

Kabeh bukti sing ana nuduhake yen cyclosporin duweni efek spesifik lan pemulihan ing wektu sing padha karo jarum sel, cyclosporin ora nyandhet hematopoiasis lan ora mengaruhi fungsi sel fagositik. Pasien karo cyclosporin kurang arah bakteri tinimbang nalika njupuk jarum sel liyane ing terapi imunosupresif.

Transplantasi organ khusus lan sumsum balung wis kasil ditindakake kanggo pangguna cyclosporin kanggo nyegah lan nambani potongan lan potongan menyang host. Ciclosporin wis kasil digunakake ing pasien transplantasi ati sing positif utawa negatif karo virus hepatitis C (HCV). Sandimmun neoral uga migunani ing pirang-pirang kasus sing kita deleng utawa bisa dianggep amarga penyebab otoimun.

Farmakokinetik

penyerapan

Sawise nggunakake lisan, puncak getih Cyclosporin ing getih tekan sajrone 1-2 jam. Bioavailabilitas oral mutlak Ciclosporin sawise nggunakake Sandimmun Neooral yaiku 20 nganti 50%, AUC lan CMAX suda 13 lan 33% dicathet nalika nggunakake Sandimmun Neooral kanthi panganan lemak dhuwur. Hubungan antara dosis lan paparan (AUC) cyclosporin sacara linear ing kisaran dosis terapeutik.

Bedane ing AUC lan CMAX antarane individu lan ing individu sing padha kira-kira 10-20%. Solusi Sandimmun Neoral lan kapsul alus padha. Distribusi cyclosporin disebarake ing njaba volume getih sirkulasi, kanthi volume distribusi rata-rata 3,5 / kg. Ing getih, 33-47% ana ing plasma, 4-9% ing limfosit, 5-12% ing sel granular, 41-58% ing eritrosit. Ing plasma, kira-kira 90% cyclosporin gabung karo protein-saling, utamane karo lipoprotein.

Metabolisme

cyclosporin dimetabolisme kanthi kuat kanggo ngasilake udakara 15 metabolit. Metabolisme dumadi utamane ing ati liwat cytochrome P450 3A4 (CYP3A4), lan jalur metabolisme utama kalebu mono lan dihydroxylation lan N-Demethylation ing posisi sing beda ing molekul. Kabeh zat metabolik sing ditemtokake kalebu struktur peptida utuh saka senyawa induk; Sawetara duwe aktivitas imunosupresif sing lemah (nganti 1/10 obat ora diganti dening segara).

Eliminasi

Eliminasi utamane liwat empedu, mung 6% dosis oral sing dibuwang liwat urin, mung 0,1% diekskresikan liwat urin ing bentuk sing ora diproses.

Ana variabel gedhe ing data laporan babagan wektu sampah pungkasan cyclosporin gumantung saka teknologi tes lan populasi tes. Wektu adol pungkasan kira-kira 6,3 jam kanthi sukarelawan sehat lan nganti 20,4 jam kanggo pasien sing gagal ati sing abot. Wektu pembuangan ing pasien transplantasi ginjel kira-kira 11 jam, beda-beda gumantung saka 4 nganti 25 jam.

Subyek khusus

gagal ginjal

Ing panaliten sing ditindakake ing pasien kanthi gagal ginjal tahap pungkasan, sistem reresik awak iki kira-kira 2/3 saka reresik awak rata-rata (pasien kanthi fungsi ginjel normal. Ing ngisor 1% dosis dibuwang kanthi pamisahan.

Gagal hepatik

Konsentrasi cyclosporin mundhak kira-kira 2-3 kaping sing bisa diamati ing pasien gagal ati. Ing panaliten sing ditindakake ing pasien kanthi gagal ati sing abot, buktiake biopsi, wektu setengah umur pungkasan yaiku 20,4 jam (antarane 10,8 nganti 48,0 jam dibandhingake karo 7,4 nganti 11,0 jam ing wong sehat).

Bocah-bocah

Data dinamis saka pasien bocah sing nggunakake Sandimmun Neoral utawa Sandimmun winates banget. Saka 15 pasien transplantasi ginjal sing umure 3-16 taun, total reresik getih cyclosporin sawise nggunakake sandimmun intravena yaiku 10,643,7 ml / min / kg (kuantitatif: ria spesifik cyclo-trac). Ing panaliten saka 7 pasien karo transplantasi ginjel umur 2-16 taun, reresik cyclosporin beda-beda gumantung saka 9,8 nganti 15,5 ml / menit / kg. Luwih saka 9 pasien karo transplantasi ati umur 0.65-6, reresik yaiku 9.3T5.4 ml / min / KH (kuantitatif: HPLC). Yen dibandhingake karo pasien diwasa sing ditransplantasi, bedane bioavailabilitas antarane Sandimmun Neoral lan Sandimmun ing pasien bocah-bocah padha karo pengamatan sing dipikolehi ing pasien diwasa.

Sadurunge njupuk Sandimmun Neoral 100mg Novartis anti-transplantasi sawise transplantasi organ, transplantasi sel induk, sumsum tulang (5 blister x 10 tablet)

Cara nggunakake

obat oral.

Dosis

Dosis dosis saben dina neoral Sandimmun tansah dipérang dadi rong panggunaan. Amarga variasi sing signifikan ing antarane individu lan ing individu sing padha saka panyerepan lan eliminasi lan kemampuan interaksi farmakokinetik obat kasebut, dosis kudu dititrasi kanggo saben individu adhedhasar respon klinis lan toleransi. Ing pasien transplantasi organ, konsentrasi cyclosporin ing ngisor kudu dipantau kanthi rutin kanggo ngindhari efek samping amarga konsentrasi sing dhuwur lan kanggo nyegah pembuangan amarga konsentrasi sing sithik.

Ing pasien sing diobati dening organ sing ora diatur, pemantauan konsentrasi Ciclosporin ing getih diwatesi kanthi nilai winates kajaba ing kasus kegagalan perawatan sing ora bisa diprediksi utawa berulang, nalika ngawasi konsentrasi obat bisa uga cocog kanggo verifikasi kahanan kayata konsentrasi sing sithik banget amarga ora netepi, nyuda panyerepan saka saluran pencernaan utawa interaksi farmakokinetik umum.

transplantasi organ

Transplantasi organ khusus

Perawatan karo Sandimmun Neoral kudu diwiwiti sajrone 12 jam sadurunge operasi kanthi dosis 10 mg / kg bobot awak, dibagi dadi 2 kali. Dosis iki kudu dijaga kaya saben dina, digunakake kanggo 1 2 minggu sawise operasi, sadurunge ngurangi dosis kanthi bertahap gumantung saka konsentrasi obat ing getih nganti dosis pangopènan tekan udakara 2 - 6 mg / kg, dibagi dadi 2 kaping dina.

Yen digunakake karo imunosupresan liyane (umpamane, kortikosteroid utawa bagean saka 3-4 obat), dosis Sandimmun Neooral bisa uga luwih murah (umpamane 3 - 6 mg/kg, dibagi dadi 2 kaping ing terapi wiwitan).

Transplantasi sumsum balung

Dosis wiwitan kanggo digunakake ing dina sadurunge grafting. Ing mayoritas kasus kasebut, Sandimmun nyuntikake infus intravena (I.V.) dipilih kanggo tujuan kasebut. Dosis intravena sing disaranake yaiku 3-5 mg / kg saben dina. Terusake ngirimake dosis iki ing wektu sawise transplantasi nganti 2 minggu, sadurunge ngganti menyang bentuk lisan kanggo njaga karo Sandimmun Neooral kanthi dosis saben dina kira-kira 12,5 mg / kg, dibagi dadi 2 panggunaan. Perawatan pangopènan kudu diterusake paling sethithik 3 sasi (lan bakal luwih apik yen dijaga 6 sasi) sadurunge ngurangi dosis kanthi bertahap nganti pungkasan 1 taun sawise grafting.

Yen nggunakake Sandimmun Neoral kanggo perawatan awal, dosis saben dina sing disaranake yaiku 12,5 - 15 mg / kg, dibagi dadi 2 panggunaan, diwiwiti dina sadurunge transplantasi organ. Dosis Sandimmun Neoral bisa uga dibutuhake utawa nggunakake saluran intravena, yen ana gangguan gastrointestinal sing bisa nyuda panyerepan obat.

Ing sawetara pasien, penyakit korupsi marang host (GVHD) kedadeyan sawise mandheg nggunakake cyclosporin, nanging biasane pasien nanggapi kanthi lancar nalika diobati maneh. Ing kasus kasebut, dosis wiwitan 10 nganti 12,5 mg / kg kudu digunakake, disusul dosis oral sadurunge sing sadurunge nanggapi saben dina. Dosis sing sithik dibutuhake kanggo ngobati cyclosporin kanggo nambani grafting marang host sing entheng lan kronis.

Kasus ora transplantasi

Nalika nggunakake Sandimmun Neooral ing salah sawijining indikator sing ora disetujoni, sampeyan kudu netepi aturan umum ing ngisor iki:

Sadurunge wiwitan perawatan, konsentrasi kreatinin sing dipercaya kudu disetel ing serum paling ora kaping pindho, lan perlu kanggo ngevaluasi fungsi ginjel kanthi rutin sajrone proses perawatan kanggo nyetel dosis.

Siji-sijine baris sing ditampa yaiku garis lisan (kapadhetan fase intravena ora diidini), lan dosis saben dina kudu dipérang dadi rong kaping. Kajaba kanggo pasien kanthi uveitis endogen sing ngancam sesanti lan bocah sing nandhang sindrom nefrotik, dosis saben dina ora ngluwihi 5 mg/kg.

Kanggo njaga perawatan, dosis paling murah efektif lan diserap kanthi apik, sing kudu ditemtokake kanggo saben pasien.

Sampeyan kudu mandheg ngobati Sandimmun Neooral yen pasien ora nemoni respon sing marem ing wektu tartamtu (informasi spesifik sing dideleng ing ngisor iki) utawa efek kasebut ora cocog karo pandhuan safety sing kasedhiya.

Perlu ngawasi tekanan getih kanthi rutin. Bilirubin lan paramèter kudu diidentifikasi sadurunge proses fungsi ati sadurunge miwiti kursus lan kudu dipantau kanthi rapet sajrone proses perawatan. Jumlah lipid, kalium, magnesi lan asam urat kudu ditemtokake ing ngarep lan serum periodik.

inflamasi dug endogen

Kanggo mbantu nyuda penyakit kasebut, dosis wiwitan kudu diwiwiti kanthi 5 mg / kg saben dina, dibagi dadi 2 kaping, digunakake nganti perbaikan digali lan perbaikan penglihatan. Yen ora ana perbaikan, dosis bisa ditambah dadi 7 mg / kg dina kanggo wektu sing winates.

Kanggo entuk remisi awal, utawa kanggo nglawan inflamasi mata, sampeyan bisa nggunakake kortikosteroid sistemik kanthi dosis saben dina 0,2 - 0,6 mg/kg prednison utawa sing padha, yen mung sandimmun neoral ora diobati. Kanggo perawatan pangopènan, perlu nyuda dosis kanthi bertahap nganti dosis efektif paling murah lan ora ngluwihi 5 mg / kg / dina sajrone mundur.

Sindrom nefrotik

Kanggo nambah penyakit kasebut, dosis sing disaranake dibagi dadi 2 ombenan saben dina. Yen fungsi ginjel normal (kajaba ing kasus proteinuria), dosis saben dina kaya ing ngisor iki:

5 mg/kg kanggo wong diwasa, lan

6 mg/kg kanggo bocah-bocah. Sandimmun Neoral kudu digabungake karo kortikosteroid dosis rendah kanggo lisan yen neoral solemmun ora jelas, utamane kanggo pasien resistensi steroid.

Yen sawise 3 wulan perawatan tanpa perbaikan, sampeyan kudu mandheg nggunakake Sandimmun Neooral. Nyetel dosis kanggo saben pasien, gumantung saka efektifitas (protein-nhieu) lan safety (utamane creatinin-huyet bar), nanging ora ngluwihi 5 mg / kg / dina (ing wong diwasa) lan 6 mg / kg / dina (ing bocah-bocah). Kanggo perawatan pangopènan, dosis kudu dikurangi kanthi bertahap nganti tingkat sing paling murah nanging isih valid.

atritis reumatoid

Ing 6 minggu pisanan perawatan, dosis saben dina sing disaranake yaiku 3 mg / kg, dibagi dadi 2 minuman. Yen ora cukup efektif, dosis saben dina bisa nambah kanthi bertahap gumantung saka toleransi, nanging ora ngluwihi 5 mg / kg saben dina. Kanggo entuk efek sing lengkap, perawatan Sandimmun Neooral mbutuhake 12 ketaatan.

Kanggo perawatan pangopènan, dosis kudu dititrasi miturut pasien individu nganti dosis paling murah kanthi efektif, adhedhasar toleransi.

Bisa nggabungake Sandimmun Neooral karo dosis rendah lan/utawa obat anti-inflamasi nonsteroid. Sampeyan uga bisa nggabungake sandimmun Neooral kanthi dosis methotrexat sing sithik saben minggu yen pasien ora duwe respon lengkap nalika nggunakake methotrexate siji, elang yaiku dosis wiwitan 2,5 mg / kg sandimmun neoral, dibagi dadi 2 minuman saben dina, kanthi pilihan nambah dosis nalika toleransi diidini.

Psoriasis

Amarga owah-owahan penyakit iki, perawatan kudu individual kanggo saben pasien. Kanggo mbantu nyuda penyakit kasebut, dosis wiwitan sing disaranake yaiku 2,5 mg / kg saben dina, dibagi dadi 2 kali. Yen sawise 1 sasi tanpa nambah penyakit, bisa nambah dosis saben dina, nanging ora kudu ngluwihi 5 mg / kg. Pasien kudu mandheg kanthi lesi psoriasis sing ora nanggapi kanthi puas sajrone 6 minggu panggunaan kanthi dosis 5 mg / kg / dina utawa karo pasien nanging dosis efektif ora cocog karo instruksi safety sing wis ditetepake.

Dosis wiwitan 5 mg/kg saben dina wis dituduhake menyang pasien ing kondisi sing kudu didandani kanthi cepet. Sandimmun neoral bisa mandheg nalika wis ketemu karo kepinginan, lan kambuh banjur dites kanthi miwiti nggunakake maneh Sandimmun Neooral karo dosis efektif sadurunge. Kanggo sawetara pasien, perawatan tetep bisa terus. Kanggo perawatan pangopènan, dosis kudu dititrasi miturut individu kanthi dosis paling murah kanthi efektif lan ora ngluwihi 5 mg / kg saben dina.

Dermatitis atopik

Amarga sifat utawa owah-owahan saka penyakit iki, perawatan kudu individu saben pasien. Dosis saben dina sing disaranake yaiku 2,5 - 5 mg / kg, dibagi dadi 2 minuman. Yen dosis wiwitan 2,5 mg / kg / dina ora cocog karo kepinginan ing 2 minggu perawatan, dosis saben dina kudu nambah kanthi cepet nganti maksimal 5 mg / kg. Ing kasus serius, kontrol cepet lan lengkap saka penyakit iki bakal luwih gampang kanggo entuk yen dosis wiwitan 5 mg / kg. Sampeyan bisa nyuda dosis kanthi bertahap sawise respon sing dikarepake, lan yen bisa, kudu mandheg nggunakake Sandimmun Neooral. Bisa ngatur kambuh mengko kanthi terus-terusan Sandimmun Neoral.

Senadyan proses 8 minggu sing bisa uga cukup kanggo nggawe efek mundur, nanging suwene 1 taun uga nuduhake efektif lan bisa ditoleransi, anggere perlu ngetutake instruksi pemantauan.

Subyek khusus

gagal ginjal

Kabeh indikasi:

cyclosporin ekskresi minimal liwat ginjel lan farmakokinetik ora kena pengaruh gagal ginjel. Nanging, amarga kemampuan kanggo racun ginjel, rekomendasi kudu ngawasi fungsi kasebut kanthi teliti.

Indikasi non-transplantasi:

Pasien gagal ginjal, kajaba pasien sindrom nefrotik, ora kudu nggunakake cyclosporin. Kanggo pasien sindrom gagal ginjel, dosis wiwitan ora kudu ngluwihi 2,5 mg / kg / dina.

Gagal ati

cyclosporin dimetabolisme kanthi kuat liwat ati. Ing setengah umur pungkasan owah-owahan antarane 6,3 jam ing sukarelawan sehat nganti 20,4 jam ing pasien kanthi gagal ati sing abot. Dosis kudu dikurangi ing pasien kanthi gagal ati sing abot kanggo njaga tingkat getih ing kisaran dosis sing disaranake.

Bocah-bocah

Pengalaman nggunakake cyclosporin ing bocah-bocah isih winates. Pasinaon klinis kalebu bocah saka umur 1 taun nggunakake dosis cyclosporin standar tanpa masalah khusus. Ing pirang-pirang panaliten, pasien pediatrik mbutuhake lan ngidinke dosis cyclosporin sing diwilang kanthi bobote luwih kg ing wong diwasa.

Ora dianjurake kanggo nggunakake Sandimmun Neooral kanggo bocah-bocah sing nandhang penyakit transplantasi non-organ, kajaba kanggo sindrom nefrotik.

Lansia (≥ 65 taun)

Pengalaman ing ciclosporin ing wong tuwa diwatesi, nanging ora ana laporan babagan masalah khusus nalika njupuk obat kasebut ing dosis sing disaranake.

Ing uji klinis rheumatoid arthritis sing diobati nganggo ciclosporin oral, 17,5% pasien padha karo utawa luwih saka 65 taun. Pasien kasebut luwih cenderung ngasilake hipertensi sistolik sajrone perawatan lan luwih cenderung nambah creatininin -menyang bar nganti> 50% luwih dhuwur tinimbang tingkat asli sawise njupuk obat 3-4 sasi.

Riset klinis karo cyclosporin ing pasien transplantasi organ lan pasien psoriasis ora kalebu cukup wong> 65 taun kanggo nemtokake manawa dheweke nanggapi wong enom. Pengalaman klinis liyane sing dilaporake ora ngerteni bedane nanggepi obat kasebut nalika mbandhingake pasien tuwa karo wong enom. Umumé, pilihan dosis kanggo pasien tuwa kudu ati-ati, asring diwiwiti kanthi dosis sing sithik ing kisaran dosis sing diidini, sing nuduhake tingkat gangguan ati, ginjel utawa jantung sing luwih dhuwur ing wong tuwa lan sing ngiringi utawa njupuk obat liyane.

Transfer saka sandimmun oral (solusi oral) menyang Sandimmun Neoral (kapsul alus)

Data sing kasedhiya nuduhake yen sawise ngalih saka Sandimmun menyang Sandimmun Neooral kanthi rasio dosis 1: 1, konsentrasi ngisor cyclosporin ing getih padha karo. Nanging, ing akeh pasien, konsentrasi puncak ing plasma (CMAX) luwih dhuwur lan area ing sangisore kurva (AUC) mundhak. Ing sawetara pasien, owah-owahan kasebut luwih penting lan bisa uga duwe makna klinis. Tingkat owah-owahan iki gumantung banget marang owah-owahan penyerapan cyclosporin ing saben wong amarga nggunakake sandimmun sadurunge, dikenal minangka panggunaan biologis sing gampang diganti. Pasien kanthi konsentrasi obat sing minimal utawa ganti utawa dosis sandimmun bisa uga kurang diserep utawa panyerepan ciclosporin sing ora stabil (kayata pasien kandung empedu, pasien transplantasi ati kanthi stasis empedu utawa sekresi empedu sing kurang, bocah utawa sawetara pasien transplantasi ginjel) bisa nyerep kanthi apik nalika ngalih menyang Sandimmun Neoral. Mulane, kanggo subyek ing ndhuwur, bioavailabilitas cyclosporin sawise nransfer 1: 1 saka Sandimmun menyang Sandimmun Neoor bisa uga luwih gedhe tinimbang biasanipun, saengga perlu nyetel dosis mudhun supaya cocog karo tingkat obat minimal sing bakal digayuh.

Perlu ditekanake manawa panyerepan cyclosporin saka Sandimmun Neoor kurang owah lan korélasi antara konsentrasi cyclosporin minimal lan jumlah obat sing diserap (AUC) luwih kuwat lan sandimun. Iki ndadekake konsentrasi ciclosporin minimal luwih stabil lan dadi parameter sing bisa dipercaya sajrone ngawasi perawatan.

Amarga konversi saka Sandimmun dadi Sandimmun Neoor bisa nambah jumlah obat sing diserap, mula aturan ing ngisor iki kudu dipatuhi:

Ing pasien transplantasi organ, Sandimmun Neooral kudu miwiti perawatan kanthi dosis sandimmun sing padha. Konsentrasi ngisor cyclosporin ing kabeh getih kudu dipantau ing shift menyang sandimmun neoral. Kajaba iku, paramèter safety klinis kayata Creatinin-Tuyet lan tekanan getih kudu dipantau ing 2 wulan pisanan sawise transfer obat kasebut. Yen konsentrasi ngisor cyclosporin ing getih ngliwati wates perawatan lan/utawa nalika paramèter safety klinis saya tambah parah, dosis kasebut kudu diatur.

Kanggo pasien kanthi indikasi kanggo ora transplantasi organ, mula sandimmun Neooral kanthi dosis saben dina sing padha karo sandimmun sadurunge. Sawise konversi 2-4-8 minggu, tingkat bun kudu dipantau ing serum lan tekanan getih. Yen tingkat bun serum utawa tekanan getih ngluwihi sadurunge konversi tamba banget pinunjul utawa yen tingkat bun serum mundhak luwih saka 30% dibandhingake konsentrasi sadurunge nggunakake sandimmun liwat 1 test, tamba wis suda. Sampeyan uga perlu kanggo ngawasi konsentrasi ngisor obat ing getih yen ana keracunan utawa ora efektif kaya sing diramalake karo cyclosporin.

ngalih ing antarane sel ciclosporin oral

Transisi saka cyclosporin oral iki menyang wangun lisan liyane kudu ditindakake kanthi ati-ati lan pengawasan saka dokter. Inisiasi bentuk persiapan anyar kudu ditindakake bebarengan karo ngawasi konsentrasi cyclosporin ing getih kanggo mesthekake yen tingkat cyclosporin isih tetep kaya nalika nggunakake formulir sing wis disiapake sadurunge.

Cathetan: Dosis ing ndhuwur mung kanggo referensi. Dosis spesifik gumantung saka kahanan lan tingkat kemajuan penyakit kasebut. Kanggo dosis sing cocog, sampeyan kudu takon dhokter utawa spesialis medis.Apa sing kudu ditindakake nalika overdosis? LD50 (vena) ciclosporin yaiku 148 mg/kg (tikus), 104mg/kg (tikus) lan 46 mg/kg (kelinci).

Gejala

Pengalaman keracunan akut nganggo cyclosporin diwatesi. Dosis oral cyclosporin nganti 10 g (udakara 150 mg / kg) wis ditolerir kanthi akibat klinis sing relatif entheng kayata muntah, turu, sirah, tachycardia lan ing sawetara pasien, fungsi ginjel cacat rata-rata, pulih dhewe. Nanging, gejala beracun sing mbebayani wis dilaporake kanthi ora sengaja nggunakake overdosis cyclosporin kanthi infus ing bayi durung wayahe.

Pangobatan

Ing kabeh kasus overdosis, langkah-langkah dhukungan umum kudu dipatuhi lan diobati kanthi gejala. Nimbulake muntah lan lavage lambung bisa ditindakake sajrone sawetara jam pisanan sawise njupuk obat kasebut. Siklosporin ora ngapresiasi banget, uga ora diilangi liwat dialisis dening karbon aktif.

Ing kahanan darurat, langsung nelpon puskesmas 115 utawa menyang puskesmas sing paling cedhak.

Apa sing kudu ditindakake yen sampeyan lali 1 dosis? Nanging, yen wektu kanggo ngendhokke karo dosis sabanjuré cendhak banget, skip dosis lan terus tanggalan tamba. Aja nggunakake dosis kaping pindho kanggo ngimbangi dosis sing ora kejawab.

Efek sisih

Efek samping utama diamati ing studi klinis lan ana hubungane karo panggunaan cyclosporin kalebu disfungsi ginjel, tremor, rambut, hipertensi, diare, anorexia, mual lan muntah.

Akeh efek samping sing kedadeyan karo terapi ciclosporin gumantung saka dosis lan nyuda dosis. Ing macem-macem indikasi, spektrum umum saka efek sisih biasane padha; Nanging, ana bedane frekuensi lan keruwetan. Minangka asil saka dosis wiwitan sing luwih dhuwur lan wektu pangopènan sing tahan suwe amarga dikarepake sawise transplantasi organ, efek samping luwih umum, luwih serius kanggo pasien transplantasi organ tinimbang pasien sing diobati kanthi indikasi liyane.

Reaksi anafilaksis wis diamati nalika nggunakake jalur intravena.

Pasien sing njupuk obat imunosupresif, kalebu cyclosporin lan regime perawatan cyclosporin, nambah risiko infeksi (virus, bakteri, jamur, parasit). Infeksi awak lan lokal bisa kedadeyan. Infeksi sing ana uga bisa dadi luwih elek lan aktivasi maneh infeksi polyomavirus bisa nyebabake penyakit ginjel sing disebabake dening polyomavirus (PVan) utawa multi-drive white substance (PML). Kasus abot lan/utawa pati wis dilaporake.

Pasien sing nggunakake obat imunosupresif, kalebu cyclosporin lan regime perawatan cyclosporin, nambah risiko tumor limfatik utawa kelainan hiperaktivitas limfatik lan tumor ganas liyane, utamane ing kulit. Frekuensi tumor ganas mundhak kanthi intensitas lan wektu perawatan. Sawetara tumor ganas bisa nyebabake fatal.

Reaksi obat sing ora becik saka obat kasebut saka uji klinis (Tabel 1) kadhaptar dening Sistem Klasifikasi Organisasi Meddra. Ing saben klasifikasi sistem organisasi, reaksi salabetipun obat kasebut diklasifikasikake miturut frekuensi, pisanan sing paling umum. Ing saben klompok frekuensi, reaksi salabetipun obat kasebut ditampilake kanthi urutan keruwetan bertahap. Kajaba iku, frekuensi sing cocog kanggo saben reaksi obat sing saleh adhedhasar konvensi ing ngisor iki: Umum banget (> 1/10), umum (> 1/100, 1/1,000, 1/10,000, Reaksi obat saka uji klinis

Gangguan getih lan limfatik

Umum: leukopenia.

Umum banget: hiperlipidemia

Umum banget: Run, sirah Kampanye

arang banget: Edema cakram visual kalebu duri, kanthi kemampuan nyuda penglihatan sekunder amarga hipertensi intrakranial jinak.

Umum banget: Hipertensi

umum: Mual, muntah, rasa ora nyaman ing weteng, diare, hipertrofi, ulkus weteng.

Langka: Pankreatitis.

umum: Fungsi ati sing ora biasa.

Umum banget: Rambut wanita.

umum: nyeri otot, kram.

Langka: kekirangan otot, penyakit otot.

Umum banget: Disfungsi ginjel.

Langka: Gangguan haid, payudara gedhe ing wong lanang.

umum: mriyang, lemes.

Kurang: busung, tambah bobot.

Reaksi salabetipun obat saka pengalaman sawise sirkulasi (frekuensi ora dingerteni).

Reaksi salabetipun ing ngisor iki asale saka pengalaman sawise sirkulasi Neoral utawa Sandimmun Sandimmun liwat laporan spontan lan kasus medis. Amarga reaksi kasebut dilapurake kanthi sukarela saka klompok populasi skala sing ora dingerteni, ora bisa ngetung keandalan frekuensi kasebut, mula ora jelas. Reaksi salabetipun obat kasebut kadhaptar adhedhasar sistem rating organisasi Meddra.

Gangguan getih lan limfatik:

Trombosis getih mikro, sindrom larut urea getih; komite hemorrhage trombosit; Anemia, trombositopenia.

Gangguan metabolisme lan nutrisi:

Hiperkemop hipergarik, hiperurisemia, hiperkalemia, penurunan magnesium darah.

Gangguan sistem saraf

Sindrom penyakit otak kalebu pemulihan (preses), pratandha lan gejala kayata konvulsi, kebingungan, ilang orientasi, nyuda respon, agitasi, insomnia, gangguan penglihatan, wuta serebral, koma, kelemahane, ilang serebellum, lan gangguan penglihatan, gangguan visual amarga hiperglikemia; migren.

Gangguan pencernaan

Pankreatitis akut

Kelainan ati hepatik

keracunan ati lan karusakan ati kalebu stasis bilier, jaundice, hepatitis, lan gagal ati kanthi sawetara tiwas.

Tambah rambut lan rambut.

penyakit otot; kejang otot, nyeri otot, kelemahan otot, nyeri ekstremitas ngisor

Gangguan sistem reproduksi lan payudara

Payudara gedhe ing wong lanang.

Kesel, tambah bobot.

keracunan ing ati lan karusakan ati. Umume laporan kalebu pasien sing nandhang penyakit liyane kanthi bebarengan lan abot, penyakit sadurunge, lan faktor jamming kalebu komplikasi infeksi lan panggunaan obat liyane sing beracun kanggo ati liyane. Ing sawetara kasus, utamane ing pasien karo transplantasi organ, pati wis dilaporake.

Nyeri ing perangan ngisor

Ana sawetara laporan individu babagan kasus nyeri ekstrem ngisor sing ana hubungane karo cyclosporin. Nyeri ekstrem ngisor uga kacathet minangka bagéan saka sindrom nyeri sing disebabake dening inhibitor Calcineurin (CIPS) kaya sing diterangake ing literatur.

Toksisitas ginjel akut lan kronis

Pasien sing diobati karo inhibitor calcineurin (CNIS), kalebu cyclosporin lan regimen, kalebu cyclosporin, nambah risiko keracunan ginjel akut lan kronis. Ana laporan saka uji klinis lan saka pengalaman sawise sirkulasi obat-obatan sing ana gandhengane karo panggunaan cyclosporin: kasus keracunan ginjal akut dilaporake babagan kelainan elektrolit elektrolit, kayata hiperkalemia, nyuda magnesium getih, pertumbuhan hiper urea ing pirang-pirang kasus ing sasi pisanan perawatan. Kasus laporan babagan owah-owahan morfologis kronis kalebu hidrosip arteri, atrofi tubulus ginjal lan fibrosis interstitial.

Kabar dhokter babagan efek sing ora dikarepake nalika nggunakake obat kasebut.

Pènget

Before using the drug you need to read the instructions carefully and refer to the information below. contraindicated Sandimmun neoral drugs in the following cases: Hypersensitivity to ciclosporin or any excipients of Sandimmun Neoral. serious and/or life -threatening events. For example, Bosentan, Dabigatran Edexilate and Aliskiren. Caution when using Medical monitoring Sandimmun Neooral is only prescribed by physicians with experience in immunotherapy and fully monitoring, including regular entity examination, blood pressure measurement and testing test parameters for safety. Organ transplant patients use this drug should be managed in facilities with adequate laboratories and medical support. The physician is responsible for maintenance treatment that needs all information to monitor patients. cells and other malignant diseases Like other immunosuppressive drugs, ciclosporin increases the risk of lymphoma and other malignant diseases, especially skin diseases. The increased risk seems to be more related to the level and time limit for immunosuppressive rather than the use of specific drugs. Therefore, a treatment that contains many immunosuppressive drugs (including ciclosporin) needs to be used carefully, because it can lead to lymphocytic proliferation disorders and tumors of concentrated organs, some tumors can be fatal. Due to the risk of malignant skin disease, the patient should be warned that the patient uses Sandimmun Neoral to avoid excessive contact with ultraviolet light. Infections Like other immunosuppressive drugs, Ciclosporin leads patients to develop many types of bacteria, fungi, parasites and viruses, often opportunistic pathogens. Activation of hidden polyomavirus infection can cause kidney disease caused by polyomavirus (PVan), especially kidney disease caused by BK virus (BKVN), or a multi -throne white substance due to JC Virus that has been observed in patients with Ciclosporin. These conditions are often related to the use of too many immunosuppressive drugs and must be considered in distinguished diagnosis in patients using immunosuppressive drugs that have impaired renal function or have neurological symptoms. Severe cases and/or death have been reported. It is necessary to apply previous and effective prevention strategies, especially for long -term patients with immunosuppressive drugs. Acute and chronic kidney toxicity A common and serious complication is increased creatinine and urea in serum, which can be seen in the first few weeks using ciclosporin. These functional changes depend on dosage and recover, often responding when reducing the dose. When long -term treatment, some patients may develop changes in the structure of the kidneys (such as degeneration of urinary artery, renal tubular atrophy, interstitial renal fiber) which needs to be distinguished from changes due to chronic graft waste in kidney transplant patients. Need to closely monitor kidney function assessment parameters. May need to reduce the dose when there are abnormal values. toxicity on the liver and liver damage ciclosporin can also cause serum bilirubin depend on dosage and have restoration and liver enzyme. There have been required reports and spontaneous reports after the drug circulates cases of liver toxicity and liver damage including jaundice, hepatitis and liver failure in patients treated with ciclosporin. Most reports include patients with other significant diseases, hidden diseases, and other factors including complications of infection and simultaneous use of other drugs that are toxic to other liver. In some cases, mainly in patients with organ transplantation, death has been reported. Need to closely monitor the parameters of liver function assessment. When encountering abnormal values, the drug is needed. Elderly In elderly patients, kidney function should be monitored with special caution. Monitor ciclosporin concentration in organ transplant patients When using ciclosporin for organ transplant patients, regular monitoring of Ciclosporin levels is an important safety measure. To monitor the whole blood ciclosporin level, the specific single -line antibody method to measure the main drug is often selected; High -performance liquid chromatography (HPLC) is also used to measure the main drug and also be used well. When using plasma or serum, it is necessary to follow the process of standard extraction (time and temperature). To monitor the beginning of liver transplant patients, or can use specific single -line antibodies, or measure in parallel with both specific single -line antibodies and non -specific single -line antibodies to ensure the dosage creates adequate immunosuppressive inhibition. It should be remembered that the concentration of ciclosporin in the blood, plasma or serum is only one of many factors involved in the patient's clinical condition. Therefore, the results are only helping to guide the dosage related to clinical and other tests. Hypertension Need to monitor blood pressure regularly when using ciclosporin, when having hypertension, an appropriate anti -hypertension drug must be used. Priority is given to the use of anti -blood pressure drugs that do not affect the pharmacokinetics of ciclosporin, like isradipine. hyperlipidemia Because ciclosporin has slightly increased and has blood lipid recovery, the patient's lipid indicators should be determined before treatment and after the first month of treatment. When increased lipid-lipid, weight limit fat and, and consider reducing the dose if appropriate. Hemorrhage ciclosporin increases the risk of increased potassium, especially in patients with renal dysfunction. It is necessary to be cautious when coordinating ciclosporin with potassium drugs (for example: potassium -keeping pills, angiotensin transferring enzyme inhibitors, angiotensin II receptor resistant drugs) and potassium -containing drugs, as well as patients according to potassium -rich diets, need to check the concentration of potassium blood in the above cases. Magnesi blood reduction ciclosporin increases the purification of magnesium, which can lead to reduced blood magnesium concentration of symptoms, especially during the period of organ transplantation. Therefore, it is necessary to check the level of magnesium in the blood in the period of organ transplantation, especially when there are symptoms/nerve signs. If considered necessary, can add Magnesi. Hyperglycemia Be cautious with patients with hyper uric acid (see the side effect of the drug). Vacuum Vaccination Reducing Power While using ciclosporin, vaccinations may be reduced; Need to avoid using poison-reduced live vaccines. Drug interaction Be careful when using ciclosporin combination with drugs that increase or reduce ciclosporin concentration in plasma through inhibition or induction CYP3A4 and/or P Glycoprotein. Need to monitor the toxicity on the kidneys when starting to use ciclosporin along with active ingredients that increase ciclosporin concentration or with kidney toxic drugs. Should avoid simultaneous use of ciclosporin and tacrolimus. Ciclosporin is a CYP3A4, P-Glycoprotein touch-pumping pump and organic anions (OATP) and can increase the blood concentration of the substances that are the substrates of these enymnins and shipping substances when used simultaneously. Be careful when using Ciclosporin simultaneously with these drugs or avoid using simultaneously (see the drug interaction). Ciclosporin increases the concentration of HMG-CoA-Reductase inhibitors. When used simultaneously with ciclosporin, the statin's dose should be reduced and should be avoided simultaneously with certain statins based on the recommendations on the prescription of these statins. Using statins should temporarily postpone or stop in patients with signs and symptoms of muscle disease or in people with risk factors that lead to serious kidney damage, including renal failure, secondary kidney disease after a chess award. After simultaneous use of ciclosporin and lercanidipin, the area below the concentration curve (AUC) of lercanidipin tripled and the area under the concentration curve of Ciclosporin increased by 21%. Therefore, avoid combining ciclosporin with lercanidipine. The use of ciclosporin after 3 hours after using lercanidipine does not change the scad of lercanidipine but the AUC of ciclosporin increases to 27%. Therefore, this combination needs to be used carefully with the distance of using 2 drugs for at least 3 hours. Special excipients: ethanol pay attention to the content of ethanol (see the description and ingredients) when used for pregnant and nursing women, in patients with liver or epilepsy, alcoholic patients, or if using Neoral sandimmun for children. Additional caution in oral transplantation indications Patients with renal failure (except for patients with renal damage syndrome with permission level), uncontrolled hypertension, uncontrolled infection, or any form of cancer should not use ciclosporin. Additional caution in endogenous dug inflammation Because Sandimmun Neoral can impair kidney function, it is necessary to regularly assess the kidneys, and when creatininin-bars increase by more than 30% compared to the original level in more than one quantitative, it is necessary to reduce the dose of Sandimmun Neooral to 25-50%. If an increase of more than 50% compared to the original level, it is advisable to consider reducing the dose further. These recommendations also apply even if the patient's testing values are in normal testing range. Should use cautious sandimmun Neoral in patients with neuron syndrome Behcet. The nervous condition of the patient with Behcet neuron syndrome should be carefully monitored. Not much experience in using Sandimmun Neoral for children with endogenous. Additional caution in kidney syndrome Sandimmun Neooral can impair kidney function, need to evaluate the kidney function regularly and when creatininin-bars increase by more than 30% compared to the original level in more than 1 test, weighing 25-30% of the Sandimmun Neooral material. If an increase of more than 50% compared to 1 should consider reducing the additional dose, the patient has an abnormal renal function at first abnormalities that should start at a daily dose of 2.5 mg/kg and must be monitored very carefully. In some patients, it may be difficult to detect kidney dysfunction caused by Sandimmun Neooral, because there are changes in renal function related to kidney syndrome itself. This explains why in rare cases, the kidney structure changes due to the use of Sandimmun Neooral without increasing serum creatinine. Therefore, it is necessary to consider making kidney biopsy for patients with a minimum of kidney disease dependent on steroids that treatment for sandimmun neoral has lasted for more than 1 year. Sometimes reports on malignant diseases (including Hodgkin lymphoma) in patients with nephrotic syndrome using immunosuppressive drugs (including ciclosporin). Additional caution in rheumatoid arthritis Because Sandimmun Neooral can impair kidney function, it is necessary to authenticate creatinin-chest at the beginning at least 2 tests before treatment and serum creatinine should be monitored every 2 weeks in the first 3 months of treatment and then once a month. After the month of treatment, serum creatinine should be measured every 4-8 weeks depending on the stability of the disease, in the medications simultaneously with ciclosporin and at the same time, it is necessary to check more often if there is an increase in the dose of Sandimmun Neooral or when used simultaneously with non-steroid anti-inflammatory drugs (NSAID) or increase the dose of NSAID (see drug interactions). If the serum creatinine still increases more than 30% compared to the original level in more than one test, the sandimmun neoral dose is required. If Creatinin-bars increased more than 50%, it is required to reduce the dose by 50%. These recommendations apply even when the patient's testing values are in normal range. If within 1 month and the reduction of the dose has not yet been reduced to the amount of creatinine, it is necessary to stop using Sandimmun Neoral. It is also necessary to stop the drug if there is hypertension while using Sandimmun Neoral without controlled by appropriate antihypertensive drugs. As with other long -term immunological inhibitors (including ciclosporin), attention must be paid to increasing the risk of lymphocytic hyperactivity disorders. Especially cautious when combining Sandimmun Neooral with Methotrexate. Additional caution in psoriasis Because Sandimmun Neoral can cause impaired renal function, the serum creatinine concentration should be determined at least twice the test before treatment, and the creatinin-huyet needs to be monitored every 2 weeks in the first 3 months of treatment. After that, if creatinine was stable, it was necessary to test the monthly distance. If the serum creatinine increases and keeps an increase of> 30% compared to the original in more than 1 test, the sandimmun neoral dose must be reduced by 25-50%. If increasing by 50% compared to the original level, it is advisable to consider reducing additional dose. These recommendations apply even if the patient's creatinine values are within normal testing range. If the dose reduction has not been reduced to reduce creatinine within 1 month, the Sandimmun Neoral should be stopped. also recommends stopping the use of Sandimmun Neooral when during treatment, there is hypertension without controlled by appropriate therapy. Only for the elderly when psoriasis is difficult to treat and need to monitor the kidney function especially. Not much experience in using Sandimmun Neoral for children with psoriasis. For patients with psoriasis using ciclosporin, as well as for users of classical immunosuppressant drugs, there is a report on malignant diseases (especially in the skin). Non-specific skin lesions for psoriasis, but suspected malignant or money-properties should be biopsy before starting the use of Sandimmun Neooral. Patients with malignant skin changes or cashics can only use Sandimmun Neooral after appropriate treatment of those lesions and when there is no other choice for effective treatment. In a few patients with psoriasis use ciclosporin, there is a lymphocytic hypertension disorder and will respond when stopping immediately. Patients with Sandimmun Neooral are not used at the same time, U UV radiation B or optical optical therapy PUVA. Additional caution in atopic dermatitis Because Sandimmun Neoral can impair the kidney function, the serum creatinine level is required at least twice before the test and serum creatinine needs 5i every 2 weeks in the first 3 months of treatment. After that, if creatinine is stable, it is necessary to test the monthly distance. If serum creatinine increases> 30% compared to the original in more than 1 test, it must be reduced by 25-50% of the dose of Sandimmun Neooral. If increasing by 50% compared to the original level, it is advisable to consider reducing additional dose. These recommendations apply even if the patient's creatinine values are within normal testing. If the dose is reduced but still has not given the results reducing creatinine within 1 month, the sandimmun neoral should be stopped. also need to stop using Sandimmun Neooral while taking this drug that has hypertension that cannot be controlled by appropriate therapy. Experience using Sandimmun Neooral in children with atopic dermatitis is still limited. Only for elderly patients with atopic dermatitis is difficult to treat and must monitor carefully kidney function. Benign lymph nodes often accompanied by atopic dermatitis outbreaks and unchanged spontaneous or with the general improvement of the disease, regular monitoring of lymph nodes encountered when using ciclosporin. If lymph nodes still exist, although it has improved dermatitis, it is necessary to check it with a biopsy, as a cautious measure to ensure no lymphoma.The acute herpes simplex infection needs to be paid before the beginning of the Sandimmun Neoral, but it is not necessarily the reason for stopping the drug when the virus is infected, unless seriously infected with herpes. Staphylococcus aureus infection in the skin is not contraindicated for Sandimmun Neoral therapy, but it is necessary to control staph infection with appropriate antibacterial drugs. Erythromycin should be avoided because this antibiotic increases the concentration of "interaction), or if there is no alternative antibiotic, it is necessary to closely monitor the concentration of ciclosporin in the blood, kidney function and side effects of ciclosporin. Patients with Sandimmun Neooral are not used simultaneously with UV irradiation B or use of PuVa. The effect of the drug on driving and operating machinery There is no data on the effect of Sandimmun Neoral on driving and operating machinery. Patients undergoing central nervous system disorders when using Sandimmun Neooral should avoid driving and operating machinery. Using drugs for women during pregnancy and lactation Women are likely to be pregnant There is no special recommendation for pregnant women. Pregnant women Research on animals shows that drugs are toxic to reproduction in rats and rabbits. There are some data on the use of Sandimmun Neooral in pregnant patients. Pregnant women use immunosuppressive drugs after organ transplantation, including ciclosporin and ciclosporin treatment regimen is at risk of preterm birth (

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