Cov lus qhia rau kev siv tshuaj Trazhenta

Txhua cov ntsiav tshuaj-txheej txheem ntim muaj: cov tshuaj nquag: linagliptin 5 mg,

tus zam: mannitol, pregelatinized hmoov txhuv nplej siab, copovidone, magnesium stearate, Opadray liab (02F34337) (hypromellose 2910, titanium dioxide (E171), talc, macrogol 6000, liab hlau oxide (E172)).

Hloov biconvex ntsiav tshuaj nrog beveled sawv, them nrog zaj duab xis plhaub ntawm lub teeb xim liab, nrog lub lag luam ntawm lub tuam txhab cov cim ntawm ib sab thiab nrog cov ntawv sau "D5" nyob rau sab nraud ntawm lub ntsiav tshuaj.

Pharmacological kev txiav txim

Linagliptin yog ib qho inhibitor ntawm cov enzyme dipeptidyl peptidase-4 (txuas ntxiv - DPP-4), uas koom nrog qhov ua tsis tiav ntawm cov tshuaj hormones nce ntxiv - glucagon-zoo li peptide-1 (GLP-1) thiab glucose-dependant insulinotropic polypeptide (GIP). Cov tshuaj hormones no ua rau puas sai sai los ntawm enzyme DPP-4. Ob qho tag nrho ntawm cov tshuaj hormones no koom nrog cov kev tsim kho lub cev ntawm cov piam thaj hauv tsev. Theem theem ntawm incretin secretion thaum nruab hnub yog tsawg, nws nce nrawm dua tom qab noj mov. GLP-1 thiab GIP txhim kho cov tshuaj insulin biosynthesis thiab nws txoj kev zais los ntawm pancreatic beta-ketki ntawm cov ntshav qabzib thiab nce siab. Ntxiv rau, GLP-1 txo qis glucagon tso pa tawm los ntawm pancreatic alpha cells, uas ua rau kom txo qis cov piam thaj hauv daim siab. Linagliptin (TRAGENT) yog qhov ua tau zoo thiab thim rov qab nrog DPP-4, uas ua rau muaj kev nce qib zuj zus ntxiv thiab kev txuag lub sijhawm ntev ntawm lawv cov haujlwm. TRAGENTA tsub kom cov kua dej qabzib ntau yam tso cov kua dej insulin thiab txo qis cov glucagon tso tawm, uas ua rau muaj kev txhim kho hauv cov piam thaj hauv tsev. Linagliptin khi rau DPP-4 xaiv, hauv vitro nws qhov kev xaiv ntau tshaj qhov xaiv rau DPP-8 lossis kev ua haujlwm rau DPP-9 ntau dua 10,000 zaug.

Cov Tshuaj Pharmacokinetics

Qhov concentration ntawm linagliptin hauv ntshav txo qis peb-theem. Lub davhlau ya nyob twg ib nrab-lub neej ntev, ntau dua 100 teev, uas yog qhov tseem ceeb vim qhov khi ruaj khov ntawm linagliptin nrog DPP-4 enzyme; cov tshuaj txuam nrog tsis tshwm sim. Qhov zoo ib nrab-lub neej, tom qab rov ua dua ntawm linagliptin ntawm koob tshuaj 5 mg, yog li 12 teev. Nyob rau hauv cov ntaub ntawv ntawm noj linagliptin ntawm koob tshuaj 5 mg ib hnub ib zaug, cov ntshav plasma ruaj khov ntawm cov tshuaj tau tiav tom qab koob thib peb. Lub sijhawm tshuaj nyob hauv cov chaw muag tshuaj (tom qab noj cov tshuaj ntawm 5 mg), AUC (thaj chaw nyob hauv kev cia lub caij nyoog) ntawm plasma linagliptin ntau ntxiv kwv yees li 33% piv nrog thawj koob.

Tus tib neeg cov coefficients thiab cov coefficients ntawm kev sib txawv ntawm cov neeg mob sib txawv rau AUC ntawm linagliptin tau tsawg (12.6% thiab 28.5%, feem). Lub plasma AUC qhov tseem ceeb ntawm linagliptin nrog cov koob tshuaj nce ntau zuj zus. Cov tshuaj pharmacokinetics ntawm linagliptin hauv cov neeg ua haujlwm noj qab haus huv thiab cov neeg mob uas muaj ntshav qab zib hom 2 feem ntau zoo sib xws.

Qhov tiag ntawm bioavailability ntawm linagliptin yog li 30%. Txais tos ntawm linagliptin ua ke nrog cov zaub mov uas muaj cov rog ntau, nce lub sijhawm ntawm kev ua tiav Nrog_tah 2 teev thiab txo C_tah 15%, tab sis tsis muaj dab tsi ua rau A11Co-72ch- Kev cuam tshuam loj ntawm cov kev hloov C_tah thiab T_tah tsis xav. Yog li no, linagliptin tuaj yeem siv tau ob qho tib si nrog cov zaub mov thiab tsis hais txog ntawm cov khoom noj.

Raws li kev sib txuas ntawm cov tshuaj rau cov ntaub so ntswg, qhov nruab nrab pom meej ntim ntawm kev faib tawm hauv ib qho chaw hauv khw muag tshuaj tom qab ib qho kev tso ntshav ntawm linagliptin ntawm koob tshuaj 5 mg rau cov ntsiab lus noj qab haus huv yog li 1110 litres, uas qhia txog qhov kev faib tawm ntau hauv cov ntaub so ntswg. Kev khi ntawm lignagliptin rau plasma proteins nyob ntawm qhov tshuaj ntawm cov tshuaj thiab yog li 99% ntawm qhov siab ntawm 1 nmol / L, thiab nyob rau hauv qhov ntau> 30 nmol / L nws txo qis txog 75-89%, uas qhia txog qhov khov kho ntawm khi ntawm cov tshuaj nrog DPP-4 nrog nce ntau ntawm lignagliptin Cov. Thaum muaj kev kub siab ntau, thaum ua tiav ntawm DPP-4 tshwm sim, 70-80% ntawm linagliptin khi rau lwm cov ntshav plasma (ntau dua li DPP-4), thiab 30-20% ntawm cov tshuaj tau nyob hauv ntshav hauv ib qho chaw tsis xwm yeem.

Tom qab lub qhov ncauj tswj hwm ntawm daim ntawv lo 14C-linagliptin ntawm koob tshuaj 10 mg nrog tso zis, kwv yees li 5% ntawm kev tawm ntawm radioactivity. Ib feem me me ntawm cov tshuaj tau txais yog metabolized. Ib qhov tseem ceeb tshuaj tiv thaiv kab mob tau pom, qhov kev ua haujlwm ntawm yog 13.3% ntawm kev cuam tshuam ntawm linagliptin hauv lub xeev nyob ruaj nreg ntawm pharmacokinetics, uas tsis muaj kev ua haujlwm ntawm pharmacological thiab tsis cuam tshuam rau cov kev ua kom lignagliptin hauv plasma tiv thaiv DPP-4.

4 hnub tom qab tswj hwm ntawm 14C-daim ntawv lo linagliptin sab hauv txoj kev noj qab haus huv, txog 85% ntawm cov koob tshuaj tau muab tawm (nrog quav 80% thiab nrog zis 5%). Lub raum tshem tawm ntawm lub xeev cov chaw muag tshuaj muaj yees yog kwv yees li 70 ml / min.

Lub raum khiav tsis zoo

Txheeb xyuas cov tshuaj pharmacokinetics ntawm linagliptin (ntawm koob tshuaj 5 mg) hauv cov neeg mob uas muaj ntau qib ntawm mob raum tsis ua haujlwm piv nrog. kev noj qab haus huv cov ncauj lus kawm ua qhib kev tshawb fawb nrog ntau txoj kev noj tshuaj ntau dua. Txoj kev tshawb no suav nrog cov neeg mob raum tsis ua haujlwm, uas tau muab faib nyob ntawm creatinine tshem tawm mus rau lub ntsws (50 - 2.

Cov koob tshuaj hloov pauv nyob ntawm tub los ntxhais ntawm cov neeg mob tsis tas yuav. Kev sib deev tsis muaj kev cuam tshuam los ntawm kev kho mob rau lub pharmacokinetics ntawm linagliptin (raws li cov txiaj ntsig ntawm cov pejxeem pharmacokinetic tsom xam ua lub hauv paus ntawm cov ntaub ntawv los ntawm kev tshawb fawb txog qib I thiab theem II).

Koob tshuaj hloov kho nyob ntawm lub hnub nyoog ntawm cov neeg mob tsis yog qhov yuav tsum tau, txij li lub hnub nyoog tsis muaj kev kho mob tseem ceeb hauv cov tshuaj pharmacokinetics ntawm linagliptin. Hauv cov neeg mob laus (65-80 xyoo, tus neeg mob uas laus tshaj plaws. Yog 78 xyoo) thiab hauv cov neeg mob uas muaj hnub nyoog yau dua, ntshav ntau ntawm linagliptin yog qhov sib piv.

Kev tshawb fawb ntawm cov tshuaj pharmacokinetics ntawm lignagliptin hauv cov menyuam yaus tsis tau ua.

Kev ntsuas rau siv

Kev puas siab puas ntsws yog qhia rau cov neeg laus cov neeg mob ntshav qab zib ntshav qab zib hom 2 txhawm rau txhawm rau txhawm rau txhim kho glycemic: raws li kev kho mob monotherapy

- rau cov neeg mob uas tsis muaj glycemic tswj tsuas yog los ntawm kev noj haus lossis kev tawm dag zog, thiab rau cov neeg uas tsis tuaj yeem siv tshuaj metformin vim tsis haus tshuaj, lossis yog tias metformin tsis sib haum nrog kev ua haujlwm tsis zoo hauv lub raum.

- metformin, yog tias kev noj haus thiab kev tawm dag zog ua ke nrog metformin tsis muab cov tshuaj glycemic txaus,

- derivatives ntawm sulfonylurea thiab metformin, yog tias noj zaub mov zoo thiab ua kom lub cev ua ke nrog kev kho mob sib xyaw ua ke tsis muab glycemic tswj tau txaus,

- Cov tshuaj insulin nyob rau hauv ua ke nrog metformin lossis tsis yog nws, yog tias kev noj zaub mov zoo thiab kev siv lub cev ua ke nrog kev kho zoo li no tsis muaj kev tswj glycemic txaus.

Cev xeeb tub thiab lactation

Kev siv cov linagliptin hauv cov poj niam cev xeeb tub tseem tsis tau kawm.

Kev tshawb nrhiav tsiaj pom tias tsis muaj cov cim ntawm kev mob tsiaj nyaum. Raws li kev ceev faj, NTUJ yuav tsum zam thaum cev xeeb tub.

Cov ntaub ntawv tau hauv pharmacodynamic cov kev tshawb fawb hauv cov tsiaj qhia txog kev nkag mus ntawm linagliptin lossis nws cov khoom sib xyaw ua kua mis. Txoj kev pheej hmoo ntawm kev tshwm sim rau cov menyuam mos los yog menyuam yaus thaum lub sijhawm pub niam mis yog tsis suav nrog.

Qhov kev txiav txim siab tsis pub mis niam lossis noj TRAG yuav tsum yog nyob ntawm cov txiaj ntsig ntawm kev pub mis niam rau tus menyuam thiab kev kho mob rau tus niam.

Cov kev tshawb fawb ntawm cov txiaj ntsig ntawm TRAGENT rau tib neeg kev xeeb tub tsis tau ua. Cov kev tshawb fawb tsiaj pom tias tsis muaj kev cuam tshuam tsis zoo rau lub cev tsis tuaj yeem.

Tsuas tshuaj thiab tswj hwm

Qhov pom zoo koob tshuaj yog 5 mg thiab noj 1 zaug hauv ib hnub.

Nrog rau kev sib xyaw nrog kev siv cov tshuaj metformin, cov koob tshuaj metformin yuav tsum zoo ib yam.

Thaum noj cov tshuaj linagliptin ua ke nrog sulfonylurea derivatives lossis insulin, qis dua ntawm sulfonylurea lossis insulin derivatives yuav tsum xav txog txo kev pheej hmoo ntawm hypoglycemia.

Lub raum khiav tsis zoo

Cov neeg mob uas lub raum tsis ua hauj lwm koob tshuaj yuav tsis hloov kho.

Lub siab ua haujlwm tsis zoo

Pharmacokinetic cov kev tshawb fawb qhia pom tias kev hloov kho tshuaj tsis tas yuav tsum muaj rau cov neeg mob ua kom lub siab tsis zoo, txawm li cas los xij, tsis muaj kev paub dhau los ntawm kev siv tshuaj kho mob hauv cov neeg mob ntawd.

Koob tshuaj hloov kho raws li lub hnub nyoog tsis xav tau.

Txawm li cas los xij, kev kho mob hauv kev kho mob nrog cov neeg mob laus dua 80 xyoo yog qhov tsawg, pawg neeg mob no yuav tsum tau ceev faj.

Menyuam yaus thiab tub ntxhais hluas

Kev nyab xeeb thiab ua haujlwm ntawm linagliptin rau cov menyuam yaus thiab cov tub ntxhais hluas tsis tau tsim.

Yog tias ib koob tshuaj ntawm cov tshuaj tsis tiav, nws yuav tsum ua kom sai li sai tau thaum tus neeg mob nco qab qhov no. Tsis txhob noj ob zaug nyob hauv ib hnub.

Sab sij huam

Kev nyab xeeb ntawm Kev Taug Xyuas Tau Tshuaj Ntsuam Xyuas tau tag nrho 6602 tus neeg mob ntshav qab zib hom 2, nrog rau 5955 cov neeg mob noj lub hom phiaj ntawm 5 mg.

Cov kev tshawb fawb tshuaj placebo suav nrog cov kev tshawb fawb uas cov linagliptin tau siv raws li hauv qab no:

nyob rau hauv daim ntawv ntawm monotherapy (siv sijhawm luv, kav ntev txog 4 lub lis piam)

raws li kev kho mob monotherapy (ntev> 12 lub lis piam) ntxiv rau metformin

ntxiv rau kev sib xyaw ntawm metformin nrog sulfonylureas

kev ntxiv tshuaj rau cov insulin hauv kev sib txuas nrog lossis tsis muaj metformin.

Qhov ntau zaus ntawm kev phiv yog qhia raws li: ntau zaus (> 1/10), feem ntau (ntawm> 1/100 txog 1/1000 txog 1/10000 rau

Noj ntau dhau

Thaum lub sijhawm tswj xyuas cov kev kho mob hauv cov ncauj lus zoo, ib koob tshuaj linagliptin, nce mus txog 600 mg (120 zaug koob tshuaj uas pom zoo), tau pom zoo zoo. Tus neeg tsis muaj kev paub txog kev noj tshuaj ntau dua 600 mg.

Yog tias muaj qhov noj ntau dhau, nws raug nquahu kom siv cov kev ntsuas ib txwm muaj ntawm kev txhawb nqa qhov xwm txheej, piv txwv li, tshem tawm ib qho tshuaj tsis xwm yeem los ntawm lub plab hnyuv, kev soj ntsuam kev kho mob thiab kev kho mob raws li kev ntsuas pom.

Kev cuam tshuam nrog lwm yam tshuaj

Hauv tshuaj ntsuam xyuas tshuaj vitro

Linagliptin yog qhov ua kom muaj kev sib tw tsis muaj zog ntawm CYP3A4 isoenzyme, thiab qhov tsis muaj zog lossis txo qis ntawm cov txheej txheem ntawm kev ua ntawm isoenzyme no. Linagliptin tsis inhibit lwm yam CYP isoenzymes thiab tsis yog qhov ua rau lawv xav tsis txog.

Linagliptin yog lub cev rau P-glycoprotein (P-gp) thiab txwv tsis pub P-glycoprotein-mediated digoxin thauj. Muab cov ntaub ntawv no thiab cov txiaj ntsig ntawm vivo sib cuam tshuam yeeb tshuaj, lub peev xwm ntawm linagliptin los cuam tshuam nrog lwm cov substrates rau P-gp yog suav tias tsis zoo.

Hauv vivo tshuaj ntsuam kev sib cuam tshuam

Cov nyhuv ntawm lwm cov tshuaj ntawm linagliptin

Cov ntaub ntawv hauv qab no kev kho mob pom tau hais tias muaj kev cuam tshuam me me ntawm kev sib cuam tshuam hauv tsev kho mob nrog rau kev siv tshuaj ib txhij.

Metformin: kev sib xyaw ua ke ntawm kev siv tshuaj metformin rov qab rau ib zaug ntawm 850 mg 3 zaug hauv ib hnub thiab linagliptin ntawm koob tshuaj 10 mg 1 zaug hauv ib hnub tsis ua rau thaj chaw kho mob hloov pauv tseem ceeb ntawm pharmacokinetics ntawm linagliptin hauv cov neeg tuaj noj qab haus huv.

Sulfonylurea derivatives: pharmacokinetics nyob rau hauv lub xeev qhov sib luag ntawm 5 mg ntawm linagliptin tsis muaj kev cuam tshuam los ntawm kev siv ua ke ntawm kev siv ib zaug ntawm 1.75 mg ntawm glibenclamide (glyburide).

Ritonavir: kev sib xyaw ua ke ntawm linagliptin (ib koob tshuaj 5 mg ntawm qhov ncauj) thiab ritonavir (ntau koob ntawm 200 mg ntawm qhov ncauj), ib yam tshuaj tiv thaiv ntawm P-glycoprotein thiab isoenzyme CYP3A4, nce AUC thiab C_tah linagliptin txog 2 zaug thiab 3 zaug, ntsig txog. Qhov tsom pub dawb, uas feem ntau tsawg dua li 1% ntawm kev kho tshuaj ntawm linagliptin, nce 4-5 zaug tom qab sib koom tes nrog ritonavir. Kev ua qauv ntawm ntshav muaj peev xwm lignagliptin nyob hauv lub xeev qhov sib luag ntawm cov tshuaj pharmacokinetics nrog thiab tsis muaj ritonavir tau qhia tias kev nce ntxiv yuav tsum tsis txhob nrog cov lignagliptin nce ntxiv. Cov kev hloov pauv no hauv cov chaw muag tshuaj ntawm lignagliptin tsis yog qhov tseem ceeb hauv kev kho mob. Yog li, qhov chaw kho mob sib cuam tshuam nrog lwm tus P-glycoprotein / SURZA4 inhibitors tsis xav.

Rifampicin: rov ua ua ke siv ntawm 5 mg ntawm linagliptin thiab rifampicin, tus nquag ua haujlwm ntawm P-gp thiab isoenzyme CYP3A4, ua rau txo qis ntawm qhov tseem ceeb ntawm AUC thiab C_tah lignagliptin, feem, los ntawm 39.6% thiab 43.8%, thiab kom txo qis hauv kev cuam tshuam ntawm kev ua si ntawm basal dipeptidyl peptidase-4 los ntawm 30%. Yog li, qhov kev ua tau zoo tshaj plaws ntawm linagliptin, siv nrog kev sib xyaw nrog P-gp lub zog ua haujlwm, tsis tuaj yeem ua tiav, tshwj xeeb tshaj yog siv lub caij nyoog ntawm kev sib xyaw. Kev siv nrog lub zog sib xyaw nrog P-gp thiab CYP3A4, xws li carbamazepine, phenobarbital thiab phenytoin, tsis tau kawm.

Cov nyhuv ntawm linagliptin ntawm lwm cov tshuaj

Hauv cov kev tshawb fawb soj ntsuam, raws li qhia hauv qab no, tsis muaj kev cuam tshuam los ntawm lub chaw muag tshuaj ntawm metformin, glyburide, simvastatin, warfarin, digoxin thiab qhov ncauj tshuaj tiv thaiv, uas yog qhov tseeb hauv vivo thiab ua raws li lub peev xwm qis ntawm lignagliptin nkag rau hauv kev sib txuas yeeb tshuaj nrog cov substrates rau CYP3A4 , CYP2C9, CYP2C8, P-dr thiab thauj cov lwg me me ntawm cations organic.

Metformin: kev sib xyaw ua ke siv ntawm linagliptin ntawm koob tshuaj 10 mg ib zaug ib hnub thiab 850 mg ntawm metformin, ib qho mob ntawm cov organic cations, tsis ua rau thaj chaw tseem ceeb kws kho mob ntawm metformin hauv cov neeg tuaj noj qab haus huv. Yog li, linagliptin tsis yog qhov tiv thaiv ntawm Uransportag • sib kho los ntawm cov organic cations.

Sulfonylurea derivatives: kev sib xyaw ua ke ntawm 5 mg ntawm linagliptin thiab ib koob tshuaj ntawm 1.75 mg ntawm glibenclamide (gliburide) ua rau muaj kev tsis txaus ntseeg hauv kev kho mob tsawg hauv AUC thiab C_tah glibenclamide los ntawm 14%. Txij li thaum glibenclamide feem ntau yog metabolized los ntawm CYP2C9, cov ntaub ntawv no tseem tau lees tias linagliptin tsis yog inhibitor ntawm CYP2C9. Tsis muaj kev sib cuam tshuam hauv chaw kho mob yog xav tau nrog lwm tus sulfonylurea derivatives (piv txwv li, glipizide, tolbutamide thiab glimepiride), uas, zoo li glibenclamide, feem ntau yog metabolized nrog CYP2C9.

Digoxin: kev sib xyaw ua ke nrog kev siv 5 mg ntawm linagliptin thiab 0.25 mg ntawm digoxin tsis cuam tshuam rau pharmacokinetics ntawm digoxin hauv cov neeg tuaj noj qab haus huv. Yog li, hauv vivo linagliptin tsis yog inhibitor ntawm P-glycoprotein-mediated thauj.

Warfarin: linagliptin, thov dua ib zaug ntawm koob tshuaj 5 mg ib hnub, tsis hloov pauv tshuaj pharmacokinetics ntawm S (-) lossis R (+) warfarin, uas yog tshuaj rau CYP2C9 thiab tau txais kev tso cai ib zaug.

Simvastatin: linagliptin thaum noj los ntawm cov neeg ua haujlwm noj qab haus huv nyob rau hauv ntau qhov muaj feem cuam tshuam tsawg kawg rau pharmacokinetics ntawm simvastatin, ib qhov tsis txaus siab rau CYP3A4. Tom qab noj linagliptin ntawm koob tshuaj 10 mg (saum toj no koob tshuaj) ua ke nrog simvastatin ntawm ib koob ntawm 40 mg rau 6 hnub, AUC ntawm simvastatin hauv cov ntshav ntshav tau nce 34%, thiab C_tah hauv cov ntshav ntshav - los ntawm 10%.

Qhov kev txwv tsis pub muaj qhov ncauj: kev siv sib xyaw ntawm linagliptin ntawm koob tshuaj 5 mg nrog levonorgestrel lossis ethinyl estradiol tsis hloov pauv chaw muag tshuaj ntawm cov tshuaj no.

Kev tiv thaiv kev nyab xeeb

Kev ntxhov siab yuav tsum tsis txhob siv rau hauv cov neeg mob uas muaj hom 1 mob ntshav qab zib mellitus lossis rau kev kho mob ntshav qab zib ketoacidosis.

Qhov xwm txheej ntawm cov ntshav qog nqaij hlav nyob rau hauv rooj plaub ntawm kev siv cov linagliptin li cov tshuaj tua kab mob tau muab piv rau cov placebo.

Hauv cov kev tshawb fawb soj ntsuam, nws tau tshaj tawm tias qhov tshwm sim ntawm kev mob ntshav qab zib nyob rau hauv cov ntaub ntawv ntawm kev siv ntawm linagliptin hauv kev sib xyaw nrog cov tshuaj uas tsis ntseeg tias ua rau hypoglycemia (metformin, thiazolidinedione derivatives) zoo ib yam li cov tshuaj tiv thaiv cov tshuaj placebo.

Thaum noj cov tshuaj linagliptin ntxiv rau sulfonylurea derivatives (nrog rau kev kho mob metformin yooj yim), pes tsawg tus neeg mob qog ntshav nce ntxiv piv nrog cov pab pawg placebo.

Cov tsim tawm ntawm sulfonylureas thiab cov kua dej insulin tuaj yeem ua rau cov ntshav qab zib ntshav qab zib tsawg. Linagliptin txuam nrog sulfonylurea derivatives thiab / lossis insulin yuav tsum ua nrog ceev faj. Yog tias tsim nyog, yuav tsum tau txo koob tshuaj sulfonylurea lossis tshuaj insulin rau lwm tus.

Thaum lub sijhawm tom qab tau tshaj tawm kev siv linagliptin, cov lus ceeb toom ntawm kev nthuav dav ntawm kev nthuav dav ntawm tus mob ntsig ua tus kab mob siab tau txais. Cov neeg mob yuav tsum tau qhia paub txog cov yam ntxwv ntawm tus yam ntxwv ntawm tus mob pancreatitis: mob mob plab mus ntev. Kev raug mob ntawm tus kab mob Pancreatitis tau pom tom qab kev ncua ntawm linagliptin. Yog pom tias muaj tus mob pancreatitis, TRAG yuav tsum tsis ua mus ntxiv.

Tso tawm daim ntawv thiab muaj pes tsawg leeg

Lub trazenta muaj nyob rau hauv daim ntawv ntawm cov zaj duab xis-ntsiav tshuaj: biconvex, puag ncig, nrog cov ntug beveled, lub teeb liab hauv cov xim, nrog kev sau ua D5 ntawm ib sab thiab lub cim ntawm cov tuam txhab tsim tawm ntawm lwm tus (7 pcs. Hauv cov hlwv, hauv ib daim duab los qhia 2, 4 los yog 8 blisters, 10 pcs. Hauv cov hlwv, hauv daim duab los qhia 3 lub hlwv).

Muaj pes tsawg leeg ib 1 ntsiav tshuaj:

• cov tshuaj nquag: linagliptin - 5 mg,
• ntu ntu: pregelatinized hmoov txhuv nplej siab, copovidone, hmoov txhuv nplej pob kws, magnesium stearate, mannitol,
• zaj duab xis sheath: Opadray liab 02F34337 (titanium dioxide, macrogol 6000, talc, hypromellose, zas hlau oxide liab).

Tsuas tshuaj thiab tswj hwm

Cov tshuaj vwm siv tau qhov ncauj. Kev noj tshuaj tsis yog nyob ntawm lub sijhawm noj mov thiab tuaj yeem ua lub sijhawm thaum nruab hnub.

Cov koob tshuaj pom zoo yog 1 ntsiav tshuaj (5 mg) ib hnub ib zaug.

Yog tias rov qab noj dua ntxiv, tus neeg mob yuav tsum siv cov tshuaj kom sai li nws nco qab cov ntsiav tshuaj ploj. Muab ob npaug tshuaj thiab noj 2 ntsiav tshuaj hauv ib hnub yuav tsum tsis txhob ua.

Thaum muaj mob hauv lub siab thiab / lossis lub raum tsis ua haujlwm, thiab hauv cov neeg laus, yuav tsum tsis txhob kho qhov hnyav.

Sab sij huam

Muaj cov mob tshwm sim ntau rau kev kho mob monotherapy nrog Trazent thiab kev sib txuam nrog kev kho mob nrog lwm tus neeg mob hypoglycemic:

• lub plab zom mov: pancreatitis,
• kev ua pa: hnoos,
• kev tiv thaiv kab mob: kev ua kom tsis haum lub cev,
• cov kab mob kis: nasopharyngitis.

Cov tshuaj hauv qab no uas yog ib feem ntawm txoj kev kho mob tuaj yeem ua rau muaj kev phiv ntxiv:

• pioglitazone, metformin thiab pioglitazone: hyperlipidemia thiab qhov hnyav tuaj,
• sulfonylurea derivatives: hypertriglyceridemia,
• Cov tshuaj insulin: cem quav,
• sulfonylurea derivatives thiab metformin: mob ntshav qab zib.

Hauv lub sijhawm soj ntsuam tom qab tshaj tawm, kev phiv los ntawm cov kab ke hauv qab no thiab cov kabmob tau raug sau tseg:

• plab hnyuv tawm: ua rau lub plab zom mov ntawm lub qhov ncauj,
• kev tiv thaiv kab mob: urticaria, Quincke's edema,
• daim tawv nqaij: ua pob.

Cov lus qhia tshwj xeeb

Thaum siv cov tshuaj Trazhenta ib txhij nrog sulfonylurea derivatives, ceev faj yuav tsum ua kom tawm dag zog, txij li tom kawg tuaj yeem ua rau mob ntshav qab zib. Yog tias tsim nyog, nws muaj peev xwm txo cov koob tshuaj sulfonylurea derivatives.

Trazhenta tsis nce ntxiv kev pheej hmoo ntawm kev tsim kab mob ntawm cov kab mob plawv.

Yog xav tias tsam muaj kab mob pancreatitis tiag, cov tshuaj yuav tsum tsis ua mus ntxiv.

Cov kev kawm tshwj xeeb ntawm cov nyhuv ntawm linagliptin ntawm kev muaj peev xwm tsav tsheb thiab ua haujlwm nrog cov phom sij txaus ntshai tsis tau ua. Dua li ntawm qhov no, vim muaj kev pheej hmoo ntawm kiv taub hau, thaum kho nrog cov tshuaj, ceev faj yuav tsum ua kom zoo thaum koom nrog kev ua si uas yuav tsum muaj kev xav ntau ntxiv thiab qhov ceev ntawm psychomotor tshua.

Yeeb tshuaj sib cuam tshuam

Nrog rau kev siv cov tshuaj Trazhenta nrog metformin, glibenclamide, simvastatin, pioglitazone, warfarin, digoxin, rifampicin, ritonavir thiab tshuaj noj hauv qhov ncauj, cov kws kho mob ntawm lignagliptin thiab cov tshuaj teev tsis tau hloov lossis tsis hloov pauv.

Txoj kev ntawm daim ntawv thov Trazenti thiab ntau npaum li cas

Trazhenta noj qhov ncauj ntawm qhov ncauj pom zoo ntawm 5 mg (1 ntsiav tshuaj) ib hnub ib zaug.

Cov cuab yeej siv tau txhua lub sijhawm ntawm hnub, tsis hais noj mov, nyiam dua txhua hnub nyob rau tib lub sijhawm. Yog tias ib qho ntawm cov ntsiav tshuaj ploj, koj tuaj yeem siv nws txhua lub sijhawm sai li uas tus neeg mob nco qab qhov no, tab sis nws tsis pom zoo kom noj ob zaug hauv ib hnub.

Cov Ntaub Ntawv Ntxiv

Cov tshuaj uas yog neeg mob ntawm sulfonylureas, feem ntau, ua rau muaj kev txhim kho hauv lub qog ntshav qab zib. Yog li, qee kis, nws muaj peev xwm txo qis lawv cov tshuaj ntau npaum li cas thaum sau ntawv nrog Trazhenta.

Rau cov neeg mob uas mob raum tsis zoo, cov tshuaj no tau pom zoo kom coj los ua ke nrog lwm cov tshuaj rau hypoglycemic.

Raws li kev txheeb xyuas, Trazhenta thiab analogues txo qis kev saib xyuas ntawm glycosylated hemoglobin thiab qabzib thaum noj cov ntsiav tshuaj sai.

Vim tias qhov ua rau kiv taub hau, ceev faj yog qhia thaum tsav tsheb thiab lub tshuab loj thaum siv tshuaj kho.

Cov lus qhia rau Trazent qhia tias cov ntsiav tshuaj yuav tsum tau muab cia rau hauv qhov tsaus ntuj, qhuav, txias thiab tawm ntawm qhov chaw ncav cuag ntawm cov menyuam.