ICefditoren Pivoxil

ICefditoren Pivoxil

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Udidi lweziyobisi: Isizukulwana sesithathu se-cephalosporins

By Uhlaziyo lweMedia; Ukuhlaziywa ngu-Varixcare.cz. Igqityelwe ukuhlaziywa ngoFebruwari 19, 2021.



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Iipilisi zeCefditoren Pivoxil 200 mg kunye ne-400 mg



Ukunciphisa ukukhula kweebhaktiriya ezinganyangekiyo ngamachiza kunye nokugcina ukusebenza kweepilisi zeCefditoren Pivoxil kunye nezinye iziyobisi ezichasene ne-antibacterial, iCefditoren Pivoxil kufuneka isetyenziselwe kuphela ukunyanga izifo ezithi zingqine okanye zikrokrelwe ngamandla ukuba zibangelwa ziintsholongwane.

Inkcazo yeCefditoren Pivoxil

Iipilisi zeCefditoren Pivoxil ziqulathe i-Cefditoren Pivoxil, i-semi-synthetic cephalosporin antibiotic yolawulo lomlomo. Yiprodrug ene-hydrolyzed by esterases ngexesha lokufakwa, kwaye ichiza lihanjiswa kwigazi elijikelezayo njenge-cefditoren esebenzayo.



Ngokwamachiza, iCefditoren Pivoxil ngu (-) - (6R, 7R) -2,2-dimethylpropionyloxymethyl 7 - [(Z) -2- (2-aminothiazol-4-yl) -2-methoxy-iminoacetamido] -3 - [(( Z) -2- (4-methylthiazol-5-yl) ethenyl] -8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate. Ifomula yobungqina nguC25H28U-N6OKANYE7S3kunye nobunzima beemolekyuli ngu-620.73. Ifomula yolwakhiwo lweCefditoren Pivoxil iboniswe ngezantsi:

ICefditoren Pivoxil



Uhlobo lwe-amorphous lweCefditoren Pivoxil eyenzelwe ukusetyenziswa kweklinikhi ngumgubo otyheli omthubi. Isinyibilika ngokukhululekileyo ekunciphiseni ihydrochloric acid kwaye inyibilike kumanqanaba alingana no-6.06 mg / mL kwi-ethanol kunye<0.1 mg/mL in water.



Iipilisi zeCefditoren Pivoxil ziqulathe i-200 mg okanye i-400 mg ye-cefditoren njenge-Cefditoren Pivoxil kunye nezinye izinto ezingasebenziyo: i-croscarmellose sodium, i-mannitol, i-magnesium stearate, i-sodium caseinate (iprotein yobisi), kunye ne-sodium tripolyphosphate. Ipeyinti yecwecwe iqulethe i-carnauba wax, i-hypromellose, i-polyethylene glycol kunye ne-titanium dioxide. Amacwecwe aprintwe nge-inki equkethe i-opacode eluhlaza okwesibhakabhaka S-1-10533.

ICefditoren Pivoxil - Ikhemesti yezonyango

Pharmacokinetics

Ukufunxa

Ukufumaneka komlomo ngomlomo

Ukulandela ukulawulwa ngomlomo, i-Cefditoren Pivoxil ifunxwe ukusuka kwithumbu lesisu kunye ne-hydrolyzed ukuya kwi-cefditoren ngama-esterases. Ubuninzi beeplasma (Cubuninziye-cefditoren phantsi kweemeko zokuzila umndilili we-1.8 ± 0.6 µg / mL kulandela idosi enye ye-200 mg kwaye yenzeka i-1.5 ukuya kwiiyure ezi-3 emva kedosi.

Ngaphantsi kokonyuka ngokulinganayo kwethamo kwiCubuninzikunye nendawo ephantsi kwekhefu lexesha lokuxinana (AUC) zajongwa kumthamo we-400 mg nangaphezulu. ICefditoren ayiqokeleli kwiplasma kulandela ukulawulwa kabini kwemihla ngemihla kwizifundo ezinomsebenzi oqhelekileyo we-renal. Ngaphantsi kweemeko zokuzila, uqikelelo lokufumaneka ngokupheleleyo kweCefditoren Pivoxil lumalunga ne-14%. Ukufumaneka ngokupheleleyo kweCefditoren Pivoxil kulawulwa ngesidlo esinamafutha asezantsi (i-693 cal, 14 g fat, 122 g carb, 23 g protein) yi-16.1 ± 3.0%.

Iziphumo zokutya

Ulawulo lweCefditoren Pivoxil kulandela ukutya okunamafutha aphezulu (i-858 cal, 64 g fat, 43 g carb, 31 g protein) kukhokelele kwi-70% yokunyuka kwe-AUC kunye ne-50% yokunyuka kwe-C.ubuninzixa kuthelekiswa nolawulo lweCefditoren Pivoxil kwimeko yokuzila. Emva kwesidlo esinamafutha aphezulu, uCubuninziI-avareji ye-3.1 ± 1.0 µg / mL ilandela idosi enye ye-200 mg yeCefditoren Pivoxil kunye no-4.4 ± 0.9 µg / mL kulandela idosi eyi-400 mg. ICefditoren AUC kunye noCubuninziIxabiso elivela kwizifundo ezenziwa ngesidlo esinamafutha asezantsi (i-648 cal, 27 g fat, 73 g carb, 29 g protein) ziyafana nezo zifunyenwe kulandela ukutya okunamafutha aphezulu.

Ukuhanjiswa

Umthamo wentetho yokuhanjiswa kwimeko ezinzileyo (VssI-cefditoren yi-9.3 ± 1.6 L. Ukubopha kwe-cefditoren kwiiproteni zeplasma zi-avareji ye-88% ukusukai-In vitroUkuchongwa, kwaye ukuzimelela koxinaniso kwi-cefditoren concentrations ukusuka kwi-0.05 ukuya kwi-10 µg / mL. ICefditoren ikakhulu ibotshelelwe kwi-albhamu ye-serum yomntu kwaye ukubopha kwayo kuyancipha xa i-serum albumin concentrations incitshisiwe. Ukubopha kwi-α-1-acid glycoprotein isusela kwi-3.3 ukuya kwi-8.1%. Ukungena kwiiseli ezibomvu zegazi akunantsingiselo.

Ulusu blister fluid

Ubuninzi be-cefditoren kwi-blister fluid eyenziweyo ifunyenwe i-4 ukuya kwiiyure ze-6 emva kolawulo lwedosi ye-400 mg yeCefditoren Pivoxil enentsingiselo ye-1.1 ± 0.42 µg / mL. Kuthetha ukuba amaxabiso e-blister fluid AX amaxabiso ayengama-56 ± 15% yeeplasma ezixineneyo.

Iitoni

Kwizigulana ezikhawulezileyo ezenza i-tonsillectomy ekhethiweyo, uxinzelelo lwe-cefditoren kwithishu yeethoni 2 ukuya kwiiyure ze-4 emva kolawulo lwedosi ye-200 mg yeCefditoren Pivoxil yayiyi-0.18 ± 0.07 µg / g. Kuthetha ukuba iithoni zoxinaniso lwe-cefditoren yayiyi-12 ± 3% yezingqinisiso ze-serum ezihambelanayo.

Ulwelo lweCerebrospinal (CSF)

Idatha yokungena kwe-cefditoren kulwelo lwe-cerebrospinal fluid ayifumaneki.

Imetabolism kunye nokuNgena

I-Cefditoren isuswe kwi-plasma, inesiphelo sokuphelisa ukuphela kobomi (t1/2I-1.6 ± 0.4 yeeyure kubantu abadala abasempilweni. ICefditoren ayixatyiswanga kakuhle. Emva kokufakwa, i-cefditoren isuswa ikakhulu kukukhutshwa komchamo, ngokususwa kwezintso malunga ne-4-5 L / h. Izifundo ezenziwa nge-arhente yokuthintela i-tubular ye-arhente yokuthintela i-probenecid ibonisa ukuba ukhuseleko lwe-tubular, kunye ne-glomerular filtration iyabandakanyeka ekususeni i-cefditoren. Ukususwa kwezintso kwi-Cefditoren kuncitshisiwe kwizigulana ezinokungoneliseki kwezintso. (Jonga abantu abakhethekileyo,Ukungoneliseki kweNtsokwayeUhlalutyo lweHemodialysis.)

I-Hydrolysis yeCefditoren Pivoxil kwicandelo layo elisebenzayo, i-cefditoren, ikhokelela ekwenziweni kwepivalate. Ukulandela idosi ezininzi zeCefditoren Pivoxil, ngaphezulu kwe-70% ye-pivalate ifunxwe. I-pivalate ikakhulu ishenxiswa (> 99%) ngokukhutshwa kwezintso, phantse ngokukodwa njenge-pivaloylcarnitine. Ukulandela irejimeni ye-200 mg ye-BID yeentsuku ezili-10, intsingiselo yokwehla kweeplasma ye-carnitine iyonke yayiyi-18.1 ± 7.2 nmole / mL, emele ukwehla kwe-39% kwi-plasma carnitine concentrations. Ukulandela irejimeni ye-400 mg ye-BID yeentsuku ezili-14, ukwehla kokuthetha koxinaniso lweplasma ye-carnitine yayiyi-33.3 ± 9.7 nmole / mL, emele ukwehla ngama-63% kwi-plasma carnitine concentrations. Ukugxilwa kwePlasma ye-carnitine kubuyile kuluhlu oluqhelekileyo lokulawula ngaphakathi kwe-7 ukuya kwiintsuku ezili-10 emva kokupheliswa kweCefditoren Pivoxil. (JongaUKULUMKELA,ngokubanzikwayeULAWULO.)

Abemi abakhethekileyo

Geriatric

Iziphumo zobudala kwi-pharmacokinetics ye-cefditoren yavavanywa kwizifundo ezingama-48 zamadoda nabasetyhini abaneminyaka engama-25 ukuya kwengama-75 banikwa i-400 mg Cefditoren Pivoxil BID yeentsuku ezisi-7. Utshintsho lomzimba olunxulumene nokwanda kweminyaka lukonyusa ubungakanani bokuvezwa kwe-cefditoren kwi-plasma, njengoko kungqinwa yi-26% ephezulu Cubuninzikunye ne-33% ephezulu ye-AUC kwizifundo ezineminyaka engama- years iminyaka engama-65 xa kuthelekiswa nezifundo ezincinci. Inqanaba lokususwa kwe-cefditoren kwi-plasma yayisezantsi kwizifundo ezineminyaka eyi-years engama-65, nge-t1/2Ixabiso le-16-26% ixesha elide kunezifundo ezincinane. Ukucinywa kwe-renal kwe-cefditoren kwizifundo ezineminyaka eyi-65 iminyaka yayiyi-20-24% isezantsi kunezona zifundo zincinci. Olu tshintsho lunokubalelwa kwiinguqu ezinxulumene nobudala kugqitho lwe-creatinine. Akukho luhlengahlengiso lwedosi luyimfuneko kwizigulana ezindala ezinesiqhelo (kubudala bazo) umsebenzi we-renal.

Isini

Iziphumo zesini kwi-pharmacokinetics ye-cefditoren yavavanywa kwizifundo ezingama-24 zamadoda kunye nezi-24 zabasetyhini ezinikwe i-400 mg Cefditoren Pivoxil BID yeentsuku ezisi-7. Ubungakanani bokuvezwa kwiplasma kwakukukhulu kubantu basetyhini kunakwamadoda, njengoko kungqinwa yi-14% ephezulu yeCubuninzikunye ne-16% ephezulu ye-AUC yamabhinqa xa kuthelekiswa neyamadoda. Ukucoca i-renal kwe-cefditoren kwabasetyhini yayiyi-13% isezantsi kunamadoda. Lo mahluko unokubangelwa kukungafani okunxulumene nesini kubunzima bomzimba. Akukho luhlengahlengiso lwethamo luyimfuneko kwisini.

Ukungoneliseki kweNtso

ICefditoren pharmacokinetics iphandwe kwizifundo zabantu abadala ezingama-24 ezinamanqanaba ohlukeneyo omsebenzi wokurhola emva kolawulo lweCefditoren Pivoxil 400 mg BID yeentsuku ezisi-7. Ukuncipha kwemvume yokudala (CLcr) yayanyaniswa nokonyuka kwesiqwengana se-cefditoren engafakwanga kwiplasma kunye nokwehla kwenqanaba lokususa i-cefditoren, kukhokelela ekuvezweni okungaphezulu kwenkqubo kwizifundo ezinokukhubazeka kwezintso. C ongasikelwanga mdaubuninzikwaye i-AUC yayifana kwizifundo ezinobuthathaka obuthathaka bezintso (CLcr: 50-80 mL / min / 1.73 m2) xa kuthelekiswa nezifundo ezinomsebenzi oqhelekileyo wezintso (CLcr:> 80 mL / min / 1.73 m2). Iphakathi (CLcr: 30-49 ml / min / 1.73 m2okanye ezinzima (CLcr:<30 mL/min/1.73 m2) Ukukhubazeka kwezintso kwonyuse ubungakanani bokuvezwa kwiplasma, njengoko kungqinwa kukungagungqi kweCubuninziamaxabiso angama-90% kunye no-114% ngaphezulu kunye ne-AUC ama-232% nama-324% ngaphezulu kunaleyo yezifundo ezinomsebenzi oqhelekileyo wezintso. Ireyithi yokupheliswa kweplasma yayisezantsi kwizifundo ezinokungahambi kakuhle okanye ukukhubazeka okukhulu kwezintso, kunye nentsingiselo efanelekileyo t1/2Ixabiso le-2.7 kunye neeyure ezingama-4.7. Akukho lungelelwaniso lwethamo luyimfuneko kwizigulana ezinokukhubazeka okuncinci kwezintso (CLcr: 50-80 mL / min / 1.73 m2). Kuyacetyiswa ukuba kungabikho ngaphezulu kwe-200 mg ye-BID enikezelwa kwizigulana ezinokuthothisa kwezintso ngokulinganayo (CLcr: 30-49 ml / min / 1.73 m2) kunye ne-200 mg QD inokwenziwa kwizigulana ezinokukhubazeka okukhulu kwezintso (CLcr:<30 mL/min/1.73 m2). (JongaIDOSI NOLAWULO.)

Uhlalutyo lweHemodialysis

ICefditoren pharmacokinetics iphandwe kwizifundo zabantu abadala ezithandathu ezinesifo se-renal sokugqibela (ESRD) esenza i-hemodialysis enikwe idosi enye ye-400 mg yeCefditoren Pivoxil yahluka kakhulu. Intsingiselo t1/2yayiziiyure ezingama-4.7 zaza zaqala kwiiyure eziyi-1.5 ukuya kwezili-15. IHemodialysis (ixesha leeyure ezi-4) isuswe malunga neepesenti ezingama-30 ze-cefditoren ukusuka ekujikelezeni kwenkqubo kodwa ayitshintshanga ukuphela kokupheliswa kwesiqingatha sobomi. Idosi efanelekileyo yezigulana ze-ESRD ayichongwanga. (JongaIDOSI NOLAWULO.)

Isifo sesibindi

I-Cefditoren pharmacokinetics yavavanywa kwizifundo zabantu abadala ezithandathu ezinokuthothisa okungathethekiyo kwe-hepatic (Umntwana-uPugh Class A) kunye nesithandathu esinokukhubazeka okuphakathi kwe-hepatic (Umntwana-Pugh Class B). Ukulandela ukulawulwa kweCefditoren Pivoxil 400 mg BID yeentsuku ezisi-7 kwezi zifundo, kuthetha ukuba uCubuninzikwaye amaxabiso e-AUC ayemancinci (<15%) greater than those observed in normal subjects. No dose adjustments are necessary for patients with mild or moderate hepatic impairment (Child-Pugh Class A or B). The pharmacokinetics of cefditoren in subjects with severe hepatic impairment (Child-Pugh Class C) have not been studied.

Microbiology

I-Cefditoren yi-cephalosporin enomsebenzi we-antibacterial ngokuchasene ne-gram-positive kunye ne-gram-negative pathogen. Umsebenzi we-bactericidal we-cefditoren uvela kuthintelo lwe-synthesis yodonga lweseli ngokudibana kweeproteni ezibopha ipenicillin (PBPs).

I-Cefditoren izinzile xa kukho iintlobo ze-lact-lactamases, kubandakanya iipenicillinase kunye nezinye ze-cephalosporinases. ICefditoren ibonakalisiwe ukuba iyasebenza ngokuchasene neentlobo ezininzi zebacteria zilandelayo, zombinii-In vitronakusulelo lweklinikhi, njengoko kuchaziwe kwiIZALATHISO NOSETYENZISOicandelo.

I-Aerobic Gram-Positive Microorganisms

IStaphylococcus aureus(Iintlobo ze-methicillin-ezichaphazelekayo, kubandakanya i-ß-lactamase-Production strains)

Qaphela: ICefditoren ayisebenzi ngokuchasene nemethicillin-resistantIStaphylococcus aureus

IStreptococcus pneumoniae(Iintlobo zeepenicillin ezinokubakho kuphela)

IStreptococcus pyogenes

I-Aerobic Gram-Negative Microorganisms

Haemophilus influenzae(kubandakanya iintlobo ze-ß-lactamase ezivelisa)

Haemophilus parainfluenzae(kubandakanya iintlobo ze-ß-lactamase ezivelisa)

UMoraxella catarrhalis(kubandakanya iintlobo ze-ß-lactamase ezivelisa)

Ezilandelayoi-In vitroidatha iyafumaneka,kodwa ukubaluleka kwazo kwezonyango akwaziwa. Imiboniso yeCefditoreni-In vitroUbuncinci be-inhibitory concentrations (MICs) ye-≦ 0.125 µg / mL ngokuchasene uninzi (≧ 90%) iintlobo zezi bhakteriya zilandelayo; Nangona kunjalo, ukhuseleko kunye nokusebenza kwe-cefditoren kunyango losulelo lweklinikhi ngenxa yezi ntsholongwane khange kumiselwe kwizilingo ezaneleyo nezilawulwa kakuhle.

I-Aerobic Gram-Positive Microorganisms

IStreptococcus agalactiae

IStreptococcusAmaqela C no-G

IStreptococcus, iqela le-viridans (iintlobo zeepenicillin ezinokuthi zithinteke kwaye ziphakathi)

Uvavanyo lokuqonda

Iindlela zokuCoca

Iindlela zobungakanani ezisetyenziselwa ukumisela ii-MICs zibonelela ngoqikelelo olunokuphinda lubekho kwiintsholongwane. Ii-MICs kufuneka zimiselwe kusetyenziswa inkqubo emiselweyo. Iinkqubo ezimiselweyo zisekwe kwiindlela zokunyibilikisa1(umhluzi) okanye ulingana nokuxinana kwe-inoculum esemgangathweni kunye nokugxininiswa okumiselweyo komgubo we-cefditoren. Amaxabiso eMIC afunyenweyo kufuneka atolikwe ngokwezi khrayitheriya zilandelayo:

UkuvavanyaHaemophilusspp.ukuyakwayeIStreptococcusspp. kubandakanyaS. pneumoniaeb:

Iiklinikhi ezikwanti

I-MIC (Μg / mL)

Ingcaciso

S. pneumoniae

Umgangatho wee-0.125

0.250

Ixabiso eliphantsi

Ukuchaphazeleka (S)

Ephakathi (I)

Ukumelana (R)

Haemophilusspp.

Umgangatho wee-0.125

0.250

Ixabiso eliphantsi

Ukuchaphazeleka (S)

Ephakathi (I)

Ukumelana (R)

S. pyogenes

Umgangatho wee-0.125

Ukuchaphazeleka (S)

ukuyaLo mgangatho wokutolika usebenza kuphela kuvavanyo lokuchaphazeleka kwengqondo yomhluzi ngeHaemophilusspp. usebenzisaHaemophilusUvavanyo oluPhakathi (HTM).1

bLe migangatho yokutolika isebenza kuphela kwiimvavanyo zokuchaphazeleka komhluzi nge-microdilutionIStreptococcusspp. usebenzisa umhluzi ohlengahlengisiweyo we-Mueller-Hinton broth ene-2-5% yegazi lehashe eligreyidiweyo.1

Iikhrayitheriya zovavanyo lokuqonda ukungabinakho ukusekwaS. aureus

Ingxelo ye-Susceptible ibonisa ukuba i-pathogen inokuthi ithintelwe ukuba i-antimicrobial compound egazini ifikelela kuxinzelelo oluqhele ukufezekiseka. Ingxelo yesiGaba esiPhakathi ibonisa ukuba iziphumo kufuneka zithathelwe ingqalelo ngokulinganayo, kwaye, ukuba i-microorganism ayinabungozi ngokupheleleyo kwezinye iindlela, amayeza afanelekileyo eklinikhi, uvavanyo kufuneka luphindwe. Eli nqanaba lithetha ukuba kunokwenzeka kokusebenza kweeklinikhi kwiindawo zomzimba apho iyeza ligxile emzimbeni okanye kwiimeko apho kunokusetyenziswa idosi ephezulu. Eli nqanaba likwabonelela ngendawo yokuthintela ethintela izinto ezincinci, ezingalawulwayo kubuchwephesha ekubangeleni ukungangqinelani okukhulu kutoliko. Ingxelo ye-Resistant ibonisa ukuba i-pathogen ayinakuthintelwa ukuba i-antimicrobial compound egazini ifikelela ekugxininiseni ngokuqhelekileyo inokufezekiswa kwaye olunye unyango kufuneka lukhethwe.

Iinkqubo zovavanyo lokuchaphazeleka ngokusemgangathweni zifuna ukusetyenziswa kolawulo lweelebhu zentsholongwane ukulawula imiba yezobuchwephesha yeenkqubo zaselebhu. I-cefditoren powder esemgangathweni kufuneka ibonelele ngezi zinto zilandelayo ze-MIC kwezi ntlobo zolawulo lomgangatho:

Amagciwane

MNCINANE Uluhlu(iig / ml)

IStreptococcus pneumoniaeukuyaI-ATCC 49619

Haemophilus influenzaebI-ATCC 49766

Haemophilus influenzaebI-ATCC 49247

0.016-0.12

0.004-0.016

0.06-0.25

ukuyaOlu luhlu lolawulo lomgangatho lusebenza kuphelaS. pneumoniaeI-ATCC 49619 ivavanywe yinkqubo ye-microdilution isebenzisa i-cation-adjusted Mueller-Hinton broth ene-2-5% yegazi eligaziweyo.1

bOlu luhlu lolawulo lomgangatho lusebenza kuphelaH. influenzaeI-ATCC 49247 kunye ne-ATCC 49766 kuvavanywa inkqubo ye-microdilution kusetyenziswa i-HTM.1

Iimpawu kunye nokusetyenziswa kweCefditoren Pivoxil

I-Cefditoren Pivoxil ibonakalisiwe kunyango losulelo olungephi ukuya kolulinganiselweyo kubantu abadala nakwishumi elivisayo (abaneminyaka eli-12 ubudala okanye ngaphezulu) ezibangelwa ziintsholongwane ezinokuchaphazeleka kwizifo ezichongiweyo kwezi meko zidweliswe ngezantsi.

Ukwanda kweBacterial Exacerbation ye-Bronchitis engapheliyoyenziwe nguHaemophilus influenzae(kubandakanya iintlobo ze-ß-lactamase ezivelisa),Haemophilus parainfluenzae(kubandakanya i-ß-lactamase yokuvelisa iintlobo),IStreptococcus pneumoniae(penicillin susceptible strains), okanyeUMoraxella catarrhalis(kubandakanya iintlobo ze-ß-lactamase ezivelisa).

I-Pneumonia eFunyenwe nguLuntuyenziwe nguHaemophilus influenzae(kubandakanya iintlobo ze-ß-lactamase ezivelisa),Haemophilus parainfluenzae(kubandakanya iintlobo ze-ß-lactamase ezivelisa),IStreptococcus pneumoniae(iintlobo ezinobungozi beepenicillin kuphela), okanyeUMoraxella catarrhalis(kubandakanya i-ß-lactamase yokuvelisa iintlobo).

iziphumo ebezingalindelekanga ze-meloxicam kunye notywala

Pharyngitis / tonsilsyenziwe nguIStreptococcus pyogenes. QAPHELA: I-Cefditoren Pivoxil iyasebenza ekupheliseni iIStreptococcus pyogenesukusuka kwi-oropharynx. Amacwecwe e-Cefditoren Pivoxil khange afundwe kuthintelo lwe-rheumatic fever elandelayoIStreptococcus pyogenespharyngitis / tonsillitis. Kuphela yi-penicillin ye-intramuscular ebonakalisiweyo ukuba iyasebenza ekuthinteleni i-rheumatic fever.

Ulusu oluntsonkothileyo kunye noSulelo loLwakhiwo lolusuyenziwe nguIStaphylococcus aureus(kubandakanya iintlobo ezivelisa lact-lactamase) okanyeIStreptococcus pyogenes.

Ukunciphisa ukukhula kweebhaktiriya ezinganyangekiyo ngamachiza kunye nokugcina ukusebenza kweCefditoren Pivoxil kunye nezinye iziyobisi ezichasene ne-antibacterial, iCefditoren Pivoxil kufuneka isetyenziselwe kuphela ukunyanga izifo ezithi zingqine okanye zikrokrelwe ngamandla ukuba zibangelwa ziintsholongwane. Xa inkcubeko kunye nolwazi lokuchaphazeleka lufumaneka, kufuneka ziqwalaselwe xa kukhethwa okanye kuguqulwa unyango lwe-antibacterial. Ukungabikho kwedatha enjalo, i-epidemiology yendawo kunye neepateni zokuchaphazeleka kunokuba negalelo kukhetho lonyango olunamandla.

Ukungqinelana

I-Cefditoren Pivoxil iyaphikiswa kwizigulana ezinokwaliwa kwiklasi ye-cephalosporin ye-antibiotics okanye naliphi na icandelo layo.

I-Cefditoren Pivoxil iyaphikiswa kwizigulana ezinesiphene se-carnitine okanye iimpazamo ezizelwe kwimetabolism ezinokubangela ukunqongophala kwe-carnitine eklinikhi, kuba ukusetyenziswa kweCefditoren Pivoxil kubangela ukuphuma kwezintso kwe-carnitine. (JongaAMANYATHELO, Ngokubanzi.)

Iipilisi zeCefditoren Pivoxil ziqukethe i-sodium caseinate, iprotheni yobisi. Izigulana ezinobisi lweeprotein hypersensitivity (hayi ukunganyamezelani kwe-lactose) akufuneki zinikezwe iCefditoren Pivoxil.

Izilumkiso

NGAPHAMBI KOKUNYANGISWA KUNYE NE-Cefditoren Pivoxil ISETYENZISIWE, KUFUNEKA KWENZIWE UKUBA KUFUNYANWE UKUBA UMGAQO UTHETHE NJANI UKUGQIBELA KWI-CYPERSENSITIVITY TO Cefditoren Pivoxil, EZINYE I-ORPHALOSPORINS, UKUBA i-Cefditoren Pivoxil iza kunikwa abaguli be-PENICILLIN-SENSITIVE PATIENTS, ISILUMKISO KUFUNEKA SISETYENZISWE NGOKUBA UMNQOPHISO WE-CROSS-HYPERSENSITIVITY PHAKATHI KWI-LACTAM ANTIBIOTICS KUQHELEKILE NGOKUQHELEKILEYO UKUGQIBELA I-AITI I-ITI IYA KUKUQHUBA I-AYI NGOKUQHELEKILEYO. UKUBA UKUSETYENZISWA KWE-ALERGIC KWI-Cefditoren Pivoxil KUYENZEKA, IZIYOBISI AZIYEKI. IZINTO EZINOKWENZEKA ZINOKUFUNA UNYANGO NGE-EPINEPHRINE KUNYE NEZINYE IIMILINGANISO ZOKUNGXAMISEKA, KUFUNEKA I-OXYGEN, I-FLUIDS EZITHANDEKAYO, I-ANTIHISTAMINES EZITHANDEKAYO, I-CORTICOSTERO INCOSAZI, I-AYISIMAZI YOKUFUNDA.

I-Pseudomembranous colitis iye yaxelwa phantse kuzo zonke iiarhente zokulwa neentsholongwane, kubandakanya iCefditoren Pivoxil, kwaye inokuthi iqale ngobukrakra ukusuka kubumnene ukuya kusongela ubomi. Ke ngoko, kubalulekile ukuba uqwalasele oku kufunyanwa kwizigulana ezinikezela kurhudo emva kolawulo lweearhente zokulwa neentsholongwane.

Unyango kunye neearhente zokulwa neentsholongwane lutshintsha iintyatyambo eziqhelekileyo zekolon kwaye lunokuvumela ukwanda kwe-clostridia. Izifundo zibonisa ukuba ityhefu eveliswe yiIClostridium difficile (C. difficile)ngoyena nobangela uphambili wesifo sokudumba okuchasene namayeza.

Emva kokuba kufunyaniswe isifo sepseudomembranous colitis, kufanelekile amanyathelo onyango. Amatyala amancinci e-pseudomembranous colitis ahlala ephendula ekuyekisweni kweziyobisi kuphela. Kwimeko ezimodareyithi ukuya kwezinzima, kufuneka kuthathelwe ingqalelo kulawulo olunamanzi kunye neelectrolyte, isongezelelo seprotein, kunye nonyango lwechiza lokulwa neentsholongwane.Kunzimaukudumba.

Ukulumkela

ngokubanzi

Ukumisela i-Cefditoren Pivoxil ngokungabikho kosulelo lwebhaktiriya oluqinisekisiweyo okanye olurhanelwa okanye isibonakaliso seprophylactic akunakulindeleka ukuba sibonelele kwisigulana kwaye sonyusa umngcipheko wophuhliso lweebhaktheriya ezinganyangekiyo ngamachiza.

I-Cefditoren Pivoxil ayikhuthazwa xa unyango olude lwe-antibiotic luyimfuneko, kuba ezinye iikhompawundi eziqulethe izoyikiso zibangele ukubonakaliswa kweklinikhi yokunqongophala kwe-carnitine xa isetyenziswe kwisithuba seenyanga. Akukho ziphumo zeklinikhi yokuncipha kwe-carnitine enxulumene nonyango lwexesha elifutshane. Iziphumo ekugxininiseni kwe-carnitine yeekharityhulamu zexesha elifutshane eziphindaphindiweyo zeCefditoren Pivoxil aziwa.

Kwizigulana zenyumoniya ezifumaneke eluntwini (N = 192, iminyaka engama-50.3 ± 17.2 yeminyaka) inikwe irejimeni ye-200 mg ye-BID kangangeentsuku ezili-14, ukwehla kokuthetha koxinzelelo lwe-serum ye-carnitine iyonke ngelixa kunyango yayiyi-13.8 ± 10.8 nmole / mL, emele I-30% yehle kwi-serum carnitine concentrations. Kwizigulana zenyumoniya ezifunyenwe luluntu (N = 192, iminyaka engama-51.3 ± 17.8 yeminyaka) inikwe irejimeni ye-BID engama-400 mg kangangeentsuku ezili-14, ukwehla kokuthetha koxinzelelo lwe-serum ye-carnitine iyonke ngelixa kunyango yayiyi-21.5 ± 13.1 mole / mL, emele Ukuhla kwe-46% kwi-serum carnitine concentrations. Ukugxilwa kwePlasma ye-carnitine kubuyile kuluhlu oluqhelekileyo lokulawula ngaphakathi kweentsuku ezisi-7 emva kokupheliswa kweCefditoren Pivoxil. Ukwehla kokuthelekiswa kwe-carnitine kwabonwa kumavolontiya asempilweni (iminyaka yobudala engama-33.6 ± 7.4 iminyaka) kulandela irejimeni ye-200 mg okanye ye-400 mg ye-BID. (JongaIKHEMIKHALI YEKHAYAUvavanyo lwenyumoniya olufunyenwe eluntwini alubonisanga ziganeko zichaphazela ukwehla koxinzelelo lwe-serum carnitine.

Nangona kunjalo, abanye abantu abaphantsi (umz. Ngapha koko, idosi efanelekileyo kwizigulana ezinesifo se-renal sokugqibela asichongwanga. (JongaIdosi NOLAWULO, abaguli abanesifo sokungasebenzi kakuhle).

Njengakwamanye amayeza okubulala iintsholongwane, unyango olude lungakhokelela ekuveleni nasekukhuleni kwezinto ezinganyangekiyo. Ukuqwalaselwa ngononophelo kwesigulana kubalulekile. Ukuba ukosuleleka kakhulu kwenzeka ngexesha lonyango, kufuneka kwenziwe olunye unyango olufanelekileyo.

I-Cephalosporins inokunxulunyaniswa nokuwa komsebenzi weprothrombin. Abo basemngciphekweni babandakanya abaguli abane-renal okanye i-hepatic impair, okanye imeko yokungondleki, kunye nezigulana ezifumana ikhosi yexesha elide yonyango lwe-antimicrobial, kunye nezigulana ebezizinziswe ngaphambili kunyango lwe-anticoagulant. Ixesha leprothrombin kufuneka libekwe esweni kwizigulana ezisemngciphekweni kunye nevithamini K engaphandle elawulwa njengoko kubonisiwe. Kwezilingo zeklinikhi, kwakungekho mahluko phakathi kwe-cefditoren kunye ne-cephalosporins yokuthelekisa kwimeko yexesha elandayo leprothrombin.

Ulwazi kubaguli

Izigulana kufuneka zicetyiswe ukuba iziyobisi ezichasene ne-antibacterial kubandakanya ne-Cefditoren Pivoxil kufuneka zisetyenziselwe kuphela ukunyanga izifo ezosulelayo. Abalunyangi usulelo lwentsholongwane (umzekelo, ingqele eqhelekileyo). Xa iCefditoren Pivoxil imiselwe ukunyanga usulelo lwebacteria, izigulana kufuneka zixelelwe ukuba nangona kuqhelekile ukuba uzive ungcono kwikhosi yonyango, amayeza kufuneka athathwe kanye njengoko kuyalelwe. Ukutsiba iidosi okanye ukungaligqibi ikhosi epheleleyo yonyango kunoku (1) kunciphise ukusebenza konyango olukhawulezileyo kwaye (2) kwandise amathuba okuba iintsholongwane zikhule zichasane kwaye azizukunyangwa nguCefditoren Pivoxil okanye ezinye iziyobisi ezichasayo kwixa elizayo.

I-Cefditoren Pivoxil kufuneka ithathwe kunye nokutya ukuphucula ukufunxeka.

I-Cefditoren Pivoxil inokuthi ithathwe ngokudibeneyo kunye nezicwangcisi zomlomo.

Akukhuthazwa ukuba iCefditoren Pivoxil ithathwe ngokukhawuleza kunye ne-antacids okanye ezinye iziyobisi ezithathwa ukunciphisa isisu. (JongaAMANYATHELO, Unxibelelwano lweziyobisi.)

Iipilisi zeCefditoren Pivoxil ziqukethe i-sodium caseinate, iprotheni yobisi. Izigulana ezinobisi lweeprotein hypersensitivity (hayi ukunganyamezelani kwe-lactose) akufuneki zinikezwe iCefditoren Pivoxil.

Ukusebenzisana kweziyobisi

Izinto zokucwangcisa zomlomo

Iidosi ezininzi zeCefditoren Pivoxil zazingenampembelelo kwi-pharmacokinetics ye-ethinyl estradiol, icandelo le-estrogenic kuninzi lokucwangcisa ngomlomo.

IiAntacids

Ukulawulwa ngokudibeneyo kwethamo elinye le-antacid equle zombini i-magnesium (800 mg) kunye ne-aluminium (900 mg) i-hydroxides inciphise ukufakwa ngomlomo kwethamo elinye le-400 mg yeCefditoren Pivoxil elawulwa emva kwesidlo, njengoko kungqinwa ukwehla kwe-14% Kuthetha ukuba nguCubuninzikunye nokwehla nge-11% kwi-AUC. Nangona ukubaluleka kweklinikhi kungaziwa, ayikhuthazwa into yokuba iCefditoren Pivoxil ithathwe ngokudibeneyo ne-antacids.

H2-Izichasi ezichasene nomamkeli

Ukulawulwa ngokudibeneyo kwethamo elinye le-famotidine (20 mg) efakwe ngaphakathi ngaphakathi yanciphisa ukufakwa ngomlomo kwethamo elinye le-400 mg yeCefditoren Pivoxil elawulwa emva kwesidlo, njengoko kungqinwa ukwehla kwe-27% kwentsingiselo Cubuninzikunye ne-22% yokwehla kwe-AUC. Nangona ukubaluleka kweklinikhi kungaziwa, ayikhuthazwa into yokuba iCefditoren Pivoxil ithathwe ngokudibeneyo ne-H2abachasi be-receptor.

Iiprobene

Njengakwezinye i-ß-lactam antibiotics, ukusebenzisana ngokubambisana kwe-probenecid kunye neCefditoren Pivoxil kukhokelele ekwandeni kokuvezwa kweplasma ye-cefditoren, nge-49% yokunyuka kwe-Cubuninzi, i-122% inyuka kwi-AUC, kunye ne-53% inyuke ngo-t1/2.

Ukudibana kovavanyo lweziyobisi / elebhu

I-Cephalosporins yaziwa ukuba ngamanye amaxesha ifaka uvavanyo oluchanekileyo lwe-Coombs. Impendulo engeyonyani yeglucose kumchamo inokwenzeka ngovavanyo lokunciphisa ubhedu (isisombululo sikaBenedict okanye sikaFehling okanye iipilisi zeCLINITEST®), kodwa hayi ngovavanyo lwe-enzyme lwe-glycosuria (umzekelo, CLINISTIX®, TES-TAPE®). Njengokuba iziphumo ebezingalunganga zinokuvela kuvavanyo lwe-ferricyanide, kuyacetyiswa ukuba kungasetyenziswa indlela ye-glucose oxidase okanye ye-hexokinase ukumisela amanqanaba egazi / iplasma yeswekile kwizigulana ezifumana iCefditoren Pivoxil.

ICarcinogenesis, iMutagenesis, ukungasebenzi kakuhle kokuchuma

Akukho zifundo ze-carcinogenicity zexesha elide ezenziweyo kunye neCefditoren Pivoxil. I-Cefditoren Pivoxil yayingeyiyo i-mutagenic kwi-Ames ye-bacterial reverse mutation assay, okanye kwi-mouse lymphoma mutation assay kwi-hypoxanthineguanine phosphoribosyltransferase locus. Kwiiseli zamaphaphu zaseTshayina ze-hamster lung, i-chromosomal aberrations yaveliswa nguCefditoren Pivoxil, kodwa hayi nge-cefditoren. Izifundo ezilandelayo zibonise ukuba i-chromosome aberrations ibangelwa kukukhutshwa kwe-formaldehyde kwi-pivoxil ester moietyi-In vitroInkqubo ye-assay. Nokuba i-cefditoren okanye i-Cefditoren Pivoxil ayivelisanga i-chromosomal aberrations xa ivavanywai-In vitrowolingo lwe-lymphocyte yegazi lomntu, okanye kwikwi vivoimouse micronucleus kulingwa. I-Cefditoren Pivoxil ayikhange ibangele i-DNA engacwangciswanga xa ivavanywa. Kwiigundane, ukuchuma kunye nokuzala kwakhona akuchaphazelekanga yiCefditoren Pivoxil kumthamo womlomo ukuya kuthi ga kwi-1000 mg / kg / ngosuku, malunga namaxesha angama-24 idosi yomntu ye-200 mg BID esekwe kumg / m2/usuku.

Iziphumo zokukhulelwa-Teratogenic

Udidi lokukhulelwa B

ICefditoren Pivoxil yayingeyiyo iteratogenic ukuya kuthi ga kwiidosi eziphezulu ezivavanyiweyo kwiigundane kunye nemivundla. Kwiigundane, le dose yayiyi-1000 mg / kg / ngosuku, ephantse ibe ngama-24 edosi yomntu eyi-200 mg BID esekwe kumg / m2/usuku. Kwimivundla, elona dose liphezulu lavavanywa yayiyi-90 mg / kg / ngosuku, ephantse iphindaphindwe kane idosi yomntu ye-200 mg BID esekwe kumg / m2/usuku. Le dosi ivelise ubutyhefu obukhulu bomama kwaye ikhokelele kwityhefu yomntwana kunye nokuqhomfa.

Kwisifundo sophuhliso lwasemva kokubeleka kwiigundane, i-Cefditoren Pivoxil ayivelisanga ziphumo zingalunganga kubomi basemva kokubeleka, ukukhula ngokwasemzimbeni kunye nokuziphatha, amandla okufunda, kunye namandla okuzala ekukhuleni ngokwesondo xa kuvavanywa idosi ukuya kuthi ga kwi-750 mg / kg / ngosuku, elona dose liphezulu kuvavanywayo . Oku kuphantse kube li-18 idosi yomntu ye-200 mg BID esekwe kumg / m2/usuku.

Akukho zifundo zaneleyo nezilawulwa kakuhle kwabasetyhini abakhulelweyo. Kuba izifundo zokuzala kwezilwanyana azisoloko ziqikelela ukuphendula kwabantu, eli chiza kufuneka lisetyenziswe ngexesha lokukhulelwa kuphela xa kufuneka ngokucacileyo.

Ezabasebenzi kunye nokuhanjiswa

I-Cefditoren Pivoxil ayifundanga ukuba isetyenziswe ngexesha lomsebenzi kunye nokuhanjiswa.

Oomama Abongikazi

ICefditoren yafunyanwa kubisi lwebele lweempuku ezincancisayo. Ngenxa yokuba amachiza amaninzi akhutshiwe kubisi lomntu lwebele, isilumkiso kufuneka senziwe xa iCefditoren Pivoxil yenziwa kubafazi abangabongikazi.

Ukusetyenziswa kwabantwana

Ukusetyenziswa kweCefditoren Pivoxil akukhuthazwa kwizigulana ezingaphantsi kweminyaka eli-12 ubudala. Ukhuseleko kunye nokusebenza kweetafile zeCefditoren Pivoxil kolu luhlu lwabantu, kubandakanya naziphi na iimpembelelo zoxinzelelo lwe-carnitine, azikenziwa. (JongaAMANYATHELO, Ngokubanzi.)

Ukusetyenziswa kweGeriatric

Kwizigulana ezingama-2675 kwizifundo zeklinikhi ezifumene iCefditoren Pivoxil 200 mg BID, 308 (12%) zazineminyaka engama-65 ubudala. Kwizigulana ezingama-2159 kwizifundo zeklinikhi ezifumene iCefditoren Pivoxil 400 mg BID, 307 (14%) zazineminyaka engama-65 ubudala. Akukho mahluko ubalulekileyo eklinikhi ekusebenzeni okanye kukhuseleko waqwalaselwa phakathi kwezigulana ezindala kunye nezincinci. Akukho luhlengahlengiso lwedosi luyimfuneko kwizigulana ezinesifo esiqhelekileyo (sobudala bazo) umsebenzi we-renal. Eli chiza liyaziwa ukuba liphume kakhulu zizintso, kwaye umngcipheko wokuphendula okunetyhefu kweli chiza unokuba mkhulu kwizigulana ezinomsebenzi wokungasebenzi kakuhle kwezintso. Ngenxa yokuba abaguli abalupheleyo kunokwenzeka ukuba banciphise ukusebenza kwezintso, ukhathalelo kufuneka lwenziwe ekukhetheni idosi, kwaye kunokuba luncedo ukubeka esweni umsebenzi we-renal. (JongaIsikali NO ULAWULO.)

IZIGANEKO EZIBALASELEYO

Uvavanyo lweklinikhi- Iipilisi zeCivditoren zePivoxil (zaBadala kunye neziGulana eziFikisa iminyaka eli-12 ubudala)

Kwizilingo zeklinikhi, abaguli abadala abangama-4834 kunye nabakwishumi elivisayo baye banyangwa ngeedosi ezinconyelwayo zeepilisi zeCefditoren Pivoxil (200 mg okanye 400 mg BID). Uninzi lweziganeko ezigwenxa zazinobulali kunye nokuzimela. Akukho kufa okanye ukukhubazeka ngokusisigxina okuye kwabangelwa yi-cefditoren.

Iziganeko ezimbi ezilandelayo zazicingelwa ngabaphandi ukuba kunokwenzeka, mhlawumbi, okanye ngokuqinisekileyo zinxulumene neepilisi ze-cefditoren kwizilingo zedosi ezininzi:

Unyango olunxulumene noNyango kwiZilingo kubantu abadala nakwabaguli abafikisayo kwiminyaka eli-12 ubudala)
ICefditoren Pivoxil Thelekisaukuya
I-200 mg ye-BID I-400 mg ye-BID
N = 2675 N = 2159 N = 2648
Iziganeko ≧ Urhudo Shumi elinanye% Shumi elinantlanu% 8%
1% Isicaphucaphu 4% 6% 5%
Intloko ebuhlungu 3% 2% 2%
Intlungu zesisu 2% 2% 1%
I-Moniliasis yelungu lobufazi 3%b 6%c 6%d
Dyspepsia 1% 2% 2%
Ukuhlanza 1% 1% 2%

ukuyaibandakanya i-amoxicillin / clavulanate, cefadroxil monohydrate, cefuroxime axetil, cefpodoxime proxetil, clarithromycin, kunye ne-penicillin

b1428 ababhinqileyo

cI-1135 yabasetyhini

ipilisi l544 icala elinye

d1461 ababhinqileyo

Iziganeko zizonke zeziganeko ezigwenxa, kwaye ngakumbi isifo sorhudo, sonyuke ngeqondo eliphakanyisiweyo eliphezulu leCefditoren Pivoxil.

Unyango olunxulumene neziganeko ezigwenxa ezanyangezelwa yi-0.1% yezigulana ezafumana i-200 mg okanye i-400 mg ye-BID yeCefditoren Pivoxil yayingamaphupha angaqhelekanga, i-allergies reaction, i-anorexia, i-asthenia, isifuba, ixesha lokujiya lenyukile, ukuqhina, isiyezi, umlomo owomileyo, ulwaziso, ukudumba kobuso, umkhuhlane, ukuqumba, usulelo lomngundo, isifo sesisu, isifo sokuqaqanjelwa sisisu, ukonyuka kokutya, ukuqaqanjelwa sisisu, leukopenia, leukorrhea, uvavanyo lwesibindi ukusebenza ngokungaqhelekanga, i-myalgia, uvalo, i-moniliasis yomlomo, iintlungu, i-peripheral edema, i-pharyngitis, i-pseudomembranous colitis, irhashalala, irhashalala, irhashalala , somnolence, stomatitis, ukubila, ukungcamla okugqwethekileyo, ukunxanwa, i-thrombocythemia, i-urticaria kunye ne-vaginitis. Iimpawu ze-Pseudomembranous colitis zingaqala ngexesha okanye emva konyango lwezifo. (JongaIZILUMKISO.)

Amashumi amathandathu ananye angama-2675 (2%) abaguli abafumene i-200 mg ye-BID kunye ne-69 ye-2159 (3%) yezigulana ezafumana i-400 mg ye-BID yeCefditoren Pivoxil iyekile amayeza ngenxa yezehlo ezimbi ebekucingelwa ngabaphandi, mhlawumbi, okanye ngokuqinisekileyo enxulumene nonyango lwe-cefditoren. Ukupheliswa ikakhulu bekuphazamiseka esiswini, kuhlala kurhudo okanye isicaphucaphu. Urhudo yayisisizathu sokupheliswa kwi-19 yama-2675 (0.7%) yezigulana ezafumana i-200 mg ye-BID kunye ne-31 ye-2159 (1.4%) yezigulana ezafumana i-400 mg BID yeCefditoren Pivoxil.

Utshintsho kwiiparameter zelebhu zokubaluleka kweklinikhi okunokwenzeka, ngaphandle kokujonga ubudlelwane beziyobisi kwaye ezenzeka kwi-1% yezigulana ezifumene iCefditoren Pivoxil 200 mg okanye i-400 mg BID, yayiyi-hematuria (3.0% kunye ne-3.1%), yonyusa umchamo iiseli ezimhlophe zegazi ( I-2.3% kunye ne-2.3%), ukunciphisa i-hematocrit (2.1% kunye ne-2.2%), kunye nokunyusa iswekile (1.8% kunye ne-1.1%). Ezo ziganeko zenzeke kwi-0.1% yezigulana zibandakanya oku kulandelayo: ukwanda / ukunciphisa iiseli ezimhlophe zegazi, ukwanda kwe-eosinophils, ukwehla kwe-neutrophils, ukwanda kwe-lymphocyte, ukwanda kwenani leplatelet, ukwehla kwe-hemoglobin, ukwehla kwesodium, ukonyuka kwe-potassium, ukunciphisa i-chloride, ukunciphisa i-phosphorus engaphiliyo, ukunciphisa i-calcium, inyusa i-SGPT / ALT, inyusa i-SGOT / AST, yonyusa i-cholesterol, yehla i-albhamuin, proteinuria, kunye nokunyusa i-BUN. Ayaziwa ukuba oku kungahambi kakuhle kubangelwe sisiyobisi okanye imeko ephantsi iyanyangwa.

I-Cephalosporin Class yeempendulo eziGwenxa

Ukongeza kwiziphumo ezibi ezichazwe apha ngasentla eziye zabonwa kwizigulana ezanyangwa ngeCefditoren Pivoxil, ezi ziphumo zilandelayo zichaseneyo kunye neziphumo zovavanyo zelabhoratri eziguqulweyo ziye zaxelwa i-cephalosporin class antibiotics:

Ukuphendula okungalunganga: Ukuphendula ngokuchaseneyo, i-anaphylaxis, umkhuhlane weziyobisi, iStevens-Johnson syndrome, i-serum-like reaction, i-erythema multiforme, i-epidermal necrolysis, i-colitis, ukungasebenzi kakuhle kwezintso, i-nephropathy enetyhefu, i-hyperactivity eguqukayo, i-hypertonia, ukungasebenzi kakuhle kwe-hepatic kubandakanya i-cholestasis, i-aplastic anemia, i-hemolytic anemia, ukopha, kunye ne-superinfection.

Uvavanyo lweLabhoratri eguqulweyo: Ixesha elide leprothrombin, uvavanyo oluchanekileyo lweCombombs, uvavanyo lobuxoki lwe-glucose yomchamo, i-alkaline phosphatase ephezulu, i-bilirubin ephezulu, i-LDH, i-creatinine, i-pancytopenia, i-neutropenia, kunye ne-agranulocytosis.

Ii-cephalosporins ezininzi ziye zanyanzeliswa ekubangeleni ukubanjwa, ngakumbi kwizigulana ezinokukhubazeka kwezintso xa idosi ingancitshiswanga. (JongaIDOSI NOLAWULOUkuba ukubanjwa kunxulunyaniswa nonyango lweziyobisi, ichiza kufuneka liyekwe. Unyango lwe-Anticonvulsant lunokunikwa ukuba kubonisiwe eklinikhi.

Amava entengiso

La mava mabi alandelayo, ngaphandle kolwalamano lwabo noCefditoren Pivoxil, axeliwe ngexesha lokuthengisa emva kokuthengisa, ukuqala ngokuvunywa eJapan ngo-1994: inyumoniya, i-eosinophilic pneumonia acute, ukusilela kwezintso, i-arthralgia, thrombocytopenia, erythema multiforme, uStevens-Johnson I-Syndrome, i-epidermal necrolysis enetyhefu kunye neempendulo ze-anaphylactoid ezinokuthi zikhatshwe yi-hypotension.

Ukugqithisa

Ulwazi malunga ne-Cefditoren Pivoxil overdosage ebantwini alufumaneki. Nangona kunjalo, ngamanye antibiotics-lactam amayeza okubulala iintsholongwane, iziphumo ezibi kulandela ukugcwala komzimba zibandakanya isicaphucaphu, ukugabha, uxinzelelo lwe-epigastric, isifo sorhudo kunye nokuxhuzula. IHemodialysis inokunceda ekususweni kwe-cefditoren emzimbeni, ngakumbi ukuba umsebenzi we-renal uphazamisekile (i-30% yokuncitshiswa kweeplasma emva kweeyure ezi-4 ze-hemodialysis). Phatha i-ogqithdosting ngokweempawu kwaye wenze amanyathelo okuxhasa njengoko kufuneka.

Kwizifundo ezinobungozi bezilwanyana ezinobuthi, i-Cefditoren Pivoxil xa ivavanywa kumyinge womlomo we-5100 mg / kg kwiigundane ukuya kuthi ga kwi-2000 mg / kg kwizinja azibonisanga ziphumo zempilo zixhalabisayo. Iziphumo ezithile, ezinje ngesifo sorhudo kunye nesitulo esithambileyo esihlala iintsuku ezimbalwa ziye zabonwa kwezinye izilwanyana njengoko kulindelwe uninzi lwee-antibiotics zomlomo ngenxa yokuthintela i-microflora yamathumbu.

I-Cefditoren Pivoxil Isikali kunye noLawulo

(JongaIZALATHISO NOSETYENZISOyezifo ezibonakalisiweyo.)

Isikali seCefditoren Pivoxil kunye noLawulo * lwabantu abadala kunye nolutsha (Iminyaka eli-12)

Uhlobo losulelo

Ubungakanani

Ubude bexesha (Iintsuku)

I-Pneumonia eFunyenwe nguLuntu

I-400 mg ye-BID

14

Ukwanda kweBacterial Exacerbation ye-Bronchitis engapheliyo

I-400 mg ye-BID

10

Pharyngitis / tonsils

I-200mg BID

Ulusu oluntsonkothileyo kunye nolwakhiwo lwezifo

* Kufuneka kuthathwe kunye nokutya

Izigulana ezinokungoneliseki kweNtso

Akukho lungelelwaniso lwethamo luyimfuneko kwizigulana ezinokukhubazeka okuncinci kwezintso (CLcr: 50-80 mL / min / 1.73 m2). Kuyacetyiswa ukuba kungabikho ngaphezulu kwe-200 mg ye-BID enikezelwa kwizigulana ezinokuthothisa kwezintso ngokulinganayo (CLcr: 30-49 ml / min / 1.73 m2) kunye ne-200 mg QD inokwenziwa kwizigulana ezinokukhubazeka okukhulu kwezintso (CLcr:<30 mL/min/1.73 m2). Idosi efanelekileyo kwizigulana ezinesifo se-renal sokugqibela ayichongwanga.

Izigulana ezineZifo zeHepatic

Akukho luhlengahlengiso lwedosi luyimfuneko kwizigulana ezinokuthamba okanye ukumodareyitha kokuphazamiseka kwesibindi (Umntwana-Pugh Class A okanye B). I-pharmacokinetics ye-cefditoren khange ifundwe kwizigulana ezinokukhubazeka okunesibindi (i-Child-Pugh Class C).

Ibonelelwa njani ngeCefditoren Pivoxil

Amacwecwe e-Cefditoren Pivoxil aqukethe i-Cefditoren Pivoxil elingana ne-200 mg okanye i-400 mg ye-cefditoren iyafumaneka njengemhlophe, i-elliptical, iipilisi ezifakwe ifilimu ezibhalwe nge-CBP 200 okanye i-CBP 400 ngombala oluhlaza okwesibhakabhaka. Ezi pilisi ziyafumaneka kwiiphakheji zeblister, ngolu hlobo lulandelayo:

  • I-NDC 24486-802-20: 400 mg 20 count blister. Amacwecwe e-Cefditoren Pivoxil aqukethe i-Cefditoren Pivoxil elingana ne-400 mg ye-cefditoren ayafumaneka emhlophe, elliptical, amacwecwe agutyungelwe ifilimu abhalwe i-CBP 400 ngombala oluhlaza okwesibhakabhaka.
  • I-NDC 24486-802-28: 400 mg 28 yokubala iblister. Amacwecwe e-Cefditoren Pivoxil aqukethe i-Cefditoren Pivoxil elingana ne-400 mg ye-cefditoren ayafumaneka emhlophe, elliptical, amacwecwe agutyungelwe ifilimu abhalwe i-CBP 400 ngombala oluhlaza okwesibhakabhaka.
  • I-NDC 24486-801-20:Inani lamabala angama-20. Amacwecwe e-Cefditoren Pivoxil aqukethe i-Cefditoren Pivoxil elingana ne-200 mg ye-cefditoren ayafumaneka emhlophe, elliptical, amacwecwe agutyungelwe ifilimu abhalwe i-CBP 200 ngombala oluhlaza okwesibhakabhaka.

UKUGCINWA

Gcina kuma-25 ° C (77 ° F); iihambo ezivunyelweyo ukuya kwi-15 ° -30 ° C (59 ° -86 ° F). [Jonga ubushushu begumbi elilawulwayo le-USP.] Khusela ekukhanyeni nasekufuma. Ukuhambisa kwisitya esomeleleyo, esinganyangekiyo.

Abaqeqeshi bezempilo banokutsalela umnxeba iAristos Pharmaceuticals Information Line (1-866-280-5755) ngolwazi ngale mveliso.

IZALATHISO

1. IKomiti yeSizwe yeMigangatho yeLebhu yeLabhoratri.Iindlela zoLusu lokuLumkisa iiAntimicrobial Susceptibility Uvavanyo lweeBacteria ezikhula ngokwasemoyeni- uHlelo lwesihlanu; Umgangatho ovunyiweyo, uXwebhu lwe-NCCLS M7-A5, Vol. 20, No. 2, NCCLS, Wayne, PA, Januwari 2000.

Rx kuphela

Yenziwe ngu:

I-Tedec-Meiji Farma, S.A.

IMadrid, eSpain

Ihanjiswe ngu:

Imbuyekezo Aristos Pharmaceuticals, Inc.

CaryI-NC 27518

I-CTS-002-1211-00-SPL

A233140-201111 / 01

Iipilisi zeCivditoren Pivoxil

ICefditoren Pivoxil 200 mg

ICefditoren Pivoxil
Itafile yeCefditoren Pivoxil, ifilimu yambathiswe
Ulwazi lweMveliso
Uhlobo lweMveliso INKCAZELO YABANTU ILELAYIBHILE YEZIYOBISI Ikhowudi yento (Umthombo) I-NDC: 24486-801
Umgaqo woLawulo NGOMLOMO Ishedyuli ye-DEA
Isithako esisebenzayo / Umoya oSebenzayo
Igama lezithako Isiseko soMandla Amandla
ICefditoren Pivoxil (CEFDITOREN) UMNQOPHISO 200 mg
Izithako ezingasebenziyo
Igama lezithako Amandla
ICARNAUBA WAX
ICOSCARMELLOSE SODIUM
I-D & C RED NO. 27
INDLELA YOKUSEBENZA
I-FD & C IBHULE NO. 1
IHYDROXYPROPYL CELLULOSE (TYPE H)
IZIPHUMO
IMAGNESIUM STEARATE
IIMPAWU ZE-POLYETHYLENE GLYCOLS
IPROPHELELE GLYCOL
SHELLAC
SODIUM CASEINATE
ISODIUM TRIPOLYPHOSPHATE
TITANIUM DIOXIDE
Iimpawu zeMveliso
Umbala MHLOPHE (Mhlophe) Inqaku akukho manqaku
Imilo I-OVAL (Elliptical) Ubungakanani 17mm
Incasa Ikhowudi yoShicilelo I-CBP; 200
Iqulathe
Ukupakisha
# Ikhowudi yento Inkcazo yephakheji
1 I-NDC: 24486-801-20 I-20 TABLET, IFILIMU IPHOTSHIWE (20 TABLET) kwi-1 BLISTER PACK
Ulwazi lweNtengiso
Udidi lokuThengisa Inombolo yesicelo okanye iMonograph Citation Umhla wokuQalisa ukuThengisa Umhla Wokuphela Wentengiso
NDA I-NDA021222 01/01/2010 03/31/2014
ICefditoren Pivoxil
Itafile yeCefditoren Pivoxil, ifilimu yambathiswe
Ulwazi lweMveliso
Uhlobo lweMveliso INKCAZELO YABANTU ILELAYIBHILE YEZIYOBISI Ikhowudi yento (Umthombo) I-NDC: 24486-802
Umgaqo woLawulo NGOMLOMO Ishedyuli ye-DEA
Isithako esisebenzayo / Umoya oSebenzayo
Igama lezithako Isiseko soMandla Amandla
ICefditoren Pivoxil (CEFDITOREN) UMNQOPHISO 400 mg
Izithako ezingasebenziyo
Igama lezithako Amandla
ICOSCARMELLOSE SODIUM
INDLELA YOKUSEBENZA
IMAGNESIUM STEARATE
SODIUM CASEINATE
ISODIUM TRIPOLYPHOSPHATE
IHYDROXYPROPYL CELLULOSE (TYPE H)
ICARNAUBA WAX
IIMPAWU ZE-POLYETHYLENE GLYCOLS
TITANIUM DIOXIDE
I-D & C RED NO. 27
I-FD & C IBHULE NO. 1
IZIPHUMO
IPROPHELELE GLYCOL
SHELLAC
Iimpawu zeMveliso
Umbala MHLOPHE (Mhlophe) Inqaku akukho manqaku
Imilo OVAL Ubungakanani 5mm
Incasa Ikhowudi yoShicilelo I-CBP400
Iqulathe
Ukupakisha
# Ikhowudi yento Inkcazo yephakheji
1 I-NDC: 24486-802-20 I-20 TABLET, IFILIMU IPHOTSHIWE (20 TABLET) kwi-1 BLISTER PACK
2 I-NDC: 24486-802-28 ITHEBILELE, IFILIMU IPHOTSHIWE (28 TABLET) kwi-1 BLISTER PACK
Ulwazi lweNtengiso
Udidi lokuThengisa Inombolo yesicelo okanye iMonograph Citation Umhla wokuQalisa ukuThengisa Umhla Wokuphela Wentengiso
NDA I-NDA021222 01/01/2010 03/31/2014
Umlebheli -Imbuyekezo Aristos Phamaceuticals, Inc. (010201166)
Imbuyekezo Aristos Phamaceuticals, Inc.

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