Maxxhepa Urso 300 kapsul obat kanggo sirosis disebabake empedu mentah (3 blister x 10 tablet)

Bentuk sediaan Kothak 3 blister x 10 tablet
Spesifikasi asam ursodeoxycholic

Komposisi

Informasi komposisi	Isi
asam ursodeoxycholic	300 mg

Migunakake

indikasi

Obat Maxxhepa®urso digunakake ing kasus ing ngisor iki:

Pengobatan sirosis empedu primer (PBC). A05AA02

Asam ursodeoxycholic (UDCA, Ursodiol) minangka asam batang banyu alam, asalé saka kolesterol, nyathet bagean cilik saka jumlah total asam empedu ing manungsa.

Asam ursodeoxycholic nggunakake lisan kanggo nambah jumlah asam empedu iki sing ana hubungane karo dosis, dadi asam empedu utama, ngganti / ngowahi konsentrasi asam empedu sing beracun ing asam empedu. lara ati).

Asam ursodeoxycholic nglindhungi ati, gusi empedu, larut watu empedu, nyuda lipid getih, nyuda kolesterol getih lan sawetara efek ngatur kekebalan:

Nglindhungi sel epitelium empedu sing rusak saka efek beracun saka asam empedu.

Nyandhet pati miturut program sel ati.

Ngurangi sekresi kolesterol, nyuda penyerapan kolesterol ing usus lan ngrangsang pelepasan watu kolesterol anyar ing empedu.

Ngrangsang sel ati lan sel sekresi empedu.

Ngurangi watu, nambah konsentrasi asam empedu, nambah aktivitas enzim lipase, ningkatake fungsi pencernaan.

Efek imunosupresif: Ngurangi manifestasi patologis antigen sesuai karo jaringan asli HLA I ing sel ati lan HLA II ing sel epitel tabung empedu, nyandhet Interleukin-2, nyuda jumlah eosinofilia.

farmakokinetik

penyerapan:

UDCA normal nyakup bagean cilik saka jumlah total asam empedu ing manungsa (udakara 5%). Sawise ngombe, umume UDCA diserap dening difusi pasif lan panyerepan iki ora lengkap.

Metabolisme:

Sanalika sawise diserap, kira-kira 70% asam ursodeoxycholic disekresi yen ora penyakit ati. Iki nyebabake tingkat getih sirkulasi sing kurang. Nalika penyakit ati saya tambah parah, tingkat sekresi ati mudhun.

Ing ati, asam ursodeoxycholic digandhengake karo glisin utawa taurin, banjur diekskripsikake menyang empedu. Kompleks asam ursodeoxycholic iki diserap ing usus cilik miturut mekanisme pasif lan aktif. Kompleks kasebut uga bisa dipisahake ing ileum kanthi enzim usus, sing nyebabake pembentukan asam ursodeoxycholic gratis, sing bisa diserap maneh lan digabungake ing ati. Asam ursodeoxycholic ora nyerep menyang usus, ing ngendi meh 7-oh minangka asam lithocholic. Bagéyan saka asam Ursodeoxycholic diowahi dadi isomer Chenodiol / Chenodioxycholic (CDCA). Chenodiol uga dikurangi 7-oh dadi asam lithocholic.

Metabolit iki kurang larut lan diekskripsikake ing feces. Bagéyan cilik saka asam lithocholic diserap maneh, digabungake karo glisin utawa taurin ing ati lan dipasang ing sulfat kaping 3.

Distribusi:

Ing wong sing sehat, paling ora 70% asam ursodeoxycholic (non-conjugate) ditempelake ing protein plasma. Ora ana informasi babagan kohesi asam ursodexolic sing ana gandhengane karo protein plasma ing wong sing sehat utawa pasien karo sirosis empedu primer. Nanging, amarga efek asam ursodeoxycholic sing ana gandhengane karo konsentrasi ing empedu tinimbang ing plasma, konsentrasi serum dudu faktor sing nuduhake bioaktivitas klinis.

volume distribusi kasebut durung ditemtokake, nanging dianggep kurang amarga obat kasebut disebar utamane ing empedu lan usus cilik. Ing madu, konsentrasi puncak asam Ursodeoxycholic digayuh sajrone 1-3 jam.

Jaman:

Asam ursodeoxycholic ngilangake utamane ing feces. Nalika diobati, ekskresi liwat urin mundhak, nanging isih kurang saka 1%, kajaba ing penyakit ati kolestatik sing serius.

Sadurunge njupuk Maxxhepa Urso 300 kapsul obat kanggo sirosis disebabake empedu mentah (3 blister x 10 tablet)

How to use Maxxhepa®urso drug used orally, should swallow whole tablet with water. Note to take the medication regularly. Dosage There is no limitation of age when taking Maxxhepa®uro in the treatment of first bile cirrhosis (PBC) and dissolving gallbladder stones. First biliary cirrhosis (PBC) Adults: UDCA recommended dose is 14 ± 2 mg/kg/day. In the first 3 months of treatment, using Maxxhepa®urso should be divided into 2-4 times a day. Along with the improvement of the liver values can be used once in the evening. Taxing Maxxhepa®urso in the treatment of first bile cirrhosis (PBC) can continue indefinitely. Children: Dosage calculated by body weight. Table 1: Dosage of UDCA in the treatment of first bile cirrhosis (12 - 16 mg/kg/day). weight (kg) The dose (mg) Maxxhepa®urso dose 10 - 20 120 - 320 - 20 - 30 - 30 480 - 60 600 - 960 1 capsule x 2 - 3 times/day Time/day Adults: UDCA's common dose is 8 - 12 mg/kg/day used in the evening or divided into several doses. When necessary, the dose can be increased to 15 mg/kg daily for obese patients. The time needed to melt stones can be from 6 to 24 months, depending on the size and composition of the stones. Monitoring via gallbladder or ultrasound every 6 months can be helpful until the stones are gone. Continuous treatment for 2 consecutive cholecyst scenes with contrast and/or ultrasound 4 - 12 weeks apart from gallbladder stones. This is because these techniques are not reliable to see the stones with a diameter of less than 2 mm. The possibility of a gallbladder recurrence after the treatment of gallbladder stones with bile acid has been estimated up to 50% after 5 years. The effectiveness of maxxhepa®uro in the treatment of contrast or partial contrast gallbladder stones has not been tested, but these stones are generally thought to be less soluble than contrast stones. The non -cholesterol stones account for 10-15% of the stones without contrast and may not be dissolved by bile acid. Children: Cholesterol -rich gallbladder stones and primary bile cirrhosis are very rare in children, but when detected, the dosage should be calculated by body weight. There is no adequate data on efficiency and safety for children. Elderly: There is no evidence that suggests to change the dose for the elderly but need to be cautious when used for older patients. Table 2: UDCA's dose in the treatment of gallbladder stones (8 - 12 mg/kg/day)

weight (kg)

the dose (mg)

Maxxhepa®urso dose

80 - 240

20 - 30

160 - 360

1 capsules x 1 time/day 40

240 - 480

1 capsules x 1 time/day Time/day 840

1 capsule x 2 - 3 times/day Liver is related to cystic fibrosis in children 6 - 18 years old UDCA recommended dose is 20 mg/kg/day divided into 2-3 doses, when necessary can increase to 30 mg/kg per day. Table 3: UDCA dose in the treatment of liver disorders related to cystic fibrosis in children 6 - 18 years old (20 mg/kg/day)

weight (kg)

the dose (mg)

Maxxhepa®urso dose

200-400

- 20-30

400-600 1 capsule x 2 times/day 40

600-800

1 capsule x 2 - 3 times/day Time/day

50 - 60

1000-1200

2 capsules x 2 times/day width = "175"> 2 capsules x 2 times/day Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose? Overall, other symptoms of overdose are rarely occurring because the absorption of UDCA decreases when increasing the dose and therefore more part will be excreted in the feces. Specific measures are unnecessary and the consequences of diarrhea should be treated with symptoms with water and electrolyte recovery. In an emergency, call the 115 emergency center immediately or go to the nearest local health station. What to do when forgetting 1 dose? If this dose is close to the time of the next dose, skip the missed dose and use the next dose regularly according to the schedule. Do not use double dose.

Efek sisih

Ing dosis sing disaranake, UDCA bisa ditoleransi kanthi becik lan efek sing ora dikarepake.

Umum (ADR ≥ 1/100)

Gangguan gastrointestinal: Pupuk utawa diare, mual, muntah.

Jarang banget (ADR Gangguan gastrointestinal: Nyeri weteng ndhuwur sing abot, konstipasi.

Pènget

Sadurunge nggunakake obat kasebut, sampeyan kudu maca instruksi kasebut kanthi teliti lan deleng informasi ing ngisor iki.

contraindicated

Obat Maxxhepa®urso contraindicated ing kasus ing ngisor iki:

Hipersensitivitas kanggo UDCA utawa bahan apa wae saka obat kasebut. energi. meteng.

Ati-ati nalika nggunakake

Ngawasi pasien:

Kudu nggunakake UDCA ing pengawasan medis.

Sajrone 3 sasi pisanan perawatan, paramèter fungsi ati kayata Aspartate Transaminase (AST/SGOT), Alanine Transaminase (ALT/SGPT) lan gamma-glutamyl transferase (γGT) kudu dipantau dening dhokter saben 4 minggu, banjur saben 3 sasi. Saliyane ngidini identifikasi sing nanggapi lan ora nanggapi ing antarane pasien sing diobati karo sirosis bilier, monitor iki uga bakal nggampangake deteksi dini gagal ati sing didhelikake, utamane ing pasien karo sirosis bilier Tien Phat.

Nalika digunakake kanggo ngobati sirosis bilier pisanan (PBC):

Pangertosan sirosis arang banget ing kasus iki, kondisi iki suda sebagian sawise perawatan.

Ing pasien karo sirosis bilier primer, kasus gejala klinis sing arang banget bisa rusak ing wiwitan perawatan, umpamane, gatal bisa nambah. Ing kasus iki, dosis kudu dikurangi dadi 250 mg UDCA saben dina lan banjur mboko sithik nambah dosis sing disaranake.

Yen diare, suda dosis lan yen diare saya suwe, perawatan kudu mandheg.

Nalika digunakake kanggo mbubarake watu kolesterol ing kandung empedu:

Sampeyan kudu ngunjungi kandung empedu (fotografi kandung empedu fotometrik) kanthi gambar umum lan gambar macet ing posisi ngadeg lan ngapusi (mriksa liwat ultrasonik) 6 - 10 sasi sawise miwiti perawatan kanggo ngevaluasi kemajuan terapi perawatan lan deteksi pas wektune kalsifikasi kandung empedu, gumantung saka ukuran kerikil.

Yen sampeyan ora bisa ndeleng kandung empedu ing sinar-X, utawa nalika ngitung watu kandung empedu, nyuda kandung empedu utawa kerep kram empedu, UDCA ora kudu digunakake.

bahan bantu:

Obat kasebut ngandhut laktosa. Mula, pasien sing nandhang penyakit genetik langka yaiku intoleransi galaktosa, kekurangan laktase utawa Glukosa-Galaktosa ora kudu nggunakake obat iki.

Subyek khusus

Wanita sing bisa ngandhut: Iki mung kudu digunakake kanggo wanita sing bisa ngandhut yen nggunakake metode kontrasepsi sing dipercaya: kontrasepsi non-hormon utawa kontrasepsi anti-oral dosis rendah dianjurake. Nanging, ing pasien wanita nggunakake tablet UDCA kanggo nyawiji watu gallbladder, kudu nggunakake kontrasepsi non-hormon, amarga kontrasepsi oral bisa nambah watu empedu. Kemungkinan meteng kudu diilangi sadurunge miwiti perawatan.

Anak: Keamanan lan efektifitas UDCA ing bocah-bocah durung dikonfirmasi.

Pasien sing luwih tuwa: Pasinaon sing cocog kanggo UDCA durung ditindakake ing pasien sing luwih tuwa. Nanging, masalah sing kapisah ing wong tuwa bakal mbatesi panggunaan utawa keuntungan UDCA ing wong tuwa.

Ati/empedu/pankreas: Pasien sing ngalami pendarahan amarga vena varikos, hepatitis, asites, utawa transplantasi ati darurat, kudu diobati kanthi perawatan khusus sing cocog. Ati-ati kudu digunakake nalika nggunakake UDCA ing kasus obstruksi bilier sebagian amarga panyebab eksternal.

Efek obat-obatan ing nyopir lan ngoperasikake mesin

UDCA ora duwe pengaruh utawa bisa diabaikan ing kemampuan nyopir lan ngoperasikake mesin.

Nggunakake obat kanggo wanita nalika ngandhut lan lactation

Nggunakake obat kanggo wanita ngandhut:

Ora ana utawa sawetara data babagan panggunaan UDCA ing wanita ngandhut khusus ing 3 wulan pisanan ngandhut. Pasinaon kewan nuduhake yen keracunan sing nyebabake teratogenisitas ing tahap awal meteng. Aja nggunakake UDCA nalika meteng. Mungkasi perawatan lan bukak dhokter sanalika sampeyan nemokake meteng.

Gunakake obat kanggo wanita sing nyusoni:

Isih durung dingerteni manawa UDCA bakal diekskresi liwat ASI. Mulane, UDCA ora bisa digunakake kanggo wanita sing nyusoni. Yen sampeyan kudu nambani UDCA, sampeyan kudu mandheg nyusoni.

Interaksi obat

ora kudu nggunakake UDCA bebarengan karo karbon aktif, Colestyramin, Colestipol utawa antacid sing ngemot aluminium hidroksid lan/utawa smektit (aluminium oksida), amarga obat kasebut nempelake UDCA ing usus cilik, saéngga ngalangi penyerapan lan efektifitas. Yen perlu nggunakake obat kasebut ngemot salah sawijining zat kasebut, kudu diombe paling ora 2 jam sadurunge utawa sawise nggunakake UDCA.

UDCA bisa mengaruhi panyerepan cyclosporin saka usus cilik. Ing pasien sing njupuk cyclosporin, dhokter kudu mriksa konsentrasi cyclosporin ing getih lan nyetel dosis cyclosporin yen perlu.

Ing sawetara kasus khusus, UDCA bisa nyuda panyerepan ciprofloxacin.

Ing panaliten klinis ing sukarelawan sehat nggunakake UDCA (500 mg / dina) lan Rosuvastatin (20 mg / dina), kanthi alon nambah konsentrasi rosuvastatin ing plasma. Keterlibatan klinis interaksi obat iki karo obat statin liyane ora dingerteni.

UDCA wis nuduhake manawa bisa nyuda puncak plasma (CMAX) lan area ing kurva (AUC) obat Calcium Nitrendipine ing sukarelawan sehat. Ngawasi kanthi rapet asil panggunaan simultan nitrendipine lan UDCA wis dianjurake. Dosis nitrendipine bisa tambah. Interaksi obat nyuda efektifitas perawatan Dapson.

Hormon sing nggawe estrogen lan sawetara obat kolesterol getih kayata clofibrate nambah sekresi kolesterol ing ati lan mulane bisa ningkatake watu empedu, sing efek kontra nggunakake UDCA kanggo nyawiji watu kandung empedu.

Panyimpenan

Ninggalake papan sing adhem, aja nganti cahya, suhu ngisor 30⁰C.

Obat liyane

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