Telmisartan (Mikardis)
Kev piav qhia cuam tshuam rau 04.11.2016
- Lub npe Latin: Telmisartan
- ATX Code: C09CA07
- Yam tshuaj muaj sia: Telmisartan (Telmisartan)
- Chaw tsim tshuaj paus: TEVA Tshuaj Tsob Nroj, JSC rau Ratiopharm International GmbH, Hungary / Lub Tebchaws Yelemees
Ua raws li daim ntawv tso tawm, ib ntsiav tshuaj muaj 80 lossis 40 mg ntawm cov tshuaj nquag.
Cov Tshuaj Hauv Tshuaj
Telmisartan yog xaiv xaiv angiotensin II receptor antagonist. Nws sib tw nrog angiotensin rau kev ua raws li AT1 receptors. Tsis muaj kev cuam tshuam rau lwm cov receptors tau sau tseg.
Telmisartan tsis txwv qhov kev txiav txim ntawm renin, ACE, tsis thaiv cov channel raws lub luag haujlwm rau kev ua ions, txo cov ntsiab lus aldosterone hauv ntshav.
Ib koob tshuaj 80 mg yuav luag txhua qhov ua kom tiav ntshav siabtshwm sim los ntawm angiotensin II. Qhov siab tshaj plaws yuav kav ntev li 24 teev, tom qab ntawd maj mam poob qis. Hauv qhov no, qhov cuam tshuam zoo ntawm cov tshuaj yog hnov tsawg kawg 48 teev tom qab noj cov ntsiav tshuaj.
Telmisartan txo qis ob qho systolic thiab diastolic siab, tab sis tsis cuam tshuam rau cov mem tes dhia. Tsis muaj teebmeem txog kev quav dab tsi lossis kev kho mob ntau ntxiv hauv lub cev tau sau tseg.
Cov Tshuaj Pharmacokinetics
Tom qab noj tau, cov tshuaj zoo dua thiab nqus tau sai. Bioavailability yog kwv yees li 50%. Nws khi zoo heev rau cov protein ntau.
Qhov siab tshaj plaws ntshav ntshav feem ntau yog siab dua rau cov poj niam thaum noj ib koob. Tab sis qhov no tsis cuam tshuam rau qhov siv tau.
Kev zom zaub mov tshwm sim hauv lub siab. Qhov no ua rau tsis tsaug zog metaboliteKev tshem tawm ntawm uas feem ntau tshwm sim los ntawm txoj hnyuv. Ib nrab-lub neej ntawm lub cev yog li 20 teev.
Kev ntsuas rau siv
Nws yog siv los kho leeg ntshav siab thiab rau kev tiv thaiv kev tuag ntawm cov kab mob ntawm cov hlab plawv tom qab mob stroke, plawv nresperipheral vascular kab mob sab laug ventricular hypertrophy.
Cov Yuav Tsum Tau Ua
Nws yog txwv tsis pub sau ntawv rau Telmisartan nrog:
- obstructive kab mob ntawm biliary ib ntsuj av,
- loj heev daim siab ua hauj lwm,
- thawj tshuab qeej,
- fructose intolerance,
- kev xav tob tob rau cov tshuaj nquag lossis lwm yam tshuaj uas yog ib feem ntawm cov tshuaj,
- ntawm cev xeeb tub,
- tsis tau muaj 18 xyoo.
Sab sij huam
Cov kev mob tshwm sim tsawg tsawg.
Ib ntawm 100-1000 tus neeg mob uas noj tshuaj muaj cov tsos mob li nram no:
Hauv 1 ntawm 1000-10000 tus neeg mob tau pom tias:
- mob txeeb zig thiab mob ntswscystitis, pharyngitis, mob hlab ntsws) lossis sepsis,
- thrombocytopenia,
- qib txo hemoglobin,
- kev xav ntawm kev ntxhov siab
- pom kev tsis sib to taub
- tachycardia,
- poob hauv ntshav siab thaum hloov txoj haujlwm ntawm lub cev (los ntawm kab rov tav mus rau ntsug),
- mob plab tsis xis nyob
- qhov ncauj qhuav
- lub siab ua tsis taus haujlwm,
- ua rau daim siab ua haujlwm cov enzymes,
- nce ntshav ntxiv ntawm uric acid,
- mob tej pob txha
- erythema,
- angioedema,
- ua pob khaus lom,
- eczematous ua pob.
Cov kev mob tshwm sim uas tsis tshua muaj tshwm sim los yog qhov uas nws ua tsis tau raug txiav txim meej meej:
- leeg leeg mob sib thooj leeg leeg,
- nce ntxiv ntawm eosinophils hauv cov ntshav.
Kev sib txuam
Kev sib cuam tshuam ntawm Telmisartan nrog lwm cov tshuaj:
- Baclofen, Amifostine thiab lwm cov tshuaj tiv thaiv mob siab - cov nyhuv hypotensive yog kho kom zoo,
- barbiturates, narcotic siv yeeb siv tshuaj, ethanol thiab antidepressants - qhov tshwm sim ntawm orthostatic hypotension muaj kev ntshai lossis kev pheej hmoo ntawm nws tshwm sim nce,
- Furosemide, Hydrochlorothiazide thiab qee qhov lwm yam tshuaj ntxiv ntshav - cov nyhuv hypotensive nce,
- Digoxin - Muaj kev nce siab ntxiv Digoxin hauv ntshav
- lithium npaj - ib qho kev hloov pauv ntawm kev rov qab ua siab ntawm cov roj ntsha lithium hauv cov ntshav, kev soj ntsuam ntawm qhov ntsuas no yog qhov tsim nyog,
- NSAIDs - qhov pheej hmoo ntawm cov tsos mob hnyav nce ntxiv lub raum tsis ua hauj lwmtshwj xeeb nrog lub cev qhuav dej
- poov tshuaj-sparing diuretics, poov tshuaj, Heparin, Cyclosporin, Tacrolimus, Trimethoprim - kev nce siab ntawm cov poov tshuaj nyob hauv cov ntshav ntshav,
- GCS - hypotensive nyhuv txo,
- Amlodipine - Kev ua haujlwm ntawm Telmisartan yog nce zuj zus.
Pharmacological kev txiav txim
Angiotensin II receptor antagonist.
Telmisartan yog tus paub tab ntawm kev tiv thaiv angiotensin II. Nws muaj qhov xwm txheej siab rau AT1 receptor subtype ntawm angiotensin II, dhau los ntawm qhov kev txiav txim ntawm angiotensin II yog pom tau hais. Telmisartan hloov chaw angiotensin II los ntawm nws cov lus cog rau lub receptor, tsis muaj qhov kev txiav txim ntawm agonist nyob rau hauv kev sib raug zoo nrog cov receptor no. Telmisartan tsuas yog khi rau AT1 receptor subtype ntawm angiotensin II. Kev muab ntawv txuas tas mus li. Telmisartan tsis muaj kev sib nyiam rau lwm tus txais (nrog rau AT2 receptors) thiab lwm qhov kev kawm tsawg dua angiotensin receptors. Lub luag haujlwm tseem ceeb ntawm cov receptors, nrog rau cov txiaj ntsig ntawm lawv qhov kev xav tau dhau los nrog angiotensin II, qhov kev tsub zuj zus uas nce nrog kev teem sijhawm ntawm telmisartan, tseem tsis tau kawm. Nws txo qhov kev nkag siab ntawm aldosterone nyob rau hauv cov ntshav, tsis inhibit renin hauv ntshav ntshav thiab tsis thaiv cov ion ion, tsis inhibit ACE (kininase II, ib qho enzyme uas kuj rhuav tshem bradykinin). Yog li, kev nce qib hauv kev phiv los ntawm bradykinin tsis yog kev cia siab.
Telmisartan ntawm ib koob ntawm 80 mg ua rau tag nrho cov kev cuam tshuam ntawm kev kub siab ntawm angiotensin II. Qhov pib ntawm kev ua haujlwm ntawm hypotensive raug sau tseg tsis pub dhau 3 teev tom qab thawj thawj coj ntawm telmisartan. Cov nyhuv ntawm cov tshuaj no kav rau 24 teev thiab tseem ceeb txog li 48 teev. Tshaj tawm qhov teebmeem hypotensive feem ntau pib 4-8 lub lis piam tom qab noj ib txwm.
Hauv cov neeg mob ntsig txog kev mob ntshav siab, telmisartan txo qis systolic thiab diastolic ntshav siab, tsis cuam tshuam rau lub plawv dhia.
Thaum muaj kev tshem tawm sai ntawm telmisartan, cov ntshav siab maj mam rov qab los rau nws thawj qib tsis muaj kev txhim kho ntawm kev tshem tawm tus mob.
Tsuas tshuaj thiab tswj hwm
Cov tshuaj yog tawm hauv lub qhov ncauj, tsis hais los ntawm cov khoom noj.
Nrog rau cov hlab ntsha o, qhov kev pom zoo thawj zaug ntawm cov tshuaj yog 1 ntsiav tshuaj (40 mg) ib hnub ib zaug. Nyob rau hauv rooj plaub uas qhov kev kho mob ua tsis tiav, qhov koob tshuaj yog nce txog 80 mg ib hnub ib zaug. Thaum txiav txim siab tias yuav nce qhov ntau npaum li cas, nws yuav tsum raug coj mus rau hauv tus account tias qhov siab tshaj plaws antihypertensive feem ntau ua tiav tsis pub dhau 4-8 lub lis piam tom qab pib kho.
Txhawm rau txo qis kev mob plawv thiab tuag, cov koob tshuaj pom zoo yog 1 ntsiav tshuaj (80 mg) ib hnub ib zaug. Hauv thawj lub sijhawm ntawm kev kho mob, yuav tsum tau kho ntshav ntxiv thiaj li tsim nyog.
Cov neeg mob lub raum tsis ua hauj lwm (suav nrog cov mob hemodialysis), cov neeg laus, kev hloov tshuaj tsis tas yuav tsum tau.
Hauv cov neeg mob uas muaj me me mus txog qib qog ua lub siab ua haujlwm (chav A thiab B ntawm Kev Ntsuas Me-Pugh), koob tshuaj txhua hnub yuav tsum tsis pub tshaj 40 mg.
Sab sij huam
Cov kev soj ntsuam txog qhov tshwm sim tsis cuam tshuam nrog tus tub los ntxhais, hnub nyoog lossis haiv neeg ntawm cov neeg mob.
Cov kab mob: kab mob sepsis, suav nrog rau qhov mob tuag tes tuag taw, mob txeeb zig (nrog rau mob cystitis), mob ua pa sab saud.
Los ntawm cov kab mob hemopoietic: ib qho txo qis ntawm hemoglobin, ua haujlwm ntshav, eosinophilia, thrombocytopenia.
Los ntawm sab ntawm lub hauv nruab nrab hauv lub paj hlwb: insomnia, ntxhov siab vim, kev nyuaj siab, kiv taub hau.
Los ntawm cov hlab plawv system: cim txo nyob rau hauv cov ntshav siab (nrog rau orthostatic hypotension), bradycardia, tachycardia, tsaus muag.
Los ntawm txoj kev ua pa: ua pa luv.
Los ntawm lub plab zom mov: lub qhov ncauj qhuav, pom lub plab, tsis xis nyob hauv plab, ntuav, dyspepsia, raws plab, mob plab, ua rau lub siab ua haujlwm tsis zoo, nce kev ua haujlwm ntawm hepatic transaminases.
Los ntawm cov kab mob zis: ua rau lub raum tsis ua haujlwm (suav nrog mob raum tsis ua haujlwm), mob peripheral edema, hypercreatininemia.
Los ntawm cov leeg mus rau hauv lub cev: mob pob txha caj qaum, mob nraub qaum, mob leeg nqaij (mob plab ntawm cov leeg plab), mob rau hauv qhov qis qis, mob myalgia, mob hauv cov leeg (cov tsos mob zoo ib yam li qhov pom ntawm cov leeg), mob hauv siab.
Kev tsis haum tshuaj: kev tsis haum tshuaj, kev tsis haum lub cev rau qhov muaj tshuaj lossis tshuaj ntxiv rau cov tshuaj, mob caj dab, mob zas, erythema, tawv nqaij khaus, ua pob (nrog rau tshuaj), urticaria, pob khaus lom.
Kev ntsuas ntsuas: hyperuricemia, nce qib ntawm ntshav CPK, hyperkalemia.
Lwm yam: hyperhidrosis, mob khaub thuas zoo li syndrome, pom kev tsis txaus, asthenia (tsis muaj zog).
Kev siv tshuaj yeeb tshuaj MIKARDIS® lub sijhawm cev xeeb tub thiab lactation
Mikardis® yog qhov sib kis hauv kev xeeb tub thiab lactation.
Nrog kev npaj cev xeeb tub, Mikardis® yuav tsum tau hloov nrog lwm cov tshuaj tiv thaiv kabmob. Thaum xeeb tub yog tsim muaj, Mikardis yuav tsum tau tsum tsis ua haujlwm sai li sai tau.
Hauv kev tshawb fawb preclinical, tsis muaj kev cuam tshuam teratogenic ntawm cov tshuaj tau tshawb pom, tab sis ib tug nyhuv fetotoxic tau sau tseg.
Cov lus qhia tshwj xeeb
Hauv qee cov neeg mob, vim tias kev tsuj ntawm RAAS, tshwj xeeb tshaj yog thaum siv cov tshuaj sib xyaw ua ke ntawm cov kab ke no, lub raum ua haujlwm (suav nrog mob raum tsis ua haujlwm) yog qhov tsis taus. Yog li, txoj kev kho nrog nrog ob qhov kev cuam tshuam ntawm RAAS yuav tsum tau nqa tawm ntawm tus kheej thiab nruj me ntsis ntawm kev ua haujlwm lub raum (nrog rau kev saib xyuas qee zaus ntawm cov poov tshuaj potassium thiab creatinine ntau).
Thaum muaj kev vam khom rau lub suab vascular thiab lub raum kev ua haujlwm feem ntau ntawm RAAS kev ua si (piv txwv, hauv cov neeg mob uas muaj lub plawv tsis ua haujlwm ntev, lossis lub raum mob, suav nrog lub raum leeg mob stenosis los yog txoj hlab ntshav ntawm ib lub raum), kev teem sijhawm siv tshuaj uas cuam tshuam rau cov kab mob no, tej zaum yuav muaj nrog los ntawm kev txhim kho ntawm mob hlwb hypotension, hyperazotemia, oliguria, thiab, muaj qee zaus, mob raum tsis ua haujlwm.
Raws li kev paub ntawm kev siv lwm yam tshuaj uas cuam tshuam rau RAAS, nrog kev sib koom ua ke ntawm Mikardis® thiab potassium-sparing diuretics, muaj cov tshuaj ntxiv rau cov poov tshuaj, poov tshuaj uas muaj cov ntsev noj, thiab lwm yam tshuaj uas ua rau kom cov tshuaj potassium ntau ntxiv nyob rau hauv cov ntshav (piv txwv li, heparin), qhov ntsuas no yuav tsum raug soj ntsuam hauv cov neeg mob.
Hloov lwm txoj kev, Mikardis® tuaj yeem siv nrog kev sib txuas nrog thiazide diuretics, xws li hydrochlorothiazide, uas ntxiv rau muaj cov nyhuv hypotensive (piv txwv li, MikardisPlus® 40 mg / 12.5 mg, 80 mg / 12.5 mg).
Hauv cov neeg mob uas muaj mob ntshav siab ntau dhau los, qhov koob tshuaj telmisartan 160 mg rau ib hnub twg ua ke nrog hydrochlorothiazide 12.5-25 mg tau pom zoo zoo thiab ua tau zoo.
Mikardis® tsis tau muaj txiaj ntsig zoo hauv cov neeg mob ntawm cov haiv neeg Negroid.
Tso tawm daim ntawv thiab muaj pes tsawg leeg
Daim ntawv txiav txim - cov ntsiav tshuaj: puag ncig, tiaj-cylindrical, nrog scaffold thiab chamfer, dawb lossis dawb-daj daj hauv xim (5, 7, 10 thiab 20 pcs. Hauv cov hlwv pob, hauv ib daim ntawv cardboard 1, 2, 3, 4, 5, 8 lossis 10 pob, 10, 20, 28, 30, 40, 50, thiab 100 daim ib qho, hauv cov thawv corked nrog lub hau-rub nrog cov thawj-tus nplais tswj los yog hau ntswj nrog lub hau thawb-los yog nrog tus thawj tamper tswj, hauv ib lub thawv ntawv. txhua pob ntawv kuj muaj cov lus qhia rau kev siv Telmisartan).
Composition 1 ntsiav tshuaj:
- cov khoom xyaw nquag: telmisartan - 40 lossis 80 mg,
- kev zam (cov ntsiav tshuaj 40/80 mg): croscarmellose sodium - 12/24 mg, sodium hydroxide - 3.35 / 6.7 mg, povidone-K25 - 12/24 mg, lactose monohydrate (mis nyuj qab zib) - 296.85 / 474.9 mg, magnesium stearate - 3.80 / 6.4 mg, meglumine - 12/24 mg.
Arterial kub siab
Kev siv cov tshuaj telmisartan hauv ib koob ntawm 80 mg ua rau tag nrho cov kev cuam tshuam ntawm kev kub siab ntawm AT II. Cov nyhuv antihypertensive tshwm sim nyob rau thaj tsam li 3 teev tom qab txhaj tshuaj thawj zaug, kav ntev li 24 teev thiab tseem ua haujlwm tseem ceeb txog 48 teev. Ib qho qhia tau zoo tshaj plaws feem ntau yuav tshwm sim tom qab 4-8 lub limtiam ntawm cov tshuaj ib txwm siv.
Hauv cov kev mob ntshav siab, telmisartan txo qis systolic thiab diastolic ntshav siab (BP) tsis cuam tshuam rau lub plawv dhia (HR).
Tom qab kev txiav txim siab tsis meej txog cov tshuaj, cov ntshav siab rov qab mus rau nws tus nqi qub rau ob peb hnub. Ntsoos ntsoos mob los tsis tshwm sim.
Raws li kev sib piv soj ntsuam hauv kev soj ntsuam, cov nyhuv hypotensive ntawm telmisartan piv rau cov tshuaj ntawm lwm cov chav kawm (piv txwv, atenolol, hydrochlorothiazide, enalapril, lisinopril, amlodipine). Txawm li cas los xij, hnoos qhuav hauv cov neeg mob uas tau txais telmisartan tau tshwm sim ntau tsawg dua li cov neeg mob noj ACE inhibitors.
Kev Tiv Thaiv Kab Mob Tiv Thaiv Kab Mob
Hauv cov neeg mob uas muaj hnub nyoog 55 xyoos thiab laus dua nrog kev hloov pauv ischemic nres, mob stroke, mob hlab ntsha hlwb (CHD), mob txhab ntshav thiab mob ntshav qab zib hom 2 (xws li sab laug ventricular hypertrophy, micro- lossis macroalbuminuria, retinopathy) muaj keeb kwm ntawm rau cov pab pawg muaj kev pheej hmoo mob plawv, telmisartan muaj cov txiaj ntsig zoo xws li cov lus sib dhos hauv kev txo qis cov kev sib txuam ua ntej: tsev kho mob vim mob plawv tsis ua haujlwm neostatal stroke, nonfatal myocardial infarction, mob plawv tuag.
Telmisartan, zoo ib yam li ramipril, kuj tau pom tias muaj txiaj ntsig zoo hauv kev txo qis zaus ntawm cov ntsiab lus theem nrab: cov mob ntshav tsis tuag, mob ntshav qab zib tsis ua haujlwm, thiab mob plawv tuag.
Qhov ua tau zoo ntawm telmisartan nyob rau hauv cov koob tshuaj tsawg dua 80 mg los txo cov kev pheej hmoo ntawm cov hlab plawv kev tuag tsis tau kawm.
Tsis zoo li ramipril, telmisartan tsis tshua muaj kev phiv phiv xws li hnoos qhuav thiab mob caj dab. Txawm li cas los xij, tiv thaiv tom qab ntawm nws qhov kev nqus, kev mob ntshav ncig ntau dua tshwm sim.
Daim ntawv noj tshuaj:
1 ntsiav tshuaj muaj:
ntau npaum 40 mg
cov tshuaj heev: telmisartan - 40 mg
tus zam: sodium hydroxide - 3.4 mg, povidone K 30 (polyvinylpyrrolidone nruab nrab molecular phaus) - 12.0 mg, meglumine - 12.0 mg, mannitol - 165,2 mg, magnesium stearate - 2.4 mg, talc - 5.0 mg Cov.
ntau npaum li 80 mg
yam tshuaj: telmisartan - 80 mg
tus zam: sodium hydroxide - 6.8 mg, povidone K 30 (polyvinylpyrrolidone nruab nrab lub cev hnyav) - 24.0 mg, meglumine - 24.0 mg, mannitol - 330,4 mg, magnesium stearate - 4,8 mg, talc - 10.0 mg.
Cov ntsiav tshuaj yog xim dawb los yog yuav luag dawb, puag ncig, tiaj-cylindrical nrog bevel thiab nqis siab tshaj.
Cov chaw muag tshuaj
Cov Tshuaj Hauv Tshuaj
Telmisartan yog qhov kev paub tseeb angiotensin II receptor antagonist (hom AT1), siv tau thaum noj ntawm qhov ncauj. Nws muaj qhov sib txuam siab tshaj plaws rau lub AT subtype1 angiotensin II receptors los ntawm kev ua tiav ntawm angiotensin II yog pom tau hais. Txom cov tshuaj angiotensin II los ntawm qhov sib txuas nrog cov receptor, tsis muaj cov kev ua ntawm agonist nyob rau hauv kev sib raug zoo nrog cov khoom no.
Telmisartan khi nkaus xwb rau qhov AT subtype1 angiotensin II cov neeg txais. Kev sib txuas lus yog kav ntev. Tsis muaj kev sib txuam rau lwm tus txais, suav nrog cov tshuaj tiv thaiv2 receptor thiab lwm yam tsawg kawm angiotensin receptors. Lub luag haujlwm tseem ceeb ntawm cov receptors, nrog rau cov txiaj ntsig ntawm lawv qhov kev xav tau dhau los nrog angiotensin II, qhov kev cia siab ntawm uas nce nrog kev teem sijhawm ntawm telmisartan, tseem tsis tau kawm. Nws txo nws cov concentration ntawm aldosterone hauv cov ntshav, tsis inhibit renin hauv ntshav ntshav thiab tsis thaiv cov ion ion.Telmisartan tsis thaiv qhov kev mob angiotensin-hloov pauv enzyme (kininase II) (ib qho enzyme uas tseem zom bradykinin). Yog li, kev nce qib hauv kev phiv los ntawm bradykinin tsis yog kev cia siab.
Hauv cov neeg mob, telmisartan ntawm ib koob ntawm 80 mg ua rau tag nrho cov kev cuam tshuam ntawm kev mob siab ntawm angiotensin II. Qhov pib ntawm kev tawm tsam qhov kev tiv thaiv tau sau tseg tsis pub dhau 3 teev tom qab thawj thawj coj ntawm telmisartan. Cov nyhuv ntawm cov tshuaj no mob tsawv rau 24 teev thiab tseem ceeb txog li 48 teev. Ib cov lus hais tawm tsam antihypertensive feem ntau muaj 4-8 lub lis piam tom qab kev tswj hwm ntawm qhov ncauj ib txwm muaj.
Hauv cov neeg mob uas mob ntshav tawm hauv lub cev, telmisartan txo qis systolic thiab diastolic ntshav siab (BP) yam tsis cuam tshuam rau lub plawv dhia (HR).
Nyob rau hauv cov ntaub ntawv ntawm kev tshem tawm sai ntawm telmisartan, ntshav siab maj mam rov qab los rau nws thawj qib tsis muaj kev txhim kho ntawm "kev tshem tawm" syndrome.
Cov Tshuaj Pharmacokinetics
Thaum noj ntawm qhov ncauj, nws nrawm nrawm los ntawm lub plab zom zaub mov. Bioavailability yog 50%. Thaum noj ib txhij nrog zaub mov noj, qhov txo qis hauv AUC (thaj chaw hauv qab qhov xav txog lub sijhawm-nkhaus) yog li ntawm 6% (ntawm ib koob 40 mg) txog 19% (ntawm ib koob ntawm 160 mg). 3 teev tom qab noj, qhov kev nkag siab hauv cov ntshav ntshav yog qib, tsis hais noj lub sijhawm noj mov. Muaj qhov sib txawv ntawm ntshav ntau nyob rau hauv cov txiv neej thiab poj niam. Nrogmax(qhov siab tshaj plaws) thiab AUC yog kwv yees li 3 thiab 2 zaug, ntsig txog, ntau dua hauv cov poj niam piv nrog cov txiv neej tsis muaj qhov cuam tshuam txog kev ua tau zoo.
Kev sib txuas lus nrog cov ntshav plasma protein - 99.5%, feem ntau nrog albumin thiab alpha-1 glycoprotein. Tus nqi nruab nrab ntawm pom meej qhov ntim ntawm kev faib tawm hauv qhov sib npaug ntawm cov tshuaj siab yog 500 litres. Nws yog metabolized los ntawm kev sib txuas nrog glucuronic acid. Metabolites yog tus tsis muaj tshuaj nyob hauv tsev muag tshuaj. Kev tshem tawm ib nrab-lub neej yog ntau tshaj 20 teev. Nws yog tawm los ntawm txoj hnyuv tsis hloov, nthuav tawm los ntawm ob lub raum - tsawg dua 2% ntawm qhov muab tshuaj. Tag nrho cov ntshav hauv lub plasma yog qhov siab (900 ml / min) piv nrog "hepatic" ntshav txaus (li 1500 ml / min.).
Tus kws tshuaj ntawm telmisartan hauv cov neeg laus laus tsis txawv ntawm cov neeg mob hluas. Koob tshuaj yuav tsis haum.
Cov neeg mob raum tsis ua haujlwm
Kev hloov pauv hauv cov neeg mob lub raum tsis ua haujlwm, tsis suav nrog cov neeg mob ntawm hemodialysis. Telmisartan tsis raug tshem tawm los ntawm hemodialysis.
Cov neeg mob mob siab tsis ua haujlwm
Hauv cov neeg mob uas muaj me me mus txog qib qog ua lub siab ua haujlwm (chav A thiab B ntawm Kev Ntsuas Me-Pugh), koob tshuaj txhua hnub yuav tsum tsis pub tshaj 40 mg.
Kev siv kho cov menyuam yaus
Cov cim tseem ceeb ntawm cov tshuaj pharmacokinetics ntawm telmisartan hauv cov menyuam hnub nyoog 6 txog 18 xyoo tom qab noj telmisartan ntawm koob tshuaj 1 mg / kg lossis 2 mg / kg rau 4 lub lis piam, feem ntau, piv nrog cov ntaub ntawv tau txais hauv kev kho mob ntawm cov neeg laus, thiab paub meej tias qhov tsis txaus ntseeg ntawm pharmacokinetics ntawm telmisartan tshwj xeeb txog Cmax.
Yeeb tshuaj sib cuam tshuam
Telmisartan yuav ua rau muaj kev cuam tshuam hypotensive ntawm lwm cov neeg sawv cev antihypertensive. Lwm hom kev sib txuam ntawm cov tseem ceeb hauv chaw kho mob tsis tau txheeb xyuas.
Kev siv ua ke nrog digoxin, warfarin, hydrochlorothiazide, glibenclamide, ibuprofen, paracetamol, simvastatin thiab amlodipine tsis ua rau muaj kev sib cuam tshuam hauv chaw kho mob. Muaj kev nce ntxiv hauv nruab nrab lub siab ntawm digoxin hauv cov ntshav ntshav los ntawm qhov nruab nrab 20% (hauv ib kis, 39%). Nrog rau kev tswj hwm tib lub sijhawm ntawm telmisartan thiab digoxin, nws raug nquahu kom qee lub sijhawm txiav txim siab qhov concentration ntawm digoxin hauv cov ntshav.
Nrog kev siv tib lub sijhawm ntawm telmisartan thiab ramipril, qhov pom ntawm 2.5-nce hauv AUC0-24 thiab Cmax ntawm ramipril thiab ramipril tau pom. Cov kab mob tseem ceeb hauv qhov tshwm sim no tsis tau teeb tsa.
Nrog rau kev tswj fwm ntawm ACE inhibitors thiab lithium kev npaj, ib qho kev thim rov qab nce rau hauv cov concentration ntawm lithium hauv cov ntshav tau pom, nrog cov tshuaj lom. Hauv qee qhov tsis tshua muaj tshwm sim, cov kev hloov pauv no tau hais qhia nrog kev tswj hwm ntawm angiotensin II antagonist receptors. Nrog rau kev tswj hwm tib lub sijhawm ntawm lithium thiab angiotensin II receptor antagonists, nws raug nquahu kom txiav txim siab qhov concentration ntawm lithium hauv cov ntshav.
Kev kho nrog NSAIDs, suav nrog acetylsalicylic acid, COX-2 inhibitors, thiab tsis xaiv tshuaj NSAIDs, tuaj yeem ua rau mob raum tsis ua haujlwm hauv cov neeg mob lub cev qhuav dej. Cov yeeb tshuaj ua yeeb yam rau renin-angiotensin-aldosterone system (RAAS) tej zaum yuav muaj cov nyhuv synergistic. Hauv cov neeg mob uas tau txais NSAIDs thiab telmisartan, bcc yuav tsum tau them nyiaj rau thaum pib kho thiab lub raum rov qab saib xyuas.
Kev poob qis hauv cov nyhuv ntawm cov neeg sawv cev tiv thaiv kab mob, xws li telmisartan, los ntawm kev cuam tshuam ntawm vasodilating cov nyhuv ntawm prostaglandins tau pom nrog kev sib koom tes nrog NSAIDs.
Tsuas tshuaj thiab tswj hwm
Cov ntsiav tshuaj Telmisartan yog tsim rau kev tswj hwm qhov ncauj txhua hnub thiab noj nrog kua, nrog lossis tsis noj mov.
Txoj kev kho mob qhov tseem ceeb ntawm txoj hlab ntshav tshiab
Qhov pom zoo cov neeg laus pom zoo yog 40 mg ib hnub ib zaug.
Hauv qhov xwm txheej uas xav ua kom ntshav siab tsis tiav, koob tshuaj Telsartan® tuaj yeem nce ntxiv mus txog 80 mg ib zaug ib hnub.
Thaum nce ntxiv cov koob tshuaj, nws yuav tsum raug coj mus rau hauv tus account tias qhov siab tshaj plaws antihypertensive feem ntau ua tiav tsis pub dhau plaub mus rau yim lub lis piam tom qab pib kho.
Telsartan® tuaj yeem siv nrog kev sib xyaw nrog thiazide diuretics, piv txwv li, hydrochlorothiazide, uas ua ke nrog telmisartan muaj ib qho ntxiv hypotensive nyhuv.
Hauv cov neeg mob uas muaj mob ntshav liab ntau heev, qhov koob tshuaj telmisartan yog 160 mg / hnub (ob ntsiav tshuaj ntawm Telsartan® 80 mg) thiab muaj kev sib xyaw nrog hydrochlorothiazide 12.5-25 mg / hnub tau zoo siab thiab zoo.
Kev tiv thaiv ntawm kev mob plawv thiab cov txig tuag
Qhov pom zoo koob tshuaj yog 80 mg ib zaug ib hnub.
Nws tsis tau txiav txim siab tias qhov koob tshuaj no qis dua 80 mg puas ua haujlwm zoo los txo cov kev mob plawv thiab kev tuag.
Thaum pib theem pib ntawm kev siv tshuaj Telsartan® rau kev tiv thaiv kev mob plawv thiab tuag, nws raug nquahu kom tswj ntshav siab (BP), thiab nws kuj yuav tsum tau kho cov ntshav siab nrog cov tshuaj uas txo cov ntshav siab.
Telsartan® tuaj yeem siv tau tsis hais txog ntawm cov khoom noj.
Kev hloov pauv hauv cov neeg mob lub raum tsis ua haujlwm, tsis suav nrog cov neeg mob ntawm hemodialysis. Muaj tsawg qhov kev paub hauv kev kho cov neeg mob uas lub raum tsis ua haujlwm loj thiab tus mob hemodialysis. Rau cov neeg mob zoo li no, pom zoo kom pib nrog koob tshuaj qis dua 20 mg. Telsartan® tsis tshem tawm cov ntshav thaum hemofiltration.
Hauv cov neeg mob uas muaj me me mus rau lub cev tsis haum lub siab, qhov kev noj tshuaj txhua hnub yuav tsum tsis pub tshaj 40 mg ib hnub ib zaug.
Koob tshuaj yuav tsis haum.
Nosological kev faib tawm (ICD-10)
Ntsiav tshuaj | 1 tab. |
yam tshuaj: | |
telmisartan | 40/80 mg |
tus zam: sodium hydroxide - 3.4 / 6.8 mg, povidone K30 (polyvinylpyrrolidone nruab nrab lub cev hnyav) - 12/24 mg, meglumine - 12/24 mg, mannitol - 165.2 / 330.4 mg, magnesium stearate - 2.4 / 4 , 8 mg, talc - 5/10 mg |
Chaw tsim tshuaj paus:
Severnaya Zvezda CJSC, Russia
Qhov chaw nyob raug cai ntawm cov khw:
111141, Moscow, Zeleny prospekt, d. 5/12, p. 1
Thov cov chaw tsim khoom thiab txais chaw nyob:
188663, Leningrad cheeb tsam., Vsevolozhsk koog tsev kawm ntawv, chaw nyob hauv nroog Kuzmolovsky, lub tsev ntawm Rhiav No. 188
Cev xeeb tub thiab lactation
Kev siv Telmisartan-SZ yog contraindicated thaum cev xeeb tub. Thaum kuaj pom kev xeeb tub, cov tshuaj yuav tsum nres tam sim ntawd. Yog tias tsim nyog, lwm txoj kev kho yuav tsum raug kho (lwm cov chav kawm ntawm cov tshuaj tiv thaiv kev tiv thaiv uas pom zoo siv thaum cev xeeb tub).
Kev siv ntawm ARA II thaum lub sijhawm thib ob thiab thib peb lub cev xeeb tub ntawm cev xeeb tub yog contraindicated.
Hauv kev kawm txog kev ua ntej ntawm telmisartan, cov teebmeem teratogenic tsis pom, tab sis fetotoxicity tau tsim. Nws paub tias kis tau rau ARA II thaum lub sijhawm thib ob thiab thib peb lub cev xeeb tub ua rau lub cev tsis ua haujlwm rau lub cev (txo lub raum tsis ua haujlwm, oligohydroamnion, ncua ossification ntawm pob txha taub hau), ntxiv rau neonatal toxicity (lub raum tsis ua haujlwm, hypotension, hyperkalemia). Cov neeg mob npaj lub cev xeeb tub yuav tsum tau txais lwm txoj kev kho ntxiv. Yog hais tias kev kho mob ntawm ARA II tshwm sim thaum lub hlis thib ob ntawm cev xeeb tub, nws raug nquahu kom soj ntsuam lub raum thiab kev ua haujlwm ntawm lub pob txha taub hau hauv qhov me nyuam los ntawm ultrasound.
Cov menyuam mos uas lawv niam tau txais ARA II yuav tsum ua tib zoo saib kom muaj hlab ntshav hauv hypotension.
Kev Kho Mob nrog Telmisartan-SZ yog contraindicated thaum pub niam mis.
Tsis muaj kev tshawb fawb txog kev muaj tub muaj taus tau ua.