UBND TiNH KON TUMSOYTE

CONGHoA xA HOI can NGHIA~T NAMDQc I~p - T\I' do - H~nh phiic

Kon Tum, ngay J.G thang 5 ndm 2017S6: JUt/SYT-NVDvIv c~pnhat thong tin duoc ly

d6i voi cac thuoc

Kinh giri:- Cac dan vi true thuoc S6 Y tS;- Cac co so kinh doanh thuoc.

Thuc hien cac Cong van s6 5748/QLD-DK ngay 27/4/2017 cua C\lCQUlinly Diroc - B9 Y tS v@viec C?Pnhat thong tin duoc ly d6i voi thuoc chua khangsinh nhom fluoroquinolon, Cong van s6 5749/QLD-DK ngay 27/4/2017 cua C\lCQuan ly Duoc - B9 Y tS v@viec C?Pnhat huang d~n su dung thuoc chong viemkhong steroid (NSAIDs) va khong phai aspirin, Cong van s6 5750IQLD-DKngay 27/4/2017 cua C\lC Quan ly Duoc - B9 Y tS v@viec C?P nhat thong tinduoc ly d6i voi thuoc chua hoat chat hydroxyzin, Cong van s6 5751/QLD-DKngay 27/4/2017 cua C\lC Quan ly Diroc - B9 Y tS v@viec C?P nhat thong tinduoc ly d6i voi thuoc chua warfarin.

DS bao dam viec sir d\lng thu6c an toan va hQ'Ply, S6 Y tS thong bao:

1.DAi vOi cac coosO'kham b~nh, chii'a b~nh

- Thong bao va cung c~p kip thai, dfty du cac thong tin lien quan dSn tinhan toan, hi~u qua clla cac thu6c neu tren cho can b9 y tS va nguai b~nh, d~c bi~tla bac SI diSu trio

- Tang cuang thvc hi~n vi~c thea d5i tac d\lng khong mong mu6n Cllathu6c trong qua trinh luu hanh va Slr d\mg, phat hi~n va xu tri kip thai cactruang hQ'p xay ra pharr ung co h~i clla thu6c neu tren (nSu co); gui bao caoADR v@Trung tam qu6c gia v@Thong tin thu6c va Theo d5i phan Ung co h;;ticlla thu6c (13-15 Le Thanh Tong, Hil N9i) ho~c Trung tam khu V\l'Cv@Thong tinthu6c va Theo d5i phan lrng co h~i Clla thu6c TP. H6 Chi Minh (201B NguybzChi Thanh, Qwjn 5, TP. H6 Chi Minh).

2. DAi vOi cac cooslY kinh doanh thuAc

Cong ty C6 phftn DuQ'c - VTYT Kon Tum, Cong ty TNI-lli DuQ'c ph~mAlpha, Nha thu6c tu nhan va Qufty thu6c B~nh vi~n n~m b~t kip thai cac thongtin lien quan dSn tinh an toan, hi~u qua clla thu6c neu tren; tu v~n huang d~nnguai b~nh th?n tn;mg khi su dt:mg.

3. Cac ph\ll\lc C?Pnh?t thong tin duQ'cly Clla cac thu6c neu tren duQ'Cguikern thea Cong van nay, d6ng thai duQ'c dang tai tren Trang Thong tin di~n tuSa Y tS tinh Kon Tum (dia chi: syt.kontum.gov.vn).

Sa y t~ thong bao dS cac dan vi sir dung, kinh doanh thu8c bi~t va thirchien/,

Nai nh¥n:- Nhtr tren;- Lanh dao Sa Y t~;- Phong Y t€ cac huyen, thanh ph6;- Thanh tra Sa Y t~;- Phong Nghiep vu Y;- Trang Thong tin Di~n tit Sa Y t€;- Liru: VT, NVD. ~

2

BOYTEcue QuAN LV DU'QC

CONG HOA XA H(n CHU NGHIA VI~T NAMDQcJ$p - Tq d.Q- Hanh phue

PHVLVC

Cac Dqi dung thay dAiI b8 sung dBi vOi thuBc chUa khaDg sinh nhomfluoroqulnolon dung dltang toan than

.(Dinhkem thea cong van sln:tftIQLD-DK ngawf{tf/.lt7.tr-a C~c Qulin ly Dulle)

I L-

1. Chi dinh ",S~p x@pthong tin v~cac chi dinh duci day cuai cung, sau cac chi dinh khac duocuu tien su dung hon. Dang thai, b3 sung cac thong tin duqc cung cAp du&i day:

Nh.ilm khuan Quung ti2t niiu khong phirc' t{lP[. ..JDe khang sinh fluoroquinolon, trong d6 c6 [ten thua,e] lien quan deJ:tphan img cohai nghiem trong (xem muc Canh bao va t~ trong) va nhi~m khuful duong ti@tni~u khong plnrc tap cr mQt sA b~nh nhan co 'th~ t\I khoi, chi nen sir dung [tenthu6c] cho nhtrng b~nhnhan khong c6 l\ra chQn diSu tri khac thay th~o

{oo}lJ{1t nhiim khutm cap cua viem phlquan m(ln tinn{...}Do khang sinh fluoroquinolon,. trongd6 co [ten thu8c] lien quan den phan lIng coh~i nghiem trQng (xem m\lc Canh bao va th~ trQng) va dqt nhi8m khuAn d.p euaviem .ph~quan m~n tinh 6 mQt s8 b~nhnhdn co tha tv kh6i, chi nen sir d\1ng [tenthu6cJ aho nhiTmgb~nh nhan. khong coll:ra chc;m di&utri khac thay th@.

[ ..]".,." A , h d 0 kh /(IV ,em xoang cap tm· 0 VI uan{...]Do khang sinh tluoroquinolon~ trong do co. [ten thu6c] lien quan dSn phfm (rng coh~i nghi~m trc;mg (xe~ m\lc Carth bao va th~n trQng) va viem xoang cap tinh dovi khUdn 6 tnQt s6 b~nhnhan co th@ tl,l ldloi, chi nen su d\IUg [ten thu6c] ehonhimg h~nh ohan kb,ong co Iva chQp.di~u.tri khao thay th6.

[..]2. Li~u dung va ca.ch dungS~px~p cae thong tin v~ li~u dUng (bao gbm li6u dung mQt lAn, sa lAndung trongngay va thai gian di~u tri) tuong ung vai cae chi dinh viem xoang cAp tinh do vi

I. /

khuan, dQ'tnhi8m khuAn c~p cua viem phS quan man tinh va nhiSm khuan dtrongtiSt ni~u khong phiro tap sau cac chi,dinh khac duQ'c tru tien su dung hon.3. Canh I?aova thin trQ.ngBJ sung cdc thong tin duoc cung cap dum dCiy:

Cac phan trng c6 h~i nghiem trong c6 kha nang khdng h6i phuc va gay tan~t, bao gam vism gan, dUt gan, b~rth If thAnkinh ngoai bien va cac tao dung b~t19i tren thAnkinh trung uong,

Cac khang sinh nh6m fluoroquinolon colien quan d~n cac phan img 'c6 hainghiem trong co kha nang gay tan t?t va khong h6i phuc tren cac h~ C<Y quan khacnhau cua co th8. Cac phan irng nay c6 thS xu§t hi~ntd&ng thOi tren cling b~nhnhan. Cae phan Ung e6 h~ thuang duQ'c ghi nh?fi gdm viem gan, d(rt gan, daukhap, dau cO', b~nh ly thAn kinh ngo~i vi vA ca-ctac d\lng bdt 19i tren h~ th8ngthAnkinh trung uang (ao giac, 10 au, trk eam, .m:~tngti, dau dAu r$1g: va hI Ian).Cae phan tmg nay c6 thB xay ra trong \Tongvai gia d~n vAi tuAn sau khi su d\lIlgthu8e. B~nh nhan (] b~t Icy tudi nao hO~bkhong c6 ySu t6 nguy eO'tAn t~-tir truoedSu c6 tha g~p nhUng phan Ung c6 h~i tren.,

Ngt'mg sit d\lflg thq& ngay kill c6 d~u hi~u ho~c tFi~JlehUng dAu tien euabAtIcY phau (mg c6 h~ ngbjem trQng nari. Them vao d6, trarih sir d\lD.g'c~ckhangsinh nh6m fluoro€}uinolQn eho cae 'b~nh nhan eta ttr.l1gg~p cac phan (mg nghicmtr<;mglien quan dSn fluoroquinolon.l.

--_

I ,

!f

B6YT~ClJC QUAN LY DlJQC

CONG HOA xA H(H CHU NGHIA VItT NAMDoc lap - Tu do - Hanh phuc

PHVLVCINGUY co BIEN CO TREN TIM ~CH LIEN QUANDEN VI¥C sir DVNGcAc THUOC CHONG VIEM KHONG STEROID, KHONG PH.AI ASPIRIN

(EJinhkem theo cong van 86 !if.f(fJ ...IQLD-DK ngay2.fitrIZtlt/Ua Cue Qucin lyDU(Jc)

1. TaDg quan v~ dQ an toan treD tim mach cua cac thu8c chAng viem khongsteroid va quy~t djDh cua eae CO'quan QUaD Iy DuC}'c ph§m tren th~ gi6'i

co quan Quan Ij Thuac va Th,!c,ph8m Hoa Ky (T!JSJ,DA):Til dAunhung nam 2000, du li~u thu duoc ill cac tha nghiem lam sang ngau

nhien c6 ·CO'mau d6i chirng Ion dii cho thay nguy co hnyet kh6i tim mach khi sirdung cac thuoc chong viem khong steroid (NSAIDs) uc ch8 chon loc tren COX-2.Thang 9/2004, nha san xuat Merck t\l nguyen rut rofecoxib kh6i thi tnrong sau khixac dinh duoc nguy co bien c6 tim mach tang len khi SlY dung thu6c nay trong thirnghlem lam sang ve hQi chimg da polyp tuyen c6 tinh chAtgia dinh. Bay duQ'ccoila di~m khai dAu cho S\I ra dO'icua hang lo~t bao cao tang quan, phan tich gQP diCthir nghi~lll lam sang va nghien cw dich t8 dUQchQc ve tat ca cac NSAlDs (Ic ch6chQnlQctren COX-2 va khong chQn lQc.

Ngay 917/2015, US.FDA tiep wc thong bao ve vi~c tang cubng canh baonguy co nhM mau co tim va dQt quy' khi sir dvng cae NSAIDs. US.FDA yeu cAunhan thu8c va to' HDSD cua tAt ca cac thuBc NSAIDs can ke dan va khong cAnke .don (OTe) deu cAn c~p nh~t d~ phan anh mQt s8 thong tin nhu: nguy co nh6i mauco tim va dQt quy' c6 th6 xuat hi~n s6m trong vai tuAn d~u tien sir d\IDgNSAlDs;nguy co nay tang len khi su d\mg NSAIDs lieu cao va keo daL C6 quan pi~m chothfty tAt'ca cac NSAIDs d~u c6 nguy cO'tuang tv nhau. Tuy nhien, thea US.FDA,chua c6 dAy du b~ng chUng dS c6 thS xac dinh chile chilo NSAID C\l thS nao c6nguy co cao han hay thap han NSAID khac. l':l'SAIDs c6 th·Slam tang ngu)' co nh6imau co tim ho~c dQt quy 6 b~nh nhiin rn~c kem ho~c khong mic ·kem b~nh tim, coho~c khong co cac y~u t6 nguy co xuftt hi~n b~nh tim, vai tY l~,uuc ootIDkhac nhaugiua cae nghien Clm, ph\! thuQc vao lo~i thu6c va liSu thu6c da str d\lng.

Thang 11/20 16, k~t qua cua thix nghi~m Uim sang PRECISION m6i duQ'ccong b6. Day la mQt thu nghi~m Himsang ng~u nhien, mil .doi, c6 d6i chUng, cacnhorn su d\Ulg thu6e song song nh~m danh gia dQ an toan tren tim m~ch cuacelecoxib, ibuprofen ho~c naproxen trong diSu td thOal h6a kh6p ho~c viem kh6pd~g thftp 6 b~nh nhiin sfu1c6 ho~c co nguy co cao xuftt hi~n b~nh tim m~ch khl sird\lflg cac thuBc nay. K~t qua cha th~y celecoxib Slr d\illg a muc li~u trung binh eod9 an toan tren tim m~ch khong thua kern ibuprofen ho~c naproxen- Tuy nhien, das&b~nh nhan trong thir nghi~m PRECISON du<,Jcsu d\lng celecoxib 6 li6u 200 mg.VI v~y, k&tqua eua nghien CUllehi phan anh dQ an toan eua vi~c Slr d\lng muc li~utrung binh eua celecoxib rna khong nghien cuu d~n fmh huang eua vi~e su d\lIlgthu6c a mue liSu cao.

!r, I

ti'

CO'quan Qulin Ij DU'(tc phlim Chou Au (EMA):Nam 2005, Co quan QUlin 19Duoc phfun Chau Au (EMA) cling da c6 mQt

sd dQng thai lien quan dS!1vi~c ,sir dung cac NSAIDs chon 19c va khong chon 19C.KSt luan oua EMA c6 diem khac bi~t so voi US.FDA, cho ring cac thudc uc chSchon 19CCOX-2 c6 nguy co huySt khdi tim mach cao hon so v6i cac NSAIDskhong chon 19C.Do c6 mBi lien quan giiia nguy co tim mach va vi~c sir dung cacNSAIDs tee chS chon 19c COX-2, cac thude nay duQ'c khuyen cao su dung a lieuhang ngay thAp nhAt c6 hi~u qua trong thai gian ng~ nhAt c6 th~. Tuy nhien, EMAcfing khong loai tnr viec su dung cac NSAIDs khong chon 19Cc6 lien quan dSn SlJtang nhe nguy co huySt khdi tim mach, d~c bi~t 0 b~nh nhan dung lieu cao, keo dai.. Narn 2012, thee de nghi cua Co quan Quan 11'Duoc phfun Anh (MHRA)cung voi: nhiing phat hien ve d9 an toan cua cac NSAiDs mm'duQ'c oong bd, Uyban danh gia nguy co Canb giac duQ'c (PRAC) ctia EMA da b!t dAu tiSn harth rasoat I~i dii li~u ve dQ an toan cua cac NSAIDs. Tren co so d6, PRAC khuy@ncaocac bi~n phap gUun thieu nguy co huySt khdi tim m~ch khi sir d\lOg cac thu8c ucch8 ch9n 19CCOX-2 cling cAn ap d\lng cho dic1ofenac. H!}i dAng Chau Au da raquy€t dinh cu8i cimg, ap d\lOg khuy@ncao tren vai cac thudc chua diclofenac trentoan Chau Au vao ngay 25/09/2013. Nguy co nay cling dugc canh bao v&iea nh6mthudc va khuySn cao tAt'cft cac NSAIDs nen diing lieu hang ngay tMp nhAtc6 hi~uqua trong thm gian ng!n nhAt c6 th~.

CO'quan Qulin Ij Du(tc ph lim Australia, (TGA)Nam 2012, Co quan Qulin 19DuQ'cphfun Australia (TGA) da tiSn hanh ph§n

tich dii li~u ve nguy co tim m~ch trong y van lien quan den vi~c sir d\lI1g8' thudcNSAIDs dugc hru hanh ~i Australia. Co quan nay cling dAng quan diem v6iUS.FDA va EMA cho ring vi~c sir d\lOg eac thude uc ch8 cox-~va hAuhet caeNSAIDs c&di~n deu larn tang nguy co b~.rihtim m~ch 0 mue trung binh tucmg tlJnhau. Nhan thude va ta HDSD eua cae thude ke dan c6 ehua NSAIDs dang lUllhanh a Australia deu da the hi~n duQ'Cphil hgp va dAydu cac bing chUng hi~n c6vS dQan toan tren tim m~ch cua cac NSAIDs. .

CO'quan Quan Ij Du(J'c phlim Singapore (HSA):T~i Singapore, CO'quan Quan ly DuQ'cphfun (HSA) eta giam sat ch~t cha dQ

an toan tren tim m~ch khi su dl,mgcac NSAIDs tir nam 2005. Ngay tir thai diem d6,sau khi tien hB.n.hdanh gii:ican hbg nguy co - IQ'ilch, HSA da ket lu~n c6 SlJ tangnh~ nguy co tim m~ch lien quan den vi~c su d\lOgNSAIDs. Tuang flJ nhu cae CO'quan Quan 19 DuQ'c phAro khac, HSA nh~ th§.y trong nhiing nam gAo day, caeb;:. h r ).", d l' ~ k' d.l.· d' Ie' Jj" dl.. t~ang c 0ung ve VyC str \lng leu cao, eo )$1 J:C01enac co ~eo. quan _en SlJ angnguy co tim m~ch duQ'c cong b6 ngay cang nhi&u. Til' d6; HSA dua ra mQt s8khuy~n coo vS vi~e sil d\lOg diclofenac danh cho can bQy te de tang cu<'m.gdQantoan khi Slr dl,lIlgthu6e nay.

Cu quan Quan Ij Du(tc phbm Canada (Health Canada):Nam 2013, Co quan QUB.nly Du<;>,cphfun Canada (Health Canada) da ti~n

hanh mQt t60g guan phan tiChvS dQan.toan cua diclofenac dimg dUOngudng va d~ttn,rc trang. K8t lu~n eua cUQc ra soar nay eho thfty vi~c sir d\lOg diclofenac c6 lienquan den s1)'tang nguy co xudt hi~n bi~n c6 bdt lqi lien quan den tim va d9t quy'. f)~giam thi~u nguy ccr tren tim m~ch lien quan d~n su d\IDgdiclofenac, nhan thudc va

f\ ta HDSD cua cac thuoc nay 6 Canada d§ duQ'c c~p nh~t thong tin tren, Ti8p thea

hoat chAt·diclofenac, Health Canada efing ti~n harm mQt phan tich tAng quan diili~u v6 dQ an toan cua ca celecoxib. Health Canada cling cho fAng khi celecoxibduoe dung thea khuyen cao, hi~u qua cua thu6c nay hi~n van VUQi trQi nguy co.Health Canada cling d§ ra soat ca dQ an tom tren tim mach lien quan d8n viec sirdung li€u cao ibuprofen. K8t qua cho thAy vi~c sir dung cac thuoc ke don chuaibuprofen li€u.cao (li€u hang ngay ~ 2400 mg) co lien quan dBn tang nguy co biBnc6 bAt19i lien quan den tim va dQt quy, d~c bi~t tren b~nh nhan co ti€n sir hoac cocac y€u t6 nguy co xay ra benhtim ho~c dQtquy. Hi~u qua cua ibuprofen hi~n v§.nvuct trQinguy co do -thu6c gay ra.

Dua tren qlJySt djnh cua cac CO'quan Quan 19 Duqc phk tren the giai, d~dam bao dQan toan tren tim m~ch,. cac can bQY t~ cAn luu y cae van dS sau khi sird\U1gNSAIDs: I >-

_ Cac thu6e ch6ng viem khong steroid (NSAlDs) co th~'Hun tang nguy cO'xu§.thi~n bi~n c6 huy8t kh6i tim m~ch, bao gAm ca nhbi mau cO'tim va dOt quy'.c6 th8 dan d8n til vong. Nguy cO'nay co th8 xufrt hi~n sam trong vai tuAn dAudUngthu6c va co thS tang len theo thai gian dUng thu6c. Nguy co huyet kh6itiIn m~ch dUQ'eghi nh~ chu ySu (J li6u cao.

_ Bac si efut danh gia dinh leY S\l xuAt hi~n cua cac biSn c6 tim m~ch, ngay ca}(hi b~nh nhan khong c6 cac tri~u chUng tim m~ch truac d6. B~rih nh§n canduQ'ccanh bao v€ cae tri~u chUng eua bien e6 tim m~ch nghiem trQng va cAn .tham kham bac si ngay khi xuAthi~n cae tri~u chUng nay.DS giam thi8u nguy co mAt hi~n bien c6 bAt 19i, cAnsir d\lIlg NSAIDs 6 li6uhang ngay thAp nhAt c6 hi~u qua trong thai gian ngiin nhAtc6 the.

_ Cac thir nghi~m lam sang. va dich ta duQ'c hQc cho thAy vi~c sir d\1i1gdiclofenae c6 lien quan den tang nguy co xu~t hi~n bi~n c6 huySt kh6i timm:\ich(nhu nhai mau co ti.n.)ho~c dOtquy,), d~c bi~t khi sir d\lIlg diclofenac 6li€u cao (150 mg/ngily) va keo dili. Vi v~y, fieng d6i vm diclofenac, ch6ngchi dinh diclofenac 6 b~nh nhan suy tim sung huy€t (tit dQITden dOIV theaphan dQ chuc nang eua suy tim theo HQi Tim New York - NYHA), b~nh timthieu mau C\lCbQ, b~nh dong m~ch ngo~i vi, b~nh m~ch mau n3.o\.Can rAtth~n trqng klll sir d\lng diclofenae eho cac b~nh nhan co eac yeu t6 nguy ccr1'0nmg xu~t hi~n cae bien c5: tim m~ch (rum tang huy~t ap, tang lipid huyStthanh, dai thao duong, nghi~n thu6c hi).!. .

B¢YTgcue QuANLY OUQe

C6NG BOA XA HOI CHiJ NGHlA vrsr NAM. . .DQcI$p - Ty do - Hanb.pboc

. PIlVLVCIICae nQi dung thay d31, b3 sung tren nhan, h\l(mg dl~ sUod1}ngcua cat thuAcchAng viem khong steroid, khong phii aspirin va diclofenac dfmg duang toan

than(tJ{nh kem theo cong van 86 .~q ..lQLD ..f)K ngay .cUa C{4C Quan Ii'

Duac) oIrJ/'I~ .

[B6i v(Yit~t ca cac thuAc chAng viem khong st~roid, kh6ng phai aspirin vadiclofenac dung duong toan than, thong tin tren nhfui' thuAc va to' HDSD ck b6sung d~phan anh cac thong tin duoc cung c~p dum d~y]

1. Canh bao va th~n trong[...}Nguy ca huyit khai timm~ch:cltc thuAc chAng viem khong steroid (NSAIDs), khong phai aspirin, dung duongtoan than, c6 the lam tang ngUy co xuAthien bien cAhuyet khAi tim mach, bao gbm

J.. nh}." . , d"t 6 thl d'X d'" N l.' thA I...tCCl 01 mau cO'tim va Q quy', c e an en tu.vong. guy co nClYeo e xuahien .s6m trong vai tuan dlu dimg thuAc va c6 th~ tang len theQ thm gian dimgthuAc.NFY CO'huyet kh6i tim m~ch duQ'cghi nh~ chu yeu a.lieu: cao.Bac si can d8nh gia dinh kY S\l xuAt hien· cua cac bren c3 tim m~ch, ngay ca khibenh nh~ khong c6 cac trieu chUng tim m\\ch tnroc d6. Benh nh~ c§.n dUQc cimhbao ve cac trieu chUng cua bien c6 tim m~ch nghiem trQngva cAntham kham bac srngay kbi ~t hien cae trieu chUng nay.D~ giam thiBu nguy co xuAt hien biSn cf, bAt lQi~cAn su d\Ul~ [ten thuAc] a lieuhang ngay thAp nhAt c6 hi~u qua trong thai gian ngful nhAtc6 the.[...}

2. T~c d1}ng khong mong m~An[...}Nguy CO'huy~t kh6i tim m\\cb (xem them ph§.nCanh bao va th~n trQng)

[..]./.,

C(>NG BOA xX H(>I eHU NGHIA ~T NAMDQc Hlp - Tu do - Hanh phuc

PHVLVCIIl

Cac nQidung thay dAi, bAsung tren huang din sii' dung efta cae thuAe chuadiclofenac dung duang toan than

(Dinh kern thea cong van s6 ymq JQLD-fJK nga~I'I~ ,,j;ua Cl,JC Qu~n Ii'Du(Jc)[Uoi voi t~t ca. cac thuoc chua diclofen~c dung dirong toa!1~~r-( duong uong, tiem vad~t true trang), thong tin tren nhan thuoc va to' HDSD can bo: sung de phan anh cac

thong tin duoc cung cdp duoi day]1.U~u dung va each dung[..} . .. De giam thi~u nguy co xu~t hien bien cf:,bdt loi, c§n sir d~ng{ten thuf:,c] a li~u hangngay thftp nhAt c6 hieu qua trong thai gian ngan nh!t co th~ (xem them ph§n Canh bao

va th~ trong).{...l2. ChAng chi dinb{ ....J .B~nh ~an suy tim sung huyet (tit dQ II den dQ IV thea phan dQclnrc nang cua suy timthea HQi Tim New York - NYHA), b~nh tim thieu mau C\lC bQ, b~nh dQng mach ngoal

vi, benh mach mau nao.[ ..]3. Canh bao va th,n trQng[...}Nguy ClY huy2t kh8i tim m(lch:Cae thuf:,c ch6ng viem khong steroid (NSAIDs), khong phai aspirin, dUng duang toanthan c6 the lam tang nguy co XUdthi~n bien c6 huyet fd16i tim m~ch, bao g6m ca nh5imau co tim va dQt quy', co thS dftn dan til vong. Nguy co nay c6 thS xudt hi~n samtrons vai tuan dau dung thuf:,c va c6 the ~ang l~n thea thai gian dUng thu5c. Nguy cohuy~t khf:,i tim m~ch duQ'c ghi nh~n chu yeu a lieu cao.Bac 81c§n danh gia dinh ky S\I xuAt hi~n cua cac bien 06 tim m~ch, ngay ca. khi b~nhnhan khong co ca.c tri~u chung tim TI1~ehtruac do. B~nh nhan c§n duQ'c canh b{lOv~cae tri~u chung cua bi~n cf:,tim m~ch nghiem trQng va dn tham kham bac S1ngay khixuftt hi~n,cac tri~u chung nay. .Be giam thiSu nguy co xuAt hi~n bi~n c5 bAt 1qi, c§.n Slr dvng [ten thu5c] a li~u hfmgngay thAp nhat co hi~u qua tTong thai gian ngin nhAt co the.CAn c;m nh~c cAn th~ khi Slr d\lng diQlofenac cho b~nh nhan c6 cae yau tf:,nguy coxuAt hi~n cac bi~n of:, tim m~ch ro rN (nhu tang huy~t cip, tang lipid huy~t thanh, dai

thao duong, nghi~n thu5c hi).[...j4. Tac dt}ng khong mong mubn[...]Nguy co huyet khf:,i tim m~eh: Cae thie nghi~rn Ifun sang va d~ch t~ duqc hQc eho thAyvi~c sit dl,mg diclofenac co lien quan d~n tang nguy co xu!t hi~n bi~n c6 huyet khf:,itim m~ch (nhu: nh5i mau Cff tim h(}~cd<>tquy,-),d~c bi~t khi su d\illg dic10fenac a li~ucao (150 mg/ngay) va keo dai (xem them phdn Canh bao va th~ t1'Qng)

[. ..j.1.

B6vTECVC QUAN LY DlJQC

l'f

!\ .I

•

I~itf

BOYTEcue QUAN LY DlfQC

CONG HOA XA HOI can NGHlA \'ItT NAMDc)c IQp - 'fy' do - U,nh ehuc

PlIVLVC

Cac nQi dung thay ttAiI bA sung ttAiVOl thuAc chUa ho,i chit hydroxyzin(Dlnh kern theo cong van s65.JSJl.....lQLD-DK ngay~'f jtl/ /off

cua Cl:leQuan ly Duac)

I·

1.Li~u hrQ'llgva each dung[cdn b6 sung-cdc noi dung sau:][...}[Ten thuoc] cdn duoc sir dung (1 li~u th~p nh§t co hieu qua va trong thai gianngfuI nh§t co thS.o nguoi. Urn va tre em co can n~g tren 40kg, li~u tBi da hang ngay 1a1OOmglngay.o nguoi cao tu3i, khong nen sir dung hydroxyzin, nSu bAt bUQc phai dung, li~udung tbi da hang .ngay 1a 50mg/ngay (xem ID\1C 3).o tre em co can n~g dum 40kg, lieu tBi da hang ngay Ia 2mg/l(glngay.[...}2.ChAng chi djnh[...}

; ,L->,

[cdn b6 sung cdc n9i dung sau:] . -Benh nhanco keo dai khoang QT mic phai ho~c bfun sinh.Benh nhan co ySu t6 nguy ccr keo dill khoang QT bao gam b~nh tim m~ch, rbilo~ di~n giai nghiem trQng (h~ kali mau, hc;t.magie mau) , ti@n sir gia dinh conguaj dQt tu do nguyen nhan tim ml;lch, eh~m nhjp tim nghiem trQng ho~e dangsu d\lDgcae thubc co nguy co keo diti khoang'QT ho~c gay xoful mnh (xem mvc .:3 va 4).[...]3. Canb bao va thin tf(~)ngdJc bi~t khi SU' d'lng[can bb sung cae n9i dung sau:]{. ..jTac dung tn!n tim machHydroxyzin c6 lien quan dSn tac dl,lug keo dfii khoang QT tren di~n tam d6.Trong qua trinh giam sat thubc sau khi duqc c~p phep luu hanh tren thi tnrang,Cia ghi rih?n duQ'c cae truOng hgp keo cl:a.i khm\ng QT V~lxo~n 0111h6 b~nh nhfmsu d~ng hydroxyzin. f)a s6 b~nh nhan nay d~u co cae y~u t6 nguy ccr khac nhur6i lo~n di~n gj~h ho~c citc b~nh m~c kem co th~ la nguyen nhan gop phdn gay rabi@n c8.

........ .. ---.-..~--- ..~..""'__--.

-Hydroxyzin cAn duoc sir dung 6 li~u thAp nhAt co hieu qua va trong thoi gianng~n nhAt co thS.C~ ngirng hydroxyzin nSu xuAt ,hi~n dAu hieu hay trieu chtrng c6, th€ lien quanden loan nhip tim va b~nhnhan can d~n kham y khoa ngay l~p nrc. ,cAn d~n do b~nh nhan thong bao ngay bAtky tri~u chimg tim mach nao xay ratrong qua trinh g,irdung thuBc., .:Benh nhan cao tu6iHydroxyzin kh5n& e:1u'1,ckhuYSn cao su dung 6 ngtroi cao tudi do hydroxyzin higiam thai trir 6 guan the b~nh nhan nay so voi nguci 1611tnrong thanh, dang thai,tan&nguy co xay ra phan irng co hai (nhu tac dung khang cholinergic) (xem muc1 va 5). , .4.TU'01lg tac thuac vOi eac thuac khac va cac d~ng tIl'O'~g'tac khac[can b6 sung cdc nQi dung sau.]f...]Tuong, tac ch6ng chi dinhSir dung hydroxyzin dBng thai voi cae thu6c gay h~o did khoang QT ho~c gayxob dinh lam tang nguy ccr lo~ nhip tim: cac thu6c chdng 10~n tibip fih6m IA(nbu quinidin, disopyramid) va nhom III (nhu amiodaron, SQtalol), IDQts6 thuBckhang histamin; rnQt s6 thuac chang, lo~' thAn (nhu haloperidol), mQt s&thu6cch6ng tr~m cam"(nh~ cital~ram, ~scital~pram), mQt s6 thu8c c~6ng s6t ret (n?umefloqum), mQt so thuoc khang sinh (nhu erythromycm, levofloxacm,moxifloxacin), mQt sf, thu8c, khang uk (nhtr pentamidin), ffiQt s6: thu6c tac d\Ulgtren h~ tieu hoa (nhu prucaloprid), mQt sa thuAc duQ'c sir dl).D.gtrong ung. thu (vidl,l toremifen, vandetanib), methadon. Vi v~y, ch6n!f chi dinh kSt hQP cac thu6c

, nayvai hydroxyzin (xem m\lC 2).Tuang tac ck than trong khi s.l1" dungTh~n tr9ng khi su d\lng hydroxyzin cimg cae thu6c Unn ch~m nhjp tim va gay h~kali mau.[elm b6 sung n<3idung sau:}Tuang tae. cAnthan trong khi. sir dungHydroxyzin duQ'c chuy~n h6a hoi enzym alcol dehydrogenase va CYP3A4,CYP3A5. Khi sir d\mg d6ng thQi hydroKyzin voi cac thu6e c6 kha nang ire chSnhfrng enzym nay co th~ tam tang nBng uQ hydroxyzhl ttong mau.[.,.]5. Tae dt}~g khong mong .mu8n[cdn b6 sung cae nQi dung sauJ[..}

" :.f _ / I-

Chua 1'0 tan suat xay ra: Lo~n nhir th~t (.nhu xoan ctinh), keo dai khoang QT(xern rn\le 3).[ ..]

, ..-tI'~'

BQYTECl)CQUAN LY DU'QC

CONG HOA XA HOI em] NGHIA ~T NAM. DC>c lap - T1;t'do....H~nb pbuc

PHVLVC

Cae nqi dung thay c1ail ba sung c18i v6'i thuac chUa warfarin(Dinh kem thea cong van s6'i/!il/QLD-DK nga,!!""b cUaCIIC Qulin If Du(lc). /(7~r

(fl&ivoi tat cit C3c thuoc chtra warfarin, thong tin tren nIWn thuec va to HDSDcftn dUQcb6'sung d6 phan anh cac thong tin duoc cung oip.4u<Ji day]

I 1. Canb'bao va th~n trong. [...)Chung cald hoa m(lch mau va hO(litil- da (calciphylaxis)Chtmg calci hoa m~ch mau va hoei til da (calciphylaxis) 10.hili eheng hi6m g~pva co tY le tit vong cao. HQi chrmg nay thuimg g~p tren b~nhnhan benh th~ giaidoan cubi c6 IQcmau hoijc tren b~nh nIWn c6 milt s6 y6u t&nguy co nhu: thi6uhvt protein C hoijc S, tang phosphat mau, tang calci mau ho~c ~ albumin mau.:Cac tnrong hop calci hoa mach mau ya bcei tit da da dUQcghi nh~ tren ca benhnhan sir d\IDgwarfarin khong co benh ly th~. Trong truimg hqp xay ra hQi chUngnay, benh nhan cdn dUQcxu trl thich hqp va can nMc ngimg su d\IDgwarfarin.

[...}! .~

2..Tae dyng k_hon.gMoOg muan[...]Chua ro tan sudt xciy ra:ChUng 'calci hoa m~ch mau va ho~i tfr da (calciphylaxis) (xem them phdn Canh

bao va ~ trQng)[...].1.