ʻ instructionslelo GENTADUETO - (JENTADUETO) no ka hoʻohana

2,5 mg / 850 mg nā papa kiʻi ʻoniʻoni, 2,5 mg / 1000 mg

Aia ma ka papa papa

nā mea hana: linagliptin 2.5 mg,

metformin hydrochloride 850 mg or 1000 mg,

nā mea waiwai: arginine, mais starch, copovidone, silicon dioxide colloidal anhydrous, magnesium stearate,

panana honi: titanium dioxide (E171), hao (III) oxide melemele (E172) (no ka dosis o 2,5 mg / 850 mg), hao (III) oxide ulaula (E172), propylene glycol, hypromellose 2910, talc.

Hoʻopili ʻia nā papa papa me ke kiʻi ʻoniʻoni o ka ʻulaʻula māmā, oval, me kahi biconvex, me ka kahakaha ʻana o ka ʻōkuhi ʻo ma ka ʻaoʻao ʻelua ma ka ʻaoʻao a me ke kaha a "D2 / 850" ma kahi ʻē aʻe (no ka laʻu o 2.5 mg / 850 mg).

Hoʻopili ʻia nā papa papa me ke kiʻi kinipona o ke aniani ʻulaʻula māmā, oval, me kahi biconvex, me ka kahakaha ʻana o ka inoa ʻo kamupene ʻo BI ma ka ʻaoʻao a me ke kaha a "D2 / 1000" ma kahi ʻē aʻe (no ka inue he 2.5 mg / 1000 mg).

E hoʻokuʻu i ke ʻano, ka hoʻonohonoho ʻana a me ka pōpoki

ʻO nā papa papaʻaina i ulana ʻia ke kiʻi ʻulaʻula, he kukui i loko o ke kala, oval, biconvex, i kahakaha ʻia me ka logo Beringer Ingelheim ma kekahi ʻaoʻao a i kahakaha ai me "D2 / 850" ma ka ʻaoʻao.

Nā mea hoʻoweliweli: arginine, mais starch, copovidone, silicon dioxide, colloidal anhydrous, magnesium stearate.

Shell: titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), propylene glycol, hypromellose 2910, talc.

10 kamepiula - blisters (6) - nā ʻeke pepa.

pakuhi. lēʻa ʻoniʻoni kiʻi, 2,5 mg / 1000 mg: 60 pcs.
Reg. ʻAʻole: 10072/13/16/18 o 03/05/2018 - Hōʻike hōʻoia i ka manawa. makamae ʻaʻole palena

Hoʻopili ʻia nā papa paʻi me kahi kala ʻulaʻula māmā, oval, biconvex, i kahakaha ʻia me ka logo o ka hui ma kekahi ʻaoʻao a i kālai ʻia me "D2 / 1000" ma kēlā ʻaoʻao.

Nā mea hoʻoweliweli: arginine, mais starch, copovidone, silicon dioxide, colloidal anhydrous, magnesium stearate.

Shell: titanium dioxide (E171), iron oxide red (E172), propylene glycol, hypromellose 2910, talc.

E hoʻokuʻu i ke ʻano, ka pale a me ka hoʻonohonoho

Ua pani ʻia nā papa me ke kiʻi ʻoniʻoni o ke kala melemele kukui, oval, biconvex, me ke kahakaha ʻana o ka inoa ʻoihana hui ma kekahi ʻaoʻao a me ke kālai ʻia "D2 / 500" ma kēlā ʻaoʻao.

Nā mea kūʻai: arginine - 12,5 mg, kōpī palaoa - 20 mg, copovidone - 47.5 mg, anhydrous colloidal siliconide - 2.5 mg, magnesium stearate - 5 mg.

ʻO ka mana o nā pāpale kiʻi: titanium dioxide (E171) - 2.88 mg, kaeleʻa hao hao melemele (E172) - 0.12 mg, propylene glycol - 0.6 mg, hypromellose 2910 - 6 mg, talc - 2.4 mg.

10 kamepiula - nā laka i hana ʻia mai o PVC / PCTFE / Al (3) - nā ʻeke pepa.
10 kamepiula - nā laka i hana ʻia mai o PVC / PCTFE / Al (6) - nā ʻeke pepa.

Ka hana lāʻau lapaʻau

ʻAi pū ʻia ka lāʻau hypoglycemic no ka hoʻokō waha. ʻO Gentadueto ® kahi hui paʻa o nā mea ʻelua hypoglycemic - linagliptin a me metformin hydrochloride.

ʻO Linagliptin kahi mea hoʻomalu o ka enzyme DPP-4 (dipeptidyl peptidase 4, code EC 3.4.14.5), ka mea i pili i ka hana ʻole ʻana o nā hormones infletin - ka pona-like peptide-1 (GLP-1) a me ka glucose-dependantine insulin-antropeptide (GIP). Hoʻopau koke ʻia kēia mau hormones e ka DPP-4 ene. Hoʻokomo ʻia ʻelua o kēia mau hua ʻōlelo i loko o ke hoʻoponopono o ka physiological o ka home home home glucose. ʻO ka pae haʻahaʻa o ka neʻe o ka puke i ka lā i hoʻohaʻahaʻa ʻia, ke piʻi wikiwiki nei ma hope o ka ʻai. Hoʻonui ʻo GLP-1 a me GIP i ka biosynthesis insulin a me kāna mea e huna ai e nā maʻi beta pancreatic ma ke alo o ka pae kiʻekiʻe o ka glucose koko. Eia kekahi, hōʻemi ʻo GLP-1 i ka mea paʻa o ka glucagon e nā cell alpha pancreatic, e alakaʻi ai i kahi emi o ka hana glucose i loko o ka ate. Hoʻopili maikaʻi ʻo Linagliptin a hiki i ka DPP-4 ke kumu e piʻi nui ai ka nui o ka pae me ka mālama ʻana i ka lōʻihi o kā lākou hana. Hoʻonui ka linagliptin i ka hunaʻu o ka insulin e like me ka pae o ka glucose a hoʻemi i ka ʻōlelo huna glucoseagon, e hōʻea ana i ka holomua o ka home home home glucose. Hoʻopili ka Linagliptin iā DPP-4 maʻalahi, ma in vitro kona koho ʻana ma mua o ka selectivity no DPP-8 a i ʻole he hana no DPP-9 ma mua o 10,000 mau manawa.

Hoʻomaʻamaʻa maikaʻi ka mālama ʻana me ka linagliptin i nā māka surrogate o nā hana beta-cell, me ka HOMA (kahi hoʻohālike no ka loiloi i ka homeostasis), ka pae o ka proinsulin i ka insulin, a me ka pane ʻana o nā cell beta e like me ka laʻana o ka hoʻokaʻawale ʻaʻai.

ʻO ka metformin kahi biguanide a loaʻa kahi hopena hypoglycemic, e hoʻohaʻahaʻa ana i ke kiʻekiʻe o ka glucose glucose a me ka postprandial plasma. ʻAʻole ia e hoʻoikaika i ka Metformin i ka huna ʻana i ka insulin a no laila ʻaʻole ia e alakaʻi i ka hypoglycemia.

ʻO Metformin hydrochloride he 3 mau hana hana:

1. Hoʻemi i ka wehe ʻana o ka glucose i loko o ke akea ma ke kaomi ʻana i ka gluconeogenesis a me ka glycogenolysis,

2. ka mahuahua o ka hōʻaiʻe o ka mīkini hāpū a me ka hoʻohana ʻana i ka hoʻonui ʻana i ka naʻau o ka insulin.

3. lohi i ka emi ʻana o ka glucose i loko o nā pā.

Hoʻonohonoho ka Metformin i ka syntact glycogen intracellular e ka hana ma ka glycogen synthetase.

Hoʻonui ka metformin hydrochloride i ka mana o ka halihali i nā ʻano o nā mea lawe i ʻike ʻia i nā lā e ʻike ʻia nei.

ʻO ka metformin hydrochloride i loko o nā kānaka, me ka manaʻo o kona hopena i ka glycemia, he hopena maikaʻi loa e pili ana i ka lipid metabolism:

• hōʻemi i ka kolamu nui, kolamu ma LDL a me ka triglycerides.

Hoʻohui ʻana i ka linagliptin i ka metformin therapy

ʻO ka pono a me ka palekana o linagliptin, i hoʻohana pū ʻia me ka metformin i nā mea maʻi me ka glycemia, ʻaʻole i lawa pono ʻia e ka metformin monotherapy, i aʻo ʻia i loko o kahi helu ʻelua o ka makapō, nā papa hana hoʻokele.

ʻO ka hui pū ʻana o ka linagliptin a me ke metformin e hāʻawi i ka hoʻomaikaʻi nui a koʻikoʻi nui i nā paramika glycemic me ka ʻole e hoʻololi i ke kaupaona o ke kino ma mua o ka lawe ʻana i kēlā me kēia mahele o nā mea pono. ʻO keʻano kūikawā, ua hoʻemi nui ʻia ke pae o ka hemoglobin glycosylated A (HbA1c), ka wikiwiki o ka plasma glucose (GPN), ka glucose glucose 2 mau hola ma hope o kahi pāʻina (GLP) i hoʻemi iki ʻia.

Ka hopena koho-analilii i ka poʻe maʻi maʻi 5,239 me ka maʻi diabetes type 2 i komo i 8 mau hoʻokolohua hōʻike i hōʻike ʻia e mālama ai me ka linagliptin i hoʻonui i ka hopena cardiovascular (make cardiovascular, nonfatal myocardial infarction, nonfatal stroke a hospitalization due to unstable angina pectoris).

Lapaʻau lāʻau

Ua hōʻike ʻia nā haʻawina Bioequivalence i loko o nā limahana olakino i hōʻike ʻia ʻo Gentadueto ® ka bioequivalent i ka linagliptin i hoʻokaʻawale ʻia a me ke metformin.

ʻAʻole i hoʻohana ʻia ka hoʻohana ʻana o Gentadueto ® me ka meaʻai i kahi loli i nā parekola pharmacokinetic o ka linagliptin. ʻAʻole i loli o AUC o ka metformin, akā, ʻo ka maʻamau s serum metformin C max i ka hihia o ka lāʻau me ka meaʻai ua hoʻemi ʻia ka 18%. I ka hihia o ka hoʻohana pono ʻana i ka lāʻau me ka meaʻai, he piʻi nui i ka manawa e hōʻea i C max o ka metformin i plasma me nā hola 2 ua nānā ʻia. ʻO nā ʻāpana aʻe e hōʻike ana i nā waiwai pharmacokinetic o nā mea hoʻoikaika kū hoʻokahi o Gentadueto ®.

Ma hope o ka lawelawe waha ʻana i ka linagliptin ma ke ʻano o 5 mg, ua hopu koke ʻia ka lāʻau lapaʻau, ua hōʻea ʻo C max i ka plasma (median T max) ma hope o nā hola 1.5. ʻO ke ʻano o ka linagliptin i ka plasma e hoʻoemi ana i ka biphasic. ʻO ka bioavailability piha o ka linagliptin ma kahi o 30%. Mai ka hoʻokele ʻana o ka linagliptin me ka meaʻai i loaʻa ka nui o ka momona i loaʻa ka hopena koʻikoʻi e pili ana i ka pharmacokinetics, hiki ke hoʻohana ʻia ka linagliptin me ka meaʻai a me ka manaʻo ʻole o ka hoʻopono ʻai.

Ma hope o ka lawe ʻana i ka linagliptin i hoʻokahi pae o 5 mg, ʻo ka awelika V d ma kahi o 1110 L, e hōʻike ana i ka laula ma ka nui o nā kaili. ʻO ka paa ʻana o ka linagliptin i nā protein plasma e hilinaʻi ana i ka paʻa o ka lāʻau. Inā he 1 nmol / L ka mea paʻa, ʻo ka pilina ma kahi o 99%, a me ka piʻi o ka neʻe o linagliptin i ≥30 nmol / L, e emi ana ka palena ma ka 75-89%, e hōʻike ana i ka saturation o ka pilina o ka lāʻau lapaʻau me DPP-4 me ka hoʻonui i ka piʻi ʻana o ka linagliptin. I nā kikowaena kiʻekiʻe o ka linagliptin, i ka wā paʻa i ka DPP-4 ka piha piha loa, 70-80% o linagliptin i hoʻopaʻa ʻia i nā protein plasma ʻē aʻe, a ʻo 20-30% o ka lāʻau i loko o kahi kūlana.

I ka hihia o ka lawe ʻana i ka linagliptin i loko o kahi lāʻau o 5 mg 1 manawa / lā, ua loaʻa nā C ss o ka lāʻau i ka plasma ma hope o ke kolu o ka make, aʻo ka AUC o linagliptin i plasma e hoʻonui ʻia e pili ana i ka 33% hoʻohālikelike ʻia me ka uku mua. Ka liʻiliʻi o nā ʻano o ka AUC o nā linagliptin i liʻiliʻi (12.6% a me 28.5%, pākahi). ʻO nā waiwai o AUC o ka linagliptin i loko o ka plasma me ka hoʻonui nui i nā dosis me ka nui o ka proportionally. ʻO nā pharmacokinetics o linagliptin i ke olakino maʻi a me nā mea maʻi me ka maʻi diabetes mellitus type 2 ua like like.

Ua hōʻike ʻia nā haʻawina a vitro, ʻo linagliptin kahi substrate o P-glycoprotein a me CYP3A4. ʻO Ritonavir, kahi paʻa o ka P-glycoprotein a me CYP3A4, i alakaʻi i ka hoʻonui pālua i ka ʻike (ʻike ʻia i ke kumu o AUC) o linagliptin, a me ka hana hou ʻana o ka linagliptin me ka rifampicin, he inducer ikaika o P-glycoprotein a me ka CYP3A, ka hopena o ka hōʻuluʻulu i ka AUC %, nui ma muli o ka hoʻonui (a, e like me ke emi ʻana) o ka bioavailability o linagliptin ma muli o ke kaohi ʻana (a, me ke ʻano, mokulele) o P-glycoprotein.

Metabolism a me ka hoʻopā ʻana

Mālama ʻia kahi hapa o ka lāʻau lapaʻau. ʻO ke ala nui o ka hana hoʻopā ma ka ʻōpio (e pili ana i ka 85%). Ma kahi o 5% o ka linagliptin e hoʻopili ʻia i loko o ka pāʻai. Ua hōʻike ʻia ka nui o ka metabolite nui o ka lāʻau lapaʻau, ʻo ka pipa ʻana o ka mea i loko o ka epa kaulike ʻo 13.3% o ka hoʻolaha ʻana o ka linagliptin. ʻAʻole kēia mea metabolita i ka hana lāʻau lapaʻau a ʻaʻole i hāʻawi i ka hana pale o ka linagliptin e kū'ē i ka plasma DPP-4.

Terminal T 1/2 lōʻihi - ʻoi aku ma mua o 100 mau hola, aia ka nui ma muli o ka saturated, paʻa paʻa linagliptin me DPP-4 ʻaʻole ia i alakaʻi i ka hōʻiliʻili o ka lāʻau. ʻO ka hopena ika 1/2 maikaʻi no ka hōʻiliʻili ʻana o ka linagliptin, i hoʻoholo ʻia ma hope o ka hoʻokele ʻana o ka linagliptin i kahi manawa o 5 mg, ma kahi o 12 mau hola.

ʻO ka holoiʻana Renal ma kahi o 70 ml / min.

ʻO ka pharmacokinetics i nā hihia lapaʻau kūikawā

I nā mea maʻi me kekahi kiʻekiʻe o nā renal maikaʻi ʻole, ʻaʻole i manaʻo ʻia nā loli i ke dosing o ka linagliptin. ʻAʻole i hoʻopiʻi ka ʻeha pale hoka i ka pharmacokinetics o linagliptin i nā mea maʻi me ka maʻi type 2.

I nā mea maʻi me ka maʻi hepatic palupalu, hōʻemi a paʻakikī paha, ʻaʻole i koi aku nā loli o ka dosagliptin.

ʻAʻole i hana ʻia nā noi ʻana o nā pharmacokinetics o lignagliptin i nā keiki.

ʻAʻole koi ʻia nā loli i ke ʻano o ka wahine, ka ʻōlelo ʻana o ka iwi, ka lāhui, ka makahiki o nā mea maʻi.

Ma hope o ka nānā ʻana o ka metformin, ua hōʻea ke C max i ka plasma ma hope o nā hola 2.5. I nā poʻe olakino olakino, ʻo ka bioavailability piha o ka metformin hydrochloride ma hope o ka lawelawe waha ma loko o kahi hopena o 850 mg ka mea e pili ana i ka 50-60%. Ma hope o ka lawe ʻana i ka lāʻau lapaʻau i loko, e pili ana i ka 20-30% o ka lāʻau i ka huehue ʻole a kahawai ʻia ma loko o ka ʻōpū.

Hoʻohālikelike ka metformin hydrochloride e nā nonacar absorption pharmacokinetics. I ka manawa e hoʻohana ʻia ai ka metformin hydrochloride i nā inika i ʻōlelo ʻia ai, ua loaʻa ka C ss i ka plasma i loko o 24-48 mau hola a, ʻoiai he mea la ka emi ma mua o 1 μg / ml.

Hoʻemi ka meaʻai i ka hoʻopili ʻana o ka metformin hydrochloride a pīhoihoi paha i ka helu o ka ʻōpū. Ma hope o ka hoʻohana ʻana i ka lāʻau lapaʻau ma kahi o 850 mg me ka meaʻai, ʻo C max no 40% emi ka liʻiliʻi, AUC 25% emi iho, a ʻo ka manawa e hiki ai i C max i hoʻonui ʻia e 35 mau minuke. ʻAʻole maopopo ka ʻike koʻikoʻi o ka maʻi o ka hāʻule o kēia mau kuhikuhi.

Hoʻohālikelike ka hoʻopaʻa ʻana o ka metformin i nā protein plasma. Hoʻopili ka Metformin hydrochloride i nā ʻāpana koko ʻulaʻula. Me ka metformin max i loko o ke koko ka haʻahaʻa ma lalo o ka i ka plasma, a loaʻa i ke like me ia manawa. Manaʻo nā sela koko hoʻokoe hou i kahi ʻoihana nui no ka hoʻoili ʻana i ka lāʻau lapaʻau. Ka awelika V d ʻokoʻa mai 63 a 276 lita.

Metabolism a me ka hoʻopā ʻana

I nā kāne, ʻaʻole i ʻike ʻia nā metabolites o ka lāʻau. Hoʻopiliʻia nā Metformin hydrochloride e nā keiki i loli ʻole. ʻO ka hoʻomaʻemaʻe ʻana i ka renal hydrochloride ma mua o 400 ml / min, e hōʻike ana i ka hana o ka lāʻau e ka filomation glomerular a me ka hilo huna tubular. Ma hope o ka nānā ʻana, ʻo ka terminal T 1/2 e like me 6.5 hola

Ma kahi o ka hana renal impaired, hoʻomaʻemaʻe ka hana o ka renal i ka pānaʻi ʻana ma CC, no laila, T 1/2 lengthens, i alakaʻi i ka hoʻonui i ka plasma metformin hydrochloride pae.

ʻO ka pharmacokinetics i nā hihia lapaʻau kūikawā

Ma hope o ka hoʻohana hoʻokahi ʻana o ka metformin ma kahi o 500 mg o nā kamaliʻi, ua like like ka mole pharmacokinetics ma kēlā me kēia kumuhana olakino olakino.

Ma hope o ka hoʻohana pinepine ʻana i ka lāʻau ma ka maʻa o ka 500 mg 2 mau manawa / lā no nā lā 7 i nā keiki me ka maʻi maʻi, C max ma ka plasma a me AUC 0-t ma kahi o 33% a 40% mau haʻahaʻa ma mua o nā maʻi maʻi me ka maʻi maʻi i loaʻa metformin ma kahi o 500 mg 2 mau manawa / lā no 14 lā. No ka koho ʻia ʻana o ka ʻaiā o ka lāʻau lapaʻau kūʻokoʻa e pili ana i ka pae o ka mana o ka glycemia, ua palena kēia mau ʻikepili i ka nui o ke ʻano maʻi.

Nā hōʻailona no ka hoʻohana ʻana

Kauka 2 diabetes mellitus:

• i mea e hoʻomaikaʻi ai i ka mālama glycemic (ma ka hoʻohui ʻana i ka meaʻai a me ka hoʻōla) i nā hanana i ka manawa like o ka hoʻohana ʻana i ka linagliptin a me ka metformin e aʻo ʻia ai: i nā maʻi nā maʻi me ka metformin wale nō i lawa, ʻaʻole i nā maʻi nā mea i loaʻa mua ka hui o linagliptin a me ka metformin i hoʻokaʻawale ʻia. nā lāʻau lapaʻau me ka hopena maikaʻi,
• i ka hui pū ʻana me nā derivatives sulfonylurea (triple therapy therapy) i ka hoʻohui ʻana i ka meaʻai a me ka hoʻomaʻamaʻa ʻana no nā poʻe maʻi e hoʻomaʻemaʻe ana i ka metformin a me nā derivatives sulfonylurea i ka nui o nā hoʻomanawanui i kā ʻole ʻia.

Ka hoʻoponopono ʻia ʻana

No ka lawelawe waha.

ʻO ka dosis i ʻōlelo ʻia he 2.5 mg / 850 mg a i ʻole 2.5 mg / 1000 mg 2 mau manawa / lā.

Pono ke koho pono ʻia ʻo ka dosage e pili ana i ka regimen mālama i ke ʻano o ka mea maʻi, i kona pono a me ka hiki ʻana. ʻO ka nui loa e hoʻolako ʻia ai i kēlā me kēia lā o Gentadueto ® he 5 mg o linagliptin a me 2000 mg o ka metformin.

Pono e lawe ʻia ka Gentadueto ® me ka meaʻai i mea e hōʻemi ai i nā hopena ʻino mai ka digestive tract i hoʻoulu ʻia e ka metformin.

No nā mea maʻi e kīhai ʻole i ka maʻi mellitus type 2 e ka metformin monotherapy i ka nui o ka ʻae ʻana i ka palena loa, ʻokoʻa mau ʻia ʻo Gentadueto® no laila, ʻo 2.5 mg 2 mau manawa / lā (lā i kēlā me kēia lā he 5 mg), a hoʻomau ʻia ke ʻano o ka metformin. e like me ma mua.

No nā poʻe maʻi e hoʻoneʻe ʻia mai ka hoʻohana ʻia ʻana o ka linagliptin a me ka metformin, pono e kuhikuhi ʻia ʻo Gentadueto ® i like nā ʻano like me nā kīʻaha o linagliptin a me ka metformin.

No nā mea maʻi e kīhai ʻole i ka maʻi mellitus type 2 e ka hoʻomohala ʻelua ʻana e ka hoʻohana ʻana i ka nui o ka palena o ka metformin a me kahi deralona sulfonylurea, ʻ prescribedlele pinepine ʻia ʻo Gentadueto ® i mea e pili ana ka nui o ka linagliptin he mau 2.5 mg 2 mau manawa / lā (lā i kēlā me kēia lā 5 mg), a me ka ʻolopoli he like me ka metformin i like ma mua.

Ke hoʻohana ʻia ʻo Gentadueto ® me ka hui pū me ka derivative sulfonylurea, hiki ke koi ʻia ka hapa haʻahaʻa o ka derogative sulfonylurea e hoʻemi i ka hopena o ka hypoglycemia.

I mea e hoʻohana ai i nā ʻano like ʻole o ka metformin, loaʻa i ka Gentadueto ® i loko o nā palapalaʻano hana:

• linagliptin 2,5 mg + metformin hydrochloride 850 mg or metformin hydrochloride 1000 mg.

Gentadueto ® (ma muli o ka piha o ka metformin i loko o kona ʻano) he contraindicated i nā maʻi me ka maʻi hakahaka a i ʻole a koʻikoʻi nā maʻi (CC)

Gentadueto ® (ma muli o ka hiki ʻana o metformin i kona hoʻopili) ua contraindicated ma nā mea maʻi me ka maikaʻi ole o ka ate.

No ka mea ke hoʻopiʻi ʻia ka metformin e nā keiki, a ma ka wā kahiko, aia ka manaʻo e hoʻemi i ka hana renal, i nā poʻe maʻi maʻi kahiko e lawe ana iā Gentadueto ®, pono e kiaʻi mau i ka hana iā ia.

I ka hihia o ka nalo ʻana, pono e hopu koke i ka hoʻomanaʻo ʻana. Mai kiʻi i kahi papa pālua ʻelua i ka manawa like.

Nā hopena hopena

I ka poʻe maʻi e loaʻa ana i ka hui pūpū paʻa-linagliptin a me ka metformin

I ka manawa pinepine:

• ka hoʻohaʻahaʻa, hoʻowahāwahā, ʻeha,
• hypoglycemia.

Kaka:

• nasopharyngitis,
• hyperactivity o bronchi,
• nahe amylase hana,
• maʻi pākahi (angioedema, urticaria, pāheʻe).

ʻArelelo:

• hōʻea, hōʻeha,
• utuka
• lōkohu
• huhū
• pohuo

I ka poʻe maʻi e loaʻa ana ka metformin monotherapy

I ka manawa pinepine:

• nā ʻono hoʻoweliweli,
• ʻeha ka ʻōpū
• maʻi hepatobiliary - he hoʻololi i nā ʻōnaehana hana pili, hepatitis,
• erythema, urticaria.

ʻArelelo:

• ka huakaʻi o ka metabolic - lactic acidosis,
• hōʻino i ka lawe ʻole ʻana o ka huaora B 12 (me ka mālama lōʻihi) hiki ke alakaʻi (i nā hihia ākea loa) i kahi nele o ka nui o ka vitamin B 12, no ka laʻana, me ka megaloblastic anemia.

Nā Hoʻohui

• hypersensitivity i nā māhele o ka lāʻau lapaʻau,
• maʻi diabetes type 1
• maʻi maʻamau ketoacidosis, maʻi kanesa,
• hana ʻole a i ʻole ke kīnā ʻole a hana (KK ® i hoʻohālikelike ʻia i ka wā hāpai a me ka lactation (umauma).

ʻAʻole i hana ʻia nā haʻawina e pili ana i ka hopena o ka lāʻau lapaʻau i ka ulu kanaka. Ma nā hana preclinical e hoʻohana ana i ka nui o ka hoʻopaʻa ʻia ʻana o ka linagliptin (240 mg / kg / lā), ka mea iʻoi aku ma mua o ka ʻike ʻana o ke kanaka ma mua o 900 mau manawa.

ʻO ka hoʻopaʻa ʻana kūpono a ʻike pono ʻia i ka lāʻau ʻAioleeto ® a i ʻole nā ​​ʻāpana ponoʻī i nā wahine hāpai. Ma nā haʻawina hoʻohua mua, ʻaʻohe hopena o ka teratogen i pili me ka hoʻohana pono ʻana o ka linagliptin a me ke metformin. Hoʻohui nā ʻikepili ma ka hoʻohana ʻana i ka metformin i nā wahine hāpai.

ʻAʻole pono e hoʻohana ʻo Gentadueto ® i ka wā hapai hoʻolālā. Pono e hoʻohana ʻia ka insulin, e ʻae i ka mālama ʻana i nā hoʻoliʻi glucose o ke koko ma kahi pae kokoke i ka maʻamau a hoʻohaʻahaʻa i ka hōʻemi o ka hoʻoulu ʻana o ka maʻi fetal e ka kiʻekiʻe o ka glucose kiʻekiʻe.

Hoʻopau ka Metformin i ka waiū kanaka. ʻAʻohe mea iʻike i ka hiki o ke komo ʻana o ka lignagliptin i loko o ka waiū umauma i nā kānaka.

Nā ʻōlelo kikoʻī

ʻO ka Gentadueto ® i contraindicated i nā maʻi me nā maʻi mellitus type 1 a i ʻole no ka mālama ʻana i ka ketoacidosis maʻi.

ʻO ke hoʻohana ʻana i ka lāʻau lapaʻau Gentadueto ® i hui pū me ka insulin ʻaʻole i aʻo pono.

ʻO ka hypoglycemia kahi ʻike hoʻopiʻi o ka sulfonylureas. No laila, i ka wā e hoʻohana ai i ka lāʻau lapaʻau Gentadueto ® i hui pū me ka huaʻala o ka sulfonylurea, e noʻonoʻo ʻia. Hiki i ka hiki ke hoʻemi i ka nui o nā kōmani sulfonylurea.

ʻAʻole ke kumu o ka metformin ke kumu hypoglycemia, akā hiki ke hoʻopilikia ʻia kēia hoʻopiʻi inā hōʻemi ʻia nā mea ʻai o ka meaʻai, inā ʻaʻole i hoʻopau ʻia ka hana kino nui e ke kāʻai ʻana o nā kaloli hou, a i ʻole nā ​​mea lapaʻau hypoglycemic ʻē aʻe (no ka laʻana, ka olony sulfonylurea a me ka insulin) i hoʻohana a i ʻole etanol.

Lactic acidosis kahi hopena paʻakikī koʻikoʻi akā paʻakikī ka hopena hiki ke hōʻeha ma muli o ka hōʻiliʻili o ka metformin hydrochloride. ʻO nā hihia i hoʻopuka ʻia o ka lactic acidosis i nā mea maʻi e loaʻa ana i ka metformin hydrochloride i hana nui ʻia i ka maʻi mellitus me ke kūwaha ʻole o ka pilikia, a me ka hala ʻana o nā hopena e like me nā maʻi mellitus, nā kika, ka wā lōʻihi, ka wikiwiki, ka nui o ka inu ʻona, ka ʻōpio ʻole. i kekahi mau kūlana me ka hypoxia.

ʻO ka hoʻonāukiuki o ka acidact lactic:

• pono e noʻonoʻo pono i ka hopena o ka lactic acidosis e pili ana i ka hoʻomohala ʻana o nā hoʻopiʻi nonspecific e like me ka ʻeha o ka ʻōpū spastial a me ka asedeia koʻikoʻi.

Hōʻoia ka lactic acidosis e ka acidotic pōkole o ka hanu, ka ʻeha o ka ʻōpū a me hypothermia, i ukali ʻia e ka hoʻomohala ʻana i ka coma. ʻO nā hoʻololi o nā helu ʻalani i ka waiwai o ka diagnostic - he hōʻemi i ka pH koko, kahi piʻi i ke kiʻekiʻe o ka lactic acid i ka plasma ma mua o 5 mmol / l, kahi piʻi i ka anion deficiency a me ka lactate / pyruvate ratio. Inā kānalua ka metabolic acidosis, pono e pani ʻia ka metformin, a e hoʻokipa koke ʻia ka mea maʻi.

No ka mea ua hoʻopili ʻia ka metformin hydrochloride e nā keiki, pono ia e hoʻoholo pinepine ʻia ka pae o ka serum creatinine ma mua o ka hoʻomaka ʻana o ka lapaʻau a:

• i nā mea maʻi me ka hana maʻamau maʻamau, ma ka liʻiliʻi loa i kēlā me kēia makahiki.
• i nā mea maʻi me nā pae serum creatinine e kūlike me VGN, a i nā mea maʻi kahiko me ka liʻiliʻi o 2-4 mau manawa i ka makahiki.

I ka poʻe maʻi ma waena o ka maʻi, ua ʻike pinepine ʻia ka emi ʻana o ka asymptomatic i nā hana ʻoi. Pono ka mālama kūikawā e mālama i nā kūlana i hiki ke alakaʻi i ka hoʻokaʻawale o nā hana ʻoi aku, no ka laʻana, me ka hoʻomaka ʻana o nā antihypertensive, diuretic therapy a i ʻole ka hoʻohana ʻana o nā NSAID. Hoʻohana pono ka mālama ʻana i ka mālama ʻana i nā mea maʻi i nā makahiki he 80 a keu aku.

No ka mea, ʻo ka hoʻokele intravascular o nā ʻenehana hoʻohālikelike o ka ʻenehana o ka radiological hiki ke alakaʻi i ka hana ʻole ʻana, pono ke hoʻohana ʻia ka metformin hydrochloride i mua o kēia mau haʻawina paha. ʻO ke hoʻohana ʻana o ka metformin hydrochloride hiki ke hoʻomau i nā hola 48 ma hope o ka pau ʻana o kēia mau haʻawina a aia wale nō ma hope o ka loaʻa ʻana o nā hopena o kahi loiloi loiloi o ka hana hula, i hōʻike ʻia ʻaʻohe hoʻololi.

Pono e hoʻokuʻu ʻia ʻo Metformin hydrochloride he 48 mau hola ma mua o ke ʻano o ka hoʻokalakupua a me ka hoʻohana ʻana i ka anesthesia aoao, spinal, a i ʻole hanana epidestia. Hiki ke hoʻomau ʻia ka hoʻohana ʻana o ka lāʻau lapaʻau ma mua o nā hola 48 ma hope o ka hana ʻana a ma hope iho o ka hoʻihoʻi hou ʻana i ka mea ʻai ma ka waha, a inā wale nō nā hopena o ke loiloi hou ʻana i ka hana hana, e hōʻike ana i ka loaʻa ʻole o nā loli, ke loaʻa.

I ka wā o ka hoʻopaʻa inoa ʻana, ua hoʻopaʻa ʻia ka hoʻomohala ʻana o ka maʻi pancreatitis ma nā poʻe maʻi e lawe ana i ka linagliptin. I ka hihia o ka pancreatitis, pono e hoʻokaʻawale ʻia ʻo Gentadueto ®.

Hoʻokomo i ka hiki ke lawe i nā kaʻa a kāohi i nā mīkini

ʻAʻole i aʻo ʻia nā haʻawina e noiʻi i ka hopena o ka lāʻau lapaʻau i ka hiki ke hoʻokele i nā kaʻa a hana i nā hana e koi ai i ka piʻi nui o ka nānā a me ka wikiwiki o ka hopena psychomotor. Ke noʻonoʻo nei i nā hihia o ka huki i ka wā e lawe ai i ka lāʻau lapaʻau, pono e hoʻomaʻemaʻe. Inā ʻike ka poʻe maʻi i ka maʻi ʻeha, pono lākou e pale i nā hana e ʻoi aku ka paʻakikī, e komo pū ka lawe ʻana i nā kaʻa a me ka ʻohi ʻana i nā mīkini.

Ke keu

I ka wā o ka hoʻokolohua ʻana i nā maʻi lapaʻau i mālama ʻia i nā kumuhana olakino, hoʻokahi manuahi o ka linagliptin, e hōʻea ana i ka 600 mg (120 mau manawa i hoʻolilo ʻia). ʻAʻole ʻike ka ʻike ma ka hoʻohana ʻana i ka lāʻau ma nā inika iʻoi aku ma mua o 600 mg i nā kānaka.

I ka wā i hoʻohana ai ka metformin i nā palahilahi e like me ke kiʻekiʻe o 850 mg, ʻaʻole i ʻike ʻia ka hypoglycemia, ʻoiai aia i nā hihia o ka acidact lactic. Hiki i kahi nui o ka metformin ke alakaʻi i ka acidact lactic. No ka maʻi lactic acidosis ka māhele o ke kūlana olakino, hiki ke mālama ʻia i ka mālama ʻia i loko o ia mau hale hoʻokipa.

Nā Hoʻomaka

• hypoglycemia, nausea, dizziness ka mea hiki.

Lāʻau:

• gastage lavage, hoʻopuka ʻana o nā adsorbents,
• ke hana nei i ka maʻi hōʻailona (in / i ka hoʻomaka ʻana o nā pilima, kāohi a me ka hoʻākā maʻamau i ka ʻike glycemic. ʻO ke ala e ʻoi loa o ka lawe ʻana i ka lactate a me ka metformin hydrochloride ka hemodialysis.

Hoʻohui nūhou

ʻO ka hoʻohana pinepine ʻana i nā limagliptin mau poʻe lawelawe olakino (10 mg 1 manawa / lā) a me ka metformin (850 mg 2 mau manawa / lā) ʻaʻole i loli nui i ka pharmacokinetics o linagliptin a i me ka metformin.

ʻAʻole i lawelawe ʻia nā haʻawina ʻo pharmacokinetic o ka hoʻopili ʻana i ka lāʻau o Pereadueto ®, eia naʻe, ua mālama ʻia nā haʻawina like me nā mea kikowaena kūloko o Gentadueto ®, linagliptin a me metformin.

ʻAʻole i loaʻa i ka Linagliptin ka hopena nui i ka maʻi ma ka pharmacokinetics o ka metformin, glibenclamide, simvastatin, pioglitazone, warfarin, digoxin a me nā kūmole waha, ka mea i hoʻopili ʻia ma ka vivo data e pili ana i ka hoʻokaʻawale o nā lāʻau lapaʻau me ka substrates no CYP2C8, 4 isoenzymes, CYP2A4, glycoprotein a me ka mea lawe o nā cation organic (TOK).

Metformin. ʻO ka hoʻohana like ʻana o ka metformin (hoʻohana hou ʻia ma kahi manawa o 850 mg 3 mau manawa / lā) a me linagliptin (ma kahi pāʻālua supratherapeutic o 10 mg 1 manawa / lā) ʻaʻole ia e alakaʻi i nā loli koʻikoʻi i loko o ka pharmacokinetics o linagliptin a i metformin.

Nā hua palapala o nā sulfonylureas. ʻO ka hoʻohana pū ʻana o ka linagliptin ma ke kūloko (he nui o nā helu o ka 5 mg) a me ka glibenclamyl i loko o hoʻokahi pākahi (glyburide 1.75 mg) ʻaʻole i hoʻololi i ka pharmacokinetics o linagliptin i ka kūlolo. Eia nō naʻe, aia nō kahi emi iki o nā maʻi ma AUC a me C max o glibenclamide e 14%. Ma muli o ka koho ʻana o ka glibenclamide e CYP2C9, ua hōʻoia kēia mau ʻike i ka hopena o ka linagliptin ʻaʻole he mea hoʻololi o CYP2C9. ʻAʻole i manaʻo ʻia nā launa nui koʻikoʻi me nā derivatives o ka sulfonylurea (e.g., glipizide, tolbutamide a me ka glimepiride), ka mea, e like me ka glibenclamide, ka mea nui i ka metabolly me CYP2C9.

Thiazolidinediones. ʻO ka hoʻohana pū ʻana o ka linagliptin (hoʻokahi 10 mg / lā) a me ka pioglitazone (he nui o nā helu he 45 mg / lā), he substrate no CYP2C8 a me CYP3A4, ʻaʻohe ona hopena koʻikoʻi i ka pharmacokinetics o linagliptin a i a pioglitazone, a i ʻole nā ​​metabolites ikaika o ka pioglitazone.

Ritonavir. ʻO ka hui pū ʻana o ka linagliptin (hoʻokahiʻano o 5 mg / lā) a me ka ritonavir (nui o nā pūʻulu o 200 mg mauka) e hoʻonui ai i ka AUC a me C max o linagliptin, ma kēlā, ma kahi o 2 a 3 mau manawa. ʻAʻole i manaʻo ʻia kēia mau loli i ka pharmacokinetics o lignagliptin i manaʻo nui ʻia. No laila, ʻaʻole i kali ʻia kahi pilina maʻi lapaʻau nui me nā P-glycoprotein / CYP3A4 inhibitors, ʻaʻole koi ʻia nā loli hou.

Rifampicin. Nui ka hoʻohana ʻana i ka linagliptin a me nā rifampicin e kahe ana i ka AUC a me C max o linagliptin i ka pākeke ma ka 39.6% a me 43,8%, kēlā me kēia, a me ka emi ʻana i ka hana o ka hana o basal o DPP-4 ma kahi o 30%. No laila, ua manaʻo ʻia e mālama ʻia ka hoʻokau like o ka linagliptin i hui pū me nā mea hoʻohiwahiwa o ka maʻi o P-glycoprotein, ʻoiai ʻaʻole ia e hōʻike piha.

Digoxin. ʻO ka hoʻohana pū ʻana o ka linagliptin (5 mg / lā) a me ka digoxin (0.25 mg / lā) ʻaʻole i pili i ka pharmacokinetics o digoxin.

Warfarin. ʻO Linagliptin, i hoʻohana pinepine ʻia i ka nui o 5 mg / lā, ʻaʻole i loli i ka pharmacokinetics o S ​​(-) a i R (+) warfarin, kahi papahele no CYP2C9, e hōʻike ana i ka hiki ʻole o ka linagliptin e pale i ka CYP2C9.

Simvastatin. ʻO Linagliptin, i hoʻohana pinepine ʻia i loko o ka hopena super-therapeutic o 10 mg / lā, loaʻa iā ia ka hopena liʻiliʻi loa i ka pharmacokinetics o simvastatin, ka mea e koi ai i ka hoʻoponopono hoʻoponopono ʻia.

Nā maʻi hoʻohālikelike. ʻO ka hoʻohana pū ʻana o ka linagliptin i loko o kahi pāʻala o 5 mg me ka levonorgestrel a ethinyl estradiol ʻaʻole e hoʻololi i ka pharmacokinetics o kēia mau lāʻau i ka kūlike.

Metformin. ʻO ka hoʻohana ʻana o ka metformin i ka hoʻohālikelike ʻana i ka waiʻona maʻi nui e hoʻonui i ka nui o ka lactic acidosis (ʻoi aku paha i ka hihia o ka pōloli, maʻi kīnā ʻole kōʻaiʻai ʻole). Pono e hoʻokaʻawale i ka waiʻona a me nā lāʻau ʻawaʻawa nā huaʻawa lā.

Nā lāʻau lapaʻau cationic i hoʻopiʻi ʻia e ka sekela tubular secretion (eg, cimetidine) hiki ke launa me ka metformin, hoʻokūkū no nā maʻi transportalima tubular maʻamau. No laila, me ka hoʻohana like ʻana o nā lāʻau cationic i hoʻopili ʻia e ka neʻe tubular molina, mālama pono ʻana i ka glycemia, kahi hoʻololi o ke ʻano o ka metformin i loko o ka ʻōlelo papa kuhikuhi, a e pono ai ke hoʻoponopono ʻana i ka maʻi diabetes mellitus.

ʻO nā waiwai Pharmacological

Ua hōʻike ʻia nā haʻawina Bioequivalence i nā limahana olakino i hōʻike ʻia ʻo GENTADUETO ka mea bioequivalent i ka linagliptin i hoʻokaʻawale ʻia a me ke metformin hydrochloride i loko o ka hoʻohui hoʻohui.

ʻO ka hoʻohana ʻana i ka lāʻau GENTADUETO 2.5 / 1000 mg me ka meaʻai ʻaʻole alakaʻi i kahi loli i nā hiʻohiʻona pharmacokinetic o linagliptin. ʻO ka wahi ma lalo o ka pihi o ka paʻa-time (AUC) i ka loli o ka metformin, ʻaʻole i loli, akā ke kumukūʻai o ka nui o ke koʻo o ka metformin i ka serum i ka hihia o ka hoʻohana ʻana i ka lāʻau me ka meaʻai e hōʻemi ʻia e 18%. Hoʻohana ʻia ka hoʻohana ʻana i ka lāʻau lapaʻau ma ka ʻōpū ʻole e hoʻolōʻihi i ka hiki ʻana i ke kao nui o ka metformin i loko o kahi serum no 2 mau hola. Kuhi ʻole kēia mau loli.

Ke hōʻike nei nā ʻikepili i ka mea e hōʻike ana i ka waiʻalani pharmacokinetic o nā mea hoʻoikaika pono o ka lāʻau GENTADUETO.

Ua kūkā maikaʻi ʻia nā pharmacokinetics o lignagliptin i nā mea hana olakino olakino a me nā mea maʻi me nā maʻi diabetes type 2. Ma hope o ka lawe ʻana i ka linagliptin kūloko ma ke ʻano o ka 5 mg, ke kiʻi koke ʻia ka lāʻau lapaʻau, hōʻiliʻili ʻia nā mea kiʻekiʻe o ka plasma (median Tmax) ma hope o 1.5 mau hola. Hoʻopili nā Plasma linagliptin i ʻekolu mau manawa. He lōʻihi ka hapa hapalua o ka pahu (ʻoi aku ma mua o 100 mau hola), no ka ikaika, paʻa paʻa o ka linagliptin me DPP-4 ʻaʻole ia i alakaʻi i ka hōʻiliʻili o ka lāʻau. ʻO ka hapalua ola maikaʻi no ka hōʻiliʻiliʻana o ka linagliptin, i hoʻoholo ʻia ma hope o ka hoʻokele ʻana o ka linagliptin ma kahi o ka pā o 5 mg, ma kahi o 12 mau hola. Ma hope o ka hoʻokahi pā o 5 mg o linagliptin, hoʻohui ʻia ka plasma i ka lāʻau ma ke ʻano o ka waiwai e kūleʻa ʻia ma hope o ka lawe ʻana i ke kolu o ke kūlohelohe, ʻo ka AUC plasma o ka linagliptin e hoʻonui i ka mea he 33% hoʻohālikelike ʻia me ka uku mua. ʻO ka liʻiliʻi o nā ʻano o ka loli no ka AUC o linagliptin i liʻiliʻi: 12.6% a me 28.5%. ʻO ka pharmacokinetics o lignagliptin nonlinear ma muli o ke kaila hilinaʻi o ka lignagliptin me DPP-4. ʻO ka nui plasma AUC o ka linagliptin e hoʻonui i ka emiʻana o ka dosis ma mua o ka AUC Unuhi, e hoʻonui ana i ka nui o ka dosis. ʻO nā pharmacokinetics o linagliptin e like me ke olakino a me ka poʻe maʻi me nā maʻi maʻi 2.

Pauahi: ʻO ka bioavailability piha loa o ka linagliptin e like me 30%. ʻO ka ʻike ʻana i ka linagliptin me ka meaʻai me kahi momona momona e hoʻonui i ka manawa e hiki ai i ka plasma plasma kiʻekiʻe (Cmax) ma nā hola 2 a alakaʻi i kahi emi o Cmax ma 15%, akā ʻaʻole ia i hoʻopilikia iā AUC0-72h. ʻAʻohe loli lapaʻau nui i ka Cmax a me Tmax, no laila, hiki ke hoʻohana ʻia nā linagliptin e pili ana i ka meaʻai o ka meaʻai.

ʻO ka hoʻohālikelike: ma muli o nā kiko o ke kiko, ka nui o ka hoʻokaʻawale ʻana i ke kōpaʻa o ka hoʻonaninani kūpaʻa ma hope o hoʻokahi pāʻai o 5 mg ka mea he 1110 lita, e hōʻike ana i ka hoʻohele nui ʻana i nā kiko. ʻO ka paʻa ʻana o ka linagliptin i nā protein o ka plasma e hilinaʻi ana i ka luhi o ka lāʻau a hōʻemi i ka 99% ma 1 nmol / L i 75-89% ma ≥30 nmol / L, e hōʻike ana i ka saturation o ka pilina o ka lāʻau me DPP-4 me ka hoʻonui pinepine ʻana o ka lignagliptin. I nā kikowaena kiʻekiʻe o ka linagliptin, i ka wā paʻa i ka DPP-4 ke kī piha, 70-80% o linagliptin nakinaki i nā protein plasma (ʻaʻole D D--4), a me 30-20% o ka lāʻau i loko o kahi kūlana.

Ka metabolism a me ka hoʻopiʻi ʻana. Ma hope o ka lawe ʻana he 10 mg o linagliptin, ma kahi o 5% e hoʻopiʻi ʻia i ka urine. ʻO Metabolism hoʻokani i ka lua o ka hana ma ka hoʻopau ʻana o ka linagliptin. Ua hōʻike ʻia kahi metabolite nui me ka ʻole o ka hana pharmacological a me ka hopena pili o 13.3% o linagliptin i ke ʻano o ka waiwai kaulike, no laila, ʻaʻole ia he hopena pale o ka linagliptin ma DPP-4 i ka plasma. Ma kahi o 85% ua hoʻopiʻi ʻia (me nā feces 80% a me ka hoʻēmi 5%) ma loko o 4 mau lā ma hope o ka hoʻokele ʻana. ʻO ka wehe ʻana o Renal i ka hoʻoili uila ma kahi o 70 ml / min.

ʻO ka poʻe maʻi me ka hana renal impaired: i ka hana o ka equilibrium hoʻōla i nā mea maʻi me ka ʻoluʻolu haʻahaʻa o kahi maʻi renal, ʻo ka hōʻike o ka linagliptin e like me ka ʻōlelo o ka hoʻolaha ʻana i nā mea hana olakino olakino. I ka poʻe maʻi me ka awelika makahiki o ka maikaʻi ʻole o ka renal, kahi hoʻonui nui i hoʻonui ʻia i ka hōʻike ʻike ʻia ma kahi o 1.7 mau manawa i ʻike ʻia me ka hui pū. ʻO ka hoʻolaha ʻike ʻia i nā mea maʻi me ka maʻi diabetes mellitus type 2 a me kahi pohihihi ʻoi aku ka nui o ka renal i hoʻonui ʻia e like me 1.4 mau manawa i hoʻohālikelike ʻia me nā mea maʻi me ka maʻi type 2 me ka hana maʻamau maʻamau. ʻO nā waiwai nui o ka AUC i wānana i ka linagliptin ma ke ʻano kaulike mokulele i loko o nā mea maʻi me ka hopena o ka hope o ka renal impairment e hōʻike nei i nā pae hoʻohālikelike o ka hōʻemi i ka maʻi ma nā mea maʻi me ka maʻi hoʻokaumaha o ke kino paha Eia kekahi, ʻaʻole i excreted ke linagliptin i kahi pae therapeutically koʻikoʻi i ka wā hemodialysis a i kēlā me kēia dialysis peritoneal. I nā mea maʻi me kekahi haʻalaha maʻi ʻole, ʻaʻole pono ka hoʻoponopono ʻana o ka linagliptin, no laila, hiki iā ʻoe ke hoʻomau i ka lawe ʻana i ka linagliptin i ke ʻano o hoʻokahi papa i hoʻokahi lāʻai no ka 5 mg inā inā pau ka lāʻau DENTADUETO e hoʻopau ʻia ma muli o ka hiki ʻana o kahi hana renal impaired.

ʻO nā mea maʻi me ka hana ʻōlima hemahema: i nā mea maʻi me ka hana aho ʻole o kekahi haʻawina (ʻĀina keiki-Pugh A, B, a me C), nā kumukūʻai awelika o AUC a me Cmax o linagliptin e like me ka hui mana ma hope o ka lawe ʻana i nā helu he nui o 5 mg o linagliptin.

ʻAʻole koi ʻia ka hoʻoponopono ʻana o nā maʻi ma ke ʻano o ka wahine, ka index body body (BMI), lāhui, a me ka wā maʻi.

Hoʻopohala: ma hope o ka lawe ʻana i Metformin i loko, ua loaʻa ʻo Tmax ma hope o 2 mau hola. I nā mea hana olakino olakino, ʻo ka bioavailability piha o ka metformin hydrochloride ma hope o ke kūlohelohe i waha ma kahi o 500 mg a 850 mg paha ma kahi o 50-60%. Ma hope o ka lawe ʻana i ka lāʻau lapaʻau i loko, e pili ana i ka 20-30% o ka lāʻau i ka huihue ʻole a hoʻopiʻi ʻia i nā feces i loli ʻole.

Hoʻopili ʻia nā ʻōpū o ka metmorphine hydrochloride a paʻa ʻole, nā pharmacokinetics o ka hoʻopili ʻana. Ke lawe nei i nā kiko i ʻōlelo ʻia o nā metformin hydrochloride, paʻa nā kō i loko o ka plasma paʻa i loko o 24-48 mau hola a, me ke ʻano he kānāwai, ka liʻiliʻi o 1 μg / ml. Ma nā haʻawina loea, Cmax plasma metformin hydrochloride level over over 5 μg / ml, a hiki i nā nui loa. ʻAi ka ʻai ʻana i ke kao o ka metformin hydrochloride a hoʻolei i lalo. Ma hope o ka hoʻohana ʻana i ka lāʻau lapaʻau ma kahi o 850 mg ma, me ka meaʻai, Cmax heluhelu ʻana he 40% haʻahaʻa, ʻo AUC 25% haʻahaʻa, hoʻonui ʻia ʻo Tmax ma kahi o 35 mau minuke. ʻAʻole maopopo ka ʻike koʻikoʻi o ka maʻi o ka hāʻule o kēia mau kuhikuhi.

Hoʻohālikelike: ʻO ke kāpili ʻana o Metformin i nā protein o ka plasma he hikiʻole. Hoʻohālikelike ʻia ka metformin hydrochloride e nā sela ʻulaʻula. ʻO ka lōʻihi loa o ke kau ʻana i ka lāʻau i loko o ke koko ka haʻahaʻa ma mua o ka plasma a ua loaʻa a like i ka manawa like. Manaʻo nā sela koko hoʻokoe hou i kahi ʻoihana nui no ka hoʻoili ʻana i ka lāʻau lapaʻau. ʻO ka nui o ka nui o ka hoʻoili (Vd) i like me 63 a 276 lita.

ʻO ka Metabolism a me ka hoʻopāhaʻi: hoʻopili ʻia ka metformin hydrochloride e nā keiki i loli ʻole. I nā kāne, ʻaʻole i ʻike ʻia nā metabolites o ka lāʻau. ʻO ka hoʻomaʻemaʻe ʻana i ka renal hydrochloride ma mua o 400 ml / min, e hōʻike ana i ka hana o ka lāʻau e ka filomation glomerular a me ka hilo huna tubular. Ma hope o ka lawe ʻana i ka lāʻau lapaʻau i loko, ʻo ka hapalua o ke ola he 6.5 mau hola.

Ma kahi o ka hana renal impaired, hoʻomaʻemaʻe ka pale o ka lāʻau i ka hapa i ka hoʻomaʻemaʻe ʻana o ka creatinine, no laila ua lōʻihi ka hapalua-ola, kahi e alakaʻi ai i ka hoʻonui i ka plasma metformin hydrochloride.

ʻO GENTADUETO kahi hui paʻa o nā mea hoʻohuihua ʻelua koko - linagliptin a me ka metformin hydrochloride, me ka hana hoʻohui kōpili o ka hana e hoʻomaikaʻi ai i ka control hypoglycemic i ke koko o nā mea maʻi me ka maʻi diabetes type 2.

ʻO Linagliptin kahi mea hoʻoweliweli o ka enzyme DPP-4 (dipeptidyl peptidase 4), i pili i ka hana ʻole ʻana o nā hormones incretins - e like me peptide-1 (GLP-1) a me ka glucose-e hilinaʻi nei i ka insulinypropide polypeptide (GIP). Hoʻopau koke ʻia kēia mau hormones e ka DPP-4 ene. Hoʻokomo nā mau hua he lua i ka hoʻoponopono o ka physiological o ka home home home glucose. ʻO ka pae haʻahaʻa o ka neʻe o ka puke i ka lā i hoʻohaʻahaʻa ʻia, ke piʻi wikiwiki nei ma hope o ka ʻai. Hoʻonui ka GLP-1 a me GIP i ka biosynthesis a me ka huna ʻana o ka insulin i nā ʻāpana beta pancreatic i nā pae kiʻekiʻe a hoʻoneʻe i ke kō. Eia kekahi, hōʻemi ʻo GLP-1 i ka mea paʻa o ka glucagon e nā cell alpha pancreatic, e alakaʻi ai i kahi emi o ka hana glucose i loko o ka ate.

ʻO Linagliptin me ka maikaʻi a ke hoʻi hou a pili i ka DPP-4, ka mea e hoʻomāhuahua mau ai i ka pae o ka incretins a mālama i kā lākou hana no ka manawa lōʻihi. Hoʻonui ka Linagliptin i ka huna ʻana i ka glucose glucose i ka neʻe ʻana a hoʻemi i ka ʻōlelo huna glucagon, hoʻomaikaʻi i ka home home home glucose. Hoʻopili paʻa ʻo Linagliptin iā DPP-4; i ka vitro, uaʻoi aku ka mea i koho ʻia ma mua o DPP-8 a i kāna hana e kūʻē ai iā DPP-9 ma mua o 10,000 mau manawa.

ʻO ka metuanin hydrochloride kahi biguanide a he hopena hypoglycemic, hoʻemi ʻana i ke kiʻekiʻe o ka glucose glucose a me ka postprandial. ʻAʻole ia e hoʻoikaika i ka Metformin i ka huna ʻana i ka insulin a no laila ʻaʻole ia e alakaʻi i ka hypoglycemia.

Loaʻa iā Metformin 3 mau hana:

- ka hōʻemi o ka hoʻokumu glucose i loko o ka ate ma ka pale ʻana i ka gluconeogenesis muscle a me ka glycogenolysis

- ke hoʻonui ʻana o ka hōʻiliʻili peripheral a hoʻonui ka glucose i ka māhuahua mākeke ma ka hoʻonui ʻana i ka naʻau o ka insulin

- e hoʻolohi ana i ka hoʻopio ʻana o ka glucose i loko o ka ʻōpū

Hoʻonui ka metformin hydrochloride i ka syntact glycogen intracellular ma ka hana ʻana ma ka glycogen synthetase.

Hoʻonui ka metformin hydrochloride i ka mana o nā mea i ʻike ʻia e nā mea ʻokoʻa o ka membrane glucose kumu.

ʻO ka pili o kona hopena ma ka glycemia, ka metformin hydrochloride e loaʻa kahi hopena pono i ka lipid metabolism: e hōʻemi ana i ka pae o ka kolamu nui, kolamu ma LDL a me nā triglycerides.

ʻO ka hoʻohui i ka linagliptin i ka metformin therapy: ka hopena a me ka palekana o linagliptin i hui pū me ka metformin i nā mea maʻi me ka mana glycemic kawalan me ka metformin monotherapy i aʻo ʻia i loko o kahi ʻano ʻelua o ka makapō, nā haʻawina i hoʻokele ʻia e placebo i mau manawa he 24 mau pule. ʻO ka hui pū ʻana o ka linagliptin a me ke metformin e hoʻomaikaʻi nui i ka maikaʻi o nā paramika glycemic me ka ʻole o ka hoʻololi ʻana i ke kaupaona o ke kino ma mua o ka lawe ʻana i kēlā me kēia mahele. Ke hōʻemi nui nei i ka pae o ka hemoglobin glycosylated A (HbA1c) i hoʻohālikelike ʻia i ka placebo, mai ka pae o ka pae awelika, a me ka hoʻoliʻiliʻi plasma glucose (GPN), nā glucose glucose 2 mau hola ma hope o ka ʻaina (GLP) hoʻohālikelike ʻia me ka placebo a kiʻekiʻe aʻe. ka hapa iki o nā maʻi e hōʻea i nā pae HbA1c kiʻekiʻe.

ʻO ka mālamaʻana a me ka palekana o lignagliptin ma kahi kiko o 2.5 mg pālua i kēlā lā i kahi lā e hoʻohālikelike ʻia me 5 mg i hoʻokahi lā i ka lā hui me ka metformin i nā mea maʻi me ka mana glycemic inane i ka wā o ka metformin monotherapy i loiloi ʻia i loko o kahi wiki he ʻelua makapō, he 12 mau pule. ʻO ka loaʻa ʻana o ka linagliptin ma kahi o 5 mg hoʻokahi i ka lā a me 2.5 mg ʻelua mau manawa i ka lā i hāʻawi ʻia kahi hopena hoʻonaninani a ʻo ka nui o ka HbA1c mai ka pae mua i hoʻohālikelike ʻia me ka placebo. ʻO nā mea i ʻike ʻia i ka hypoglycemia i nā poʻe maʻi e loaʻa ana i ka linagliptin e like me ia ma ka hui pletebo. ʻO nā hōʻailona koʻikoʻi i ka paona kino ma waena o nā hui i nele.

ʻO Linagliptin i kahi hoʻopili i ka hana me ka hoʻohana ʻana i ka hui pū ʻana me ka derivatives o ka metformin a me nā derivatives o sulfonylurea: e loiloi i ka maikaʻi a me ka palekana o linagliptin (5 mg) i hoʻohālikelike ʻia me ka pletebo, ua hana ʻia kahi papa hoʻokele 24-wiki a waiho ʻia i ka poʻe maʻi i loaʻa ʻole i ka lapaʻau ʻia me ka metformin a me nā derivatives sulfonylurea. hopena maikaʻi. Hāʻawi ʻo Linagliptin i kahi holomua nui i ka HbA1c i hoʻohālikelike ʻia me ka placebo. Hoʻonui maikaʻi ka loaʻa ʻana o ka linagliptin i ke kūlana o ka poʻe maʻi i hōʻea i ka pae kūpono o ka HbA1c, a me ka hoʻokē ʻai wikiwiki (GPN) i hoʻohālikelike ʻia me ka pletebo. ʻO nā hōʻailona koʻikoʻi i ka paona kino ma waena o nā hui i nele.

ʻO Linagliptin ma ke kikowaena hou no ka mālama ʻana me ka metformin a me ka empagliflozin: I loko o nā mea maʻi me ka pau ʻole o ka mana glycemic i ka wā e lawe ai i ka metformin a me ka empagliflosin (10 mg a i ka 25 mg), ka mālamaʻana i ka hebedoma 24 me ka linagliptin 5 mg, ka mea i hana ma ke ʻano he ʻokoʻa, i alakaʻi ʻia i ka hapa nui o ka waiwai hoʻoponopono i hoʻololi ʻia. Hōʻike ka HbA1c i ka palena kahua i hoʻohālikelike ʻia me ka lāʻau placebo hoʻohui, kēlā me kēia. Ke lawe nei i ka linagliptin 5 mg, he helu nui nui o nā mea maʻi me ka HbA1c> 7.0% ma ka pae palena ma ka pae ʻana i ka HbA1c

ʻ a me ke kākele

Pono ka koho o ka lāʻau GENTADUETO i koho pono ʻia e pili ana i ka regimen mālama ola o ka mea maʻi, ka hopena a me ka ʻoluʻolu.

ʻO ka dosis i ʻōlelo ʻia he 2.5 mg / 850 mg a i ʻole 2.5 mg / 1000 mg pālua i kēlā me kēia lā. ʻO ka nui loa e hoʻolako ʻia ai i kēlā me kēia lā o GENTADUETO he 5 mg o linagliptin a me 2000 mg o ka metformin.

Nā ʻōkuhi no ka hoʻohana ʻana: pono e hana ʻia ʻo GENTADUETO ʻelua mau manawa i ka lā me ka ʻai e hōʻemi ai ka pōʻino o nā hanana ʻino i ka ʻeha gastrointestinal i hoʻokumu ʻia e ka metformin.

Pono ka poʻe maʻi e mālama i kahi papa lula me ka ʻaina haʻahaʻa hoʻokoe i loko o ke ao. Pono nā maʻi maʻi mākeke e hahai i kahi pākeke haʻahaʻa.

Pau ʻole nā ​​lae: ma kahi o ka nalowale i ka lāʻau e pono e lawe i ka manawa e hoʻomanaʻo ai ka mea maʻi i kēia. Mai lawe i kahi pāpālua pālua i ka manawa like i hoʻokahi lā, i kēia hihia, pono e ʻae ʻia ka hoʻokipa.

No nā poʻe maʻi e loaʻa ʻole ka metformin

No ka poʻe maʻi ʻaʻole i loaʻa i ka metformin, ʻo ke ʻano kaila i hoʻomaka ʻia ʻo 2.5 mg o linagliptin / 500 mg metformin hydrochloride pākahi i kēlā me kēia lā.

No ka poʻe maʻi e kī ʻole ʻole ʻia ka maʻi diabetes lā 2 me ka metformin monotherapy i ka nui loa ma ke ʻano, ʻo ka nui o ka lāʻau lapaʻau mua loa he 2.5 mg o linagliptin ʻelua i kēlā lā i kēlā me kēia lā (i kēlā me kēia lā he 5 mg), a ʻo ke ʻano o ka metformin e like me ka lawe mua ʻana. . ^ E Ha yM.

No nā mea maʻi i hoʻoneʻe ʻia mai ka hui hoʻohui o ka linagliptin a me ka metformin, pono ke ʻano o ka lāʻau GENTADUETO e like me nā ʻano o nā linagliptin a me ka metformin e like me ka mea i lawe ʻia ma mua.

No nā mea maʻi e kī ʻole ʻole ʻia ka maʻi type kīnā ʻole e ka hui hoʻohui ʻelua me ka hoʻohana ʻana i nā kaila kiʻekiʻe loa o nā metformin a me nā deralona sulfonylurea, ʻae ʻia ka lāʻau lapaʻau DENTADUETO e like ka nui o ka dosis linagliptin i ka 2.5 mg ʻelua mau manawa i kēlā me kēia lā (i nā lā o kēlā me kēia lā he 5 mg), a me ka helu ʻana like me ka metformin i like me ka mea ma mua.

Ke hoʻohana nei iā GENTADUETO i hui pū me ka derivatives sulfonylurea, pono e hoʻemi ʻia kahi liʻiliʻi o nā derivatives sulfonylurea e hoʻemi i ka hopena o ka hypoglycemia.

No nā mea maʻi he mau ʻaelike hui ʻelua me ka insulin a me ka nui o ka metformin, ʻaʻole i hāʻawi i ka mana glycemic, ʻohi ʻia ka lāʻau GENTADUETO e like me ka dosis o linagliptin e 2.5 mg ʻelua mau manawa i kēlā lā (pākahi lā no kēlā me 5 mg), a me ʻo ka hapa o metformin like me ka mea i lawe ʻia ma mua.

Ke hoʻohui pū ʻia me ka hui pū ʻana o ka linagliptin a me ke metformin me ka insulin, e koi paha ka liʻiliʻi o ka insulin e hōʻemi i ka hopena o ka hypoglycemia.

I mea e hoʻohana ai i nā ʻāpana ʻokoʻa o ka metformin, loaʻa iā GENTADUETO i loko o nā hui hoʻohui inoa: linagliptin 2,5 mg + metformin 850 mg a i ʻole metformin 1000 mg.

Nā hui ahonui kūikawā

Hola renalma maikaʻi ʻole: hiki ke hōʻemi ʻia ka lāʻau lapaʻau i nā mea maʻi me ka hoʻonaninani o ke koʻi o ka hana hanahana (ʻanuʻu 3, ka hoʻomaʻamaʻa ʻana i ka hana o 45-59 ml / min a i ʻole ka pae kānalua glomerular (GFR) o 45-59 ml / min / 1.73 m2), i ka haʻalele wale ʻole o nā hanana ʻē aʻe e hoʻonui ai i ka hōʻeha o ka acidact lactic i kahi koho i koho ʻia: ka nui o ka nui o ke kikoʻī o ka metformin he 500 mg pākahi i ka lā.

Pono e nānā pono i ka hana o nā keiki (e nānā i ka ʻāpana "Nā ʻōkuhi kūikawā").

Inā hana cleinine clearance

Hoʻopili i nā lāʻau lapaʻau

Nā kuhikuhi nui. ʻO ka hui pū ʻana o nā dosis linagliptin (10 mg hoʻokahi i ka lā) a me ka metformin (850 mg papalua i kēlā lā i kēia lā) ʻaʻole i hoʻopilikia i ka pharmacokinetics o linagliptin a i like me ka metformin i nā mea hana olakino olakino.

Ua mālama ʻia nā noi ʻana o ka lāʻau pharmacokinetic o ka lāʻau GENTADUETO me nā lāʻau lapaʻau ʻē aʻe, eia naʻe, i kēia mea, ʻo nā ʻano hua pilikino o ke ʻano lāʻau GENTADUETO, linagliptin a me metformin, i aʻo ʻia aku.

In vitro ʻO Linagliptin ka mea hōʻiliʻili haʻahaʻa nā CYP3A4 (CYP isoenzyme), he nawaliwali a hōʻemi paha e hiki ke hoʻoweliweli i ka CYP3A4 ma muli o kāna ʻano hana, akā ʻaʻole ia e kālai i nā isoenzymes CYP. ʻAʻole Linucliptin i Inducer o Cenp isoenzymes.

ʻO Linagliptin kahi papa lepo no ka glycoprotein-P (P-gp) a keʻakeʻa (i kahi liʻiliʻi) P-gp-mediated digoxin transport. Hoʻokumu i kēia mau hualoaʻa a me ka ʻikepili i loaʻa i nā noi ʻana o ka hōʻiliʻili o ka lāʻau ma vivo, ua hiki i ka linagliptin ke komo i ka hoʻopili olakino me nā papa ʻē aʻe no ka P-gp i manaʻo ʻia he maikaʻi ʻole.

Ke vivo. Hōʻike ka ʻike haʻawina i lalo nei i kahi liʻiliʻi o nā hōʻiliʻili lāʻau koʻikoʻi me nā koina e hoʻokō ai i nā lāʻau. ʻAʻole i ʻike ʻia i loko o kahi hoʻoponopono nui koʻikoʻi e koi ana i ka hoʻoponopono hoʻoponopono ʻia.

ʻAʻole i loaʻa i ka Linagliptin ka hopena koʻikoʻi ma ke ʻano o ka pharmacokinetics o ka metformin, glibenclamide, simvastatin, pioglitazone, warfarin, digoxin a i ʻole mau mea hoʻohua, e hōʻike ana i kahi haʻahaʻa haʻahaʻa e hoʻohuli i ka hopena o ka lāʻau lapaʻau ma vivo me nā substrate o ka CYP3A4, CYP2C9, P-transfer a me nā kaha o ka pū.

Metformin. ʻO ka hoʻohui ʻana o nā metformin (ʻo nā helu he nui o kēlā me kēia lā o 850 mg 3 mau manawa i ka lā) a me ka linagliptin ma kahi lāʻau o 10 mg 1 mau lā i kēlā me kēia lā ʻaʻole alakaʻi i ka loli koʻikoʻi i loko o ka pharmacokinetics o linagliptin a i nā metformin. No laila, ʻo ka linagliptin, ʻaʻole ia he pale o nā molekika o nā halihali o nā cations organik.

Nā hua palapala o nā sulfonylureas. ʻO ka pharmacokinetics o 5 mg o linagliptin i ke ʻano o ka waiwai kaulike e loli ʻole i ka wā i lawe ʻia hoʻokahi dosis o 1.75 mg o glibenclamide (gliburide). Eia nō naʻe, ua ʻike ʻia kahi emi iki o kahi maʻi i ka AUC a me Cmax o glibenclamide e 14%.No ka mea ka koho ʻana o ka glibenclamide e CYP2C9, no laila, ʻo linagliptin ka mea pale aku i ka CYP2C9. ʻAʻole paʻa nā mea pili i nā maʻi maʻi me nā derivatives o ka sulfonylurea (no ka laʻana, glipizide, tolbutamide a me ka glimepiride), ka mea, e like me ka glibenclamide, ka mea nui i ka metara me ke komo ʻana o CYP2C9.

Thiazolidinediones. ʻO ka hoʻohana nui ʻana o nā dosis linagliptin o ka nui loa o ka hopena therapeutic o 10 mg i kēlā me kēia lā a me ka pioglitazone mau dosis he 45 mg i kēlā me kēia lā, kahi substrate no ka CYP2C8 a me CYP3A4, ʻaʻohe ona hopena koʻikoʻi i ka pharmacokinetics o linagliptin a me pioglitazone a me ka pioglitazone ikaika.

Ritonavir. ʻO ka hui pū ʻana o ka linagliptin hoʻokahiʻano o 5 mg a me ritonavir i hoʻokahi mauʻano o 200 mg e hoʻonui i ka AUC a me Cmax o ka linagliptin e pili ana i ʻelua a ʻekolu mau manawa, kēlā. Hoʻolālā ʻole ʻia nā pilina ʻoihana like ʻole me nā P-gp a me CYP3A4 inhibitors a ʻaʻole koi nā loli.

Rifampicin. ʻO ka hoʻohana hou ʻana i ka linagliptin a me rifampicin e alakaʻi i kahi kahi o ka AUC, Cmax a me ka hoʻohaʻahaʻa ʻana i ka hana o ka hana basal o DPP-4. E mālama ʻia ka ʻoihana haukapila o ka linagliptin, i hui pū me ka P-gp active inducers, ʻoiai ʻo ia ka mea i hōʻike ʻole ʻia. Co-hoʻokele me nā mea waiwai ʻē aʻe o P-gp a me CYP3A4, e like me ka caramazepine, fenobarbital, a me ka phenytoin, ʻaʻole i aʻo ʻia i ka palapala.

Digoxin. ʻO ka hana hou ʻana o ka linagliptin ma kahi o ka 5 mg i kēlā me kēia lā a me digoxin i kahi wai o 0.25 mg i kēlā me kēia lā ʻaʻole i pili i ka pharmacokinetics o digoxin.

Warfarin. ʻO ka hoʻohana mau ʻana i ka linagliptin ma kahi o 5 mg i kēlā me kēia lā ʻaʻole e loli i ka pharmacokinetics o S ​​(-) a i R (+) warfarin, kahi papahele no CYP2C9, no laila, lignagliptin nele i ka hiki ke pale aku i ka CYP2C9.

Simvastatin. Hoʻohana hou ka linagliptin i ka nui therapeutic dosis o 10 mg i kēlā me kēia lā he hopena iki ma ka pharmacokinetics o simvastatin a ʻaʻohe mea hoʻoponopono koi. Ma hope o ka lawelawe ʻana i kēlā me kēia lā o linagliptin i ka nui o ka hopena therapeutic o 10 mg a me simvastatin 40 mg no nā lā 6, ua hoʻonui ʻia ka simvastatin AUC e 34%, a me ka plasma Cmax e 10%. No laila, ʻo ka linagliptin i manaʻo ʻia he mea nāwaliwali nāwaliwali o ka metabolism CYP3A4-mediated, a me ka hoʻoponopono ʻana i ka hōʻuluʻulu ʻana o ka lāʻau co-metabolized e CYP3A4 ʻaʻole pono.

Nā maʻi hoʻohālikelike. ʻO ka hoʻohana ʻana o ka linagliptin i kahi pānaʻi o 5 mg me ka levonorgestrel a ethinyl estradiol ʻaʻole e loli i ke kūlana mau o ka pharmacokinetics o kēia mau lāʻau.

ʻO nā hui e hoʻopiʻi i nā ʻōiwi: nā glucocorticoids (hoʻohana i ka ʻōnaehana a me nā topically), nā beta-2 agonists a me ka diuretics i kā lākou iho hopena hyperglycemic. I ka mālama ʻana i kēlā mau lāʻau, ʻoi aku ka hoʻomaka o kā lākou hoʻohana ʻana, pono e ʻike ʻia nā mea maʻi e pili ana i kēia a me ka mālama pinepine ʻana i nā pae o ka kaila koko.

Hoʻohui pono ʻia: ʻo ka hoʻohana ʻana o ka metformin i ka wa hoʻoiho waiʻona e hoʻonui i ka hopena o ka lactic acidosis, ʻoi aku ka hihia o ka pōloli, ka maʻi palaualelo, a i ʻole ka pohō ʻana. Pono e hoʻokaʻawale i ka waiʻona a me nā lāʻau ʻawaʻawa nā huaʻawa lā.

ʻO nā lāʻau lapaʻau cationic i hoʻopiʻi ʻia e ka neʻe tubular, e like me cimetidine, hiki ke launa me ka metformin, hoʻokūkū no ka maʻi maʻamau o ka wahie. No laila, me ka hoʻohana like ʻana o nā lāʻau cationic, mālama pono i ka glycemia, kahi hoʻololi i ke ʻano o ka metformin i loko o ka ʻōlelo hoʻoponopono papa ʻia, a me ka hoʻoponopono ʻana i ka maʻi mellitus diabetes, inā pono.

ʻO ka hoʻokolohua Intravascular o nā mea hoʻohālikelike e pili ana i ka iodine i ka wā x-ray e hiki ai ke alakaʻi i ka ulu ʻana o ka hana ʻole ʻole me ka hōʻuluʻulu ʻana o ka metformin a me ka hopena o ka lactic acidosis.

ʻO nā mea maʻi me GFR> 60 ml / min / 1.73 m2 e ho'ōki i ka lawe ʻana i ka lāʻau lapaʻau ma mua a i ʻole ke kau ʻana o ka hoʻokolokolo ʻana a mai hana hou i nā hola 48 aʻe. No nā mea maʻi me ke koena o ka hana i ʻole ke ahonui (me ka GFR ma waena o 45 a 60 ml / min / 1.73 m2), pono e hoʻohana i ka metformin 48 mau hola ma mua o ka hoʻokō ʻana i nā ʻāpana radiopaque iodine i loaʻa a ʻaʻole i hoʻomaka hou ma mua o ka 48 mau hola ma hope o ka hoʻokolokolo X-ray a me ka loiloi o ka hana papalela. . ^ E Ha yM.

E hoʻokuʻu i ke ʻano a me ka pale

Ua kau ʻia nā papa he 10 i kahi kāwili lula blister mai kahi kiʻi o polyvinyl chloride / polychlorotrifluoroethylene (PVC / PCTFE) a me ka konopala alumini.

6 nā kīlei blister me nā ʻōlelo aʻoaʻo no ka hoʻohana ʻana i nā lāʻau lapaʻau ma ka'āina a me nā ʻōlelo Lūkini e kau ʻia ana i loko o kahi kīpē o nā kaʻa.

Nā nīnau, nā pane, nā loiloi e pili ana i ka lāʻau lapaʻau Gentadueto

ʻO ka ʻikepili i hāʻawi ʻia e hana no nā lāʻau lapaʻau a me nā lāʻau lapaʻau. Aia nā ʻike e pili ana i ka lāʻau lapaʻau e pili ana i nā ʻōlelo i hoʻopili ʻia e ka mea hoʻopiʻi e ka mea hana. ʻAʻohe ʻikepili i hoʻopili ʻia ma kēia a ʻole kekahi ʻaoʻao o ka pūnaewele a mākou e hiki ke lawelawe ma kahi kūʻokoʻa pilikino pili me ka loea.

He aha ʻo Jentadueto?

ʻO Jentadueto ka hui pū ʻana o ka linagliptin a me ka metformin. ʻO Linagliptin a me ka metformin ka lāʻau lapaʻau maʻi waha e kōkua i ka mālama ʻana i ke kō koko. Hana ka Metformin ma ka hoʻemi ʻana i ka hana o ka glucose (gula) i loko o ka ate a me ka hoʻohaʻahaʻa ʻana i ke kao o ka glucose i loko o nā ʻāpana. Hana ʻia ka Linagliptin ma ka hoʻoponopono ʻana i ke kiʻekiʻe o ka insulin e hana ana i kou kino ma hope o ka ʻai ʻana.

Hoʻohana ʻia ʻo Jentadueto me ka meaʻai a me ka hana e hoʻomaikaʻi ai i ka kaohi koko koko i nā pākeke me nā maʻi maʻi 2.

ʻAʻole i manaʻo ʻia ʻo Jentadueto e mālama i ka maʻi diabetes type 1.

Hoike waiwai

ʻAʻole pono ʻoe e hoʻohana iā Jentadueto inā he maʻi kolohe koʻikoʻi a i ʻole ka maʻi ketoacidosis maʻi maʻi (e nīnau aku i kāu kauka no ka mālama ʻana).

Ke hoʻomohala nei kekahi poʻe i ka acidosis lactic ʻoiai e lawe ana i ka metformin. Haumaha nā ʻōmua mua ma hope o ka manawa, a hiki ke ʻano hōʻeha kēia ʻano. Hōʻalo ka lawe ʻana iā Jentadueto a loaʻa iā ia ke kōkua olakino kōkua inā loaʻa iā ʻoe ke ʻano ʻeha, e like me ka ʻehaʻeha ʻana a i ʻole nāwaliwali, ʻo ka pōkole o ka hanu, ka ʻeha ʻōpū, ka ʻōpū, a me ke ʻano nāwaliwali a ʻeha paha.

Nā Slideshows FDA-Hoʻonaʻau ʻia Slimming i nā lāʻau lapaʻau: Hiki iā lākou ke kōkua iā ʻoe?

Ma mua o ka lawe ʻana iā Jentadueto, e haʻi aku i kāu kauka inā he maʻi maʻi ʻeha, kahi maʻi maʻi ʻeha, maʻi o ka naʻau, ka mōʻaukala o ka pancreatitis, inā ua loaʻa iā ʻoe kahi puʻuwai ʻeha, a i ʻole he 80 a ʻoi paha kou mau makahiki a ua loaʻa ʻole kou hana maʻi maʻi.

Inā makemake ʻoe i ka hana ʻana a i ʻole scan-tomography X-ray a i hoʻohui ʻia me ka hoʻohana ʻana i ka wai i paʻi ʻia i loko o kou mau pakanā, pono ʻoe e hoʻokaʻawale i ke kau ʻana iā Jentadueto.

Ma mua o ka lawe ʻana i kēia lāʻau lapaʻau

ʻAʻole pono ʻoe e hoʻohana iā Jentadueto inā he maʻi maʻamau i ka metformin (Actoplus Met, Avandamet, Fortamet, Glucophage, Riomet) a i ʻole linagliptin, a i ʻole:

Inā he nui ʻoliʻino ʻokoʻa e pili aku ana i ka pilikia (nā pilikia hanu, ke ʻano, ke ʻano nui o ka ʻehaʻeha) i linagliptin (Tradjenta),

Inā loaʻa iā ʻoe ka maʻi ʻeha, a i ʻole

Inā loaʻa ʻoe i ka ketoacidosis maʻi maʻi (e ʻike i kāu kauka no ka mālama).

Ke hoʻomau nei kekahi poʻe i ka metformin i kahi kūlana koʻikoʻi i kapa ʻia ʻo ka acidact lactic. Hiki paha i kēia ke aʻole ʻoe e pili ana i ka palaka a me ka palaka paha, a me ka hōʻeha ʻole o ka naʻau, ka hōʻeha ʻana o ka puʻuwai a i ʻole ka maʻi hōʻeha, kahi maʻi nui, inā ʻoe ma luna o 65, inā he dehydrated, a inā he inu nui ʻoe. E kamaʻilio me kāu kauka e pili ana i kou pilikia.

I mea e hōʻoia palekana ai ʻo Jentadueto iā ʻoe, e haʻi i kāu kauka inā he:

ʻO nā maʻi ʻeha (pono paha e nānā pono kou hana ʻeha ma mua o ka lawe ʻana i kēia lāʻau lapaʻau),

mea ʻōpala

ʻO nā triglycerides kiʻekiʻe (kahi ʻano momona i ke koko)

He moolelo moolelo inu, a i ole

Inā ʻoi aku ʻoe ma mua o 80 mau makahiki a ʻaʻole nō ʻoe i hoʻāʻo hou i ka hana kidney.

Inā makemake ʻoe i ka hana ʻana a i ʻole scan-tomography X-ray a i hoʻohui ʻia me ka hoʻohana ʻana i ka wai i paʻi ʻia i loko o kou mau pakanā, pono ʻoe e hoʻokaʻawale i ke kau ʻana iā Jentadueto. Hōʻike e ʻike i kāu mau mea mālama aku ma mua o ka hoʻohana ʻana i kēia lāʻau lapaʻau.

E hāhai i nā ʻōlelo a kau kauka e pili ana i ka hoʻohana ʻana iā Jentadueto inā he māmala a ʻōlelo ʻole paha. He mea koʻikoʻi loa ka mālama koko kōpī i ka wā hāpai, a ʻokoʻa paha kāu doses i kēlā me kēia ma kēlā me kēia hapalima o ka hapai. ʻOkoʻa paha kou ʻano ʻoi i ka wā ʻo ʻoluaʻi nei.

ʻAʻole ʻike ʻia inā hoʻokomo ʻia ka linagliptin a me metformin i loko o ka waiū umauma a i ʻole ke hopena i ka pēpē. E haʻi i kāu kauka inā he kahu hānai ʻoe.

ʻAʻole i hoʻopaʻa ʻia ʻo Jentadueto e hoʻohana ʻia e kekahi ma lalo o ka makahiki 18.

Pehea e lawe ai au i kahi jentadueto?

E lawe iā Jentadueto e like me ka mea i kau ʻia e kāu kauka. E hāhai i nā kuhikuhi a pau ma ka leʻaleʻa kaupaʻa. Mai lawe i kēia lāʻau lapaʻau ma ka nui a i ʻole ka liʻiliʻi, a i ʻole no ka mea i ʻoi aku ma mua o ka ʻōlelo.

E lawe iā Jentadueto ʻelua mau manawa o ka meaʻai, ke ʻole ke haʻi ʻana i kāu kauka ma kahi ʻē aʻe.

ʻO ka haʻahaʻa koko liʻiliʻi (hypoglycemia) hiki i kekahi ke loaʻa me ka maʻi diabetes. Nā hōʻailona pū me ka hōʻeha, ka pōloli, ka luhiluhi, ka huhū, ka dizziness, ke ʻano, ka wikiwiki, ka wikiwiki o ka puʻuwai, a me nā manaʻo o ka hopohopo a i ʻole ke kahakaha. E hoʻōla wikiwiki i ke kō o ke koko haʻahaʻa, e mālama mau i ka punawai wikiwiki me ʻoe, e like me ka wai huaʻai, caramel, crackers, raisins, a ʻole kāhua kīʻaha.

Hiki i kāu kauka ke kuhikuhi i kahi kuhi Injection emergency emergency no ka hoʻohana ʻana i nā hihia o ka hypoglycemia koʻikoʻi a ʻaʻole hiki ke ʻai a inu. E ʻike ka ʻohana a me nā hoa pili i ke ʻano o ka hāʻawi ʻana iā ʻoe i kēia maʻi i kahi pōpilikia.

E nānā pū kekahi i nā hōʻailona o ke kō o ke koko (hyperglycemia), e like me ka nui o ka makewai a me ka urination, blurred vision, headache, a me ka luhi.

Hiki paha i kāu kauka ke hoʻōki i ka lawe ʻana iā Jentadueto no kahi wā pōkole inā e maʻi ana, kahi maʻi a i kahi maʻi ia paha, a i ʻole ia he mea hoʻolimalima a manaʻo paha e kipa aku.

Hiki ke hoʻoliʻi ka nui o ke kō koko i ke kaumaha, nā maʻi, nā hoʻomaʻamaʻa, nā hoʻomaʻamaʻa ʻana, nā waiʻona, a i ʻole ka heʻe ʻana. E nīnau i kāu kauka ma mua o ka hoʻololi ʻana i kāu kaha lāʻau a i ka papa kuhikuhi.

ʻO Jentadueto wale nō kahi mahele o kahi papahana mālama holoʻokoʻa, ka mea e komo pū ai i ka meaʻai, ka hana, ka hoʻomoʻa ʻana, ka hoʻokaʻina o ke koko, ka hoʻāʻo ʻana o ka nui o ke kō, a me ka mālama kūikawā. E mālama pono i nā ʻōlelo a kou kauka.

E mālama iā Jentadueto i ka mahana o ka lumi mai ka umu a me ka wela.

Ikepili Linagliptin a me ka metformin dosing ʻike

Dosis makua makua no ka Jentadueto Type 2 Diabetes:

Nā Kūlana Kūwaha Linagliptin-metformin:
- Initial dosis no nā mea maʻi e loaʻa ʻole i kēia manawa i ka metformin: linagliptin 2.5 mg / metformin 500 mg a ʻōlelo maoli ma ka lā.
- Initial dosis no nā mea maʻi e loaʻa ana i ka metformin: linagliptin 2.5 mg i hui pū me ka hapalua o kēia manawa o ka metformin maʻamau i ʻelua manawa i ka lā
- Initial dosis no nā poʻe maʻi e loaʻa nei i kēia linagliptin a me metformin e like me nā mea hoʻokaʻawale: e hoʻololi i kahi huahana hui i loaʻa ka like o ka pākaukau o kēlā me kēia mea i ke kūleʻa ʻelua i ka lā
ʻ doselelo hoʻomalu: Hoʻohālikelike ke ʻano nūnū e pili ana i ka palekana a me ka hiki.
Ka helu momona: linagliptin 5 mg / lā, metformin 2000 mg / lā

ʻO Linagliptin-metformin i hoʻokuʻu ʻia i nā papa:
- Initial dosis no nā mea maʻi e loaʻa ʻole i kēia manawa i ka metformin: linagliptin 5 mg / metformin hoʻonui-hoʻokuʻu i kahi 1000 mg maʻamau i hoʻokahi manawa i hoʻokahi lā
- Initial dosis no nā mea maʻi e loaʻa ana i ka metformin: linagliptin 5 mg i hui pū me ka huina like o kēlā me kēia lā o ka metformin maʻamau i hoʻokahi lā i hoʻokahi lā.
- Initial dosis no nā poʻe maʻi e loaʻa ana i kēia mau linagliptin a me metformin e like me nā mea hoʻokaʻawale: e hoʻololi i kahi huahana hui i loaʻa ka like o ka pākaukau o kēlā me kēia mea i hoʻokahi lā i hoʻokahi lā
ʻ doselelo hoʻomalu: Hoʻohālikelike ke ʻano nūnū e pili ana i ka palekana a me ka hiki.
Ka helu momona: linagliptin 5 mg / lā, metformin 2000 mg / lā

Nā Manaʻo:
ʻO nā mea maʻi me nā papa he 2,5 mg / metformin i hoʻokuʻu ʻia mai nā papa papa mai i 2.5 mg / metformin linagliptin e lawe i ʻelua papa ʻelua i hoʻokahi lā.
-ʻO kahi i hui pū pū me ka insulin a i ʻole he mea huna o ka insulin, kahi haʻahaʻa e hoʻēmi ana i ka insulin a i ʻole ka hoʻokahe ʻana i ka insulin e koi ʻia e hoʻemi i ka hopena o ka hypoglycemia.

Hoʻohana: E hoʻomaikaʻi i ka mana glycemic i ka pākeke me ka diabetes type type 2 ma ke ʻano he mea pili i ka meaʻai a me ka hoʻomaʻamaʻa ʻana i ka wā e kūpono ana ka mālama ʻana me ka linagliptin a me ke metformin.

E nānā pū: ʻikepili ʻo Dosage (ma ka ʻōlelo hou aku)

He aha ka mea inā he overdose?

E kiʻi i ke kōkua olakino āpau a kāhea aku paha i ka laina kōkua Poison ma 1-800-222-1222. Hiki iā ʻoe ke loaʻa nā hōʻailona o ke koko koko haʻahaʻa, e like me ka nāwaliwali loa, ka hiʻona blurred, hōʻoluʻolu, ka hoʻomaha ʻole, ka pīhoihoi, ka ʻōpū o ka ʻōpū, ka hilahila, a me nā hue (cramps).

Nā hopena ʻaoʻao Jentadueto

E kiʻi i ke kōkua olakino inā loaʻa iā ʻoe nā hōʻailona o ke ʻano maʻi i ka Jentadueto: hives, paʻakikī paʻakikī, hoʻomaʻū o kou maka, mau lehelehe, alana, a i ʻole ka ʻeha.

Kahi i ka lawe ʻana iā Jentadueto a kāhea koke aku i kāu kauka inā loaʻa aku ʻoe i nā hōʻailona o ka pancreatitis: hōʻeha nui ka ʻeha ma kou ʻōpū ma luna o kou kua, hōʻalo a me ka luaʻi, lilo ʻole o ka momona, a i ʻole ka puʻuwai wikiwiki.

Ke hoʻomohala nei kekahi poʻe i ka acidosis lactic aʻo ka lawe ʻana i ka metformin. Haumaha nā ʻōmua mua ma hope o ka manawa, a hiki ke ʻano hōʻeha kēia ʻano. E kiʻi i ke kōkua olakino inā pilikia ʻoe i nā ʻōmaʻomaʻo maʻalahi, e like me:

ʻO ka ʻeha ʻeha a nāwaliwali hoʻi ka ʻōpū

ʻAno a ʻoluʻolu paha i kou mau lima a me kou mau wāwae,

Kaumaha ka naʻau, kaumaha, ʻuhi a palupalu paha.

ʻO ka ʻehaʻeha, hōʻeha a me ka luaʻi, a

Hoʻololi a loli ʻole paha ke ʻano o ka naʻau.

Kāhea koke aku i kāu kauka inā he:

ʻO ka hopena autoimmune koʻikoʻi - kauhai, blisters, luku ʻana i ka ʻaoʻao o waho o ka ʻili.

ʻO ka hōʻeha ʻeha a hoʻomau paha paha i nā kihi,

Ka wikiwiki, piʻi wikiwiki ka momona, a i ʻole

ʻO ka ʻōhoʻomaʻo ikaika ka maʻi, he ʻehaʻeha, e ʻā ana i kou maka a i ʻole alelo paha, e ʻā ana i kou mau maka, ʻili ma ke alo, a laila a ʻulaʻula a ʻulaʻula paha e pālahalaha aku (e pili ana i ka maka a me ke kino luna paha) a ke kumu i hoʻoheʻe ai. a me ka ʻokiʻoki ʻana.

Nā hopena maʻamau ʻo Jentadueto:

ʻO ka ʻeha ʻeha, kīʻaha ʻole, a i ʻole

ʻAʻole kēia he papa inoa piha o nā hopena ʻokoʻa, a hiki mai paha. E nīnau i kāu kauka e pili ana i nā hopena ʻaoʻao. Hiki iā ʻoe ke hōʻike i nā hopena ʻaoʻao o ka FDA i ka 1-800-FDA-1088.

E ʻike pū i: nā hopena ʻokoʻa (ma kahi kikoʻī hou aku)

He aha nā lāʻau lapaʻau e hoʻopilikia iā Jentadueto?

Hiki i nā lāʻau'ē aʻe ke hoʻonui a hoʻohena paha i ka hopena o Jentadueto ma ka hoʻohaʻahaʻa ʻana i ke kō koko. E haʻi i kāu kauka e pili ana i kāu mau lāʻau lapaʻau o nā wā āpau a me nā mea e hoʻomaka ai a kāpae paha i ka hoʻohana ʻana, ma mua loa:

Rifampin (no ka mālama ʻana i nā maʻi maʻi), a i ʻole

ʻO ka insulin a me nā lāʻau maʻi maʻi hilahila paha.

ʻAʻole paʻa kēia papa inoa. ʻO nā lāʻau ʻē aʻe e hui pū me ka linagliptin a me ka metformin, e komo pū ana me nā lāʻau lapaʻau a me ka lāʻau lapaʻau hou, a me nā hua lāʻau. ʻAʻole kākau ʻia nā mea pili i hiki i kēia papa kuhikuhi.