Alvimopan

Alvimopan

Hoob: Tshuaj GI, Lwm Yam
Tshuaj Npe: [[2 (S)-[[4 (R)-(3-hydroxyphenyl) -3 (R), 4-dimethyl-1-piperidinyl] methyl] -1-oxo-3-phenylpropyl] amino] acetic acid dihydrate
Cov Qauv Molecular: C25H32N2LOS YOG4• 2H2LOS YOG
CAS Naj Npawb: 170098-38-1
Hom: Nkag siab

Tshuaj kho los ntawm Varixcare.cz ntawm Kaum Ib Hlis 23, 2020. Sau los ntawm ASHP.



Ceeb toom

  • Tsuas yog rau lub sijhawm luv (15 koob) siv hauv cov neeg mob pw hauv tsev kho mob. (Saib MI hauv qab Ceev faj.)



  • Txhawm rau siv tsuas yog los ntawm tsev kho mob cuv npe hauv EnteregKev Pab Txhawb thiab Kev Kawm (EASE) qhov program. (Saib Cov Kev Pab Cuam Tshuam Kev faib tawm raws li Kev Siv thiab Kev Tswj.)

Kev Ntsuam Xyuas Kev Ntsuam Xyuas thiab Kev Ruaj Ntseg Zoo (REMS):



FDA pom zoo REMS rau alvimopan kom ntseeg tau tias cov txiaj ntsig muaj ntau dua qhov txaus ntshai. REMS tuaj yeem siv rau ib lossis ntau qhov kev npaj ntawm alvimopan thiab muaj cov hauv qab no: cov ntsiab lus kom ntseeg tau tias muaj kev nyab xeeb siv thiab ua haujlwm. (Saib Cov Kev Pab Cuam Txwv Tsis Pub Muab faib raws li Kev Siv thiab Kev Tswj.) Saib https://www.accessdata.fda.gov/scripts/cder/rems/ .

Taw qhia

Peripherally ua Μ-opiate receptor antagonist.

Siv rau Alvimopan

Tom qab phais Ileus

Kev nrawm ntawm sab saud thiab qis dua GI rov qab los tom qab ib feem loj lossis me me tso quav nrog thawj anastomosis.



Kev ua tau zoo rau kev tswj hwm tom qab phais mob ileus hauv cov poj niam uas tau txais tag nrho lub plab hysterectomy & rab riam; nyob rau hauv cov tshuaj loog tsis tau tsim rau hnub tim.

Alvimopan Dosage thiab Kev Tswj

dav dav

Txwv Tsis Pub Muab Kev Pab Cuam

  • Tsuas muaj rau cov tsev kho mob kom siv sijhawm ntev hauv tsev kho mob siv los ntawm txoj haujlwm txwv kev faib khoom (EnteregKev Pab Txhawb thiab Kev Kawm [EASE] program) vim tias muaj kev pheej hmoo ntxiv ntawm ischemic plawv xwm txheej cuam tshuam nrog kev kho mus sij hawm ntev. (Saib REMS thiab tseem pom MI nyob hauv Ceev faj.)

  • Txhawm rau cuv npe hauv EASEtxoj haujlwm, tsev kho mob yuav tsum ua phais phais plab thiab lees paub tias cov neeg ua haujlwm uas sau ntawv, xa tawm, lossis tswj hwm alvimopan tau muab nrog EASEcov khoom siv rau npe kawm ntawv. Cov tsev kho mob yuav tsum muaj cov txheej txheem, xaj xaj, txheej txheem, lossis lwm yam kev ntsuas hauv qhov chaw txhawm rau txwv kev siv sijhawm luv (≦ 15 koob tshuaj) kev kho mob hauv tsev kho mob. Cov tsev kho mob yuav tsum xyuas kom alvimopan tsis raug faib rau kev siv sab nrauv thiab cov tshuaj tsis raug xa mus rau tsev kho mob uas tsis tau sau npe.

  • Cov ntaub ntawv hais txog EASEprogram muaj nyob ntawm 866-423-6567 (866-4ADOLOR) lossis ntawm [Web] . Cov ntaub ntawv teev npe ntawm tsev kho mob muaj nyob ntawm lub vev xaib.

Kev tswj hwm

Kev Tswj Qhov Ncauj

Preoperative koob tshuaj nyob rau hauv cov neeg mob yoo mov hauv kev tshawb fawb soj ntsuam; koob tshuaj tom qab tau tswj hwm yam tsis hais txog zaub mov hauv kev kawm.

Dosage

Muaj raws li alvimopan dihydrate; ntau npaum li cas qhia nyob rau hauv cov nqe lus ntawm anhydrous alvimopan.

Cov neeg laus

Tom qab phais Ileus
Qhov ncauj

12 mg muab 0.5-5 teev ua ntej kev phais tom qab 12 mg ob zaug ib hnub pib hnub tom qab kev phais ntau tshaj 7 hnub lossis txog thaum tso tawm.

Tsis pub ntau tshaj 15 koob tshuaj.

ropinirole tuaj yeem ua rau koj siab

Kev sau ntawv txwv

Cov neeg laus

Tom qab phais Ileus
Qhov ncauj

Qhov siab tshaj 15 koob dhau 7 hnub tom qab phais hauv cov neeg mob pw hauv tsev kho mob.

Cov Neeg Tshwj Xeeb

Hepatic tsis zoo

Tsis tas yuav hloov kho qhov ntau npaum li cas hauv cov neeg mob uas mob me me mus rau lub cev tsis zoo (Child-Pugh chav A lossis B). Tsis pom zoo rau lub cev tsis zoo. (Saib Hepatic Impairment raws li Ceev faj.)

Lub raum tsis zoo

Tsis tas yuav hloov tshuaj ntau npaum li cas hauv cov neeg mob uas mob raum tsis zoo. Tsis pom zoo rau cov neeg mob uas muaj kab mob hauv lub raum kawg. (Saib Renal Impairment raws li Ceev faj.)

Cov Neeg Mob Geriatric

Kev hloov tshuaj raws li hnub nyoog tsis xav tau.

Crohn tus kab mob

Tsis tas yuav hloov kho tshuaj. (Saib Cov Neeg Tshwj Xeeb hauv Pharmacokinetics.)

Ceev faj rau Alvimopan

Contraindications

  • Kev kho tshuaj ntawm opiates rau> 7 hnub sib law liag ua ntej kev tswj hwm alvimopan.

Ceeb Toom/Ceev faj

Txwv Tsis Pub Muab Kev Pab Cuam

Tsuas yog rau lub sijhawm luv (15 koob) siv hauv cov neeg mob pw hauv tsev kho mob. Rau siv tsuas yog los ntawm tsev kho mob cuv npe hauv EASEtxoj haujlwm. (Saib Cov Kev Pab Cuam Tshuam Kev faib tawm raws li Kev Siv thiab Kev Tswj.)

Kuv

Tej zaum yuav cuam tshuam nrog kev tshwm sim ntau ntxiv ntawm MI thaum siv sijhawm ntev; tsis pom nrog lub sijhawm luv (piv txwv li, days 7 hnub) siv cov quav hauv qab no. Kev sib raug zoo tsis tau tsim. (Saib Cov Lus Ceeb Toom Ntim Ntim Ntim thiab saib Cov Kev Txwv Tsis Pub Tshaj Tawm raws li Kev Siv thiab Kev Tswj.)

Kev Siv Opiate Tsis ntev los no

Ua rau rhiab heev rau alvimopan ua tau nrog tsis ntev los no raug rau opiates; qhov tshwm sim feem ntau yog cov tsos mob GI (piv txwv li, mob plab, xeev siab, ntuav, raws plab). Siv kev ceev faj hauv cov neeg mob uas tau txais> 3 koob tshuaj opiate hauv 1 lub lis piam ua ntej yuav phais. (Saib Contraindications nyob rau hauv Ceev faj.)

Kev Mob plab

Tsis pom zoo siv rau cov neeg mob uas raug phais kho kom tiav ntawm txoj hnyuv.

Cov Pej Xeem Tshwj Xeeb

Cev xeeb tub

Qeb B

Lactation

Faib rau hauv mis hauv nas; tsis paub tias faib rau tib neeg cov mis. Siv ceev faj.

Kev Siv Menyuam Yaus

Kev nyab xeeb thiab ua tau zoo tsis tau tsim los rau menyuam yaus<18 years of age.

Kev siv Geriatric

Tsis muaj qhov sib txawv tseem ceeb ntawm kev nyab xeeb thiab ua tau zoo piv rau cov neeg hluas, tab sis kev nkag siab ntau ntxiv tsis tuaj yeem txiav txim siab tawm.

Hepatic tsis zoo

Kev nce me ntsis hauv cov ntshav alvimopan ntau tuaj yeem ua rau cov neeg mob uas mob me me mus rau nruab nrab lub cev tsis zoo (Menyuam-Pugh chav A lossis B). Saib xyuas rau cov kev tsis zoo (piv txwv li, raws plab, mob plab lossis ntuav) uas tuaj yeem qhia pom alvimopan lossis cov khoom sib xyaw metabolite; txiav tawm yog tias muaj cov teebmeem zoo li no. (Saib Heev Heev Heev Heev Heev Hauv Kev Siv thiab Kev Tswj thiab saib Cov Neeg Tshwj Xeeb hauv Pharmacokinetics.)

Tsis pom zoo siv rau cov neeg mob uas muaj lub cev tsis zoo (Child-Pugh class C). Muaj peev xwm ua kom cov ntshav plasma ntau ntxiv.

Lub raum tsis zoo

Saib xyuas qhov ua tau rau cov neeg mob uas lub raum tsis zoo. Saib xyuas cov neeg uas muaj lub raum tsis zoo rau cov kev mob tshwm sim (piv txwv li, raws plab, mob plab lossis ntuav) uas tuaj yeem qhia txog alvimopan lossis cov tshuaj metabolite ntau ntxiv; txiav tawm yog tias muaj cov teebmeem zoo li no. (Saib Renal Impairment hauv Dosage thiab Administration thiab saib Cov Neeg Tshwj Xeeb hauv Pharmacokinetics.)

Tsis tau kawm hauv cov neeg mob uas muaj kab mob hauv lub raum kawg. Tsis pom zoo siv.

Cov Teeb Meem Tsis Zoo

Cem quav, hypokalemia, flatulence, dyspepsia, ntshav tsis txaus, mob nraub qaum, tso zis tso zis.

Kev sib cuam tshuam rau Alvimopan

Tsis txwv CYP isoenzymes 1A2, 2C9, 2C19, 3A4, 2D6, lossis 2E1 lossis ntxias cov isoenzymes 1A2, 2B6, 2C9, 2C19, lossis 3A4.

Alvimopan tsis txwv P-glycoprotein; alvimopan thiab nws cov metabolite yog cov txheej txheem rau P-glycoprotein.

Tshuaj cuam tshuam lossis Metabolized los ntawm Hepatic Microsomal Enzymes

Pharmacokinetic kev cuam tshuam tsis zoo.

Tshuaj Cuam Tshuam lossis cuam tshuam los ntawm P-glycoprotein Transport

Pharmacokinetic kev sib cuam tshuam tsis zoo nrog me-rau-nruab nrab P-glycoprotein inhibitors. Cov nyhuv ntawm lub zog P-glycoprotein inhibitors tsis paub.

Pharmacokinetic kev sib cuam tshuam nrog P-glycoprotein substrates tsis zoo li.

Cov Tshuaj Tshwj Xeeb

Tshuaj

Kev sib cuam tshuam

Lus tawm

Tshuaj tua kab mob (tshuaj tua kab mob ua ntej qhov ncauj)

Ua kom cov ntshav plasma ntau ntau ntawm alvimopan metabolite; tsis muaj kev hloov pauv hauv alvimopan pharmacokinetics

Tsis tas yuav hloov kho tshuaj

Histamine H.2-receptor antagonists

Ua kom cov ntshav plasma ntau ntau ntawm alvimopan metabolite; tsis muaj kev hloov pauv hauv alvimopan pharmacokinetics

Tsis tas yuav hloov kho tshuaj

Morphine

Pharmacokinetic cuam tshuam tsis zoo (tsis muaj kev hloov pauv morphine pharmacokinetics); alvimopan tsis thim rov qab cov teebmeem analgesic

Tsis tas yuav hloov kho tshuaj

Proton-pump inhibitors

Ua kom cov ntshav plasma ntau ntau ntawm alvimopan metabolite; tsis muaj kev hloov pauv hauv alvimopan pharmacokinetics

daim ntawv teev cov tshuaj uas muaj generic thiab hom

Tsis tas yuav hloov kho tshuaj

Alvimopan Pharmacokinetics

Kev nqus

Bioavailability

Qhov nruab nrab bioavailability tsis pub dhau 6% (thaj tsam 1–19%).

Khoom noj

Kev noj zaub mov muaj roj tsawg ua rau txo qis thiab nqus tau.

Kev faib tawm

Ntev

Tsis nkag siab yooj yim hla cov ntshav-lub hlwb teeb meem.

Faib rau hauv mis hauv nas; tsis paub tias faib rau tib neeg cov mis.

Plasma Protein Binding

Alvimopan: 80%. Metabolite: 94%Cov. Ua rau albumin.

Tshem tawm

Metabolism

Metabolized los ntawm cov hnyuv hauv lub cev mus rau cov metabolite nquag; metabolite tsis xav tau rau kev ua haujlwm tshuaj.

Tsis muaj cov metabolism hauv lub cev ntau.

Txoj Kev Raug Tshem Tawm

Feem ntau yog ua los ntawm cov kua tsib zais zis (65%) thiab hauv cov zis (35%).

Ib nrab neej

10-17 hnub.

Cov Neeg Tshwj Xeeb

Raug rau alvimopan yog 1.5-npaug rau ob zaug siab dua hauv cov neeg mob uas mob me me lossis nruab nrab lub cev tsis zoo (Menyuam-Pugh chav kawm A lossis B); tsub kom tau tom qab ntau koob tshuaj. Kev nthuav tawm tuaj yeem nce ntxiv kwv yees li kaum npaug hauv cov neeg mob uas muaj lub cev tsis zoo (Child-Pugh class C).

Raug rau metabolite yog ob npaug rau tsib npaug ntau dua hauv cov neeg mob uas muaj lub raum tsis zoo lossis hnyav. Alvimopan ib nrab-lub neej tau ncua ntev hauv cov neeg mob uas lub raum tsis zoo. Kev sib sau ntawm alvimopan thiab metabolite tuaj yeem ua tau tom qab siv ntau zaug hauv cov neeg mob uas lub raum tsis zoo. Tsis tau kawm hauv cov neeg mob uas muaj kab mob hauv lub raum kawg.

Raug rau alvimopan yog ob npaug siab dua hauv cov neeg mob uas muaj tus kab mob Crohn tus kab mob txheeb ze rau cov tib neeg noj qab haus huv lossis cov uas muaj mob Crohn tus kab mob; Cov tshuaj metabolite ntau dua hauv cov neeg mob Crohn tus kab mob.

Kev ruaj ntseg

Cia

Qhov ncauj

Tshuaj ntsiav

25 ° C (tej zaum yuav raug rau 15-30 ° C).

Kev ua

  • Peripherally ua Μ-opiate receptor antagonist.

  • Thaiv Μ-opiate receptors hauv GI txoj kev, yog li antagonizing peripheral inhibitory cuam tshuam ntawm opiates ntawm GI kev txav mus los thiab txhim kho GI ua haujlwm.

  • Tsis nkag siab yooj yim hla cov ntshav-lub hlwb teeb meem; yog li ntawd, tsis cuam tshuam rau opiate kev ua kom loog lossis ua rau cov tshuaj opiate thim rov qab, tsis zoo li lub hauv paus ua rau muaj kev sib cav sib ceg (piv txwv li, naltrexone, naloxone).

  • Tshaj tawm qhov muaj txiaj ntsig zoo dua rau Μ-opiate receptors ntau dua rau & delta;-thiab & kappa; -opiate receptors; muaj zog dua Μ-opiate receptor antagonist ntau dua li naloxone.

  • Tsis muaj opiate agonist kev ua lossis kev nyiam rau cov tsis tau txais tshuaj, suav nrog α1-, α ib2-, thiab β-adrenergic; dopamine hom 1 thiab 2 (D.1, D2); serotonin hom 2 (5-hydroxytryptamine [5-HT2A]); histamine (H.1); GABA; benzodiazepine; thiab muscarinic receptors.

Qhia rau Cov Neeg Mob

  • Qhov tseem ceeb ntawm kev qhia rau cov kws kho mob txog kev kho mob opiate mus sij hawm ntev lossis tsis tu ncua, suav nrog kev siv cov tshuaj opiates nyob rau lub lim tiam ua ntej tau txais alvimopan. Muaj peev xwm ua rau alvimopan los nag cov tsos mob GI (piv txwv li, mob plab, xeev siab, ntuav, raws plab) hauv cov neeg mob uas nyuam qhuav tau txais kev kho mob opiate; qhov tseem ceeb ntawm kev qhia tus kws kho mob yog tias muaj cov xwm txheej tsis zoo tshwm sim.

  • Qhov tseem ceeb ntawm kev qhia rau cov neeg mob tias alvimopan tau qhia rau siv hauv tsev kho mob nkaus xwb thiab tsis pub ntev tshaj 7 hnub tom qab phais mob plab.

  • Qhia cov neeg mob tias feem ntau tshwm sim tsis zoo ntawm alvimopan yog cem quav, dyspepsia, thiab ntuav.

  • Qhov tseem ceeb ntawm cov poj niam qhia rau cov kws kho mob yog tias lawv lossis npaj yuav cev xeeb tub lossis npaj yuav pub niam mis.

  • Qhov tseem ceeb ntawm kev qhia cov kws kho mob txog kev kho mob uas twb muaj lawm lossis xav txog, suav nrog cov ntawv yuav tshuaj thiab tshuaj OTC, nrog rau txhua yam kev mob nkeeg.

  • Qhov tseem ceeb ntawm kev qhia cov neeg mob ntawm lwm cov ntaub ntawv tseem ceeb tiv thaiv kab mob. (Saib Ceev faj.)

Kev npaj

Cov neeg tau txais txiaj ntsig hauv kev npaj tshuaj muaj muag hauv khw muag khoom tej zaum yuav muaj kev cuam tshuam tseem ceeb hauv kev kho mob rau qee tus neeg; sab laj cov ntawv cim khoom tshwj xeeb kom paub meej.

Thov saib mus rau ASHP Lub Chaw Pabcuam Yeeb Tshuaj Tsis Zoo rau cov ntaub ntawv ntawm qhov tsis txaus ntawm ib lossis ntau ntawm cov kev npaj no.

Kev faib tawm ntawm alvimopan raug txwv. (Saib Cov Kev Pab Cuam Tshuam Kev faib tawm raws li Kev Siv thiab Kev Tswj.)

Alvimopan

Txoj kev

Cov Tshuaj Ntau Lawm

Muaj zog

Hom Npe

Chaw tsim tshuaj paus

Qhov ncauj

Tshuaj ntsiav

12 mg (ntawm anhydrous alvimopan)

Nkag siab

Adolor, (ua los ntawm GlaxoSmithKline)

AHFSDI Qhov Tseem Ceeb ™. © Copyright 2021, Xaiv Kev Hloov Kho Lub Kaum Ob Hlis 1, 2014. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

& rab riam; Kev siv tam sim no tsis suav nrog hauv daim ntawv lo uas pom zoo los ntawm US Food and Drug Administration.

Qhia cov ntawv ua pov thawj

Kev Tsis Pom Zoo Kho Mob

ferrous gluconate 324 mg