Onglisa: yeeb tshuaj rau ntshav qab zib, tshuaj xyuas thiab analogues ntawm ntsiav tshuaj
Cov nplooj ntawv no muab cov npe ntawm tag nrho cov Ongliz analogues los ntawm cov pes tsawg leeg thiab qhia rau kev siv. Cov npe ntawm cov pheej yig analogues, thiab koj kuj tuaj yeem sib piv cov nqi hauv cov khw muag tshuaj.
- Qhov pheej yig tshaj analogue ntawm Ongliz:Trazenta
- Tus nyiam tshaj plaws ntawm Ongliz:Vipidia
- Kev faib tawm ATX: Saxagliptin
- Cov khoom xyaw / cov khoom xyaw: saxagliptin
# | Npe | Nqe hauv Lavxias | Nqe hauv Ukraine |
---|---|---|---|
1 | Trazenta linagliptin Analogue hauv kev taw qhia thiab txoj kev siv | 89 rub | 1434 UAH |
2 | Galvus vildagliptin Analogue hauv kev taw qhia thiab txoj kev siv | 245 RUB | 895 UAH |
3 | Vipidia alogliptin Analogue hauv kev taw qhia thiab txoj kev siv | 350 rub | 1250 UAH |
4 | Januvia sitagliptin Analogue hauv kev taw qhia thiab txoj kev siv | 1369 rub | 277 UAH |
Thaum xam xyuas tus nqi pheej yig analogues ntawm Ongliz tus nqi yam tsawg kawg nkaus uas tau pom hauv daim ntawv teev tus nqi muab los ntawm cov khw muag tshuaj tau raug coj los suav
# | Npe | Nqe hauv Lavxias | Nqe hauv Ukraine |
---|---|---|---|
1 | Vipidia alogliptin Analogue hauv kev taw qhia thiab txoj kev siv | 350 rub | 1250 UAH |
2 | Trazenta linagliptin Analogue hauv kev taw qhia thiab txoj kev siv | 89 rub | 1434 UAH |
3 | Januvia sitagliptin Analogue hauv kev taw qhia thiab txoj kev siv | 1369 rub | 277 UAH |
4 | Galvus vildagliptin Analogue hauv kev taw qhia thiab txoj kev siv | 245 RUB | 895 UAH |
5 | Nesina alogliptin Analogue hauv kev taw qhia thiab txoj kev siv | -- | -- |
Muab daim ntawv teev cov tshuaj analogues raws li kev txheeb cais ntawm cov tshuaj feem ntau thov
Analogs los ntawm qhov taw qhia thiab cov qauv ntawm kev siv
Npe | Nqe hauv Lavxias | Nqe hauv Ukraine |
---|---|---|
Januvia sitagliptin | 1369 rub | 277 UAH |
Galvus vildagliptin | 245 RUB | 895 UAH |
Nesina alogliptin | -- | -- |
Vipidia alogliptin | 350 rub | 1250 UAH |
Trazhenta linagliptin | 89 rub | 1434 UAH |
Sib txawv muaj pes tsawg leeg, tuaj yeem ua ke nyob rau hauv kev taw qhia thiab cov qauv ntawm daim ntawv thov
Npe | Nqe hauv Lavxias | Nqe hauv Ukraine |
---|---|---|
Avantomed rosiglitazone, metformin hydrochloride | -- | -- |
Bagomet Metformin | -- | 30 UAH |
Glucofage metformin | 12 RUB | 15 UAH |
Globophage xr metformin | -- | 50 UAH |
Reduxin Met Metformin, Sibutramine | 20 RUB | -- |
Dianormet | -- | 19 UAH |
Diaformin metformin | -- | 5 UAH |
Metformin metformin | 13 RUB | 12 UAH |
Tshuaj Metformin sandoz metformin | -- | 13 UAH |
Siofor | 208 rub | 27 UAH |
Formin metformin hydrochloride | -- | -- |
Emnorm EP Metformin | -- | -- |
Megifort Metformin | -- | 15 UAH |
Tshuaj hlau Metformin | -- | 20 UAH |
Tshuaj Metamin SR Metformin | -- | 20 UAH |
Metfogamma metformin | 256 rub | 17 UAH |
Tefor metformin | -- | -- |
Glycometer | -- | -- |
Glycomet SR | -- | -- |
Tshuaj nyob | 37 RUB | -- |
Metformin Canon metformin, ovidone K 90, pob kws hmoov txhuv, crospovidone, magnesium stearate, talc | 26 RUB | -- |
Insuffor metformin hydrochloride | -- | 25 UAH |
Metformin-teva metformin | 43 txhuam | 22 UAH |
Diaformin SR metformin | -- | 18 UAH |
Mepharmil Metformin | -- | 13 UAH |
Metformin Yawg Liaj Ua Teb Metformin | -- | -- |
Glibenclamide Glibenclamide | 30 RUB | 7 UAH |
Maninyl Glibenclamide | 54 rub | 37 UAH |
Glibenclamide-Health Glibenclamide | -- | 12 UAH |
Glyurenorm glycidone | 94 rub | 43 UAH |
Bisogamma Glyclazide | 91 rub | 182 UAH |
Glidiab Glyclazide | 100 tshiav | 170 UAH |
Lawj Xeeb MR | -- | 92 UAH |
Kev kuaj mob mr Gliclazide | -- | 15 UAH |
Glidia MV Gliclazide | -- | -- |
Glykinorm Gliclazide | -- | -- |
Gliclazide Gliclazide | 231 rub | 44 UAH |
Glyclazide 30 MV-Indar Glyclazide | -- | -- |
Glyclazide-Kev Noj Qab Haus Huv Gliclazide | -- | 36 UAH |
Glioral Glyclazide | -- | -- |
Kev kuaj mob Gliclazide | -- | 14 UAH |
Diazide MV Gliclazide | -- | 46 UAH |
Osliklid Gliclazide | -- | 68 UAH |
Diadeon gliclazide | -- | -- |
Glyclazide MV Gliclazide | 4 RUB | -- |
Amaril | 27 RUB | 4 UAH |
Glemaz glimepiride | -- | -- |
Glian glimepiride | -- | 77 UAH |
Glimepiride Glyride | -- | 149 UAH |
Glimepiride diapiride | -- | 23 UAH |
Thaj neeb | -- | 12 UAH |
Glimax glimepiride | -- | 35 UAH |
Glimepiride-Lugal glimepiride | -- | 69 UAH |
Av nplaum glimepiride | -- | 66 UAH |
Diabrex glimepiride | -- | 142 UAH |
Meglimide glimepiride | -- | -- |
Melpamide Glimepiride | -- | 84 UAH |
Perinel glimepiride | -- | -- |
Glempid | -- | -- |
Raug Tsim | -- | -- |
Glimepiride glimepiride | 27 RUB | 42 UAH |
Glimepiride-teva glimepiride | -- | 57 UAH |
Glimepiride Canon glimepiride | 50 RUB | -- |
Glimepiride Pharmstandard glimepiride | -- | -- |
Dimaril glimepiride | -- | 21 UAH |
Glamepiride diamerid | 2 RUB | -- |
Amaryl M Limepiride Micronized, Metformin Hydrochloride | 856 rub | 40 UAH |
Glibomet glibenclamide, metformin | 257 rub | 101 UAH |
Glucovans glibenclamide, metformin | 34 RUB | 8 UAH |
Dianorm-m Glyclazide, Metformin | -- | 115 UAH |
Dibizid-m glipizide, metformin | -- | 30 UAH |
Douglimax glimepiride, metformin | -- | 44 UAH |
Duotrol glibenclamide, metformin | -- | -- |
Gluconorm | 45 rub | -- |
Glibofor metformin hydrochloride, glibenclamide | -- | 16 UAH |
Avandamet | -- | -- |
Avandaglim | -- | -- |
Janumet metformin, sitagliptin | 9 RUB | 1 UAH |
Velmetia metformin, sitagliptin | 6026 rub | -- |
Galvus Met vildagliptin, metformin | 259 RUB | 1195 UAH |
Tripride glimepiride, metformin, pioglitazone | -- | 83 UAH |
Comboglize XR metformin, saxagliptin | -- | 424 UAH |
Comboglyz Prolong metformin, saxagliptin | 130 rub | -- |
Gentadueto linagliptin, metformin | -- | -- |
Vipdomet metformin, alogliptin | 55 RUB | 1750 UAH |
Sinjardi empagliflozin, metformin hydrochloride | 240 rub | -- |
Voglibose Oxide | -- | 21 UAH |
Glutazone pioglitazone | -- | 66 UAH |
Dropia Sanovel pioglitazone | -- | -- |
Lixumia lixisenatide | -- | 2498 UAH |
Guarem Guar cob | 9950 rub | 24 UAH |
Insvada repaglinide | -- | -- |
Novonorm Repaglinide | 30 RUB | 90 UAH |
Cov Chaw Tshaj Tawm Repaglinide | -- | -- |
Baeta Exenatide | 150 rub | 4600 UAH |
Baeta Ntev Exenatide | 10248 rub | -- |
Viktoza liraglutide | 8823 rub | 2900 UAH |
Saxenda liraglutide | 1374 rub | 13773 UAH |
Forksiga Dapagliflozin | -- | 18 UAH |
Forsiga Dapagliflozin | 12 RUB | 3200 UAH |
Invocana canagliflozin | 13 RUB | 3200 UAH |
Jardins Empagliflozin | 222 RUB | 566 UAH |
Trulicity Dulaglutide | 115 RUB | -- |
Yuav ua li cas thiaj nrhiav tau qhov pheej yig tshuaj ntawm cov tshuaj kim?
Txhawm rau kom pom qhov pheej yig cov khoom sib piv rau cov tshuaj, cov dav dav lossis cov lus sau, ua ntej txhua yam peb pom zoo kom them sai sai rau qhov muaj pes tsawg leeg, uas yog rau tib cov tshuaj nquag thiab qhia tau rau kev siv. Cov tshuaj sib xyaw zoo ib yam ntawm cov tshuaj yuav qhia tau tias cov tshuaj cuam tshuam nrog cov tshuaj, kws tshuaj sib npaug lossis chaw muag tshuaj. Txawm li cas los xij, tsis txhob hnov qab txog qhov ua tsis muaj zog ntawm cov tshuaj uas zoo sib xws, uas tuaj yeem cuam tshuam kev nyab xeeb thiab ua haujlwm. Tsis txhob hnov qab txog cov lus qhia ntawm cov kws kho mob, kev noj tshuaj rau nws tus kheej tuaj yeem tsim kev puas tsuaj rau koj kev noj qab haus huv, yog li nco ntsoov sab laj nrog koj tus kws kho mob ua ntej siv cov tshuaj.
Qhia Onglisa
LUS QHIA
ntawm kev siv cov tshuaj
Onglisa
Daim ntawv tso tawm
Zaj duab xis-coated ntsiav tshuaj.
Muaj pes tsawg leeg
Saxagliptin 2.5 thiab 5 mg,
Cov zam: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, 1 M hydrochloric acid los yog sodium hydroxide daws 1 M, Opadray II dawb (polyvinyl cawv, titanium dioxide, macrogol (PEG 3350), talc), Opadray II daj (cawv polyvinyl, titanium dioxide, macrogol (PEG 3350), talc, hlau zas xim daj oxide (E172)), kua xim Opacode xiav (shellac hauv ethyl cawv, FD&C xiav # 2 / indigo carmine txhuas xim muaj xim (E132), n-butyl cawv, propylene glycol, isopropyl cawv, 28% ammonium roksid).
Ntim
Hauv ib pob ntawm 30 ntsiav tshuaj.
Pharmacological kev txiav txim
ONGLISA - saxagliptin - ib qho muaj zog xaiv tau kev sib tw muaj zog ntawm dipeptidyl peptidase-4 (DPP-4).
Hauv cov neeg mob uas muaj ntshav qab zib hom 2 mellitus, kev tswj hwm ntawm saxagliptin txwv tsis pub cov kev ua haujlwm ntawm DPP-4 enzyme tsis pub dhau 24 teev. polypeptide (HIP), qhov txo qis hauv cov concentration ntawm glucagon thiab nce ntxiv ntawm cov piam thaj hauv cov lus teb ntawm beta hlwb, uas ua rau muaj qhov nce ntawm cov tshuaj insulin thiab C-peptide.
Kev tso tawm ntawm cov insulin los ntawm pancreatic beta hlwb thiab txo qis ntawm kev tso tawm ntawm glucagon los ntawm pancreatic alpha hlwb ua rau txo qis glycemia thiab postprandial glycemia.
Qhov kev ua tau zoo thiab kev nyab xeeb ntawm saxagliptin thaum noj ntawm 2.5 mg, 5 mg thiab 10 mg 1 lub sijhawm / tau kawm hauv rau ob qhov muag dig, qhov chaw tshuaj uas tswj tau nyob hauv 4148 cov neeg mob ntshav qab zib hom 2.Kev noj cov tshuaj tau nrog cov lus pom tseeb txhim kho hauv glycosylated hemoglobin (HbA1c), yoo plasma ntshav qab zib (GPN) thiab ntshav qab zib (PPG) ntshav plasma piv nrog kev tswj hwm.
Cov neeg mob nyob rau hauv uas hom phiaj glycemic qib tsis tuaj yeem ua tiav nrog saxagliptin raws li kev kho mob monotherapy tau ntxiv cov tshuaj metformin, glibenclamide lossis thiazolidinediones. Thaum noj saxagliptin ntawm koob tshuaj 5 mg, qhov txo qis HbA1c raug pom tom qab 4 lub lis piam thiab GPN tom qab 2 lub lis piam. Hauv pawg ntawm cov neeg mob tau txais saxagliptin sib xyaw nrog metformin, glibenclamide lossis thiazolidinediones, qhov txo qis hauv HbA1c kuj tseem pom tom qab 4 lub lis piam thiab GPN tom qab 2 lub lis piam.
Cov nyhuv ntawm saxagliptin ntawm cov lipid profile zoo ib yam li cov placebo. Thaum kho nrog saxagliptin, tsis muaj qhov ceeb toom hauv lub cev qhov hnyav.
Onglisa, cim qhia rau siv
Hom 2 mob ntshav qab zib mellitus ntxiv rau kev noj haus thiab kev tawm dag zog kom txhim kho glycemic tswj kom zoo:
- tshuaj kho mob,
- pib kev sib txuam nrog kev siv tshuaj metformin,
- ntxiv rau kev kho mob monotherapy nrog metformin, thiazolidinediones, sulfonylurea derivatives, thaum tsis muaj glycemic tswj tau txaus hauv qhov kev kho no.
Cov Yuav Tsum Muaj
- yam 1 mob ntshav qab zib mellitus (siv tsis tau kawm),
- siv cov tshuaj insulin (tsis kawm),
- mob ketoacidosis,
- kev tsis haum ntshav lub cev, tsis ua mob lactase thiab qabzib-galactose malabsorption,
- kev xeeb tub
- lactation,
- lub hnub nyoog txog 18 xyoo (kev nyab xeeb thiab tsis tau muaj kev kawm tau zoo),
- nce ib tug neeg rhiab rau ib feem ntawm cov tshuaj.
Tsuas tshuaj thiab tswj hwm
Cov tshuaj yog tawm hauv lub qhov ncauj, tsis hais los ntawm cov khoom noj.
Nrog rau kev kho mob monotherapy, qhov kev xav pom zoo ntawm saxagliptin yog 5 mg 1 zaug / hnub.
Hauv kev sib xyaw ua ke, qhov tshuaj pom zoo ntawm saxagliptin yog 5 mg 1 zaug / hnub ua ke nrog metformin, thiazolidinediones lossis sulfonylureas.
Thaum pib sib xyaw nrog kev siv tshuaj metformin, koob tshuaj saxagliptin pom zoo yog 5 mg 1 zaug / hnub, thawj koob tshuaj metformin yog 500 mg / hnub. Yog tias tsis teb rov qab, qhov tshuaj ntawm cov metformin yuav raug nce ntxiv.
Yog tias koj hla Ongliz®, koj yuav tsum noj lub ntsiav tshuaj uas ploj lawm kom sai li sai uas tus neeg mob nco qab qhov no, tab sis koj yuav tsum tsis txhob noj ob npaug ntawm cov tshuaj rau ib hnub.
Rau cov neeg mob uas tsis muaj lub raum tsis txaus (CC> 50 ml / min), tsis tas yuav txhaj tshuaj. Rau cov neeg mob uas mob raum lossis hnyav lub raum tsis ua haujlwm (CC ≤ 50 ml / min), ib yam li rau cov neeg mob hemodialysis, koob tshuaj Ongliz® yog 2,5 mg 1 zaug / hnub. Qhov tshuaj yuav tsum tau noj thaum kawg ntawm kev kho mob hemodialysis. Kev siv cov saxagliptin rau cov neeg mob ua mob rau txoj hlab ntshav peritoneal lim ntshav tsis tau kawm. Ua ntej pib kho nrog saxagliptin thiab thaum kho, nws raug nquahu kom kuaj xyuas lub raum kev ua haujlwm.
Yog tias daim siab ua haujlwm tsis zoo, hloov kho mob me, mob hnyav thiab hnyav tsis tas yuav ua haujlwm.
Koob tshuaj hloov kho hauv cov neeg mob laus tsis tas yuav. Txawm li cas los xij, thaum xaiv cov koob tshuaj, nws yuav tsum tau yug los rau hauv lub siab tias hauv pawg no ntawm cov neeg mob, qhov kev txo qis ntawm lub raum kev ua haujlwm yog qhov ntau dua.
Cov kev nyab xeeb thiab kev ua tau zoo ntawm cov tshuaj hauv cov neeg mob hnub nyoog qis dua 18 xyoo tsis tau kawm.
Thaum siv nrog cov muaj zog CYP 3A4 / 5 inhibitors, xws li ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir thiab telithromycin, koob tshuaj pom zoo ntawm Ongliz® yog 2.5 mg 1 zaug / hnub
Cev xeeb tub thiab lactation
Vim tias qhov tseeb hais tias kev siv saxagliptin thaum cev xeeb tub tsis tau kawm, cov tshuaj yuav tsum tsis txhob muab tshuaj rau lub sijhawm no.
Kuj tsis paub meej tias saxagliptin kis mus rau leej niam mis li cas.Vim tias qhov tseeb ntawm kev nkag mus ntawm saxagliptin mus rau niam mis tsis tau txiav txim siab, kev pub mis niam yuav tsum tau nres rau lub sijhawm ntawm kev kho mob nrog saxagliptin lossis kev kho yuav tsum tsis ua haujlwm ntxiv, suav txog qhov kev pheej hmoo ntawm tus menyuam thiab cov txiaj ntsig rau leej niam.
Sab sij huam
Sab saud mob ntsws
Mob txeeb zig
Mob plab zom mov
Kev mob pob txha
Ntuav
Mob taub hau.
Cov lus qhia tshwj xeeb
Kev siv cov tshuaj Onglisa® sib xyaw nrog cov tshuaj insulin, zoo li hauv kev kho peb zaug nrog metformin thiab thiazolidinediones lossis metformin thiab sulfonylurea derivatives, tsis tau kawm.
Cov neeg mob uas lub raum tsis ua hauj lwm zoo.
Kev hloov koob tshuaj yog pom zoo rau cov neeg mob uas mob raum mus rau lub raum tsis ua hauj lwm zoo, thiab rau cov neeg mob ntawm hemodialysis. Ua ntej pib txoj kev kho thiab tsis tseg thaum kho nrog cov tshuaj, nws raug pom zoo los soj ntsuam lub raum ua haujlwm.
Siv nrog rau cov tshuaj uas tuaj yeem ua rau ntshav qab zib ntshav qab zib.
Cov tsim tawm ntawm sulfonylureas tuaj yeem ua rau cov ntshav qog ntshav qis, yog li, txo qis kev pheej hmoo ntawm kev mob ntshav qab zib thaum siv Ongliz®, yuav tsum tau txo koob tshuaj sulfonylureas.
Kev ua haujlwm tsis haum siab.
Cov tshuaj yuav tsum tsis txhob raug sau tseg rau cov neeg mob uas tau muaj qhov tsis haum lub siab thaum siv lwm lub tshuaj DPP-4 inhibitors.
Cov neeg laus cov neeg mob.
Raws li kev tshawb pom hauv chav kho mob, kev ua tau zoo thiab kev nyab xeeb hauv cov neeg mob hnub nyoog 65 xyoos thiab laus dua tsis txawv ntawm cov ntsuas zoo sib xws hauv cov neeg mob uas muaj hnub nyoog yau dua. Txawm li cas los xij, nce qee tus neeg rhiab heev rau saxagliptin nyob rau qee tus neeg laus tsis tuaj yeem txiav txim siab.
Saxagliptin thiab nws cov metabolite tseem ceeb yog qee qhov tawm los ntawm lub raum, yog li nws yuav tsum tau yug los rau hauv lub siab tias nyob hauv cov neeg laus laus, kev txo qis hauv lub raum feem ntau dua. Onglisa® muaj lactose. Cov neeg mob uas muaj lub cev ua tsis taus ntshav, lactase deficiency thiab glucose-galactose malabsorption yuav tsum tsis txhob noj cov tshuaj no.
Cuam tshuam rau kev muaj peev xwm tsav tsheb thiab tswj cov tshuab.
Cov kev tshawb fawb ntawm cov nyhuv ntawm saxagliptin ntawm kev muaj peev xwm tsav tsheb thiab kev tswj cov tshuab tseem tsis tau ua. Nco ntsoov tias saxagliptin yuav ua rau kiv taub hau.
Yeeb tshuaj sib cuam tshuam
Kev tsom xam cov ntaub ntawv sim ua pov thawj qhia tias kev pheej hmoo ntawm kev cuam tshuam loj hauv kev sib tham ntawm saxagliptin nrog lwm cov tshuaj thaum siv ua ke yog qhov tsawg.
Saxagliptin metabolism feem ntau yog kev sib kho los ntawm cytochrome P450 3A4 / 5 isoenzyme system (CYP3A4 / 5). Hauv cov kev tshawb fawb hauv vitro tau pom tias saxagliptin thiab nws cov metabolite tseem ceeb tsis tiv thaiv CYP 1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1 thiab 3A4 isoenzymes thiab tsis txhob ntxias CYP 1A2, 2B6, 2C9, thiab 3A4 isoenzymes. Hauv cov kev tshawb fawb txog cov neeg ua haujlwm noj qab haus huv, cov chaw muag tshuaj ntawm saxagliptin thiab nws cov metabolite tseem tsis tau hloov pauv tseem ceeb ntawm metformin, glibenclamide, pioglitazone, digoxin, simvastatin, diltiazem, ketoconazole, omeprazole, kev sib xyaw ntawm txhuas hydroxide, magnesium hydroxide, thiab simethicone, Saxagliptin tsis hloov pauv qhov tseem ceeb pharmacokinetic ntawm metformin, glibenclamide, pioglitazone, digoxin, simvastatin, diltiazem lossis ketoconazole.
Qhov cuam tshuam ntawm qhov ua kom yuam kev ntawm CYP 3A4 / 5 isoenzymes ntawm cov chaw muag tshuaj ntawm saxagliptin tseem tsis tau kawm. Txawm li cas los xij, kev siv ua ke ntawm saxagliptin thiab inducers ntawm CYP 3A4 / 5 isoenzymes, xws li carbamazepine, dexamethasone, phenobarbital, phenytoin thiab rifampicin, tuaj yeem ua rau muaj qhov txo qis ntawm cov khoom saxagliptin hauv ntshav thiab nce ntxiv nyob rau hauv lub siab ntawm nws lub ntsiab metabolite.Cov kev tshawb fawb txog kev cuam tshuam ntawm kev haus luam yeeb, kev noj zaub mov noj, tshuaj ntsuab, thiab haus cawv rau ntawm saxagliptin tseem tsis tau kawm.
Noj ntau dhau
Cov tsos mob ntawm intoxication tsis tau piav qhia nrog kev siv lub sijhawm ntev ntawm cov tshuaj hauv cov koob tshuaj kom txog 80 zaug siab dua qhov kev pom zoo.
Kev Kho Mob: Thaum noj ntau dhau, siv tshuaj kho qhov tsos mob yuav tsum siv. Saxagliptin thiab nws cov metabolite tseem ceeb yog txaws los ntawm hemodialysis (kev tsis txaus siab: 23% ntawm qhov hno hauv 4 teev).
Cia rau cov neeg mob
Nyob rau qhov kub thiab txias tsis tshaj 30 ° C
Onglisa: cov lus qhia rau kev siv, tshuaj xyuas, ntau npaum li cas
Nrog kev nce qib ntawm hom ntshav qab zib hom 2, tus endocrinologist yuav tsum xaiv cov tshuaj kom raug. Lawv tso cai rau koj ua kom lub cev tsis muaj peev xwm mloog tau cov piam thaj hauv cov ntshav. Ib ntawm cov cuab yeej no yog Onglisa. Ua ntej yuav, nws raug nquahu rau cov neeg mob kom pom cov ntaub ntawv tsim nyog txog cov tshuaj no. Cov lus qhia rau kev siv Onglises, analogues, tshuaj xyuas thiab tus nqi - tus mob ntshav qab zib yuav tsum txaus siab rau txhua yam.
Cov lus sib xyaw ntawm cov khoom thiab daim ntawv ntawm kev tso tawm
Lub ntsiab ntawm cov ua haujlwm ntawm Onglisa yog saxagliptin hydrochloride. Qhov no yog qhov tshuaj hypoglycemic: dipeptidyl peptidase-4 inhibitor (DPP-4).
Cov khoom muaj nyob rau hauv daim ntawv ntawm ntsiav tshuaj, uas yog coated nrog zaj duab xis. Ntawm kev muag koj tuaj yeem nrhiav "Onglizu" nrog kev noj tshuaj ntawm cov tshuaj yeeb yam nquag 2.5 thiab 5 mg. Cov ntsiav tshuaj tau ntim rau hauv cov hlwv; lawv tuaj muag hauv cov thawv ntawv cardboard: txhua tus muaj 3 lub hlwv.
Cov tshuaj muaj npe nyob hauv INN (thoob ntiaj teb tsis tuav npe) saxagliptin.
Cov teeb meem Pharmacological
Thaum noj cov tshuaj hypoglycemic no, cov haujlwm ntawm enzyme DDP-4 yog suppressed rau 24 teev. Thaum noj ntshav qabzib, qhov siab ntawm GLP-1 thiab GUI nce li 2-3 zaug. Tib lub sijhawm, qib ntawm glucagon txo, cov lus teb ntawm cov kua nplaum nyob ntawm beta hlwb nce ntxiv. Vim yog qhov kev nqis tes ntawm cov txheej txheem no, cov ntsiab lus ntawm C-peptide thiab insulin nce.
Thaum cov kua dej tawm los ntawm cov txiav (nws tshwj xeeb beta hlwb), txo cov txheej txheem ntawm glucagon tso tawm los ntawm alpha hlwb, muaj qhov txo qis ntawm glycemia tom qab noj mov.
Kev nyab xeeb thiab kev ua tau zoo ntawm saxagliptin tau sim hauv 6 qhov kev tshawb fawb cov placebo hauv cov neeg mob ntshav qab zib hom 2. Qhov tseem ceeb, nws tau pom tias glycated hemoglobin, yoo cov ntshav qab zib thiab tom qab noj zaub mov zoo dua qub.
Saxaliptin tom qab kev tswj hwm tau nrawm rau hauv txoj hnyuv plab, qhov siab tshaj plaws tau pom nyob tom qab 2 teev (qhov tseem ceeb tshuaj tiv thaiv - 4) tom qab kev tswj hwm. Ntau tshaj li 75% ntawm cov koob tshuaj noj tau nqus tau. Cov tshuaj ua kom nquag pliag yog tas nrog cov kua tsib thiab zis.
Sau npe ntawm qhov cim tseg
Cov cuab yeej "Onglisa" tuaj yeem tsim kho rau cov ntshav qab zib, uas tsim raws li hom 2. Cov tshuaj yog kws kho raws li qhov txuas rau glycemic tswj ib txhij nrog kev noj haus thiab qoj ib ce.
Khaws cov ntsiav tshuaj:
- raws li ib tug txhais tau tias ntawm monotherapy,
- ua cov tshuaj ntxiv rau kev kho mob monotherapy nrog sulfonylurea derivatives, metformin, thiazolidinediones,
- rau kev pib kev kho mob sib xyaw ua ke hauv kev sib xyaw nrog metformin.
Nws yog txwv tsis pub pib noj cov tshuaj koj tus kheej yam tsis muaj kws kho mob sau.
"Onglizu" yog siv los ua ib qho kev sib txuas ntxiv rau hauv kev sib xyaw nrog lwm cov tshuaj, muab tias monotherapy nrog kev txo cov tshuaj muaj suab tsis tuaj yeem ua tiav kev tswj glycemic.
Tsuas xaiv, hom kev siv
Tus kws mus kawm ua hauj lwm endocrinologist yuav tsum sau daim ntawv kom noj cov tshuaj, coj mus rau tus mob tus neeg mob
Nrog "Onglise" monotherapy, txoj kev xaiv yog feem ntau ua rau kev nyiam ntawm 5 mg ntsiav tshuaj. Lawv raug ua noj ib hnub.
Thaum siv txoj hauv kev ua ke ntawm kev kho, nws raug nquahu kom noj saxagliptin nyob rau hauv ib qho ntawm 5 mg hauv kev sib xyaw nrog sulfonylurea derivatives, thiazolidinedione tshuaj, metformin.
Tau txiav txim siab los pib ua thawj zaug kev kho mob nrog metformin thiab saxagliptin, nws yog qhov yuav tsum tau xaiv cov tshuaj kom thawj cov tshuaj nquag nkag mus rau hauv lub cev hauv qhov nyiaj ntawm 500 mg, thib ob - 5 mg ib hnub. Thaum tsis muaj cov lus teb tsim nyog, nce cov koob tshuaj metformin.
Yog tias cov ntsiav tshuaj tom ntej ntawm Ongliza yog ncua, ces koj yuav tsum haus nws tam sim ntawd, sai li sai tau qhov mob ntshav qab zib nco qab nws. Tab sis koj tsis tuaj yeem haus 2 ntsiav tshuaj ib hnub.
Cov tshuaj rau cov neeg mob uas mob ntshav qab zib yog qhov nyuaj los ntawm cov kab mob uas cais tau yog cais:
- nrog lub raum tsis ua haujlwm, qhov koob tshuaj tsis tau hloov kho,
- nrog mob raum tsis txaus thiab mob hnyav, "Ongliza" yog tshuaj 2.5 mg (tib cov ntsiav tshuaj pom zoo rau cov neeg mob ntawm hemodialysis),
- Kev ua haujlwm ntawm lub siab tsis xav tau kev hloov kho koob,
- hauv cov neeg laus cov neeg mob raum tsis ua haujlwm, cov tshuaj yog kws kho hauv tus qauv muab rau noj.
Ua ntej noj tshuaj ua rau lub hauv paus ntawm saxagliptin, koj yuav tsum kuaj xyuas lub raum, ntsuas lawv cov haujlwm.
Cov Yuav Tsum Muaj
Ua ntej sau ntawv Onglisa, tus kws kho mob yuav tsum paub nws tus kheej li keeb kwm kev kho mob thiab seb nws puas tuaj yeem haus cov tshuaj no.
Daim ntawv teev cov contraindications suav nrog cov hauv qab no:
- tsim kev rhiab rau txhua yam ntawm cov khoom,
- galactose intolerance, kuaj ntshav qabzib-galactose malabsorption lossis lactase deficiency,
- mob ketoacidosis,
- lub caij cev xeeb tub thiab kev pub niam mis.
Cov tshuaj tsis raug cai rau cov neeg mob uas muaj insulin-tiv thaiv hom ntshav qab zib 1 thiab cov neeg mob uas siv tshuaj insulin rau kev kho mob txawm tias muaj T2DM. Hauv cov rooj plaub no, kev siv saxagliptin tseem tsis tau kawm.
Rau tib qho laj thawj, nws tsis pom zoo kom muab cov ntsiav tshuaj no rau cov menyuam yaus.
Ua ke nrog kev npaj ntawm sulfonylurea derivatives, cov tshuaj yog siv nrog ceev faj.
Tsis tas li, qhov mob yuav tsum raug saib xyuas los ntawm cov neeg mob raum tsis ua haujlwm (nrog cov qauv hnyav thiab mob hnyav), cov neeg laus.
Kev siv cov tshuaj thaum cev xeeb tub tsis tau kawm. Nws kuj tsis paub meej tias seb cov tshuaj puas kis mus rau niam mis. Yog li, thaum lub sijhawm kho, cov kws kho mob pom zoo kom tsis txhob pub mis lossis tsis kam kho nrog saxagliptin.
Muaj kev phiv ntau
Qee tus neeg mob tshwm sim thaum tab tom noj Onglisa.
Puas muaj qhov phom sij txaus ntshai thaum lawv tshwm sim? Yog tias tus neeg mob tau pom tias muaj mob tshwm sim, tom qab ntawd tus kws kho mob qhov kev sab laj yuav tsum tau saib xyuas tus mob thiab ntsuas qhov zoo ntawm kev kho mob.
Txawm hais tias hauv kev kawm txog kev sim, hauv qab no tau tsim. Qhov tshwm sim ntawm qhov tshwm sim tsis zoo hauv cov ncauj lus uas siv saxogliptin piv rau kev tshwm sim hauv cov neeg mob uas tau siv cov placebo.
Nyob rau tib lub sijhawm, tsis muaj qhov sib txawv ntawm kev noj cov tshuaj nyob rau hauv kev txiav txim siab ntawm monotherapy thiab nrog kev sib txuas ua ke.
Muaj tshwm sim tsis tu ncua ntawm cov kev mob tshwm sim:
- cov pa ua pa tuaj sab saud (sab saud),
- mob txeeb zig
- mob hlab ntsws
- mob hnyuv
- ntuav
- mob taub hau.
Cov kev tshawb pom pom tias ntawm 24 lub lim tiam ntawm txoj kev kho, qee cov neeg mob txuas ntxiv kom muaj qhov tsis haum lub siab: 1.5% ntawm cov neeg noj Onglizu thiab 0.4% ntawm cov neeg siv tshuaj placebo. Tab sis qhov tsis haum lub ntsej muag uas tshwm sim thaum kev sim tsis tau tsim kev hem thawj rau lub neej ntawm cov neeg mob thiab tsis tas yuav kho.
Nrog txoj kev kho ua ke, cov hauv qab no tau pom.
Kev siv cov saxagliptin hauv kev sib xyaw nrog glibenclamide coj los ua rau kev mob ntshav qab zib hauv 0.8% ntawm tus neeg mob, hauv pawg tswj hwm (noj cov placebo) - hauv 0.7%. Qhov tshwm sim ntawm cov ntshav qog ntshav nrog kev siv tshuaj ib txwm siv ntawm metformin thiab thiazolidinediones piv rau qhov xwm txheej ntawm cov ntshav qog ntshav qis hauv cov pab pawg neeg mob uas tau muab cov placebo.
Nrog kev sib xyaw ntawm saxagliptin thiab thiazolidinediones, peripheral edema tshwm sim hauv 8.1% ntawm tus neeg mob, hauv pawg tswj hwm - 4.3%.Tab sis qhov tshwm sim o tau mob me me lossis mob pesnrab, tsum tsis ua kev kho ntxiv. Nrog kev kho mob monotherapy thiab lwm yam kev sib txuas, qhov tshwm sim no tshwm sim hauv 1.7%, thaum noj cov placebo hauv 2.4%, feem.
Kev siv cov tshuaj Onglisa thiab cov tshuaj metformin sib xyaw ua ke tuaj yeem ua rau mob caj pas thiab mob taub hau. Nasopharyngitis tau tshwm sim hauv 6.9% ntawm cov neeg mob: nrog metformin monotherapy - 4%, saxagliptin - hauv 4.2% ntawm cov neeg mob. 7.5% yws mob taub hau: nrog metformin monotherapy - 5.2%, saxagliptin - 6.3% ntawm cov neeg mob.
Tsis muaj kev pom zoo hloov qhov ntsuas pom hauv lub chaw ntsuas thaum lub sijhawm tshawb fawb txog saxagliptin. Tsawg me ntsis ntawm cov lymphocytes yog qhov ua tau, tab sis lawv tus lej nruab nrab tseem nyob ntawm theem ruaj khov.
Ntau tus neeg mob
Cov neeg tsim khoom ntawm saxagliptin-based tshuaj, suav nrog Onglises, tsis pom zoo kom noj 2 lub tshuaj ntawm cov tshuaj nyob rau tib hnub thaum hla cov koob tshuaj ntxiv. Tab sis thaum noj cov tshuaj rau ib lub sij hawm ntev hauv cov koob tshuaj uas ntau dua li cov lus pom zoo txog 80 zaug, cov tsos mob ntawm intoxication tsis tau pom.
Tab sis cov lus qhia rau kev siv hais tias nrog kev siv ntau dhau, cov tshuaj yuav tsum tau thim los ntawm hemodialysis. Rau 4 teev, 23% ntawm cov tshuaj tau tso tawm.
Yeeb tshuaj sib cuam tshuam
Thaum sau ntawv Onglisa, cov kws kho mob tsis tshua nyiam yam tshuaj uas koj tseem siv. Tom qab tag nrho, kev pheej hmoo ntawm kev cuam tshuam tseem ceeb ntawm cov tshuaj no thiab lwm yam tshuaj muaj tsawg heev.
Qhov kev sib txuam ntawm cov tshuaj tseem ceeb ntawm saxagliptin tuaj yeem txo qis thaum siv inducers ntawm CYP 3A4 / 5 isoenzymes (xws li Phenobarbital, Carbamazepine, Phenytoin, Dexamethasone, Rifampicin).
Thaum ua ke nrog sulfonylurea derivatives, kev ceeb toom yuav tsum tau siv: kev txo cov ntshav qis yuav tshwm sim. Koj tuaj yeem txo qhov kev pheej hmoo los ntawm kev txo qhov koob tshuaj sulfonylurea npaj.
Cov lus qhia tshwj xeeb
Kev ntsuas ntawm qhov "Ongliza" cov txheej txheem cuam tshuam dab tsi rau kev muaj peev xwm tsav tsheb thiab tsav tsheb tsis tau ua. Nws tseem tsis paub zoo li cas kev haus dej cawv, haus luam yeeb, thiab siv tshuaj ntsuab kho mob cuam tshuam.
Yog tias cov neeg mob yav dhau los muaj qhov tsis haum lub siab thaum siv D1111-4 inhibitors, ces Ongliz yuav tsum tsis txhob raug tshuaj.
Nqe txoj cai thiab xaiv cov khoom tsis tau noj
Koj tuaj yeem yuav cov tshuaj hauv ntau lub tsev muag tshuaj. Tab sis nws tus nqi yog siab heev: rau ib pob ntawm 30 ntsiav tshuaj ntawm 5 mg, 1881 rubles yuav tsum tau muab. Cov tshuaj no tsis suav nrog hauv cov npe ntawm cov tshuaj tshwj xeeb uas tuaj yeem muab rau tus neeg mob ntshav qab zib hom 2 uas tuaj yeem muab pub dawb.
Cov neeg mob muaj cai nug tus kws kho mob endocrinologist kom sau tshuaj dawb rau lwm qhov kev kho mob uas tuaj yeem hloov Onglisa. Tsis tas li, hloov chaw yog qhov tsim nyog yog tias tus neeg mob tsis qaug rau saxagliptin.
Ib qho piv txwv suav nrog cov tshuaj txo suab thaj:
- "Galvus" - cov tshuaj nquag vildagliptin,
- "Januvia" - sitagliptin,
- "Vipidia" - alogliptin,
- "Trazhenta" - linagliptin,
- "Glucovans" - glibenclamide, metformin hydrochloride,
- Glucophage yog Metformin hydrochloride.
Tab sis tsuas yog tus koom nrog endocrinologist yuav tsum xaiv cov tshuaj "Onglisa" rau cov ntshav qab zib.
Ntawm cov kab npe tshwj xeeb tshaj tawm cov tshuaj tiv thaiv pom zoo tsis muaj cov tshuaj uas, nrog rau kev tso cai los ntawm Ministry of Health, tuaj yeem muab tshuaj pub dawb. Tus nqi ntawm cov analogues no tsis tuaj yeem hu ua qis.
Txhawm rau ntim ib 28 ntsiav tshuaj ntawm 50 mg ntawm Galvus, koj yuav tsum them 810 rubles.
"Januvia" yuav raug nqi rau cov neeg mob 1650 rubles. - 28 tab. 100 mg txhua qhov.
"Vipidia" hauv cov khw muag tshuaj raug nqi 1288 rubles. - 28 tab. 25 mg txhua.
"Trazhenta" tus nqi 1785 rubles. - 30 ntsiav tshuaj 5 mg txhua.
Tab sis cov tshuaj metformin-raws li tshuaj yog pheej yig dua. Glucophage raug nqi 114 rubles. (30 pcs. 500 mg ib qho), "Glucovans" 277 rubles. 30 tab. 500 / 2.5 mg ntawm metformin thiab glibenclamide, ntsig txog.
Kev Ntsuam Xyuas Rau Neeg Mob
Ua ntej yuav tau cov tshuaj kim kim li no, ntau tus xav paub seb nws zoo npaum li cas thiab seb nws puas pab lwm tus neeg mob.Tab sis qhov rhiab heev ntawm cov neeg mob ntshav qab zib rau kev kho saxagliptin tsis zoo li qub: rau qee tus neeg mob cov tshuaj no dhau los ua panacea, thaum lwm tus tsis txaus siab txog nws qhov tsis muaj txiaj ntsig.
Tab sis kev tshuaj xyuas neeg mob muab ib txoj hauv kev los daws qhov kev txiav txim ntawm cov tshuaj. Txawm hais tias kev xav ntawm lwm tus neeg, kev mob ntshav qab zib yuav tsum tau ua los ntawm cov lus pom zoo ntawm lawv txoj kev kho tus neeg endocrinologist. Yog tias lawv tsis tso siab rau nws, ces nws tsim nyog sim hloov tus kws kho mob.
Qee cov neeg mob yws tias Onglisa tsis tsim cov nyhuv xav pom. Hauv qee qhov, qhov concentration ntawm cov piam thaj tseem nce ntxiv thaum noj cov tshuaj. Cov kws kho mob tau sau ntawv ntau ntau "Ongliz" ua ib txoj kev ntawm kev kho ntxiv hauv kev kho "Siofor", "ntshav qab zib".
Tab sis ntau tus neeg mob ntshav qab zib, txawm tias muaj kev kho mob monotherapy nrog saxagliptin, tswj kom ua tiav cov txiaj ntsig zoo thiab tswj glycemia. Qhov txiaj ntsig ntawm cov tshuaj no, ntau tus cwj pwm muaj peev xwm noj tshuaj lub sijhawm twg los xij, tsis hais noj zaub mov.
Qee tus kuj sau cia tias kev sib xyaw nrog metformin tso cai rau kev kho tus mob kom zoo. Tab sis kom ua tiav qhov txiaj ntsig yam xav tau, kev kho mob mus ntev yog qhov yuav tsum tau ua. Thiab qhov no yog qhov ua rau txaus siab rau ntau tus neeg. Nrog rau tus qauv coj ua, ntsiav tshuaj txaus rau ib hlis.
Tab sis feem ntau cov neeg mob yuav tsum haus lwm cov tshuaj kom txo cov txiaj ntsig ntshav qab zib rau cov kabmob thiab cov kab ke ntawm lub cev.
Yog tias tus kws kho mob sau ntawv "Ongliza", ces koj yuav tsum sim kho nrog cov tshuaj no. Qhov tseem ceeb tshaj plaws kom nco qab txog qhov yuav tsum tau ua raws kev noj haus thiab kev nqis tes ua ntawm kev ua haujlwm qoj ib ce.
Yog tias koj so thiab haus dej haus tshuaj me me xwb, koj yuav tsis muaj peev xwm kho qhov mob no.
Cov tshuaj Onglisa - taw qhia thiab cov lus qhia rau kev siv
Ntawm cov tshuaj siv los kho mob ntshav qab zib, ib hom tshuaj hu ua Onglisa tau paub.
Nws yog tsim nyog los kawm cov lus qhia rau cov tshuaj no, txheeb xyuas nws cov yam ntxwv tseem ceeb thiab cov txiaj ntsig, nrog rau kev txiav txim siab qhov kev ntsuas twg yuav pab tiv thaiv kev txhim kho ntawm qhov tsis zoo vim tias nws siv tsis raug.
Cov ntaub ntawv dav dav, muaj pes tsawg leeg thiab daim ntawv tso tawm
Tus kab mob ntshav qab zib no muaj nyob rau Tebchaws Meskas. Nws yog tsim los soj ntsuam cov ntshav qab zib cov neeg mob. Nws muaj cov nyhuv hypoglycemic. Siv nws yuav tsum raug pom zoo los ntawm kws kho mob nkaus xwb, thiaj li tsis ua kom koj muaj mob. Yog vim li ntawd koj tuaj yeem yuav Ongliz tsuas yog nrog cov tshuaj ua kom raug.
Lub hauv paus ntawm cov tshuaj yog cov tshuaj Saksagliptin. Nws ua lub luag haujlwm tseem ceeb hauv cov tshuaj no. Qhov kev tivthaiv yog siv los nres cov tsos mob ntawm hyperglycemia los ntawm kev txo qis cov ntshav qabzib.
Yog hais tias tus neeg mob ua txhaum cov lus qhia kho mob, ces cov tshuaj tuaj yeem ua rau kom muaj kev phiv thiab mob lwm yam.
Qhov muaj pes tsawg leeg suav nrog cov khoom xyaw pabcuam:
- lactose monohydrate,
- croscarmellose sodium
- hydrochloric acid
- magnesium nplawm.
Ntxiv rau, cov tshuaj muaj qee qhov tsis txaus ntawm cov tshuaj pleev, uas yog xav tau los tsim cov zaj duab xis txheej rau cov ntsiav tshuaj (cov tshuaj muaj cov qauv tshuaj).
Lawv tuaj yeem yog daj lossis xim liab nrog lub ntsej muag xiav. Ntawm kev muag, koj tuaj yeem nrhiav tau cov ntsiav tshuaj nrog qhov ntau npaum ntawm 2.5 thiab 5 mg. Ob ntawm lawv raug muag hauv cov ntawv ntim ntawm 10 pcs.
3 tej pob khoom no tau muab ntim rau hauv ib pob.
Cov phom sij hloov pauv rau Ongliz ntsiav tshuaj
Cov analogue yog pheej yig dua los ntawm 981 rubles.
Galvus tseem tau tsim kev kho mob ntshav qab zib hom 2, tab sis nws yog qhov pheej yig dua thiab txawv ntawm Ongliz hauv cov tshuaj nquag. Nws siv vildagliptin hauv ib qhov tshuaj ntawm 50 mg. Muaj qhov sib txawv ntawm qhov tsis sib xws, ua ntej pib kev kho, nyeem cov lus qhia.
Vipidia (ntsiav tshuaj) Ntsuas: 28 Sab saum toj
Cov analogue yog pheej yig dua los ntawm 799 rubles.
Vipidia kuj sib txawv hauv kev muaj pes tsawg leeg, tab sis yog nyob rau hauv pawg kws kho mob zoo ib yam li cov tshuaj saum toj no. Nws kuj tseem siv rau hom 2 mob ntshav qab zib mellitus raws li kev kho mob thiab ua kom sib xyaw nrog lwm tus neeg lub qhov ncauj qog ntshav lossis nrog insulin.
Cov chaw muag tshuaj thiab tshuaj pharmacokinetics
Cov nyhuv ntawm cov tshuaj ntawm cov ntshav qab zib yog vim nws txoj kev ua haujlwm. Thaum nkag mus rau hauv lub cev, saxagliptin inhibits qhov kev ua ntawm qhov enzyme DPP-4. Yog li ntawd, pancreatic beta hlwb ua kom sai sai ntawm cov kua dej los ua ke. Qhov ntau npaum li cas ntawm glucagon thaum lub sijhawm no poob qis.
Vim tias cov ntsej muag no, qhov siab ntawm cov piam thaj hauv cov neeg mob cov ntshav tau tsawg dua, uas ua rau kev txhim kho kev noj qab nyob zoo (tshwj tsis yog nws qib poob qis mus rau qib tseem ceeb). Ib qho tseem ceeb ntawm cov tshuaj hauv nqe lus nug yog qhov tsis muaj kev cuam tshuam ntawm nws feem ntawm tus neeg mob lub cev qhov hnyav. Cov neeg mob siv Ongliza tsis hnyav ntxiv.
Qhov nqus ntawm saxagliptin tshwm sim sai heev yog tias koj noj tshuaj ua ntej noj mov. Nyob rau tib lub sijhawm, qhov tseem ceeb ntawm cov khoom siv tau yog nqus tau.
Saksagliptin tsis muaj lub siab nyiam nkag mus rau hauv kev koom nrog cov ntshav protein - cov tsos ntawm cov ntawv cog lus no cuam tshuam ib qho me me ntawm cov feem. Qhov siab tshaj plaws ntawm cov tshuaj tuaj yeem ua tiav nyob hauv kwv yees li 2 teev (ib qho khoom ntawm lub cev ua rau muaj qhov no). Nws yuav siv sijhawm li 3 teev los nruab nrab ib nrab ntawm cov khoom xaib Saxagliptin.
Kev taw qhia thiab contraindications
Nws yog ib qho tseem ceeb kom ua raws li cov lus qhia hais txog kev taw qhia rau kev teem caij noj tshuaj. Siv Onglisa yam tsis tsim nyog phom sij rau kev noj qab haus huv thiab lub neej. Cov tshuaj noj uas muaj cov nyhuv ntshav qab zib kom zoo yuav tsum siv rau cov neeg uas muaj ntshav siab qab zib, rau lwm cov tshuaj kho no yog qhov muaj kev phom sij.
Qhov no txhais tau tias qhov taw qhia rau cov tshuaj no yog hom 2 mob ntshav qab zib. Lub cuab yeej yog siv nyob rau hauv cov xwm txheej uas kev noj haus thiab kev tawm dag zog tsis muaj lub txiaj ntsig uas xav tau ntawm cov concentration ntawm cov piam thaj.
Onglisa tuaj yeem siv ob qho tib si cais thiab muaj kev sib xyaw nrog lwm cov tshuaj (Metformin, sulfonylurea derivatives, thiab lwm yam).
Cov tshuaj muaj contraindications:
- ntshav qab zib hom 1
- cev xeeb tub
- ntuj pub mis
- kev fab tshuaj rau cov tshuaj ntawm cov tshuaj,
- lactase tsis muaj peev xwm
- mob ntshav qab zib ketoacidosis
- galactose intolerance.
Lub xub ntiag muaj tsawg kawg ib yam los ntawm daim ntawv teev npe yog qhov laj thawj tsis kam lees siv cov ntsiav tshuaj.
Kuj tseem cais cov pab pawg ntawm cov neeg uas raug tso cai siv Onglisa, tab sis nyob rau hauv kev saib xyuas kev kho mob ntau ntxiv. Cov no suav nrog cov neeg laus, ntxiv rau cov neeg mob raum tsis ua haujlwm.
Cov lus qhia rau kev siv
Siv cov tshuaj no raws li cov cai. Yog tias tus kws kho mob tsis tau sau ntau dua cov tshuaj, ces tus neeg mob yuav tsum siv 5 mg ntawm cov tshuaj ib hnub. Qhov koob tshuaj zoo ib yam yog pom zoo nrog kev siv ua ke ntawm Onglisa nrog Metformin (ib qho kev pabcuam txhua hnub ntawm Metformin yog 500 mg).
Kev siv cov tshuaj tsuas yog sab hauv. Raws li kev noj, tsis muaj qhov taw qhia, koj tuaj yeem haus tshuaj noj ob leeg ua ntej thiab tom qab noj mov. Qhov tsuas yog xav kom siv cov tshuaj rau hauv lub moos.
Thaum hla cov koob tshuaj ntxiv, koj yuav tsum tsis txhob tos lub sijhawm teem sijhawm los haus ob koob ntawm cov tshuaj. Nws yog ib qho tsim nyog yuav tsum tau noj ib txwm li ntawm cov tshuaj sai li sai tau thaum tus neeg mob nco txog nws.
Phiv thiab haus tshaj
Qhov tshwm sim ntawm kev mob tshwm sim los ntawm kev siv Onglisa tsis yog ib txwm cuam tshuam nrog nws txoj kev tsis txaus siab. Qee zaum lawv tshwm sim los ntawm qhov tsis pom tseeb ntawm lub cev muaj sia rau nws cov cuam tshuam. Txawm li cas los xij, yog tias lawv kuaj pom, nws raug pom zoo kom qhia rau tus kws kho mob txog lawv.
Cov lus qhia rau cov tshuaj qhia cov phiv xws li:
- mob txeeb zig
- mob taub hau
- xeev siab
- mob plab
- mob hlab ntsws
- nasopharyngitis (nrog rau kev siv thooj txhij nrog metformin).
Kev kho mob tsuas yog siv los kho kom dhau cov teeb meem no. Hauv qee kis, tus kws kho mob tam sim ntawd tshem tawm cov tshuaj.
Tsis muaj cov xov xwm hais txog cov yam ntxwv ntawm kev siv ntau dua nrog cov tshuaj no. Yog tias nws tshwm sim, yuav tsum kho cov tsos mob.
Tus neeg mob lub tswv yim
Tau kawm txog qhov kev tshuaj xyuas txog cov tshuaj Onglisa, peb tuaj yeem xaus tias cov tshuaj zoo txo cov ntshav qabzib, tab sis nws tsis haum rau txhua tus thiab xav kom muaj ib tus neeg mus kom ze thiab tswj.
Cov txiaj ntsig los ntawm cov tshuaj no zoo heev. Kuv cov piam thaj tam sim no ruaj khov, tsis muaj kev phiv tshuaj thiab tsis muaj. Ntxiv rau qhov no, nws yooj yim heev rau siv nws.
Dmitry, hnub nyoog 44 xyoos
Ongliz txoj kev kho tau zoo li kuv qaug zog. Cov piam thaj hauv lub cev tsis tau pauv, dua li, qhov mob taub hau tas li tsim txom kuv - thaj, ib qho tshwm sim. Kuv tau siv ib hlis thiab sawv tsis taus nws; Kuv yuav tsum tau thov lwm yam tshuaj.
Alexander, 36 xyoo
Kuv tau siv Onglise tau 3 xyoos. Rau kuv, qhov no yog qhov cuab yeej zoo tshaj plaws. Ua ntej nws haus ntau yam tshuaj, tab sis cov txiaj ntsig tau dhau los tsawg, lossis raug tsim txom los ntawm kev mob tshwm sim. Tam sim no tsis muaj qhov teeb meem zoo li no.
sau cov tshuaj tshiab hauv kev kho mob ntshav qab zib:
Cov tshuaj yog nyob ntawm tus nqi pheej yig - tus nqi hauv ib pob yog 30 pcs. txog 1700-2000 rub. Kev yuav nyiaj, koj xav tau ntawv yuav tshuaj.
Pom zoo Lwm Yam Lus Txog
Onglisa - tshuaj noj rau ntshav qab zib
Yog tias muaj ntshav qab zib hom 2, tus kws kho mob koom yuav tsum sau tshuaj kom tsim nyog rau tus neeg mob.
Ib qho ntawm cov kev qhia ntau yog Onglisa.
Ua ntej siv, nws raug nquahu kom kawm cov lus qhia rau kev siv, tshuaj xyuas (puas muaj qhov phom sij txaus ntshai tom qab siv), muaj analogues thiab tus nqi.
Kev ntsuas rau siv
Ntawm hom 2 Ntshav Qab Zib, qhov cuam tshuam tsis haum ntawm cov hlwb rau qabzib yog tsawg. Nyob rau theem no, muaj kev ncua sijhawm nyob hauv thawj theem ntawm kev ua ke cov tshuaj hormones.
Nyob rau hauv lub neej yav tom ntej, theem ob tau ploj los vim tias tsis muaj qhov ntau ntxiv. Onglisa qeeb rau kis enzyme DPP 4, nce ntxiv nyob ntev hauv cov ntshav, insulin ntau dua yog tsim tawm. Glycemia ntawm qhov khoob thiab puv plab yog kho qhov ua haujlwm, lub cev ua haujlwm ntawm lub txiav ua rov qab. Yog li, Onglisa prolongs kev ua haujlwm ntawm lawv tus kheej cov tshuaj hormones, nce lawv cov ntsiab lus.
Cov tshuaj Onglisa uas muaj ntshav qab zib hom 2 (ntxiv rau kev noj zaub mov kom zoo thiab ua kis las) yog qhia raws li:
- kev kho mob thawj zaug nrog ob peb tshuaj, ua ke nrog metformin,
- ntxiv rau kev kho mob nrog metformin, insulin, sulfonylurea derivatives,
- tshuaj mob hlwb.
Kev Siv Onglises txhim kho glycemic tswj.
Daim ntawv tso tawm
Lub teb chaws ntawm hauv paus chiv keeb - Tebchaws Asmeskas, tab sis cov ntsiav tshuaj npaj tau tuaj yeem ntim tau hauv tebchaws Askiv lossis Ltalis.
Lawv tau tsim nyob rau hauv daim ntawv ntawm cov ntsiav tshuaj puag ncig, convex ntawm ob sab, sab nraud yog coated. Txhua lub ntsiav tshuaj muaj tus lej xiav. Cov xim ntawm Onglisa yog nyob ntawm qhov kev saib xyuas ntawm cov khoom tseem ceeb: 2.5 mg ib qho yog xim daj ntseg daj ("2.5" yog sau rau ib sab, "4214" yog sau rau sab nraud), thiab 5 mg txhua yog paj yeeb (tooj "5" thiab "4215 ").
Cov ntsiav tshuaj yog ua blisters ua los ntawm txhuas ntawv nyiaj: hauv ib pob 3 blisters ntawm 10 daim. Txhua lub hlwv muaj qhov hluav taws xob perforation faib nws mus ua 10 qhov chaw (los ntawm cov ntsiav tshuaj). Cov thawv ntim khoom yog tiv thaiv los ntawm kev ua phem nrog cov ntawv nplaum pob tshab uas piav qhia lub daj daj.
Ntshav qab zib yog ib txwm 3.8 mmol / L
Yuav ua li cas kom qab zib kom zoo nyob rau hauv 2019
Koj tuaj yeem yuav cov tshuaj ntshav qab zib Onglizu hauv cov tsev muag tshuaj. Cov tshuaj yuav tsum muaj, tab sis tsis yog txhua tus kws muag tshuaj ua raws txoj cai no. Hauv xyoo 2015, cov tshuaj tau suav nrog cov npe tseem ceeb, yog li yog muaj npe tshuaj ntshav qab zib, nws tuaj yeem nrhiav dawb.
Qhov nruab nrab, tus nqi ntawm kev ntim rau 30 ntsiav tshuaj yog txog 1800 rubles. Khaws cov tshuaj ntawm qhov kub tsawg dua 30 degrees ntawm cov menyuam yaus. Kev khaws cia yuav tsum tsis pub tshaj 3 xyoos.
Cov tshuaj phiv yog saxagliptin hydrochloride (2.5 lossis 5 mg). Qhov no yog tus sawv cev ntawm qhov niaj hnub inhibitor ntawm DPP-4.
Cov muaj mob:
- MCC
- lactose monohydrate,
- croscarmellose sodium
- magnesium stearate,
- hydrochloric acid
- dyes.
Sab nrauv ntawm cov ntsiav tshuaj muaj OpadryII zas xim.
Daim ntawv thov nta
Nyob rau theem pib ntawm kev hloov pauv ntawm kev ua haujlwm ntawm lub raum, tsis tas yuav hloov pauv qhov tsuas tshuaj.Hauv kev mob hnyav dua, kev mob hemodialysis, koob tshuaj pom zoo ntawm Ongliza tshuaj yog 2.5 mg ib hnub. Cov tshuaj tau raug pom zoo kom raug tswj hwm thaum txoj kev ua kom cov ntshav ua kom huv tiav. Ua ntej thiab thaum kho, nws yog qhov yuav tsum tau soj ntsuam kev mob ntawm lub raum.
Qhov cuam tshuam ntawm Onglises rau lub cev nrog txoj kev ua kom pom tseeb ntawm cov ntshav ua kom cov ntshav tsis tau tshawb xyuas.
Nrog rau kev hloov pauv ntawm daim siab kev ua haujlwm, tsis hais tus mob hnyav, tsis tas yuav hloov kho ib koob tshuaj.
Qhov tshwm sim ntawm kev siv Onglisa hauv cov neeg mob ntshav qab zib tshaj 65 xyoo zoo ib yam li ntawd hauv cov neeg mob hluas. Hauv cov hnub nyoog laus, koj yuav tsum tau noj tshuaj li niaj zaus noj txhua hnub. Nws yog ib qho tseem ceeb uas yuav tsum nco ntsoov tias nyob rau theem ntawm txoj kev loj hlob no, kev ua haujlwm ntawm lub raum poob qis, qhov cuam tshuam hauv qee qhov ntau yog tawm ntawm lawv.
Tsis muaj cov ntaub ntawv hais txog qhov ua tau phom sij thiab cov txiaj ntsig zoo ntawm Onglisa tsis tau muaj 18 xyoo.
Co-administration ntawm Onglisa nrog cov tshuaj insulin thaum kho tsis tau tshawb xyuas. Tsis muaj cov ntaub ntawv hais txog cov nyhuv ntawm cov tshuaj ntawm kev tsav tsheb thiab kev ua ub no nrog cov kev siv tshuab. Kiv taub hau yuav tshwm sim tom qab noj cov tshuaj.
Cov txiaj ntsig ntawm cov tshuaj nquag ua rau lub cev ntawm cev xeeb tub thiab lactating tsis tau kawm.
Tsis muaj ntaub ntawv qhia txog seb cov tshuaj nquag muaj peev xwm txeem tau los ntawm tus placenta mus rau tus me nyuam hauv plab thiab rau niam mis, yog li cov tshuaj tsis tau sau tseg rau lub sijhawm no.
Yog tias nws tsis tuaj yeem zam kev siv Onglisa, lub sijhawm ntawm kev noj tshuaj, kev pub mis niam yog nres. Hauv qhov xwm txheej no, qhov ua rau muaj kev phom sij rau tus menyuam thiab qhov yuav tshwm sim zoo rau tus niam raug suav.
Sulfonylurea derivatives txo qis dua qib qabzib. Txhawm rau zam qhov kev tiv thaiv kab mob nrog kev kho mob sib xyaw nrog Onglisa, nws yog qhov tsim nyog los txo cov koob tshuaj sulfonylurea lossis insulin.
Nrog rau keeb kwm muaj kev tsis haum loj ntawm lub siab ntawm cov mob ntshav qab zib (suav nrog kev tsis haum tshuaj tam sim ntawd thiab Quincke's edema), Ongliza tsis tau siv thaum siv lwm cov tshuaj tiv thaiv DPP-4. Nws yog ib qho tsim nyog los txheeb xyuas qhov yuav ua rau muaj kev txo qis thiab pom zoo kom kho lwm yam (cov tshuaj tiv thaiv kab mob Onglisa).
Muaj cov ntaub ntawv pov thawj ntawm kev hnoos mob leeg nrog kev siv tshuaj. Cov neeg mob yuav tsum tau qhia txog cov kev xav zoo li no thaum sau ntawv Onglisa. Yog tias muaj qhov ntxim nyiam ntawm kev tshwm sim ntawm thawj cov tsos mob ntawm tus mob pancreatitis, cov tshuaj tau muab tshem tawm.
Cov ntsiav tshuaj muaj lactose, yog li ntawd, cov neeg mob ntshav qab zib nrog kev noj qab haus huv galactose tsis kam lees, lactase tsis tuaj yeem siv Onglisa.
Kev cuam tshuam nrog lwm yam tshuaj
Cov kev kho mob yooj yim yog metformin nrog qhov xav tau ntawm kev hloov pauv hauv lub neej. Yog tias qhov kev kho mob no tsis coj qhov ua tiav qhov kev cia siab, yuav tsum tau pom zoo ntxiv cov tshuaj ntxiv.
Cov kev tshawb fawb tau ua uas pom tias muaj ntau yam me me ntawm kev sib txuam ntawm saxagliptin thiab lwm yam tshuaj.
Kev sib koom tes siv nrog inducers ntawm CYP 3A4 / 5 isoenzymes pab txo cov ntsiab lus ntawm saxagliptin metabolic khoom.
Kev noj sulfonylurea derivatives ua rau txo cov concentration ntawm cov piam thaj hauv cov ntshav. Txhawm rau kom tsis txhob muaj kev pheej hmoo, nws yog ib qho tsim nyog kom txo qis ntawm cov tshuaj Onglisa.
Tsis muaj kev tshawb nrhiav tau ua rau muaj kev cuam tshuam ntawm kev haus luam yeeb, kev noj zaub mov, lossis haus dej haus cawv ntawm saxagliptin.
Kev ceev faj txog kev ntsuas
Onglisa yog cov tshuaj muaj txiaj ntsig zoo, kev tsis xav pom qhov ua tau tshwm sim tsis tshwm sim. Muaj ntau qhov tshwm sim tsis zoo nrog saxagliptin li nrog cov tshuaj kho.
Siv Onglises yog nruj me ntsis txwv thaum:
- ntshav qab zib hom 1
- co-administration nrog cov kua dej
- lactase deficiency,
- mob ketoacidosis,
- cev xeeb tub
- pub niam mis
- tsis tau muaj 18 xyoo
- tus kheej tsis kam mus rau ib qho ntawm cov tshuaj ntawm cov tshuaj.
Nws yog qhov ua tau zoo heev rau cov neeg mob siv:
- kev txom nyem los ntawm mob nyhav thiab tsis nco qab lub raum kev ua haujlwm lossis pancreatitis yav dhau los,
- neeg laus neeg laus
- nrog rau kev siv tib txhij nrog sulfonylureas.
Thaum kho nrog Onglisa, muaj qhov ntxim nyiam ntawm kev phiv:
- mob txeeb zig
- sab sauv ntawm txoj hlab ua pa tuaj
- o ntawm lub qhov ntswg mucosa,
- o ntawm lub plab thiab cov hnyuv me,
- ntxhoo
- mob leeg txhaj leeg
- migraines.
Nrog kev kho mob sib xyaw nrog metformin, nasopharyngitis ua tau nws tus kheej hauv qee kis.
Hypersensitivity tau sau tseg hauv 1.5% ntawm tus neeg mob, nws tsis yog hem neeg, thiab tsev kho mob tsis tas yuav tsum muaj.
Thaum noj ua ke nrog thiazolidinediones, kev txiav txim los ntawm kev txheeb xyuas ntawm Onglise, qhov tshwm sim ntawm qhov muaj zog lossis nruab nrab peripheral edema tau sau tseg, uas tsis tas yuav tsum tau txiav tawm txoj kev kho.
Qhov xwm txheej ntawm cov ntshav qog ntshav thaum kho nrog Ongliza tau ua tiav nrog cov txiaj ntsig nrog cov tshuaj placebo.
Noj ntau dhau
Nrog lub sijhawm ntev ntawm kev siv tshuaj, cov cim ntawm kev lom tsis piav qhia. Yog hais tias noj ntau dhau, cov tsos mob yuav tsum ua kom zoo siab. Cov tshuaj ua haujlwm nquag thiab nws cov khoom lag luam metabolic raug ntwm los ntawm hemodialysis.
Cov lus tsis sib xws Onglises nrog tib cov tshuaj nquag tsis muaj nyob. Nov yog cov tshuaj nkaus xwb nrog saxagliptin. Cov txiaj ntsig zoo sib xws ntawm lub cev tau siv los ntawm Nesin, Lub Sij Hawm, Galvus. Nws yog txwv tsis pub siv Ongliz analogues tsis tau kev tso cai los ntawm tus kws kho mob tuaj koom.
Cov tshuaj ntshav qab zib yuav pab tswj ntshav qabzib. Cov ntsiav tshuaj yooj yim rau kev nqa. Kuv tuaj yeem sau qhov kom zoo dua uas kuv tsis tau saib pom muaj kev phiv dab tsi. Ntawm cov minuses, Kuv tuaj yeem lub npe overpriced.
Kuv nyiam cov tshuaj Onglisa, muaj kev qhia meej meej rau kev siv, nws yooj yim siv. Qee zaum mob taub hau me ntsis tau tshwm sim. Kuv pom zoo cov tshuaj.
Ongliza cov tshuaj yog tus sawv cev rau ib pawg tshiab ntawm kev txo cov tshuaj qab zib. Nws muaj cov txheej txheem sib txawv ntawm qhov muaj zog, tab sis hais txog qhov ua tau zoo nws zoo ib yam li cov tshuaj ib txwm muaj, thiab hauv kev nyab xeeb nws muaj peev xwm dhau lawv. Cov tshuaj muaj qhov cuam tshuam zoo rau cov kab mob sib kis, tiv thaiv kev mob ntshav qab zib thiab muaj teeb meem.
Qhov tsis muaj qhov zoo yog qhov tsis muaj kev phom sij ntawm hypoglycemia, qhov cuam tshuam rau tus neeg mob qhov hnyav thiab siv tau nrog rau lwm cov tshuaj qab zib. Nyob rau hauv lub neej yav tom ntej, cov kws tshawb fawb npaj siab tsim cov tshuaj uas yuav ua kom rov ua haujlwm pancreatic rau lub sijhawm ntev.
Mob ntshav qab zib ib txwm ua rau neeg tuag taus. Muaj ntshav qab zib ntau dhau yog qhov txaus ntshai heev.
Lyudmila Antonova Lub Kaum Ob Hlis 2018 tau piav qhia txog kev kho mob ntshav qab zib. Nyeem tag nrho
Cov ntawv no puas pab tau zoo?
Cov tshuaj Onglisa los ntawm ntshav qab zib mellitus - cov lus qhia ntxaws ntxiv rau kev siv
Tus kab mob no cuam tshuam txog 9% ntawm cov neeg hauv ntiaj teb. Cov chaw lag luam kws tshuaj thiab kev kho mob ntawm cov thawj coj hauv ntiaj teb tau nqis peev nyiaj ntau lab daus las, thiab cov ntshav qab zib tau sib kis ib puag ncig ntawm lub ntiaj teb, ua rau cov yau dua, dhau mus ua ib tus neeg nruj dua ntxiv.
Kev mob kis tau rau ntawm lub teev uas tsis tau xav tias: los ntawm 2020, ib nrab lab tus neeg mob uas muaj ntshav qab zib hom 2 tau kwv yees, thiab cov kws kho mob tsis tau kawm paub txog kev tswj hwm tus kabmob zoo li cas.
Yog tias muaj ntshav qab zib hom 1, uas cuam tshuam tsawg dua 10% ntawm txhua tus neeg mob ntshav qab zib, txhua yam yog yooj yim: txo qhov hnoos ntshav qabzib hauv cov ntshav los ntawm kev txhaj tshuaj insulin (tsis muaj dab tsi ntxiv tuaj yeem muaj nyob ntawd) thiab txhua yam yuav zoo (hnub no, rau cov neeg mob, lawv kuj tau tsim cov qog cuav) ), tom qab ntawd nrog hom ntshav qab zib hom 2, thev naus laus zis siab tsis ua haujlwm.
Los ntawm cov piv txwv, rau hom ntshav qab zib hom 2, piam thaj tau tshaj tawm tias yog tus yeeb ncuab tseem ceeb, txhawm rau ua lag luam nrog cov tshuaj txo cov ntshav qab zibCov. Kev kho mob ntshav qab zib nrog kev pab los ntawm kev ua kom pyramids yog qhov muaj zog heev, thaum lwm cov tshuaj tau siv rau ib qho tshuaj, tom qab ntawv thib peb cov tshuaj ntxiv rau hauv cov txheej txheem no kom txog thaum tig los ntawm insulin.
Tau 20 lub xyoo dhau los, cov kws kho mob tau tawm tsam nrog kev noj qab zib, tab sis cov txiaj ntsig yog qis dua xoom, vim tias cov kev mob tshwm sim thiab cov teeb meem los ntawm cov tshuaj feem ntau tshaj lawv cov hauj lwm zoo, tshwj xeeb yog tias koj tsis ua raws li txoj kev noj tshuaj, tsis txhob suav nrog leej twg cov tshuaj uas haum rau thiab leej twg tsis ua.
Ib ntawm cov phiajcim kabmob no yog lub plawv thiab cov hlab ntshav. Nws yog qhov tseeb hais tias kev kho mob ntshav qab zib ntau dhau ua rau lub txiaj ntsig thiab ua rau vascular tuag. Qab Zib tsuas yog cov cim ntawm hom ntshav qab zib hom 2 xwb; tus kab mob yog ua raws li mob metabolic.
Cov tshuaj ntawm cov cim tshiab Onglisa, tsim los ntawm cov kws tshawb fawb British thiab Italian, tsis tsuas yog muaj tshuaj tua kab mob, tab sis kuj muaj peev xwm tiv thaiv cardioprotective. Cov tshuaj ntawm cov incretin koob, uas suav nrog Onglisa, yog qhov kev hloov kho tshiab tshaj plaws hauv thaj chaw ntawm kev mob ntshav qab zib. Lawv ua haujlwm kom txo tau qab los noj mov thiab kom poob ceeb thawj - ib qho ntawm cov laj thawj tseem ceeb ntawm kev txhim kho mob ntshav qab zib hom 2.
Tsis tas li ntawd, ntau ntxiv rau cov ntsiab lus tsis yog ua rau kom cov ntshav qog ntshav qab zib, pab txo ntshav siab, thiab tiv thaiv kab mob pancreatic. Tus nqi siab thiab tsis muaj kev soj ntsuam mob vim lub sijhawm luv luv ntawm kev siv tshuaj tuaj yeem raug ntaus nqi rau qhov tsis zoo ntawm Onglisa, tab sis qhov no tseem yog lub sijhawm.
Kev Sib Sau thiab daim ntawv ntawm kev tso tawm
Txhua ntsiav tshuaj Onglisa, cov duab uas tau nthuav tawm hauv ntu no, muaj 2.5 lossis 5 mg ntawm saxagliptin hydrochloride hauv lub plhaub. Cov mis tau ntxiv nrog cov kev zam: cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate thiab Opadray dyes (dawb, daj thiab xiav rau 2.5 mg ntsiav tshuaj thiab dawb, liab thiab xiav rau ntau npaum li 5 mg).
Cov tshuaj tuaj yeem tuaj yeem paub tau los ntawm cov duab (cov ntsiav tshuaj biconvex nrog lub ntsej muag daj thiab kos cim 2.5 / 4214 thiab pinkish nrog engraving 5/4215). Cov ntawv luam yuav tau ntaus thwj rau ntawm ib sab nrog tus cwj mem xiav.
Koj tuaj yeem yuav cov tshuaj uas kws kho mob xaj tau. Rau Ongliz ntsiav tshuaj, tus nqi tsis yog los ntawm qeb pob nyiaj siv: rau 30 pcs. 5 mg hauv Moscow koj yuav tsum them 1700 rubles. Cov neeg tsim khoom tau txiav txim siab lub neej txee ntawm cov tshuaj nyob rau hauv 3 xyoos. Cia rau cov tshuaj yuav tsum txheem.
Cov yam ntxwv ntawm Pharmacological
Lub ntsiab tseem ceeb ntawm Onglisa yog saxagliptin. Hauv ib hnub tom qab nkag rau hauv txoj hnyuv, nws cuam tshuam kev ua si ntawm DPP-4 peptide. Thaum muaj kev sib cuag nrog cov piam thaj, qhov kev tshem ntawm cov enzyme hloov zuj zus (2-3 zaug) txhim kho kev zais ntawm glucagon-zoo li peptide-1 (GLP-1) thiab piam thaj-insulinotropic polypeptide (HIP).
Nyob rau tib lub sijhawm, qib ntawm glucagon hauv b-hlwb poob qis, kev ua haujlwm ntawm b-hlwb lub luag haujlwm rau kev tsim cov tshuaj endogenous insulin nce. Yog li ntawd, qhov ntsuas ntawm kev yoo mov thiab postprandial glycemia yog txo qis.
Kev nyab xeeb thiab kev ua tau zoo ntawm cov tshuaj tau kawm hauv 6 qhov kev sim, hauv 4148 cov neeg ua haujlwm pab dawb uas muaj hom 2 tau koom nrog.
Txhua tus neeg tuaj koom qhia pom qhov muaj nuj nqi zoo ntawm glycated hemoglobin, starvation qab zib thiab glycemia tom qab kev ua kom zoo ntawm lub cev.
Cov tshuaj ntxiv, xws li thiazolidinediones, metformin, glibenclamide, tau raug tshaj tawm rau cov neeg koom nrog ib tus uas tsis ua tiav 100% glycemic tswj.
Txog Onglis, kev tshuaj xyuas cov neeg ua haujlwm pab dawb uas tau koom nrog kev sim ua ke rau cov placebo qhia tau tias, ntawm ntau qhov sib txawv, glycated hemoglobin thiab ntshav muaj pes tsawg dua tom qab 2 lub lis piam.
Cov neeg mob noj tshuaj ntxiv tiv thaiv kab mob tau pom zoo sib xws. Qhov hnyav ntawm txhua tus neeg tuaj koom rau hauv cov kev sim kawm tseem nyob ruaj khov.
Tshuaj qhov ncauj hypoglycemic
Pharmacological kev txiav txim
Saxagliptin yog ib qho muaj zog dua kev xaiv qhov thim rov qab sib tw dipeptidyl peptidase-4 (DPP-4) inhibitor.
Hauv cov neeg mob uas muaj hom 2 mob ntshav qab zib mellitus, kev tswj hwm ntawm saxagliptin ua rau kev tawm tsam ntawm kev ua si ntawm enzyme DPP-4 rau 24 teev.
Tom qab noj cov piam thaj, inhibition of DPP-4 ua rau muaj 2-3 zaug kev nce hauv kev ua hauj lwm ntawm glucagon-zoo li peptide-1 (GLP-1) thiab glucose-dependant insulinotropic polypeptide (HIP), qhov txo qis hauv cov concentration ntawm glucagon thiab qhov nce ntawm cov piam thaj hauv lub npov cov lus teb ntawm tes, uas ua rau muaj kev nce ntxiv hauv cov concentration. tshuaj insulin thiab C-peptide.
Kev tso tawm ntawm cov insulin los ntawm pancreatic beta hlwb thiab txo qis ntawm kev tso tawm ntawm glucagon los ntawm pancreatic alpha hlwb ua rau txo qis glycemia thiab postprandial glycemia.
Qhov ua tau zoo thiab kev nyab xeeb ntawm saxagliptin thaum noj ntawm 2.5 mg, 5 mg thiab 10 mg 1 lub sijhawm / hnub tau kawm nyob rau hauv rau ob qhov muag dig, qhov chaw tshuaj uas tswj muaj 4148 cov neeg mob ntshav qab zib hom 2.
Kev noj cov tshuaj tau nrog cov lus pom tseeb txhim kho hauv glycosylated hemoglobin (HbA1c), yoo plasma ntshav qab zib (GPN) thiab ntshav qab zib (PPG) ntshav plasma piv nrog kev tswj hwm.
Cov neeg mob nyob rau hauv uas hom phiaj glycemic qib tsis tuaj yeem ua tiav nrog saxagliptin raws li kev kho mob monotherapy tau ntxiv cov tshuaj metformin, glibenclamide lossis thiazolidinediones.
Thaum noj saxagliptin ntawm koob tshuaj 5 mg, qhov txo qis HbA1c raug pom tom qab 4 lub lis piam thiab GPN tom qab 2 lub lis piam.
Hauv pawg ntawm cov neeg mob tau txais saxagliptin hauv kev sib xyaw nrog metformin, glibenclamide lossis thiazolidinediones, qhov txo qis hauv HbA1c kuj tseem pom tom qab 4 lub lis piam thiab GPN tom qab 2 lub lis piam.
Cov nyhuv ntawm saxagliptin ntawm cov lipid profile zoo ib yam li cov placebo. Thaum kho nrog saxagliptin, tsis muaj qhov ceeb toom hauv lub cev qhov hnyav.
Cov Tshuaj Pharmacokinetics
Hauv cov neeg mob uas muaj hom 2 mob ntshav qab zib mellitus thiab hauv cov neeg tuaj yeem noj qab haus huv, cov tshuaj zoo sib xws ntawm saxagliptin thiab nws cov metabolite tseem ceeb tau sau tseg.
Saxagliptin tau nrawm nrawm tom qab noj rau ntawm lub plab khoob nrog kev ua tiav ntawm Cmax ntawm saxagliptin thiab cov metabolite tseem ceeb hauv plasma rau 2 teev thiab 4 teev, nyob ntawm.
Nrog rau kev nce ntxiv hauv koob tshuaj saxagliptin, qhov sib npaug nce hauv Cmax thiab AUC ntawm saxagliptin thiab nws cov metabolite tseem ceeb tau sau tseg.
Tom qab ib qho kev tswj hwm qhov ncauj ntawm saxagliptin ntawm koob tshuaj 5 mg los ntawm cov neeg ua haujlwm noj qab haus huv, qhov nruab nrab ntawm AUC qhov tseem ceeb ntawm saxagliptin thiab nws cov metabolite tseem ceeb yog 78 ng × h / ml thiab 214 ng × h / ml, thiab ntshav plasma Cmax qhov tseem ceeb yog 24 ng / ml thiab 47 ng / ml, feem Cov.
Qhov nruab nrab ntawm lub sijhawm kawg T1 / 2 ntawm saxagliptin thiab nws cov metabolite tseem ceeb yog 2.5 teev thiab 3.1 teev, thiab, thiab qhov nruab nrab plasma inhibition T1 / 2 ntawm DPP-4 yog 26.9 teev.
Kev txwv tsis pub ntshav ntshav DPP-4 kev ua haujlwm tsawg kawg 24 teev tom qab kev saib xyuas ntawm saxagliptin yog vim nws muaj kev cuam tshuam zoo rau DPP-4 thiab lub caij nyoog khi rau nws. Qhov tseem ceeb tsub zuj zuj ntawm saxagliptin thiab nws cov metabolite tseem ceeb nrog kev siv tshuaj ntev 1 zaug / hnub tsis pom.
Tsis muaj ib qho kev vam khom ntawm kev tshem tawm saxagliptin thiab nws cov metabolite tseem ceeb ntawm cov tshuaj ntawm lub sijhawm thiab lub sijhawm ntawm kev kho mob thaum noj saxagliptin 1 lub sijhawm / hnub hauv koob tshuaj ntawm 2.5 mg txog 400 mg rau 14 hnub.
Tom qab lub qhov ncauj tswj hwm, tsawg kawg 75% ntawm koob tshuaj saxagliptin yog nqus tau. Noj mov tsis muaj kev cuam tshuam loj heev rau pharmacokinetics ntawm saxagliptin hauv cov neeg tuaj noj qab haus huv zoo.
Cov zaub mov ua rog ntau tsis cuam tshuam rau Cmax ntawm saxagliptin, thaum AUC nce 27% piv nrog kev yoo mov. Lub sijhawm nce mus txog Cmax rau saxagliptin ntau zog nce kwv yees li 0.
5 teev thaum noj cov tshuaj nrog zaub mov piv nrog yoo mov. Txawm li cas los xij, cov kev pauv hloov no tsis yog qhov tseem ceeb hauv tsev kho mob.
Kev khi ntawm saxagliptin thiab nws lub ntsiab metabolite rau cov ntshav cov protein tsis tseem ceeb, yog li, tuaj yeem xav tias kev faib tawm saxagliptin nrog kev hloov pauv ntawm cov protein sib xyaw ntawm cov ntshav pom nyob rau hauv hepatic lossis lub raum tsis ua haujlwm yuav tsis raug hloov pauv tseem ceeb.
Saxagliptin yog metabolized feem ntau nrog kev koom tes ntawm isoenzymes ntawm cytochrome P450 3A4 / 5 (CYP 3A4 / 5) nrog kev tsim cov nquag metabolite, cov nyhuv inhibitory uas tiv thaiv DPP-4 yog 2 lub sijhawm tsis muaj zog tshaj li ntawm saxagliptin.
Saxagliptin ua tawm hauv cov zis thiab cov kua tsib. Tom qab ib koob tshuaj 50 mg ntawm daim ntawv lo 14C-saxagliptin, 24% ntawm cov koob tshuaj tau raug tso tawm los ntawm lub raum ua qhov hloov pauv saxagliptin thiab 36% yog cov tshuaj metabolite ntawm saxagliptin.
Cov tshuaj tiv thaiv kab mob tag nrho hauv cov zis ntsuas rau 75% ntawm kev noj tshuaj.Qhov nruab nrab lub raum tshem tawm ntawm saxagliptin yog kwv yees li 230 ml / min, qhov nqi nruab nrab ntawm glomerular pom tau yog li 120 ml / min.
Rau lub ntsiab metabolite, lub raum tshem tawm tau sib piv nrog lub txiaj ntsig tseem ceeb ntawm glomerular pom.
Txog 22% ntawm tag nrho cov xov tooj cua tau pom nyob hauv cov quav.
Pharmacokinetics hauv cov chaw kuaj mob tshwj xeeb
Hauv cov neeg mob uas tsis muaj lub siab lub ntsws tsis txaus, AUC qhov tseem ceeb ntawm saxagliptin thiab nws cov metabolite tseem ceeb yog 1.2 thiab 1.7 npaug siab dua, feem, piv txwv li, cov neeg hauv cov neeg muaj lub raum rov ua haujlwm. Qhov nce no ntawm AUC qhov tseem ceeb tsis yog qhov tseem ceeb hauv tsev kho mob, yog li ntawd, kev kho tshuaj tsis tas yuav tsum tau ua.
Hauv cov neeg mob uas mob raum mus rau lub raum tsis ua haujlwm, zoo ib yam li cov neeg mob ntawm kev mob hemodialysis, AUC qhov tseem ceeb ntawm saxagliptin thiab nws cov metabolite tseem ceeb yog 2.1 thiab 4, ua ntu zus.
5 npaug ntau dua li ntsuas zoo sib xws hauv cov tib neeg muaj lub raum kev ua haujlwm zoo.
Rau cov neeg mob uas muaj mob nyhav thiab tsis tshua zoo lub raum kev ua haujlwm, nrog rau cov neeg mob ntawm hemodialysis, koob tshuaj saxagliptin yuav tsum yog 2.5 mg 1 zaug / hnub.
Hauv cov neeg mob uas tsis tshua muaj mob me me, mob nyhav thiab hnyav hnyav, tsis muaj kev hloov pauv ntau hauv cov chaw muag tshuaj ntawm saxagliptin, yog li kev kho kom haum rau cov neeg mob zoo li no tsis tas yuav ua.
Hauv cov neeg mob hnub nyoog 65-80 xyoo, tsis muaj qhov sib txawv hauv cov chaw muag tshuaj ntawm saxagliptin piv nrog cov neeg mob uas muaj hnub nyoog yau dua (18-40 xyoo), yog li ntawd, tsis tas yuav tsum kho ntau dua hauv cov neeg mob laus. Txawm li cas los xij, nws yuav tsum tau yug hauv siab tias hauv pawg no ntawm cov neeg mob, qhov kev txo qis ntawm lub raum ua haujlwm yog qhov ntau dua.
Hom 2 mob ntshav qab zib mellitus ntxiv rau kev noj haus thiab kev tawm dag zog kom txhim kho glycemic tswj kom zoo:
- pib kev sib txuam nrog kev siv tshuaj metformin,
- ntxiv rau kev kho mob monotherapy nrog metformin, thiazolidinediones, sulfonylurea derivatives, thaum tsis muaj glycemic tswj tau txaus hauv qhov kev kho no.
Cov tshuaj yog tawm hauv lub qhov ncauj, tsis hais los ntawm cov khoom noj.
Ntawm tshuaj mob hlwb kev pom zoo koob tshuaj saxagliptin yog 5 mg 1 zaug / hnub.
Ntawm kev sib txuas ua ke koob tshuaj pom zoo ntawm saxagliptin yog 5 mg 1 zaug / hnub hauv kev sib xyaw nrog metformin, thiazolidinediones lossis sulfonylurea derivatives.
Ntawm pib txoj kev kho ua ke nrog metformin kev pom zoo koob tshuaj saxagliptin yog 5 mg 1 zaug / hnub, thawj koob tshuaj metformin yog 500 mg / hnub. Yog tias tsis teb rov qab, qhov tshuaj ntawm cov metformin yuav raug nce ntxiv.
Ntawm dhau ntawm kev noj tshuaj Ongliza ploj ntsiav tshuaj yuav tsum tau noj sai li sai tau thaum tus neeg mob nco qab qhov no, txawm li cas los xij, koj yuav tsum tsis txhob noj ob zaug tshuaj ntawm ib hnub rau ib hnub.
Rau cov neeg mob uas lub raum tsis ua haujlwm (KK> 50 ml / feeba) Tsis tas yuav txhaj tshuaj.
Rau cov neeg mob raum tsis ua hauj lwm zoo los yog lub raum tsis ua hauj lwm zoo (KK ≤50 ml / feeb)), ib yam li rau cov neeg mob hemodialysis koob tshuaj pom zoo ntawm Ongliza yog 2.5 mg 1 zaug / hnub. Qhov tshuaj yuav tsum tau noj thaum kawg ntawm kev kho mob hemodialysis.
Kev siv cov saxagliptin rau cov neeg mob ua mob rau txoj hlab ntshav peritoneal lim ntshav tsis tau kawm. Ua ntej pib kho nrog saxagliptin thiab thaum kho, nws raug nquahu kom kuaj xyuas lub raum kev ua haujlwm.
Ntawm lub siab ua haujlwm tsis ua haujlwm me me, hnyav thiab mob hnyav Tsis tas yuav txhaj koob tshuaj.
Koob tshuaj kho nyob rau hauv cov neeg laus laus tsis tas yuav. Txawm li cas los xij, thaum xaiv cov koob tshuaj, nws yuav tsum tau yug los rau hauv lub siab tias hauv pawg no ntawm cov neeg mob, qhov kev txo qis ntawm lub raum kev ua haujlwm yog qhov ntau dua.
Kev nyab xeeb thiab ua tau zoo ntawm cov tshuaj hauv cov neeg mob hnub nyoog qis dua 18 xyoo tsis kawm ntawv.
Ntawm concomitant siv nrog hwj chim CYP 3A4 / 5 inhibitorsxws li ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir thiab telithromycin, koob tshuaj pom zoo ntawm Ongliza yog 2.5 mg 1 zaug / hnub.
Tag nrho cov zaus ntawm cov kev mob tshwm sim thaum noj cov tshuaj Onglisa 5 mg hauv kev kho mob monotherapy thiab hauv hom kev ntxiv rau kev kho nrog metformin, thiazolidinedione lossis glibenclamide piv rau qhov ntawd hauv cov pab pawg placebo.
Cov nplai ntawm qhov ntau zaus ntawm cov kev mob tshwm sim: ntau zaus (≥1 / 10), feem ntau (≥1 / 100,
Onglisa: yeeb tshuaj rau ntshav qab zib, tshuaj xyuas thiab analogues ntawm ntsiav tshuaj
Video (nyem mus ua si). |
Nrog rau kev nce qib ntawm cov ntshav qab zib tsis-insulin, cov neeg mob tsis tas yuav tswj tau theem ntawm glycemia siv cov khoom noj tshwj xeeb thiab kev tawm dag zog. Onglisa yog suab thaj txo cov tshuaj uas siv rau hauv cov xwm txheej zoo li no txhawm rau txhawm rau ua kom cov ntshav qabzib nyob hauv cov ntshav.
Zoo li ib yam tshuaj twg, Onglisa muaj qee qhov tsis sib haum, kev coj ua tsis zoo, nrog rau cov yam ntxwv ntawm kev siv. Yog li, ua ntej siv cov tshuaj, koj yuav tsum nrhiav kom paub cov ncauj lus kom ntxaws txog nws.
Onglisa (hauv lat. Onglyza) yog ib hom tshuaj muaj npe uas siv thoob ntiaj teb ntshav qab zib hom 2. Lub npe thoob ntiaj teb nonproprietary (INN) ntawm cov tshuaj yog Saxagliptin.
Video (nyem mus ua si). |
Cov chaw tsim tshuaj paus ntawm tus sawv cev hypoglycemic no yog tuam txhab American pharmacological Bristol-Myers Squibb. Lub ntsiab tivthaiv - saxagliptin raug suav hais tias yog ib qho ntawm cov kev xaiv muaj zog tshaj plaws thim rov qab kev sib tw ntawm dipeptidyl peptidase-4 (DPP-4). Qhov no txhais tau hais tias thaum cov tshuaj noj ntawm qhov ncauj, cov tshuaj yeeb tshuaj tseem ceeb tshaj qhov txiav txim ntawm DPP-4 enzyme thaum nruab hnub.
Ntxiv rau saxagliptin, Onglis ntsiav tshuaj muaj ib qho me me ntawm cov khoom ntxiv - lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, macrogol, talc, titanium dioxide, magnesium stearate thiab qee yam. Ua raws li daim ntawv tso tawm, ib ntsiav tshuaj ntawm cov tshuaj yuav muaj 2.5 lossis 5 mg ntawm cov tshuaj nquag.
Tus kab mob antidiabetic tus neeg sawv cev Onglisa ua li cas tom qab nws nkag mus rau hauv tib neeg lub cev? Saxagliptin nrawm rau hauv lub plab zom mov, nws cov ntsiab lus siab tshaj plaws hauv cov ntshav ntshav tau pom 2-4 teev tom qab siv. Cov tshuaj muaj cov nyhuv zoo li no:
- Nce nce qib ntawm ISU thiab GLP-1.
- Txo cov ntsiab lus ntawm glucagon, thiab tseem txhim kho cov tshuaj tiv thaiv ntawm cov hlwb hlwb, uas yog qhov kev nce qib ntawm C-peptides thiab insulin.
- Nws provokes tso tawm suab thaj txo cov tshuaj hormones los ntawm beta hlwb nyob hauv lub txiav.
- Tiv thaiv kev tso tawm ntawm glucagon los ntawm alpha cells ntawm islets ntawm Langerhans.
Los ntawm kev ua rau cov txheej txheem saum toj no hauv lub cev, cov tshuaj Onglis txhim kho cov txiaj ntsig ntawm glycated hemoglobin (HbA1c), cov piam thaj nyob rau ntawm lub plab khoob thiab tom qab noj mov. Cov kws kho mob tuaj yeem sau tshuaj rau hauv cov tshuaj sib xyaw nrog lwm cov kab mob hypoglycemic (metformin, glibenclamide lossis thiazolidinediones).
Cov tshuaj ua kom nquag pliag yog tawm ntawm lub cev hauv daim ntawv tsis hloov pauv thiab hauv daim ntawv ntawm kev siv tshuaj tiv thaiv nrog cov kua tsib thiab tso zis.
Qhov nruab nrab, lub raum tshem tawm ntawm saxagliptin yog 230 ml ib feeb, thiab qhov siab glomerular pom (GFR) yog 120 ml ib feeb.
Ua ntej yuav noj cov tshuaj, tus neeg mob yuav tsum tau sab laj nrog nws tus kws saib xyuas kev noj qab haus huv uas yuav txiav txim seb ib tug neeg noj npaum li cas raws li cov ntshav qab zib cov ntshav qab zib. Thaum muas cov tshuaj Onglisa, cov lus qhia rau kev siv yuav tsum ua tib zoo nyeem thiab yog tias koj muaj lus nug nug lawv tus kws kho mob.
Cov ntsiav tshuaj tau siv tsis hais lub sijhawm ua mov noj, ntxuav nrog lub khob dej. Yog tias cov tshuaj tshwm sim raws li kev kho mob monotherapy, ces cov tshuaj txhua hnub yog 5 mg. Yog tias tus kws kho mob tau sau ntawv rau kev kho mob sib xyaw, tom qab ntawd ib hnub raug tso cai siv Onglisa txhais tau tias 5 mg nrog metformin, thiazolidinediones thiab lwm yam tshuaj hypoglycemic.
Ua ke nrog Onglisa thiab metformin, koj yuav tsum tau ua raws li thawj cov koob tshuaj 5 mg thiab 500 mg, ntsig txog. Nws yog nruj me ntsis txwv tsis pub noj ob zaug hauv rooj plaub thaum tus neeg mob tsis nco qab noj cov tshuaj kom raws sijhawm. Thaum nws nco qab txog qhov no, nws yuav tsum tau haus ib ntsiav tshuaj.
Tshwj xeeb tshaj yog cov neeg mob nyob raum tsis ua hauj lwm. Nrog rau daim ntawv me ntawm lub raum tsis ua haujlwm, nws tsis tas yuav kho qhov tshuaj ntawm cov tshuaj. Hauv cov neeg mob uas mob raum lossis hnyav lub raum tsis ua haujlwm, nrog rau cov neeg mob hemodialysis, noj tshuaj rau txhua hnub yog 2.5 mg. Ntxiv rau, thaum siv cov tshuaj CYP 3A4 / 5 muaj zog heev, qhov muab tshuaj ntawm Onglis yuav tsum muaj tsawg heev (2.5 mg).
Cov chaw tsim khoom lag luam qhia txog lub ntim cov hnub tas sij hawm, uas feem ntau 3 xyoos. Cov tshuaj tau muab tso kom deb ntawm cov menyuam yaus ntawm qhov kub ntawm tsis tshaj 30 degrees.
Zaj duab xis-coated ntsiav tshuaj los ntawm daj ntseg daj mus rau lub teeb xim daj rau xim, puag ncig, biconvex, nrog cov ntawv sau "2.5" ntawm ib sab thiab "4214" ntawm lwm sab, xim nrog cov xim xiav.
Cov zam: lactose monohydrate - 99 mg *, microcrystalline cellulose - 90 mg, croscarmellose sodium - 10 mg, magnesium stearate - 1 mg **, hydrochloric acid 1 M lossis sodium hydroxide daws 1 M - yuav tsum muaj ntau, Opadry II dawb (% hnyav / phaus) - 26 mg (polyvinyl cawv 40%, titanium dioxide 25%, macrogol (PEG 3350) 20.2%, talc 14.8%), Opadry II daj (% hnyav / hnyav) - 7 mg (polyvinyl cawv 40%, titanium dioxide 24.25%, macrogol (PEG 3350) 20.2%, talc 14.8%, zas hlau oxide daj (E172) 0.75%), number case Opacode xiav *** - tus nqi uas yuav tsum tau muaj.
10 Pcs. - aluminium ntawv ci blisters (3) - pob khoom los ntawm cardboard.
* Tus nqi ntawm lactose tej zaum yuav sib txawv raws li cov nyiaj uas siv magnesium stearate.
** Tus nqi ntawm magnesium stearate yuav txawv ntawm 0.5-2 mg. Cov nyiaj siv ntau npaum li cas ntawm 1 mg.
*** Ink composition Opacode xiav (% hnyav / hnyav): shellac 45% hauv dej cawv ethyl 55.4%, FD&C xiav # 2 / indigo carmine txhuas xim muaj xim (Е132) 16%, n-butyl cawv 15%, propylene glycol 10.5%, isopropyl cawv 3%, 28% ammonium hydroxide 0.1%. Tsawg heev ntawm shellac thiab FD&C Xiav # 2 / indigo carmine txhuas xim txhuas nyob hauv cov ntsiav tshuaj thaum cim. Cov kuab tshuaj uas suav nrog tus number case tau tshem tawm thaum tus txheej txheem tsim.
Zaj duab xis-coated ntsiav tshuaj liab dawb, puag ncig, biconvex, nrog cov sau “5” ntawm ib sab thiab “4215” ntawm lwm sab, pleev xim nrog cov xim xiav xiav.
Cov zam: lactose monohydrate - 99 mg *, microcrystalline cellulose - 90 mg, croscarmellose sodium - 10 mg, magnesium stearate - 1 mg **, hydrochloric acid 1 M lossis sodium hydroxide daws 1 M - yuav tsum muaj ntau, Opadry II dawb (% hnyav / qhov hnyav) - 26 mg (polyvinyl cawv 40%, titanium dioxide 25%, macrogol (PEG 3350) 20.2%, talc 14.8%), Opadry paj yeeb liab (% hnyav / hnyav) - 7 mg (polyvinyl cawv 40%, titanium dioxide 24.25%, macrogol (PEG 3350) 20.2%, talc 14.8%, zas hlau oxide liab (E172) 0.75%), number case Opacode xiav *** - tus nqi uas yuav tsum tau muaj.
10 Pcs. - aluminium ntawv ci blisters (3) - pob khoom los ntawm cardboard.
* Tus nqi ntawm lactose tej zaum yuav sib txawv raws li cov nyiaj uas siv magnesium stearate.
** Tus nqi ntawm magnesium stearate yuav txawv ntawm 0.5-2 mg. Cov nyiaj siv ntau npaum li cas ntawm 1 mg.
*** Ink composition Opacode xiav (% hnyav / hnyav): shellac 45% hauv dej cawv ethyl 55.4%, FD&C xiav # 2 / indigo carmine txhuas xim muaj xim (Е132) 16%, n-butyl cawv 15%, propylene glycol 10.5%, isopropyl cawv 3%, 28% ammonium hydroxide 0.1%. Tsawg heev ntawm shellac thiab FD&C Xiav # 2 / indigo carmine txhuas xim txhuas nyob hauv cov ntsiav tshuaj thaum cim. Cov kuab tshuaj uas suav nrog tus number case tau tshem tawm thaum tus txheej txheem tsim.
Saxagliptin yog ib qho muaj zog dua kev xaiv qhov thim rov qab sib tw dipeptidyl peptidase-4 (DPP-4) inhibitor.
Hauv cov neeg mob uas muaj ntshav qab zib hom 2 mellitus, kev tswj hwm ntawm saxagliptin txwv tsis pub cov kev ua haujlwm ntawm DPP-4 enzyme tsis pub dhau 24 teev. polypeptide (HIP), qhov txo qis hauv cov concentration ntawm glucagon thiab nce ntxiv ntawm cov piam thaj hauv cov lus teb ntawm beta hlwb, uas ua rau muaj qhov nce ntawm cov tshuaj insulin thiab C-peptide.
Kev tso tawm ntawm cov insulin los ntawm pancreatic beta hlwb thiab txo qis ntawm kev tso tawm ntawm glucagon los ntawm pancreatic alpha hlwb ua rau txo qis glycemia thiab postprandial glycemia.
Qhov ua tau zoo thiab kev nyab xeeb ntawm saxagliptin thaum noj ntawm 2.5 mg, 5 mg thiab 10 mg 1 lub sijhawm / hnub tau kawm nyob rau hauv rau ob qhov muag dig, qhov chaw tshuaj uas tswj muaj 4148 cov neeg mob ntshav qab zib hom 2. Kev noj cov tshuaj tau nrog nrog kev txhim kho kev pom tseeb hauv glycated hemoglobin (HbA1c), yoo plasma ntshav qab zib (GPN) thiab ntshav qab zib cov ntshav qab zib (PPG) ntshav plasma piv nrog kev tswj hwm.
Cov neeg mob nyob rau hauv uas hom phiaj glycemic qib tsis tuaj yeem ua tiav nrog saxagliptin raws li kev kho mob monotherapy tau ntxiv cov tshuaj metformin, glibenclamide lossis thiazolidinediones. Thaum noj saxagliptin ntawm koob tshuaj 5 mg, txo qis HbA1c tau sau tseg tom qab 4 lub lis piam thiab GPN - tom qab 2 lub lis piam. Hauv pawg ntawm cov neeg mob tau txais saxagliptin txuam nrog metformin, glibenclamide lossis thiazolidinediones, txo HbA1c kuj tau sau tseg tom qab 4 lub lis piam thiab GPN - tom qab 2 lub lis piam.
Cov nyhuv ntawm saxagliptin ntawm cov lipid profile zoo ib yam li cov placebo. Thaum kho nrog saxagliptin, tsis muaj qhov ceeb toom hauv lub cev qhov hnyav.
Hauv cov neeg mob uas muaj hom 2 mob ntshav qab zib mellitus thiab hauv cov neeg tuaj yeem noj qab haus huv, cov tshuaj zoo sib xws ntawm saxagliptin thiab nws cov metabolite tseem ceeb tau sau tseg.
Saxagliptin nrawm sai sai tom qab kev noj ntawm lub plab khoob nrog kev ua tiav Cmax saxagliptin thiab cov metabolite tseem ceeb hauv plasma rau 2 teev thiab 4 teev, feem. Nrog kev nce hauv saxagliptin koob tshuaj, ib qho kev nce ntau hauv C tau muab sau ciamax thiab AUC ntawm saxagliptin thiab nws cov metabolite tseem ceeb. Tom qab ib qho kev tswj hwm qhov ncauj ntawm saxagliptin ntawm koob tshuaj 5 mg los ntawm cov neeg ua hauj lwm noj qab haus huv, qhov nruab nrab ntawm AUC qhov tseem ceeb ntawm saxagliptin thiab nws cov metabolite tseem ceeb yog 78 ng × h / ml thiab 214 ng × h / ml, thiab Cmax hauv ntshav - 24 ng / ml thiab 47 ng / ml, feem.
Qhov nruab nrab ntawm lub sijhawm kawg T kawg1/2 saxagliptin thiab nws cov metabolite tseem ceeb yog 2.5 teev thiab 3.1 teev, ua ntu zus, thiab tus nqi nruab nrab ntawm inhibition T1/2 Plasma DPP-4 - 26.9 teev. Kev txwv tsis pub ntshav plasma DPP-4 kev ua haujlwm tsawg kawg 24 teev tom qab kev coj ntawm saxagliptin yog vim nws muaj kev cuam tshuam zoo rau DPP-4 thiab lub caij nyoog khi rau nws. Qhov tseem ceeb tsub zuj zuj ntawm saxagliptin thiab nws cov metabolite tseem ceeb nrog kev siv tshuaj ntev 1 zaug / hnub tsis pom. Tsis muaj ib qho kev vam khom ntawm kev tshem tawm saxagliptin thiab nws cov metabolite tseem ceeb ntawm cov tshuaj ntawm lub sijhawm thiab lub sijhawm ntawm kev kho mob thaum noj saxagliptin 1 lub sijhawm / hnub hauv koob tshuaj ntawm 2.5 mg txog 400 mg rau 14 hnub.
Tom qab lub qhov ncauj tswj hwm, tsawg kawg 75% ntawm koob tshuaj saxagliptin yog nqus tau. Noj mov tsis muaj kev cuam tshuam loj heev rau pharmacokinetics ntawm saxagliptin hauv cov neeg tuaj noj qab haus huv zoo. Cov zaub mov tsis muaj rog ntau tsis cuam tshuam rau Cmax saxagliptin, thaum AUC tau nce 27% piv nrog kev yoo mov. Lub sijhawm mus txog Cmax rau saxagliptin ntau ntxiv los ntawm kwv yees li 0.5 teev thaum noj tshuaj nrog zaub mov piv nrog kev yoo mov. Txawm li cas los xij, cov kev pauv hloov no tsis yog qhov tseem ceeb hauv tsev kho mob.
Kev khi ntawm saxagliptin thiab nws lub ntsiab metabolite rau cov ntshav cov protein tsis tseem ceeb, yog li, tuaj yeem xav tias kev faib tawm saxagliptin nrog kev hloov pauv ntawm cov protein sib xyaw ntawm cov ntshav pom nyob rau hauv hepatic lossis lub raum tsis ua haujlwm yuav tsis raug hloov pauv tseem ceeb.
Saxagliptin yog metabolized feem ntau nrog kev koom tes ntawm isoenzymes ntawm cytochrome P450 3A4 / 5 (CYP 3A4 / 5) nrog kev tsim cov nquag metabolite, cov nyhuv inhibitory uas tiv thaiv DPP-4 yog 2 lub sijhawm tsis muaj zog tshaj li ntawm saxagliptin.
Saxagliptin ua tawm hauv cov zis thiab cov kua tsib. Tom qab ib koob tshuaj 50 mg ntawm daim ntawv lo 14 C-saxagliptin, 24% ntawm cov koob tshuaj tau raug tso tawm los ntawm lub raum ua qhov hloov pauv saxagliptin thiab 36% yog cov tshuaj metabolite ntawm saxagliptin. Cov tshuaj tiv thaiv kab mob tag nrho hauv cov zis ntsuas rau 75% ntawm kev noj tshuaj.Qhov nruab nrab lub raum tshem tawm ntawm saxagliptin yog kwv yees li 230 ml / min, qhov nqi nruab nrab ntawm glomerular pom tau yog li 120 ml / min. Rau lub ntsiab metabolite, lub raum tshem tawm tau sib piv nrog lub txiaj ntsig tseem ceeb ntawm glomerular pom.
Txog 22% ntawm tag nrho cov xov tooj cua tau pom nyob hauv cov quav.
Pharmacokinetics hauv cov chaw kuaj mob tshwj xeeb
Hauv cov neeg mob uas tsis muaj lub siab lub ntsws tsis txaus, AUC qhov tseem ceeb ntawm saxagliptin thiab nws cov metabolite tseem ceeb yog 1.2 thiab 1.7 npaug siab dua, feem, piv txwv li, cov neeg hauv cov neeg muaj lub raum rov ua haujlwm. Qhov nce no ntawm AUC qhov tseem ceeb tsis yog qhov tseem ceeb hauv tsev kho mob, yog li ntawd, kev kho tshuaj tsis tas yuav tsum tau ua.
Hauv cov neeg mob uas tsis tshua muaj lub raum mus rau lub raum tsis txaus, thiab rau cov neeg mob ntawm kev mob hemodialysis, qhov tseem ceeb ntawm AUC ntawm saxagliptin thiab nws cov metabolite tseem ceeb yog 2.1 thiab 4.5 npaug siab dua, feem ntau, ntau dua li cov neeg hauv lub cev uas muaj lub raum zoo li qub. Rau cov neeg mob uas muaj mob nyhav thiab tsis tshua zoo lub raum kev ua haujlwm, nrog rau cov neeg mob ntawm hemodialysis, koob tshuaj saxagliptin yuav tsum yog 2.5 mg 1 zaug / hnub.
Hauv cov neeg mob uas tsis tshua muaj mob me me, mob nyhav thiab hnyav hnyav, tsis muaj kev hloov pauv ntau hauv cov chaw muag tshuaj ntawm saxagliptin, yog li kev kho kom haum rau cov neeg mob zoo li no tsis tas yuav ua.
Hauv cov neeg mob hnub nyoog 65-80 xyoo, tsis muaj qhov sib txawv hauv cov chaw muag tshuaj ntawm saxagliptin piv nrog cov neeg mob uas muaj hnub nyoog yau dua (18-40 xyoo), yog li ntawd, tsis tas yuav tsum kho ntau dua hauv cov neeg mob laus. Txawm li cas los xij, nws yuav tsum tau yug hauv siab tias hauv pawg no ntawm cov neeg mob, qhov kev txo qis ntawm lub raum ua haujlwm yog qhov ntau dua.
Hom 2 mob ntshav qab zib mellitus ntxiv rau kev noj haus thiab kev tawm dag zog kom txhim kho glycemic tswj kom zoo:
- pib kev sib txuam nrog kev siv tshuaj metformin,
- ntxiv rau kev kho mob monotherapy nrog metformin, thiazolidinediones, sulfonylurea derivatives, thaum tsis muaj glycemic tswj tau txaus hauv qhov kev kho no.
- yam 1 mob ntshav qab zib mellitus (siv tsis tau kawm),
- siv cov tshuaj insulin (tsis kawm),