Obat Esogas 40mg Bidiphar kanggo sekresi asam lambung (1 botol + 1 tabung 5ml)

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Spesifikasi Esomeprazole

Komposisi

Informasi komposisi	Isi
Esomeprazole	40 mg

Migunakake

indikasi

Obat Esogas dituduhake ing kasus ing ngisor iki:

Ing wong diwasa:

Perawatan sekresi asam lambung yen terapi oral ora cocok, kayata:

Penyakit refluks gastroesophageal (GERD) ing pasien karo esofagitis lan/utawa duwe gejala refluks sing abot. Trang.

Ing bocah lan remaja saka 1 nganti 18 taun: Perawatan sekresi asam lambung nalika terapi lisan ora cocog, kayata penyakit refluks gastroesophageal (GERD) ing pasien esophagitis amarga refluks lan/utawa gejala sing abot.

Farmakologi

Klompok farmakologi: Inhibitor ekskresi gastroentrik kalebu inhibitor Proton.

Kode ATC: A02BC05.

Farmakologi lan mekanisme tumindak:

Esomeprazole minangka isomer S saka omeprazole, digunakake padha karo Omeprazole kanggo perawatan ulkus gastrointestinal, penyakit refluks gastroesophageal lan sindrom Zollinger - Ellison.

Esomeprazole ditempelake ing H+/K+-Aatpase ing tembok sel, sing ora aktif sistem enzim iki, nyegah langkah pungkasan saka ekskresi asam hidroklorida menyang weteng. Mulane, Esomeprazole duweni efek nyegah sekresi asam basa ing weteng lan sanajan dirangsang dening agen apa wae. Obat kasebut dianggo kanthi kuat, tahan lama. Inhibitor pompa proton duweni efek inhibisi nanging ora nyuda Helicobacter pylori, mula kudu dikoordinasi karo antibiotik (kayata amoxicillin, tetracycline lan clarithromycin) kanggo ngilangi efek bakteri kasebut.

Farmakokinetik dinamis

udakara 97% Esomeprazole ditempelake ing protein plasma. Obat kasebut dimetabolisme utamane ing ati amarga sistem enzim Cytochrom P450, isenzim CYP2C19 dadi metabolit hidroksi lan desmethyl sing ora aktif maneh, liyane dimetabolisme liwat isenzim CYP3A4 dadi osomeprazole sulfon. Nalika digunakake bola-bali, wiwitane dimetabolisme liwat ati lan reresik saka obat kasebut suda, bisa uga amarga nyegah ISOENZYM CYP2C19. Nanging, ora ana fenomena akumulasi obat-obatan nalika digunakake sapisan dina. Ing sawetara wong, amarga kekurangan CYP2C19 amarga genetika (15-20% wong Asia), transformasi Esomeprazole kalem. Ing negara sing stabil, nilai AUC ing wong sing kurang enzim CYP2C19 mundhak udakara 2 kali dibandhingake karo wong sing duwe enzim sing cukup. Wektu sade kanggo plasma kira-kira 1,3 jam. Kira-kira 80% dosis oral diilangi ing bentuk metabolit non-aktif ing urin, sisane diilangi ing feces. Ing ngisor 1% obat kasebut diilangi ing urin. Ing wong sing gagal ati sing abot, nilai AUC 2-3 kaping luwih dhuwur tinimbang wong sing duwe fungsi ati normal, mula bisa uga kudu nyuda dosis Esomeprazole ing pasien kasebut.

Sadurunge njupuk Obat Esogas 40mg Bidiphar kanggo sekresi asam lambung (1 botol + 1 tabung 5ml)

How to use for intravenous injection: The injection solution is prepared by reverting the powder jar with 5 ml of 0.9%NAC1 solution. Intravenous injection for at least 3 minutes. For intravenous infusion: intravenous solution (40 mg dose) for 10 - 30 minutes: Reconcalation of powder bottle with 5ml of 0.9% NaCl solution or Lactated Ringer or 5% Dextrose solution. Then dilute to the volume of 100 ml. After that, the solution in 2 vials is diluted in 100 ml of 0.9%NaCl solution. The solution after the preparation is transmitted in the corresponding time or speed as in the "dosage" section. Only use the transparent solution so the mixed solution must be checked by the naked eye to detect strange molecules and discoloration before use. The mixed solution should not be mixed or shared with the lines with other drugs. Should use half phase volume if only use 20 mg of esomeprazol, should remove the unused solution. Dosage adults: Treatment of stomach acid secretion when oral therapy is inappropriate: Patients who cannot take oral medication may be treated with a dose of 20 - 40 mg, 1 time/day. Patients with reflux esophagitis should be treated at a dose of 40 mg, 1 time/day. To treat symptoms of reflux disease, patients should be used for 20 mg, 1 time/day. To treat stomach ulcers due to NSAID, the usual dose is 20 mg, 1 time/day. To prevent stomach and esophagus due to NSAID in patients at risk, the dose is 20 mg, 1 time/day. Trying time with intravenous sugar is usually short and should be switched to oral medication when possible. Prevention of bleeding due to stomach and duodenum ulcers: After acute endoscopy treatment due to stomach or duodenal ulcer, 80 mg high doses in 30 minutes, followed by continuous veins of 8 mg/hour for 3 days (72 hours). After intravenous treatment, patients should continue to treat acid resistance. Children and adolescents from 1 to 18 years old: Treatment of stomach acid secretion when oral therapy is inappropriate. Patients who cannot use oral medication can be treated with intravenous injections once a day as part of the full gerd treatment process (see in the table below). Usually the time of intravenous treatment should be short and switch to oral as soon as possible. recommended dose when using ecomeprazol by vein: age group 10 mg or 20 mg, 1 time/day 10 mg, 1 time/day 12 - 18 years old 40 mg, 1 time/day 20 mg, 1 time/day Special: People with renal failure: No need to reduce the dose in people with renal failure but caution in people with severe renal failure because the experience of using these people is limited. Elderly: No need to reduce the dose in the elderly. Hepatogens: gerd: No dose adjustment in patients with mild to moderate liver failure. For patients with severe liver failure, maximum doses should not be used for 20 mg daily. For patients with severe hepatic failure, the starting of a high dose of 80 mg should be transmitted, followed by a continuous intravenous infusion of 4 mg/h in 71.5 hours may be sufficient to achieve efficiency. 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 do do when using overdose? The described symptoms related to oral doses of 280 mg are digestive and weakened symptoms. Esomeprazol single doses of oral oral 80 mg and a 308 mg of venous Esomeprazol for 24 hours do not cause unwanted effects. No specific antidote. Esomeprazol is strongly connected to plasma proteins and therefore it is not easy to appraise. In case of overdose should treat symptoms and use general support measures. In case of emergency, call the 115 emergency center immediately or go to the nearest local health station. What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double doses to compensate for missed dose.

Efek sisih

When using the drug, there are common unwanted effects (ADR) such as: Safety records: headache, abdominal pain, diarrhea and nausea are one of the most unwanted effects in clinical trials (and also during the time the drug circulates in the market). Besides, this safety record is similar to different formulas, indicated treatment, age groups and patients. There are no unwanted effects related to the determined dose. Unwanted effects are arranged according to the frequency: very common (≥ 1/10); or meet (≥ 1/100 to

Pènget

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

Contraindicated

anti-contraindications Esogas ing kasus ing ngisor iki:

Hipersensitifitas kanggo Esomeprazole utawa karo inhibitor proton liyane, utawa hipersensitifitas kanggo bahan apa wae obat kasebut.

Ati-ati nalika nggunakake

Yen ana gejala kewaspadaan (kayata bobot mundhut sing signifikan, muntah berulang, kesulitan ngulu, muntah getih utawa feces ireng) lan nalika ana ulkus ganas, utawa dicurigai ulkus weteng. Esomeprazole bisa nyuda gejala lan diagnosa alon.

Infeksi saluran cerna: Perawatan karo inhibitor pompa proton bisa nambah risiko infeksi saluran pencernaan sing disebabake dening Salmonella lan Campylobacter.

Penyerapan vitamin B12: Esomeprazole, uga antacid liyane, bisa nyuda penyerapan vitamin B12 amarga asam lambung (cyanocobalamin). Iki kudu digatekake ing pasien sing nyuda cadangan utawa risiko nyuda penyerapan vitamin B12 nalika perawatan jangka panjang.

Hipotensi getih: Ana laporan babagan hipoglikemia serius ing pasien sing diobati karo inhibitor pompa proton (PPI) kayata Esomeprazole paling ora telung sasi lan umume nggunakake PPI sajrone setahun. Manifestasi serius saka magnesi getih kayata lemes, spasticity, delirium, konvulsi, pusing lan aritmia ventrikel bisa kedadeyan, nanging bisa meneng lan ora prihatin. Ing pasien sing paling akeh kena pengaruh, pengurangan magnesium getih saya apik sawise nggunakake terapi penggantian magnesi lan mandheg nggunakake PPI. Kanggo pasien sing diarep-arep bakal diobati kanthi perawatan sing dawa karo PPI utawa pasien sing nggunakake PPT bebarengan karo digoxin utawa obat liya sing bisa ngedhunake magnesium getih (kayata diuretik), para ahli kesehatan kudu nimbang ngukur tingkat magnesium sadurunge miwiti perawatan karo PPI lan sacara periodik sajrone perawatan.

Risiko patah tulang: Nalika nggunakake inhibitor pompa proton, utamane nalika njupuk dosis sing dhuwur lan suwe (≥ 1 taun), risiko patah tulang panggul, balung bangkekan utawa balung mburi amarga osteoporosis. Panaliten Observatorium nuduhake yen inhibitor pompa proton bisa nambah risiko fraktur sakabèhé udakara 10 - 40%. Bagéyan saka paningkatan iki bisa uga amarga faktor risiko liyane. Rekomendasi dosis paling murah bisa digunakake ing wektu sing paling cendhak, cocog kanggo status klinis. Pasien sing duwe risiko osteoporosis kudu nggunakake kalsium lan vitamin D sing cukup, ngevaluasi kondisi balung lan ngatur kaya sing ditunjuk.

Lupus erythematosus (SCLE): Kasus SCLE sing arang banget ana hubungane karo inhibitor pompa proton. Yen lesi kedadeyan, utamane ing kulit sing kena sinar srengenge lan yen diiringi nyeri sendi, pasien kudu cepet golek bantuan medis lan ahli medis kudu nimbang mandheg nggunakake Esomeprazole. SCLE kedadeyan sawise perawatan karo inhibitor pompa proton sadurunge bisa nambah risiko SCLE kedadeyan karo inhibitor pompa proton liyane.

Koordinasi karo obat liyane:

Ora dianjurake kanggo nggunakake Esomeprazole karo Atazanavir. Yen digabungake karo Atazanavir karo inhibitor pompa proton ora bisa dihindari, ngawasi sacara klinis kanthi rapet nalika nambah dosis Atazanavir dadi 400 mg digabungake karo 100 mg ritonavir; Aja ngluwihi 20 mg esomeprazole.

Esomeprazole minangka inhibitor CYP2C19. Nalika miwiti utawa mungkasi perawatan karo esomeprazole, perlu nimbang kemampuan kanggo sesambungan karo obat metabolik liwat CYP2C19. Interaksi antarane clopidogrel lan esomeprazole. Keterlibatan klinis saka interaksi iki ora mesthi. Minangka langkah ati-ati, ora dianjurake kanggo nggunakake Esomeprazole lan Clopidogrel bebarengan.

Berinteraksi karo tes: paningkatan tingkat Chromographin A (CGA) bisa ngganggu deteksi tumor saraf endokrin. Kanggo ngindhari intervensi kasebut, Esomeprazole kudu dihentikan paling ora 5 dina sadurunge ngitung CGA. Yen konsentrasi CGA lan Gastrin ora bali menyang ruang lingkup referensi sawise kuantifikasi pisanan, majalah kuantitatif iki kudu diulang 14 dina sawise mungkasi perawatan karo inhibitor pompa Proton.

Sadurunge njupuk inhibitor pompa proton, kanker lambung kudu diilangi amarga obat kasebut bisa nutupi gejala, nyuda diagnosis kanker.

Ati-ati nalika digunakake ing wong sing nandhang lara ati, ngandhut utawa nyusoni. sing tahan suwe nggunakake ecomeprazol bisa nyebabake atrofi lambung utawa nambah risiko infeksi (kayata radhang paru-paru ing masyarakat).

bisa nambah risiko diare amarga Clostridium dificile nalika njupuk inhibitor pompa proton.

Esogas ngandhut

Efek obat kasebut ing kemampuan nyopir lan ngoperasikake mesin

Esomeprazole nduweni kemampuan kanggo nyopir lan ngoperasikake mesin. Efek samping kayata pusing (jarang) lan penglihatan winates (jarang) wis dilaporake. Yen pasien kena, aja nyopir utawa ngoperasikake mesin.

Nggunakake obat kanggo wanita nalika meteng lan laktasi

Kandhutan: Ora ana studi lengkap nalika nggunakake Esomeprazole ing wong ngandhut. Mung nggunakake Esomeprazole nalika meteng yen pancene perlu.

Periode nyusoni: Ora dingerteni manawa esomeprazole diekskresi ing ASI utawa ora. Nanging, Omeprazole disebarake menyang susu manungsa. Esomeprazole duweni potensi nyebabake ADR ing bayi sing nyusoni, mula kudu diputusake kanggo mungkasi nyusoni utawa mungkasi obat kasebut, gumantung saka pentinge obat kanggo ibune.

Interaksi obat

Efek saka Esomeprazole ing ndhuwur yaiku kinetik obat liya:

Inhibitor protease:

Omeprazole wis dilaporake bisa berinteraksi karo sawetara inhibitor protease. Ora jelas pentinge klinis lan mekanisme efek saka interaksi sing direkam. Tambah pH weteng sajrone perawatan karo omeprazole bisa ngganti panyerepan saka inhibitor protease. Mekanisme interaktif liyane sing bisa ditindakake yaiku liwat inhibitor enzim CYP2C19.

Kanggo Atazanavir lan Nelfinavir, konsentrasi serum wis dilaporake nalika digunakake karo omeprazole lan ora dianjurake kanggo nggunakake obat kasebut bebarengan. Ing sukarelawan sehat, panggunaan simultan omeprazole (40 mg, 1 wektu / dina) karo Atazanavir 300 mg / ritonavir 100 mg kanthi signifikan nyuda kontak karo Atazanavir (nyuda AUC, CMAX lan Cmin kira-kira 75%). Nambah dosis Atazanavir nganti 400 mg durung menehi ganti rugi kanggo efek omeprazole nalika kontak karo Atazanavir. Gunakake kombinasi omeprazole (20 mg, 1 wektu / dina) karo Atazanavir 400 mg / ritonavir 100 mg ing sukarelawan sehat nyuda kira-kira 30% kontak karo Atazanavir yen dibandhingake karo kontak ing kasus nggunakake Atazanavir 300 mg / ritonavir 100 mg, 1 wektu / dina tanpa nggunakake Omeprazole 20 mg / dina. Gunakake kombinasi omeprazole (40 mg sapisan dina) nyuda nilai rata-rata AUC, CMAX lan CMIN saka NELFINAVIR udakara 36 - 39% lan nyuda udakara 75 - 92% saka rata-rata nilai AUC, CMAX lan CMIN metabolit aktif kanthi efek farmakologis M8. Amarga efek saka pasukan farmasi lan sifat farmakokinetik sing padha saka omeprazole lan esomeprazole, ora dianjurake kanggo nggunakake Esomeprazole bebarengan karo Atazanavir lan contraindicated kanggo nggunakake Esomeprazole karo Nelfinavir.

Kanggo Saquinavir (digunakake bebarengan karo Ritonavir), nambah konsentrasi serum (80 - 100%) wis dilapurake sajrone perawatan simultan karo omeprazole (40 mg, 1 wektu / dina). Perawatan karo omeprazole 20 mg, 1 wektu / dina, ora mengaruhi kontak Darunavir (nalika digunakake bebarengan karo Ritonavir) lan Amprenavir (yen digunakake bebarengan karo Ritonavir). Esomeprazole 20 mg, 1 wektu / dina, ora mengaruhi kontak Amprenavir (apa ora digunakake bebarengan karo Ritonavir). Perawatan karo omeprazole 40 mg, 1 wektu / dina, ora mengaruhi kontak Lopinavir (bebarengan digunakake karo Ritonavir).

metotreksat:

Nalika digunakake karo PPI, nambah tingkat methotrexate wis dilaporake ing sawetara pasien. Ing perawatan saka dosis dhuwur saka methotrexate, bisa uga perlu kanggo nimbang lan mungkasi nggunakake Esomeprazole.

tacrolimus:

Panggunaan bebarengan karo Esomeprazole wis dilaporake nambah konsentrasi tacrolimus ing serum. Perlu nambah konsentrasi tacrolimus pemantauan uga fungsi ginjel (clearance bun) lan dosis tacrolimus diatur yen perlu.

Obat sing diserep gumantung marang pH:

Inhibisi asam lambung sajrone perawatan karo ecomeprazol lan PPT liyane bisa nyuda utawa nambah panyerepan obat sing gumantung marang pH lambung. Kaya obat liyane sing nyuda pH lambung, panyerepan obat kayata ketoconazole, otraconazole lan erlotinib bisa nyuda lan panyerepan digoxin bisa saya tambah nalika perawatan karo ecomeprazol. Panggunaan simultan omeprazole (20 mg / dina) lan digoxin ing obyek sehat sing nambah bioavailability digoxin kira-kira 10% (nganti 30% ing 2 saka 10 obyek riset). Ana laporan langka babagan keracunan Digoxin. Nanging, kudu ati-ati nalika nggunakake dosis dhuwur Esomeprazole ing pasien tuwa. Perlu nambah perawatan pemantauan karo digoxin.

Obat metabolik dening CYP2C19:

Esomeprazole nyegah CYP2C19, enzim utama metabolizes Esomeprazole. Mulane, nalika Esomeprazole digabungake karo obat metabolik dening CYP2C19, kayata Diazepam, Citalopram, Imipramin, Clomipramin, Phenytoin ... Konsentrasi plasma obat kasebut bisa nambah lan kudu ngurangi dosis. Ora ana studi interaktif Interim sing ditindakake ing dosis dhuwur (80 mg + 8 mg / h) nggunakake garis intravena. Efek Esomeprazole ing obat metabolik amarga CYP2C19 bisa dideteksi kanthi luwih jelas ing peta iki lan pasien kudu ngawasi kanthi rapet efek obat sing ora dikarepake sajrone perawatan intravena sajrone 3 dina.

diazepam:

Panggunaan Esomeprazole 30 mg kanthi simultan nyuda 45% reresik Diazepam (substrat CYP2C19).

fenitoin:

Panggunaan simultan saka 40 mg oral Esomeprazole lan phenytoin nambah 13% saka konsentrasi ngisor fenitoin ing plasma ing pasien epilepsi. Sampeyan kudu ngawasi konsentrasi phenytoin ing plasma nalika miwiti utawa mungkasi perawatan karo Esomeprazole.

vorikonazol:

omeprazole (40 mg sapisan dina) nambah cmax lan auc variconazol (substrat CYP2C19) dadi 15% lan 11%, masing-masing.

cilostazol:

Omeprazole uga Esomeprazole tumindak minangka inhibitor CYP2C19. Ing panaliten silang, Omeprazole digunakake ing dosis 40 mg ing obyek sehat tambah 18% CMAX lan 26% AUC saka Cilostazol lan nambah 29% CMAX lan 69% AUC saka salah siji saka metabolit aktif.

cisaprid:

Ing sukarelawan sehat, nalika nggunakake 40 mg esomeprazole oral lan cisaprid, area ing kurva nuduhake konsentrasi Cisaprid ing plasma liwat wektu (AUC) mundhak dadi 32% lan wektu semi-discharged Cisaprid (T1/2) ngluwihi 31% nanging konsentrasi puncak Cisaprid ing plasma mundhak negatif. Kisaran QTC rada suwe sawise nggunakake Cisaprid sing kapisah, ora tahan maneh nalika nggunakake Cisaprid kanthi kombinasi karo Esomeprazole.

warfarin:

Nalika 40 mg esomeprazole oral bebarengan ing pasien sing diobati karo warfarin ing uji klinis nuduhake yen wektu pembekuan getih ana ing kisaran sing bisa ditampa. Nanging, sawise nggawa obat kasebut menyang pasar, ana sawetara kasus kenaikan klinis Inr sing signifikan nalika diobati kanthi bebarengan ing rong obat kasebut ing ndhuwur. Pasien kudu dipantau ing wiwitan lan pungkasan perawatan karo warfarin utawa turunan cooumarin liyane.

klopidogrel:

Asil saka panaliten babagan subyek sehat nuduhake interaksi farmakokinetik (PK)/Farmasi (PD) antarane clopidogrel (dosis pangopènan 300 mg 75 mg / dina) lan Esomeprazole (40 mg / dina kanthi lisan) nyebabake penurunan ADF rata-rata.

Ing panaliten babagan obyek sehat, nalika Clopidogrel bebarengan digunakake karo kombinasi Esomeprazole 20 mg + Asa 81 mg dibandhingake karo clopidogrel unik, paparan metabolit aktif Clopidogrel wis suda meh 40%. Nanging, tingkat maksimum inhibitor platelet (disebabake ADP) ing obyek kasebut padha ing clopidogrel tunggal lan klompok kasebut nggunakake Clopidogrel lan Esomeprazole + ASA.

Data sing ora konsisten babagan manifestasi klinis interaksi PK / PD Esomeprazole ing acara kardiovaskular utama wis dilaporake saka pengamatan klinis lan riset riset. Kanggo tujuan sing ati-ati, panggunaan bebarengan karo clopidogrel ora dianjurake.

Interaksi non-klinis klinis:

amoxicillin utawa quinidine:

Esomeprazole wis ditampilake ora duwe pengaruh klinis sing signifikan marang farmakokinetik amoxicillin utawa quinidine.

Naproxen utawa Rofecoxib:

Esomeprazole lan Naproxen utawa Rofecoxib utawa Rofecoxibs ora nuduhake interaksi farmakokinetik klinis ing studi jangka pendek.

Pengaruh obat liya ing farmakokinetik Esomeprazole:

Inhibitor CYP2C19 lan/utawa CYP3A4:

Esomeprazole dimetabolisme dening CYP2C19 lan CYP3A4. Nalika nggunakake Esomeprazole bebarengan karo Esomeprazole lisan kanthi inhibitor CYP3A4, Clarithromycin (500 mg, 2 kali / dina) tikel AUC saka Esomeprazole. Panggunaan Esomeprazole bebarengan karo inhibitor CYP2C19 lan CYP3A4 bisa nambah paparan Esomeprazole. Inhibitor CYP2C19 lan CYP3A4 Voriconazole nambah AUC Esomeprazole dadi 280%. Ora perlu nyetel dosis Esomeprazole kanthi rutin ing kasus kasebut. Nanging, perlu kanggo nimbang nyetel dosis ing pasien kanthi gagal ati sing abot lan yen diwenehi perawatan jangka panjang.

Obat induksi CYP2C19 lan/utawa CYP3A4:

Obat induksi CYP2C19 utawa CYP3A4 utawa loro-lorone (kayata rifampicin lan suket St. John) bisa nyebabake nyuda ecomeprazole serum amarga hipotermia Esomeprazole.

Obat penurun getih kayata diuretik thiazid utawa diuretik: bisa nambah risiko hipoglikemia nalika digunakake karo ecomeprazol. Priksa konsentrasi Magnesi sadurunge miwiti nggunakake inhibitor pompa proton banjur sacara periodik.

Anak: Pasinaon interaktif obat mung ditindakake ing wong diwasa.

Panyimpenan

Ing panggonan sing garing, suhu ora ngluwihi 30 ° C, ngindhari cahya.

Obat liyane

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