Rocephin

Lub npe dav: Ceftriaxone sodium
Dosage form: txhaj tshuaj, hmoov, rau kev daws
Chav kawm tshuaj: Peb tiam cephalosporins

Ntawm nplooj ntawv no
Nthuav

Rx xwb



Txhawm rau txo qhov kev loj hlob ntawm cov kab mob tiv thaiv kab mob thiab tswj kev ua haujlwm ntawm Rocephin thiab lwm yam tshuaj tua kab mob, Rocephin yuav tsum tau siv tsuas yog los kho lossis tiv thaiv kev kis kab mob uas muaj pov thawj lossis xav tias yuav tshwm sim los ntawm cov kab mob.

Lub npe Rocephin tau raug txiav tawm hauv Teb Chaws Asmeskas Yog tias cov khoom lag luam ntawm cov khoom no tau pom zoo los ntawm FDA, tej zaum yuav muaj. generic equivalents muaj .

Rocephin Description

Rocephin yog ib hom tshuaj tsis muaj menyuam, semisynthetic, broad-spectrum cephalosporin tshuaj tua kab mob rau kev txhaj tshuaj los yog intramuscular. Ceftriaxone sodium yog (6R.7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-raws li-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7ob-(Los ntawm)-(LUB-methyloxime), disodium ntsev, sesquaterhydrate.

topamax dosing rau migraine

Cov tshuaj formula ntawm ceftriaxone sodium yog C18H16N8NaobLUB7S3• 3.5 HobO. Nws muaj qhov ntsuas qhov hnyav ntawm 661.59 thiab cov qauv hauv qab no:

Rocephin yog ib tug dawb mus rau yellowish-txiv kab ntxwv crystalline hmoov uas yog yooj yim soluble nyob rau hauv dej, sparingly soluble nyob rau hauv methanol thiab heev me ntsis soluble nyob rau hauv ethanol. Lub pH ntawm 1% aqueous tov yog kwv yees li 6.7. Cov xim ntawm Rocephin cov kev daws teeb meem yog los ntawm lub teeb daj mus rau amber, nyob ntawm qhov ntev ntawm kev cia, concentration thiab diluent siv.

Rocephin muaj kwv yees li 83 mg (3.6 mEq) ntawm sodium ib gram ntawm ceftriaxone kev ua.

Rocephin - Clinical Pharmacology

Qhov nruab nrab plasma concentrations ntawm ceftriaxone tom qab ib zaug 30-feeb intravenous (IV) infusion ntawm 0.5, 1 lossis 2 gm koob tshuaj thiab intramuscular (IM) kev tswj hwm ntawm ib qho 0.5 (250 mg / mL lossis 350 mg / mL concentrations) lossis 1 gm koob tshuaj nyob rau hauv cov ntsiab lus noj qab haus huv raug nthuav tawm hauv Rooj 1 .

Table 1 Ceftriaxone Plasma Concentrations Tom Qab Kev Tswj Ib Leeg
Dose/Route Qhov nruab nrab Plasma Concentrations (µg / mL)
0.5h ua 1 hnu 2 hnu 4 hnu 6 hnu 8 hnu 12 hnu 16 hnu 24 hnu
ND = Tsis tau txiav txim siab.
*
IV koob tshuaj tau infused ntawm tus nqi tas li tshaj 30 feeb.
0.5g IV * 82 59 48 37 29 23 kaum tsib 10 5
0.5gm ib
250 mg/ml 22 33 38 35 30 26 16 ND 5
0.5gm ib
350 mg/ml nees nkaum 32 38 3. 4 31 24 16 ND 5
1 gm IV * 151 111 88 67 53 43 28 18 9
1gm ib 40 68 76 68 56 44 29 ND ND
2 gm IV * 257 192 154 117 89 74 46 31 kaum tsib

Ceftriaxone tau nqus tag nrho tom qab IM kev tswj hwm nrog qhov siab tshaj plaws plasma concentration tshwm sim ntawm 2 thiab 3 teev tom qab noj tshuaj. Ntau qhov koob tshuaj IV lossis IM txij li 0.5 mus rau 2 gm ntawm 12- mus rau 24-teev ib ntus ua rau 15% mus rau 36% tsub zuj zuj ntawm ceftriaxone saum toj ib koob tshuaj.

Ceftriaxone concentration hauv cov zis yog qhia hauv Rooj 2 .

Table 2 Urinary Concentrations ntawm Ceftriaxone Tom Qab Kev Siv Tshuaj Ib Leeg
Dose/Route Qhov nruab nrab tso zis (µg / mL)
0-2 teev 2-4 teev 4-8 teev 8-12 hnub 12-24 hnub 24-48 hnub
ND = Tsis tau txiav txim siab.
0.5g IV 526 ib 366 142 87 70 kaum tsib
0.5gm ib 115 425 308 127 96 28
1 gm IV 995 ib 855 ib 293 ib 147 132 32
1gm ib 504 ib 628 ib 418 237 ND ND
2 gm IV 2692 ib Xyoo 1976 757 ib 274 198 40

Peb caug-peb feem pua ​​​​rau 67% ntawm cov koob tshuaj ceftriaxone raug tso tawm hauv cov zis raws li cov tshuaj tsis hloov pauv thiab cov seem tau muab zais rau hauv cov kua tsib thiab thaum kawg pom nyob rau hauv cov quav raws li microbiologically inactive compounds. Tom qab 1 gm IV koob tshuaj, qhov nruab nrab ntawm ceftriaxone, txiav txim siab los ntawm 1 mus rau 3 teev tom qab noj, yog 581 µg / mL hauv cov kua tsib hauv lub zais zis, 788 µg / mL hauv cov kab mob hauv cov kua tsib, 898 µg / mL hauv cov cystic duct bile. , 78.2 µg / gm nyob rau hauv lub gallbladder phab ntsa thiab 62.1 µg / mL nyob rau hauv lub concurrent plasma.

Tshaj li 0.15 mus rau 3 gm koob tshuaj ntau yam hauv cov neeg laus noj qab haus huv, qhov txiaj ntsig ntawm kev tshem tawm ib nrab ntawm lub neej nyob ntawm 5.8 txog 8.7 teev; pom meej ntim ntawm 5.78 mus rau 13.5 L; plasma clearance ntawm 0.58 mus rau 1.45 L / teev; thiab lub raum tshem tawm ntawm 0.32 txog 0.73 L / teev. Ceftriaxone yog reversibly khi rau tib neeg cov ntshav plasma proteins, thiab cov binding poob los ntawm tus nqi ntawm 95% khi ntawm plasma concentrations.<25 µg/mL to a value of 85% bound at 300 µg/mL. Ceftriaxone crosses the blood placenta barrier.

Qhov nruab nrab qhov tseem ceeb ntawm qhov siab tshaj plaws plasma concentration, tshem tawm ib nrab-lub neej, plasma clearance thiab ntim ntawm kev faib tawm tom qab 50 mg / kg IV koob thiab tom qab 75 mg / kg IV koob tshuaj rau cov menyuam yaus uas muaj kab mob meningitis yog qhia hauv Table 3 . Ceftriaxone nkag mus rau qhov mob meninges ntawm cov menyuam mos thiab cov neeg mob menyuam yaus; CSF concentrations tom qab 50 mg / kg IV koob thiab tom qab 75 mg / kg IV koob kuj tau pom hauv Table 3 .

Table 3 Qhov Nruab Nrab Pharmacokinetic Parameters ntawm Ceftriaxone hauv Cov Neeg Mob Meningitis
50 mg/kg IV 75 mg/kg IV
Qhov siab tshaj plaws Plasma concentration (µg / mL) 216 275
Kev tshem tawm Ib nrab-lub neej (h) 4.6 4.3
Plasma Clearance (mL / teev / kg) 49 60
Kev faib tawm (mL / kg) 338 ib 373
CSF Concentration-inflamed meninges (µg/mL) 5.6 6.4
Ntau yam (µg / mL) 1.3-18.5 Nws 1.3-44 Nws
Lub sij hawm tom qab koob tshuaj (h) 3.7 (± 1.6) 3.3 (± 1.4)

Piv nrog rau cov neeg laus noj qab haus huv, cov tshuaj pharmacokinetics ntawm ceftriaxone tsuas yog hloov pauv me ntsis hauv cov neeg laus thiab cov neeg mob lub raum tsis zoo lossis lub siab ua haujlwm tsis zoo ( Rooj 4 ); Yog li ntawd, kev kho tshuaj ntau npaum li cas tsis tsim nyog rau cov neeg mob no nrog ceftriaxone ntau npaum li 2 gm ib hnub. Ceftriaxone tsis raug tshem tawm mus rau ib qho tseem ceeb ntawm cov ntshav plasma los ntawm hemodialysis; Hauv rau ntawm 26 tus neeg mob lim ntshav, qhov tshem tawm ntawm ceftriaxone tau txo qis heev.

Table 4 Qhov nruab nrab Pharmacokinetic Parameters ntawm Ceftriaxone hauv tib neeg
Pab pawg neeg Tshem Tawm Ib Nrab Lub Neej
(hr)
Plasma Clearance
(L / teev)
Volume ntawm Distribution
(L)
*
Creatinine tshem tawm.
Cov ntsiab lus noj qab haus huv 5.8-8.7 Nws 0.58-1.45 Nws 5.8-13.5 Nws
Cov Neeg Laus (qhov nruab nrab hnub nyoog, 70.5 xyoo) 8.9 ib 0.83 ua 10.7 ib
Cov neeg mob raum tsis zoo
Cov neeg mob hemodialysis (0-5 mL / min) * 14.7 ib 0.65 ib 13.7 Nws
Mob hnyav (5-15 mL / min) 15.7 ib 0.56 ib 12.5 ib
Nruab nrab (16-30 mL / min) 11.4 0.72 ib 11.8 ib
Me me (31-60 mL / min) 12.4 0.70 ib 13.3
Cov Neeg Mob Mob Siab 8.8 ib 1.1 13.6 ib

Kev tshem tawm ntawm ceftriaxone tsis hloov pauv thaum Rocephin koom ua ke nrog probenecid.

Pharmacokinetics nyob rau hauv nruab nrab pob ntseg kua

Nyob rau hauv ib txoj kev tshawb no, tag nrho cov ceftriaxone concentrations (ua khi thiab unbound) tau ntsuas nyob rau hauv nruab nrab pob ntseg kua tau thaum lub sij hawm muab tso rau ntawm tympanostomy hlab nyob rau hauv 42 cov me nyuam cov neeg mob nrog otitis media. Cov sij hawm ua piv txwv yog los ntawm 1 mus rau 50 teev tom qab ib qho kev txhaj tshuaj intramuscular ntawm 50 mg / kg ntawm ceftriaxone. Qhov nruab nrab (± SD) ceftriaxone theem hauv pob ntseg nruab nrab mus txog qhov siab tshaj ntawm 35 (± 12) µg / mL ntawm 24 teev, thiab tseem nyob ntawm 19 (± 7) µg / mL ntawm 48 teev. Raws li qhov nruab nrab pob ntseg kua ceftriaxone concentrations nyob rau hauv lub 23 mus rau 25 teev thiab lub sij hawm 46 mus rau 50 teev, ib nrab-lub neej ntawm 25 teev yog xam. Ceftriaxone muaj feem xyuam rau cov ntshav plasma proteins. Qhov ntev ntawm kev khi rau cov protein nyob rau hauv nruab nrab pob ntseg kua yog tsis paub.

Kev sib tham nrog Calcium

Ob txoj kev tshawb fawb hauv vitro, ib qho siv cov neeg laus plasma thiab lwm qhov plasma neonatal los ntawm txoj hlab ntaws ntshav tau raug coj los ntsuas kev cuam tshuam ntawm ceftriaxone thiab calcium. Ceftriaxone concentrations txog li 1 mM (ntau tshaj qhov ua tiav hauv vivo tom qab kev tswj hwm ntawm 2 grams ceftriaxone infused tshaj 30 feeb) tau siv ua ke nrog calcium ntau txog 12 mM (48 mg / dL). Kev rov qab los ntawm ceftriaxone los ntawm plasma raug txo nrog calcium ntau ntawm 6 mM (24 mg / dL) lossis siab dua hauv cov neeg laus cov ntshav lossis 4 mM (16 mg / dL) lossis siab dua hauv cov ntshav plasma. Qhov no tuaj yeem cuam tshuam txog ceftriaxone-calcium nag lossis daus.

Microbiology

Mechanism ntawm Action

Ceftriaxone yog cov kab mob bactericidal uas ua los ntawm inhibition ntawm cov kab mob ntawm cov phab ntsa ntawm cov kab mob. Ceftriaxone muaj kev ua haujlwm ntawm qee qhov beta-lactamases, ob qho tib si penicillinases thiab cephalosporinases, ntawm cov kab mob Gram-negative thiab Gram-positive.

Mechanism ntawm Resistance

Kev tiv thaiv rau ceftriaxone feem ntau yog los ntawm hydrolysis los ntawm beta-lactamase, hloov pauv ntawm penicillin-binding proteins (PBPs), thiab txo permeability.

Kev sib tham nrog lwm cov tshuaj tua kab mob

Hauv kev tshawb fawb hauv vitro tau pom tias muaj kev cuam tshuam antagonistic nrog kev sib xyaw ntawm chloramphenicol thiab ceftriaxone.

Ceftriaxone tau pom tias ua haujlwm tawm tsam feem ntau ntawm cov kab mob hauv qab no, ob qho tib si hauv vitro thiab hauv chaw kho mob cov kab mob raws li tau piav qhia hauv Kev qhia thiab kev siv (1) ntu:

Cov kab mob Gram-negative
Acinetobacter calcoaceticus yog cov kab mob
Enterobacter aerogene
Cov kab mob enterobacter cloacae
Escherichia coli
Hemophilus influenzae
Hemophilus parainfluenzae
Klebsiella oxytoca
Klebsiella pneumoniae
Moraxella catarrhalis
Morganella hmoov
Neisseria gonorrhoeae muaj
Neisseria meningitidis
Proteus mirabilis
Proteus
Pseudomonas aeruginosa
Serratia marcescens

Gram-zoo kab mob
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Streptococcus pyogenes muaj
Viridans pab pawg streptococci

Cov kab mob anaerobic
Bacteroides fragilis
Clostridium hom
Peptostreptococcus hom

Hauv qab nohauv vitrocov ntaub ntawv muaj, tab sis lawv qhov tseem ceeb ntawm kev kho mob tsis paub. Tsawg kawg yog 90 feem pua ​​​​ntawm cov kab mob hauv qab no pom muaj nyob rau hauv vitro yam tsawg kawg nkaus inhibitory concentration (MIC) tsawg dua lossis sib npaug rau qhov cuam tshuam rau ceftriaxone. Txawm li cas los xij, kev ua tau zoo ntawm ceftriaxone hauv kev kho cov kab mob hauv chaw kho mob vim tias cov kab mob no tsis tau tsim nyob rau hauv kev sim tshuaj txaus thiab tswj tau zoo.

Cov kab mob Gram-negative
Citrobacter diversus
Citrobacter freundii
Kev pabhom (xws likev pab cuam rettgeri)
Salmonellahom (xws liSalmonella typhi)
Shigellahom

Gram-zoo kab mob
Staphylococcus aureus

Cov kab mob anaerobic
Porphyromonas (Bacteroides) melaninogenicus
Prevotella (Bacteroides) bivius

Cov Txheej Txheem Kev Ntsuam Xyuas Kev Nyuaj Siab

Thaum muaj, lub chaw kuaj mob microbiology yuav tsum muab cov txiaj ntsig ntawm cov txiaj ntsig hauv vitro susceptibility test rau cov khoom siv tshuaj tua kab mob uas siv hauv cov tsev kho mob hauv tsev rau tus kws kho mob raws li cov ntawv ceeb toom tsis tu ncua uas piav qhia txog qhov cuam tshuam ntawm nosocomial thiab cov kab mob kis tau hauv zej zog. Cov ntawv ceeb toom no yuav tsum pab tus kws kho mob xaiv cov khoom siv tshuaj tua kab mob rau kev kho mob.

Cov txheej txheem dilution:

Cov txheej txheem ntau yog siv los txiav txim siab txog tshuaj tiv thaiv kab mob tsawg tsawg inhibitory concentrations (MICs). Cov MICs no muab kev kwv yees ntawm kev raug cov kab mob mus rau cov tshuaj tiv thaiv kab mob. Cov MICs yuav tsum tau txiav txim siab siv txoj kev ntsuas tus qauv1.3. MIC qhov tseem ceeb yuav tsum tau txhais raws li cov txheej txheem tau muab hauv Table 5 .

Cov txheej txheem diffusion:

Ntau txoj hauv kev uas yuav tsum tau ntsuas ntawm cheeb tsam diameters kuj muab kev kwv yees rov ua dua ntawm cov kab mob cuam tshuam rau cov tshuaj tiv thaiv kab mob. Qhov loj ntawm cheeb tsam muab kev kwv yees ntawm qhov cuam tshuam ntawm cov kab mob mus rau cov tshuaj tiv thaiv kab mob. Qhov loj ntawm cheeb tsam yuav tsum tau txiav txim siab siv txoj kev ntsuas tus qauv.23Cov txheej txheem no siv cov ntawv disks impregnated nrog 30 mcg ceftriaxone los ntsuas qhov cuam tshuam ntawm cov kab mob mus rau ceftriaxone. Cov txheej txheem kev txhais lus disk diffusion tau muab rau hauv Table 5 .

Cov txheej txheem anaerobic:

Rau cov kab mob anaerobic, qhov susceptibility rau ceftriaxone li MICs tuaj yeem txiav txim siab los ntawm tus qauv agar test method3.4. Cov txiaj ntsig MIC tau txais yuav tsum tau txhais raws li cov txheej txheem tau muab hauv Table 5 .

Table 5 Susceptibility Test Interpretive Criteria for Ceftriaxone
Kab mob Yam tsawg kawg Inhibitory Concentrations
(mcg / ml)
Disk Diffusion Zone Diameters
(mm)
(S) Txaus siab (I) Nruab nrab (R) Resistant (S) Txaus siab (I) Nruab nrab (R) Resistant
*
Susceptibility txhais cov txheej txheem rauEnterobacteriaceaeyog ua raws li koob tshuaj 1 gram IV q 24h. Rau kev sib cais nrog kev cuam tshuam nruab nrab, siv ib koob ntawm 2 grams IV q 24h rau cov neeg mob uas lub raum ua haujlwm.
RauHemophilus influenzae, cov txheej txheem kev txhais tau yooj yim yog ua raws li koob tshuaj 2 grams IV txhua 24 teev hauv cov neeg mob uas lub raum ua haujlwm tsis zoo.
Tam sim no tsis muaj cov ntaub ntawv ntawm resistant isolates precludes txhais ib yam dab tsi lwm yam tshaj li 'Susceptible'. Yog tias cais tawm cov txiaj ntsig MIC uas tsis yog qhov cuam tshuam, lawv yuav tsum raug xa mus rau lub chaw soj nstuam rau kev kuaj ntxiv.
§
Disc diffusion txhais cov txheej txheem rau ceftriaxone discs tawm tsamStreptococcus pneumoniaeTsis muaj, txawm li cas los xij, cais tawm ntawm pneumococci nrog oxacillin cheeb tsam thaj tsam ntawm> 20 mm yog qhov raug (MIC ≦ 0.06 mcg / mL) rau penicillin thiab tuaj yeem suav tias muaj kev cuam tshuam rau ceftriaxone.Streptococcus pneumoniaeKev cais tawm yuav tsum tsis txhob tshaj tawm tias yog penicillin (ceftriaxone) resistant lossis nruab nrab ntawm ib qho oxacillin cheeb tsam ntawm ≦ 19 mm. Ceftriaxone MIC yuav tsum tau txiav txim siab rau cov kev sib cais nrog oxacillin cheeb tsam diameters ≦ 19 mm.
Enterobacteriaceae * ≦ 1 ob ≧4 23 20-22 ≦19
Hemophilus influenzae , ≦2 - - ≧26 - -
Neisseria gonorrhoeae muaj * ≦ 0.25 - - ≧ 35 - -
Neisseria meningitidis ≦ 0.12 - - ≧ 34 - -
Streptococcus pneumoniae § meningitis cais tawm ≦ 0.5 ib ≧ 2 - - -
Streptococcus pneumoniae § non-meningitis cais ≦1 ob ≧4 - - -
Streptococcuspawg beta-hemolytic ≦ 0.5 - - ≧ 24 - -
Viridans pab pawg streptococci ≦ 1 ob ≧ 4 ≧ 27 25-26 ≦24
Cov kab mob anaerobic (agar method) ≦ 1 ob ≧ 4 - - -

Susceptibility ntawm staphylococci rau ceftriaxone yuav raug txiav tawm los ntawm kev sim tsuas yog penicillin thiab cefoxitin lossis oxacillin.

Ib tsab ntawv ceeb toom ntawmRaug mobqhia tau hais tias cov tshuaj tiv thaiv kab mob zoo li yuav inhibit qhov kev loj hlob ntawm cov kab mob yog tias cov tshuaj tiv thaiv kab mob nce mus txog qhov concentration ntawm qhov chaw kis kab mob. Ib tsab ntawv ceeb toom ntawmNruab nrabqhia tias qhov tshwm sim yuav tsum raug suav hais tias yog qhov sib npaug, thiab yog tias cov kab mob tsis tuaj yeem ua rau muaj kev cuam tshuam rau lwm txoj kev kho mob, cov tshuaj yuav tsum tau rov ua dua. Cov pawg no qhia txog kev siv tshuaj kho mob hauv lub cev qhov chaw uas cov tshuaj muaj lub cev muaj zog los yog nyob rau hauv cov xwm txheej uas siv cov tshuaj ntau npaum li cas. Pawg no tseem muab thaj chaw tsis muaj kev tiv thaiv me me uas tsis muaj peev xwm tswj tau los ntawm kev ua rau muaj qhov sib txawv loj hauv kev txhais lus. Ib tsab ntawv ceeb toom ntawmResistantqhia tau hais tias cov tshuaj tua kab mob tsis zoo yuav cuam tshuam kev loj hlob ntawm cov kab mob yog tias cov tshuaj tiv thaiv kab mob nce mus txog qhov ntau ntawm cov tshuaj feem ntau ua tiav ntawm qhov chaw kis kab mob; lwm yam kev kho mob yuav tsum tau xaiv.

Kev Tswj Xyuas Zoo:

Standardized susceptibility test cov txheej txheem yuav tsum tau siv lub chaw soj nstuam tswj xyuas thiab xyuas kom meej qhov tseeb thiab precision ntawm cov khoom siv thiab reagents siv nyob rau hauv lub assay, thiab cov tswv yim ntawm tus neeg ua qhov kev xeem.1, 2, 3, 4. Tus qauv ceftriaxone hmoov yuav tsum muab cov nram qab no ntau yam ntawm MIC qhov tseem ceeb sau tseg hauv Table 6 . Rau cov txheej txheem diffusion siv 30 mcg disk, cov txheej txheem hauv Table 6 yuav tsum tau ua tiav.

Table 6 Txais Kev Tswj Xyuas Qhov Zoo rau Ceftriaxone
QC lim Yam tsawg kawg Inhibitory Concentrations
(mcg / ml)
Disk Diffusion Zone diameters
(mm)
Escherichia coli ATCC25922 ib 0.03-0.12 Nws 29-35 : kuv
Staphylococcus aureus ATCC 25923 ------------ 22-28 : kuv
Staphylococcus aureus ATCCib 29213 1–8 ----------
Haemophilus influenzae ATCC49247 ib 0.06-0.25 Nws 31-39 : kuv
Neisseria gonorrhoeae ATCC49226 ib 0.004-0.015 Nws 39-51 : kuv
Pseudomonas aeruginosa ATCC 27853 8-64 17-23
Streptococcus pneumoniae ATCC49619 ib 0.03-0.12 Nws 30-35 : kuv
Bacteroides fragilis ATCC25285 (Agar Method) 32-128 : kuv ----------
Bacteroides thetaiotaomicron ATCC29741 (txuas ntxiv) 64–256 : kuv ----------

Kev taw qhia thiab kev siv rau Rocephin

Ua ntej muab kev kho mob nrog Rocephin, cov qauv tsim nyog yuav tsum tau muab rau kev sib cais ntawm cov kab mob uas ua rau muaj kab mob thiab txiav txim siab ntawm nws qhov cuam tshuam rau cov tshuaj. Kev kho mob yuav raug tsim ua ntej tau txais cov txiaj ntsig ntawm kev kuaj mob.

Txhawm rau txo qhov kev loj hlob ntawm cov kab mob tiv thaiv kab mob thiab tswj cov txiaj ntsig ntawm Rocephin thiab lwm yam tshuaj tua kab mob, Rocephin yuav tsum tau siv tsuas yog los kho lossis tiv thaiv kev kis kab mob uas muaj pov thawj los yog xav tias yuav tshwm sim los ntawm cov kab mob uas raug mob. Thaum cov kab lis kev cai thiab cov ntaub ntawv cuam tshuam muaj, lawv yuav tsum tau txiav txim siab hauv kev xaiv lossis hloov kho cov kab mob tua kab mob. Thaum tsis muaj cov ntaub ntawv no, kev kis kab mob hauv zos thiab cov qauv kev puas tsuaj tuaj yeem ua rau muaj kev xaiv empiric ntawm kev kho.

Rocephin yog qhia rau kev kho mob ntawm cov kab mob hauv qab no thaum tshwm sim los ntawm cov kab mob uas raug:

QHOV CHAW UA HAUJ LWM QHOV CHAW UA HAUJ LWMtshwm sim los ntawmStreptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilislos yogSerratia marcescens

ACUTE BACTERIAL OTITIS Mediatshwm sim los ntawmStreptococcus mob ntsws, Hemophilus influenzae(xws li beta-lactamase ua hom kab mob) lossisMoraxella catarrhalis(xws li beta-lactamase ua hom kab mob).

CEEB TOOM: Nyob rau hauv ib txoj kev tshawb fawb kev kho mob qis dua tau pom nrog ib koob tshuaj Rocephin piv rau 10 hnub ntawm kev kho qhov ncauj. Hauv kev tshawb fawb thib ob uas sib piv cov nqi kho tau raug pom ntawm ib koob tshuaj Rocephin thiab tus sib piv. Qhov muaj peev xwm txo qis kev kho mob ntawm Rocephin yuav tsum sib npaug tiv thaiv cov txiaj ntsig zoo ntawm kev kho parenteral (saib Kev Kawm Kho Mob ).

Cov tawv nqaij thiab tawv nqaij kab mob sib kistshwm sim los ntawmStaphylococcus aureus, Staphylococcus epidermidis, kab mob Streptococcus pyogenes, Viridans pawg streptococci,Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, ib Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis ib los yogPeptostreptococcushom.

QHOV CHAW UA HAUJ LWM INFECTIONS (teeb meem thiab tsis nyuaj)tshwm sim los ntawmEscherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganiilos yogKlebsiella pneumoniae.

TSIS TXAUS SIAB GONORRHEA (cervical/urethral and rectal)tshwm sim los ntawmNeisseria gonorrhoeae,suav nrog ob hom penicillinase- thiab nonpenicillinase-ua hom, thiab pharyngeal gonorrhea tshwm sim los ntawm nonpenicillinase-ua hom ntawmNeisseria gonorrhoeae muaj.

PELVIC INFLAMMATORY DISEASEtshwm sim los ntawmNeisseria gonorrhoeae muaj.Rocephin, zoo li lwm yam cephalosporins, tsis muaj kev tawm tsamChlamydia trachomatis. Yog li ntawd, thaum cephalosporins siv rau hauv kev kho mob ntawm cov neeg mob pelvic inflammatory kab mob thiabChlamydia trachomatisyog ib qho ntawm cov kab mob uas xav tias muaj kab mob, qhov tsim nyog cov tshuaj tiv thaiv kab mob yuav tsum tau ntxiv.

BACTERIAL SEPTICEMIAtshwm sim los ntawmStaphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzaelos yogKlebsiella pneumoniae.

Pob txha thiab sib koom ua ke kab mobtshwm sim los ntawmStaphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniaelos yogEnterobacterhom.

INTRA-ABDOMINAL INFECTIONStshwm sim los ntawmEscherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridiumhom (Ceeb toom: feem ntau hom ntawmClostridium difficileyog resistant) los yogPeptostreptococcushom.

MENINGITIStshwm sim los ntawmHaemophilus influenzae, Neisseria meningitidislos yogStreptococcus pneumoniaeRocephin kuj tau siv tau zoo nyob rau hauv tsawg tus neeg mob ntawm meningitis thiab shunt kis los ntawmStaphylococcus epidermidis ib thiabEscherichia coli. ib

ib
Kev ua tau zoo rau cov kab mob no hauv cov kab mob hauv nruab nrog cev tau kawm hauv tsawg dua kaum kab mob.

SURGICAL PROPHYLAXIS

Kev tswj hwm ua ntej ntawm ib koob tshuaj 1 gm ntawm Rocephin tuaj yeem txo qhov tshwm sim ntawm cov kab mob tom qab phais hauv cov neeg mob uas tau txais cov txheej txheem phais cais raws li cov kab mob sib kis los yog muaj feem cuam tshuam (xws li,Qhov chaw mos los yog lub plab hysterectomy los yog cholecystectomy rau cov kab mob cholecystitis nyob rau hauv cov neeg mob uas muaj kev pheej hmoo siab, xws li cov neeg muaj hnub nyoog tshaj 70 xyoo, nrog mob cholecystitis tsis xav tau kev kho mob antimicrobial, obstructive jaundice los yog kab mob duct bile pob zeb) thiab nyob rau hauv cov neeg mob uas phais mob. qhov chaw ua haujlwm yuav muaj kev pheej hmoo loj (xws li,thaum lub sij hawm coronary artery bypass phais). Txawm hais tias Rocephin tau pom tias muaj txiaj ntsig zoo li cefazolin hauv kev tiv thaiv kev kis kab mob tom qab kev phais mob hlab ntsha tawg, tsis muaj kev sim tshuaj placebo los ntsuas cov tshuaj tua kab mob cephalosporin hauv kev tiv thaiv kab mob tom qab kev phais mob plawv.

Thaum muab tshuaj ua ntej cov txheej txheem phais uas nws tau qhia, ib koob tshuaj 1 gm ntawm Rocephin muab kev tiv thaiv los ntawm feem ntau cov kab mob vim yog cov kab mob raug mob thoob plaws hauv cov txheej txheem.

Contraindications

Mob siab heev

Rocephin yog contraindicated nyob rau hauv cov neeg mob uas paub hypersensitivity rau ceftriaxone, ib yam ntawm nws excipients los yog rau lwm yam cephalosporin. Cov neeg mob uas yav dhau los hypersensitivity tshwm sim rau penicillin thiab lwm yam beta lactam antibacterial agents tej zaum yuav muaj kev pheej hmoo siab ntawm hypersensitivity rau ceftriaxone (saib CEEB TOOM – Hypersensitivity ).

Neonates

Premature neonates

Rocephin yog contraindicated nyob rau hauv cov me nyuam yug ntxov ntxov mus txog rau lub hnub nyoog postmenstrual ntawm 41 lub lis piam (hnub nyoog gestational + chronological hnub nyoog).

Hyperbilirubinemic neonates

Hyperbilirubinemic neonates yuav tsum tsis txhob kho nrog Rocephin. Ceftriaxone tuaj yeem hloov bilirubin los ntawm nws txoj kev khi rau cov ntshav albumin, ua rau muaj kev pheej hmoo ntawm bilirubin encephalopathy hauv cov neeg mob no.

Neonates Xav Tau Calcium Muaj IV Solutions

Rocephin yog contraindicated nyob rau hauv neonates (≦ 28 hnub) yog hais tias lawv xav tau (los yog xav kom yuav tsum tau) kev kho mob nrog calcium uas muaj IV kev daws teeb meem, nrog rau tas li calcium uas muaj infusions xws li parenteral khoom noj khoom haus vim muaj kev pheej hmoo ntawm nag lossis daus ntawm ceftriaxone-calcium (saib CLINICAL PHARMACOLOGY , CEEB TOOM thiab KEV PAB CUAM THIAB KEV PAB CUAM ).

Cov xwm txheej ntawm qhov tshwm sim tuag nyob rau hauv uas cov khoom siv crystalline tau pom nyob rau hauv lub ntsws thiab lub raum ntawm kev txiav txim siab tau raug tshaj tawm hauv cov menyuam mos uas tau txais Rocephin thiab cov kua dej uas muaj calcium. Hauv qee qhov ntawm cov xwm txheej no, tib txoj kab kev txhaj tshuaj tau siv rau ob qho tib si Rocephin thiab calcium uas muaj cov kua dej thiab hauv qee qhov precipitate tau pom nyob rau hauv cov kab mob infusion. Tsis muaj cov ntawv ceeb toom zoo sib xws hauv cov neeg mob uas tsis yog cov menyuam yaus.

Lidocaine

Intravenous tswj ntawm ceftriaxone daws uas muaj lidocaine yog contraindicated. Thaum cov tshuaj lidocaine siv los ua cov kuab tshuaj nrog ceftriaxone rau kev txhaj tshuaj intramuscular, tsis suav tag nrho cov contraindications rau lidocaine. Xa mus rau cov ntaub ntawv sau tshuaj ntawm lidocaine.

Ceeb toom

Hypersensitivity Reactions

Ua ntej kev kho nrog Rocephin yog tsim los, yuav tsum tau ua tib zoo nug los txiav txim seb tus neeg mob puas tau muaj cov tshuaj tiv thaiv kab mob yav dhau los rau cephalosporins, penicillins thiab lwm yam tshuaj beta-lactam lossis lwm yam tshuaj. Cov khoom no yuav tsum tau ceev faj rau penicillin thiab lwm tus neeg mob beta-lactam-sensitive. Cov tshuaj tua kab mob yuav tsum tau muab nrog ceev faj rau txhua tus neeg mob uas tau pom tias muaj qee yam kev ua xua, tshwj xeeb tshaj yog rau cov tshuaj. Kev mob hnyav hnyav heev yuav tsum tau siv cov subcutaneous epinephrine thiab lwm yam kev ntsuas kub ceev.

Raws li nrog rau tag nrho cov tshuaj tua kab mob beta-lactam, qhov tshwm sim loj thiab qee zaus ua rau tuag taus (piv txwv li, anaphylaxis) tau tshaj tawm. Nyob rau hauv cov ntaub ntawv ntawm hypersensitivity tshwm sim heev, kev kho mob nrog ceftriaxone yuav tsum tau txiav tam sim ntawd thiab yuav tsum tau pib kev ntsuas kub txaus.

Kev sib tham nrog cov khoom uas muaj calcium

Tsis txhob siv cov diluents uas muaj calcium, xws li Ringer's solution los yog Hartmann's solution, kom rov ua dua Rocephin vials los yog ntxiv dilute ib reconstituted vial rau IV kev tswj hwm vim hais tias ib tug precipitate tuaj yeem tsim. Kev nag lossis daus ntawm ceftriaxone-calcium tuaj yeem tshwm sim thaum Rocephin sib xyaw nrog cov tshuaj calcium uas muaj nyob hauv tib txoj kab kev tswj hwm IV. Rocephin yuav tsum tsis txhob noj ib txhij nrog calcium uas muaj IV cov kev daws teeb meem, suav nrog cov calcium uas muaj cov infusions tas li xws li cov khoom noj khoom haus parenteral ntawm Y-site. Txawm li cas los xij, hauv cov neeg mob uas tsis yog neonates, Rocephin thiab calcium uas muaj cov kev daws teeb meem yuav raug muab coj los ua ke ntawm ib leeg yog tias cov kab infusion raug ntxuav kom huv ntawm cov dej sib xyaw nrog cov kua dej sib xws. Cov kev tshawb fawb hauv vitro siv cov neeg laus thiab cov menyuam mos ntshav ntshav los ntawm cov hlab ntsha hauv cov hlab ntsha qhia tau tias cov menyuam mos muaj kev pheej hmoo siab los ntawm nag lossis daus ntawm ceftriaxone-calcium (saib CLINICAL PHARMACOLOGY , CONTRAINDICATIONS thiab KEV PAB CUAM THIAB KEV PAB CUAM ).

Clostridium difficile - Cov kab mob sib kis

Clostridium difficileKev mob raws plab (CDAD) tau raug tshaj tawm nrog kev siv ze li ntawm txhua yam tshuaj tua kab mob, suav nrog Rocephin, thiab tej zaum yuav muaj qhov hnyav los ntawm mob raws plab me me mus rau qhov mob plab tuag. Kev kho mob nrog cov tshuaj tua kab mob hloov pauv qhov qub flora ntawm txoj hnyuv ua rau overgrowth ntawmC. nyuaj.

C. nyuajtsim cov co toxins A thiab B uas pab txhawb kev txhim kho CDAD. Hypertoxin tsim cov kab mobC. nyuajua rau muaj kev mob hnyav ntxiv thiab kev tuag, vim tias cov kab mob no tuaj yeem ua rau cov tshuaj tua kab mob thiab yuav tsum tau colectomy. CDAD yuav tsum raug txiav txim siab hauv txhua tus neeg mob uas muaj mob raws plab tom qab siv tshuaj tua kab mob. Ua tib zoo saib xyuas keeb kwm yog tsim nyog txij li CDAD tau tshaj tawm tias tshwm sim ntau tshaj li ob lub hlis tom qab kev tswj hwm cov tshuaj tua kab mob.

Yog tias CDAD xav tias lossis paub tseeb, kev siv tshuaj tua kab mob txuas ntxiv tsis qhia tawm tsamC. nyuajtej zaum yuav tsum tau txiav tawm. Tsim nyog kua thiab electrolyte tswj, protein supplementation, tshuaj tua kab mob ntawmC. nyuaj, thiab kev soj ntsuam kev phais yuav tsum tau teeb tsa raws li kws kho mob qhia.

Hemolytic Anemia

Cov tshuaj tiv thaiv kab mob hemolytic anemia tau pom nyob rau hauv cov neeg mob uas tau txais cephalosporin cov tshuaj tua kab mob xws li Rocephin. Cov mob hnyav ntawm hemolytic anemia, suav nrog cov neeg tuag, tau raug tshaj tawm thaum kho ob tus neeg laus thiab menyuam yaus. Yog tias tus neeg mob muaj ntshav qab zib thaum nyob rau ntawm ceftriaxone, kev kuaj mob ntawm cephalosporin txuam nrog anemia yuav tsum tau txiav txim siab thiab ceftriaxone nres kom txog thaum lub etiology raug txiav txim.

Cov kev ceev faj

Kev loj hlob ntawm Tshuaj-resistant kab mob

Kev sau tshuaj Rocephin thaum tsis muaj pov thawj los yog xav tias muaj kab mob loj heev los yog cov tshuaj tiv thaiv kab mob tsis zoo yuav muab txiaj ntsig rau tus neeg mob thiab ua rau muaj kev pheej hmoo ntawm kev txhim kho cov kab mob tshuaj tiv thaiv kab mob. Kev siv Rocephin ntev ntev tuaj yeem ua rau muaj kev loj hlob ntawm cov kab mob uas tsis muaj kev cuam tshuam. Ua tib zoo saib tus neeg mob yog qhov tseem ceeb. Yog tias superinfection tshwm sim thaum kho, kev ntsuas tsim nyog yuav tsum tau ua.

Cov neeg mob uas muaj lub raum tsis zoo los yog mob siab

Ceftriaxone raug tso tawm los ntawm ob qho tib si biliary thiab lub raum excretion (saib CLINICAL PHARMACOLOGY ). Yog li, cov neeg mob lub raum tsis ua haujlwm ib txwm yuav tsum tsis muaj kev hloov pauv hauv cov koob tshuaj thaum noj tshuaj Rocephin li niaj zaus.

Kev hloov tshuaj yuav tsum tsis tsim nyog rau cov neeg mob uas muaj lub siab ua haujlwm tsis zoo; Txawm li cas los xij, nyob rau hauv cov neeg mob uas muaj ob lub raum tsis ua haujlwm thiab mob raum tseem ceeb, yuav tsum tau ceev faj thiab siv Rocephin yuav tsum tsis pub tshaj 2 gm ib hnub.

Ceftriaxone tsis raug tshem tawm los ntawm peritoneal- lossis hemodialysis. Hauv cov neeg mob uas tau lim ntshav tsis tas yuav tsum tau txhaj tshuaj ntxiv tom qab lim ntshav. Hauv cov neeg mob uas muaj ob lub raum hnyav thiab lub siab ua haujlwm tsis zoo, kev soj ntsuam ze rau kev nyab xeeb thiab kev ua tau zoo yog qhia.

Cov nyhuv ntawm Prothrombin Sijhawm

Kev hloov pauv hauv lub sijhawm prothrombin tau tshwm sim hauv cov neeg mob kho nrog Rocephin. Saib xyuas lub sijhawm prothrombin thaum kho Rocephin hauv cov neeg mob uas tsis muaj vitamin K synthesis lossis cov khw muag khoom vitamin K tsawg (xws li, kab mob siab ntev thiab tsis muaj zaub mov noj). Kev tswj hwm vitamin K (10 mg txhua lub lim tiam) yuav tsim nyog yog tias lub sijhawm prothrombin ntev ua ntej lossis thaum kho.

Kev siv cov ceftriaxone nrog vitamin K antagonists tuaj yeem ua rau muaj kev pheej hmoo los ntshav. Cov kev txwv tsis pub coagulation yuav tsum tau saib xyuas ntau zaus, thiab cov koob tshuaj anticoagulant hloov raws li, ob qho tib si thaum thiab tom qab kho nrog ceftriaxone (saib TXOJ CAI TSHIAB ).

Pseudolithiasis ntawm lub gallbladder

Ceftriaxone-calcium precipitates nyob rau hauv lub gallbladder tau pom nyob rau hauv cov neeg mob uas tau txais Rocephin. Cov precipitates no tshwm sim ntawm sonography raws li ib tug ncha tsis muaj acoustical shadowing qhia sludge los yog raws li ib tug ncha nrog acoustical shadowing uas tej zaum yuav misinterpreted raws li gallstones. Qhov tshwm sim ntawm cov precipitates zoo li yog qhov loj tshaj plaws hauv cov neeg mob menyuam yaus. Cov neeg mob tej zaum yuav asymptomatic lossis tuaj yeem tsim cov tsos mob ntawm tus kab mob gallbladder. Cov xwm txheej zoo li yuav rov qab los thaum txiav tawm ntawm ceftriaxone sodium thiab lub koom haum ntawm kev tswj hwm kev saib xyuas. Tso tseg ceftriaxone sodium hauv cov neeg mob uas tsim cov tsos mob thiab cov tsos mob qhia txog kab mob gallbladder thiab/los yog cov kev tshawb pom sonographic tau piav qhia saum toj no.

Urolithiasis thiab Post-Renal Acute Renal Failure

Ceftriaxone-calcium precipitates nyob rau hauv lub urinary ib ntsuj av tau pom nyob rau hauv cov neeg mob uas tau txais Rocephin thiab tej zaum yuav kuaj tau raws li sonographic txawv txav. Qhov tshwm sim ntawm cov precipitates zoo li yog qhov loj tshaj plaws hauv cov neeg mob menyuam yaus. Cov neeg mob yuav muaj asymptomatic lossis tuaj yeem tsim cov tsos mob ntawm urolithiasis, thiab ureteral obstruction thiab tom qab lub raum mob raum tsis ua haujlwm. Cov xwm txheej zoo li yuav rov qab los thaum txiav tawm ntawm ceftriaxone sodium thiab lub chaw tswj hwm tsim nyog. Xyuas kom muaj dej txaus rau cov neeg mob tau txais Rocephin. Txiav Rocephin rau cov neeg mob uas tsim cov tsos mob thiab cov tsos mob qhia txog urolithiasis, oliguria lossis lub raum tsis ua haujlwm thiab / lossis cov kev tshawb pom sonographic tau piav qhia saum toj no.

Pancreatitis

Cov neeg mob ntawm tus mob pancreatitis, tejzaum nws thib ob rau biliary obstruction, tau tshaj tawm hauv cov neeg mob kho nrog Rocephin. Feem ntau cov neeg mob tau nthuav tawm cov xwm txheej txaus ntshai rau biliary stasis thiab biliary sludge (ua ntej kev kho mob loj, mob hnyav, tag nrho cov khoom noj khoom haus parenteral). Lub luag haujlwm cofactor ntawm Rocephin-txog cov kua dej ua kua dej tsis tuaj yeem txiav tawm.

Cov ntaub ntawv rau cov neeg mob

  • Cov neeg mob yuav tsum tau ntuas tias cov tshuaj tua kab mob xws li Rocephin tsuas yog siv los kho cov kab mob. Lawv tsis kho cov kab mob (xws li mob khaub thuas).
  • Thaum Rocephin raug tshuaj los kho tus kab mob, cov neeg mob yuav tsum tau qhia tias txawm hais tias nws yog ib qho kev xav zoo thaum ntxov ntawm txoj kev kho, cov tshuaj yuav tsum tau noj raws nraim li qhia. Kev hla koob tshuaj lossis tsis ua tiav tag nrho cov kev kho mob tuaj yeem (1) txo qhov ua tau zoo ntawm kev kho tam sim ntawd thiab (2) ua rau kom cov kab mob tuaj yeem tiv taus thiab yuav tsis kho los ntawm Rocephin lossis lwm yam tshuaj tua kab mob yav tom ntej.
  • Kev mob raws plab yog ib qho teeb meem tshwm sim los ntawm cov tshuaj tua kab mob uas feem ntau xaus thaum cov tshuaj tua kab mob txiav tawm. Qee zaum tom qab pib kho cov tshuaj tua kab mob, cov neeg mob tuaj yeem tsim cov quav dej thiab cov ntshav (nrog lossis tsis muaj mob plab thiab ua npaws) txawm tias lig li ob lossis ntau lub hlis tom qab noj cov tshuaj tua kab mob kawg. Yog tias qhov no tshwm sim, cov neeg mob yuav tsum hu rau lawv tus kws kho mob sai li sai tau.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Xav txog qhov ntev tshaj plaws ntawm kev kho mob thiab cov chav kawm ntawm cov tshuaj, kev tshawb fawb carcinogenicity nrog ceftriaxone hauv cov tsiaj tsis tau ua. Lub sijhawm ntev tshaj plaws ntawm kev tshawb fawb tsiaj toxicity yog 6 lub hlis.

Mutagenesis

Kev kuaj tshuaj toxicology suav nrog Ames kuaj, kuaj micronucleus thiab kuaj rau chromosomal aberrations hauv tib neeg lymphocytes kab lis kev cai hauv vitro nrog ceftriaxone. Ceftriaxone tsis pom muaj peev xwm ua rau mutagenic hauv cov kev tshawb fawb no.

Kev puas tsuaj ntawm Fertility

Ceftriaxone ua rau tsis muaj kev cuam tshuam ntawm kev xeeb tub thaum muab tso rau hauv cov nas ntawm cov koob tshuaj txhua hnub txog li 586 mg / kg / hnub, kwv yees li 20 npaug ntawm cov tshuaj pom zoo ntawm 2 gm / hnub.

Kev xeeb tub

Cov teebmeem teratogenic

Cev xeeb tub qeb B

Kev tshawb fawb txog kev yug me nyuam tau ua nyob rau hauv nas thiab nas ntawm koob tshuaj txog li 20 npaug ntawm tib neeg koob tshuaj thiab tsis muaj pov thawj ntawm embryotoxicity, fetotoxicity lossis teratogenicity. Hauv primates, tsis muaj embryotoxicity lossis teratogenicity tau pom ntawm koob tshuaj kwv yees li 3 npaug ntawm tib neeg koob tshuaj.

Txawm li cas los xij, tsis muaj kev tshawb fawb txaus thiab tswj tau zoo hauv cov poj niam cev xeeb tub. Vim tias kev tshawb fawb txog kev yug tsiaj tsis yog ib txwm kwv yees ntawm tib neeg cov lus teb, cov tshuaj no yuav tsum tau siv thaum cev xeeb tub tsuas yog xav tau kom meej.

Cov teebmeem Nonteratogenic

Hauv cov nas, hauv ntu I (kev xeeb tub thiab kev loj hlob dav dav) thiab ntu III (perinatal thiab postnatal) kev tshawb fawb nrog cov tshuaj ceftriaxone intravenously, tsis muaj qhov cuam tshuam tsis zoo rau ntau yam kev xeeb tub thaum cev xeeb tub thiab lactation, suav nrog kev loj hlob tom qab yug me nyuam, kev coj cwj pwm ua haujlwm thiab kev muaj peev xwm ua rau me nyuam. ntawm cov xeeb ntxwv, ntawm koob tshuaj 586 mg / kg / hnub lossis tsawg dua.

Niam laus

Tsawg concentrations ntawm ceftriaxone raug tso tawm hauv tib neeg cov kua mis. Kev ceev faj yuav tsum tau siv thaum Rocephin muab rau tus poj niam laus.

Kev siv menyuam yaus

Kev nyab xeeb thiab kev ua tau zoo ntawm Rocephin hauv cov menyuam mos, cov menyuam mos thiab cov neeg mob menyuam yaus tau raug tsim los rau cov koob tshuaj uas tau piav qhia hauv KEV PAB CUAM THIAB KEV PAB CUAM ntu. Cov kev tshawb fawb hauv vitro tau pom tias ceftriaxone, zoo li qee qhov lwm yam cephalosporins, tuaj yeem hloov bilirubin los ntawm cov ntshav albumin. Rocephin yuav tsum tsis txhob noj rau cov menyuam yaus hyperbilirubinemic, tshwj xeeb tshaj yog ntxov ntxov (saib CONTRAINDICATIONS ).

Kev siv Geriatric

Ntawm tag nrho cov kev kawm hauv kev tshawb fawb soj ntsuam ntawm Rocephin, 32% yog 60 thiab tshaj. Tsis muaj qhov sib txawv ntawm kev nyab xeeb lossis kev ua tau zoo ntawm cov kev kawm no thiab cov tub ntxhais hluas, thiab lwm yam kev paub txog kev kho mob tsis tau txheeb xyuas qhov sib txawv ntawm cov lus teb ntawm cov neeg laus thiab cov neeg mob hluas, tab sis qhov rhiab heev ntawm qee cov neeg laus tsis tuaj yeem txiav tawm.

pom zoo txhua hnub koob tshuaj qhiav

Cov tshuaj pharmacokinetics ntawm ceftriaxone tsuas yog hloov pauv me ntsis hauv cov neeg mob laus dua piv rau cov neeg laus noj qab haus huv thiab kev hloov kho ntau npaum li cas tsis tsim nyog rau cov neeg mob laus uas muaj ceftriaxone ntau npaum li 2 grams tauj ib hnub yog tias tsis muaj lub raum tsis zoo thiab mob siab. (saib CLINICAL PHARMACOLOGY ).

Kev cuam tshuam ntawm Kev Ntsuas Kev Ntsuas

Hauv cov neeg mob kho nrog Rocephin, Coombs qhov kev sim yuav ua tau zoo. Rocephin, zoo li lwm yam tshuaj tua kab mob, tuaj yeem ua rau muaj txiaj ntsig zoo rau galactosemia.

Cov txheej txheem nonenzymatic rau kev txiav txim siab cov piam thaj hauv cov zis tuaj yeem muab cov txiaj ntsig tsis zoo. Vim li no, kev txiav txim siab tso zis-qabzib thaum kho nrog Rocephin yuav tsum tau ua tiav enzymatically.

Lub xub ntiag ntawm ceftriaxone tuaj yeem ua rau txo qis qhov ntsuas ntshav qabzib uas tau txais nrog qee qhov ntsuas ntshav qabzib. Thov xa mus rau cov lus qhia siv rau txhua qhov system. Lwm txoj kev sim yuav tsum tau siv yog tias tsim nyog.

Kev Phem Tsis Zoo

Rocephin feem ntau zam tau zoo. Hauv kev sim tshuaj ntsuam xyuas, cov kev cuam tshuam tsis zoo hauv qab no, uas tau pom tias muaj feem cuam tshuam nrog kev kho Rocephin lossis tsis paub tseeb etiology, tau pom:

LOCAL REACTIONS- mob, induration thiab rhiab heev yog 1% tag nrho. Phlebitis tau tshaj tawm hauv<1% after IV administration. The incidence of warmth, tightness or induration was 17% (3/17) after IM administration of 350 mg/mL and 5% (1/20) after IM administration of 250 mg/mL.

KEV PAB CUAM KEV PAB CUAM THIAB KEV PAB CUAM KEV PAB CUAM- txhaj tshuaj qhov chaw mob (0.6%).

HYPERSENSITIVITY- pob txha (1.7%). Tsawg zaus tshaj tawm (<1%) were pruritus, fever or chills.

Kab mob thiab kab mob- kab mob fungal ntawm qhov chaw mos (0.1%).

HEMATOLOGIC-eosinophilia (6%), thrombocytosis (5.1%) thiab leukopenia (2.1%). Tsawg zaus tshaj tawm (<1%) were anemia, hemolytic anemia, neutropenia, lymphopenia, thrombocytopenia and prolongation of the prothrombin time.

Ntshav thiab lymphatic mob- granulocytopenia (0.9%), coagulopathy (0.4%).

GASTROINTESTINAL- raws plab / quav quav (2.7%). Tsawg zaus tshaj tawm (<1%) were nausea or vomiting, and dysgeusia. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see CEEB TOOM ).

HEPATIC- nce aspartate aminotransferase (AST) (3.1%) lossis alanine aminotransferase (ALT) (3.3%). Tsawg zaus tshaj tawm (<1%) were elevations of alkaline phosphatase and bilirubin.

RENAL- nce ntawm BUN (1.2%). Tsawg zaus tshaj tawm (<1%) were elevations of creatinine and the presence of casts in the urine.

CENTRAL NERVOUS SYSTEM- mob taub hau lossis kiv taub hau tau qhia qee zaus (<1%).

GENITOURINARY-moniliasis lossis vaginitis tau qhia qee zaus (<1%).

MISCELLANEOUS-diaphoresis thiab dej ntws tawm tau qhia qee zaus (<1%).

INVESTIGATIONS- ntshav creatinine nce (0.6%).

Lwm yam tsis tshua pom muaj kev phiv tshwm sim (<0.1%) include abdominal pain, agranulocytosis, allergic pneumonitis, anaphylaxis, basophilia, biliary lithiasis, bronchospasm, colitis, dyspepsia, epistaxis, flatulence, gallbladder sludge, glycosuria, hematuria, jaundice, leukocytosis, lymphocytosis, monocytosis, nephrolithiasis, palpitations, a decrease in the prothrombin time, renal precipitations, seizures, and serum sickness.

Postmarketing Experience

Ntxiv nrog rau qhov tsis zoo tshwm sim tau tshaj tawm thaum kev sim tshuaj, cov kev paub tsis zoo hauv qab no tau tshaj tawm thaum lub sijhawm kho mob hauv cov neeg mob kho nrog Rocephin. Cov ntaub ntawv feem ntau tsis txaus los tso cai kwv yees qhov xwm txheej lossis tsim kom muaj qhov ua rau.

Ib qho me me ntawm qhov tshwm sim ntawm kev tuag nyob rau hauv uas cov khoom siv crystalline tau pom nyob rau hauv lub ntsws thiab lub raum ntawm kev txiav txim siab tau raug tshaj tawm hauv cov menyuam mos uas tau txais Rocephin thiab cov kua dej uas muaj calcium. Hauv qee qhov ntawm cov xwm txheej no, tib txoj kab kev txhaj tshuaj tau siv rau ob qho tib si Rocephin thiab calcium uas muaj cov kua dej thiab hauv qee qhov precipitate tau pom nyob rau hauv cov kab mob infusion. Yam tsawg kawg ib tus neeg tuag tau raug tshaj tawm nyob rau hauv ib tug menyuam mos uas muaj Rocephin thiab cov kua dej calcium uas muaj nyob rau ntawm lub sijhawm sib txawv ntawm cov kab sib txawv; Tsis muaj cov khoom siv crystalline tau pom ntawm kev tuag hauv lub cev xeeb tub no. Tsis muaj cov ntawv ceeb toom zoo sib xws hauv cov neeg mob uas tsis yog cov menyuam yaus.

GASTROINTESTINAL- pancreatitis, stomatitis thiab glossitis.

GENITOURINARY- oliguria, ureteric obstruction, tom qab lub raum mob raum tsis ua haujlwm.

DERMATOLOGIC -exanthema, allergic dermatitis, urticaria, edema; Cov kab mob kis tau zoo tshaj plaws exanthematous pustulosis (AGEP) thiab cais cov neeg mob ntawm cov tawv nqaij tsis zoo (erythema multiforme, Stevens-Johnson syndrome lossis Lyell's syndrome / toxic epidermal necrolysis) tau tshaj tawm.

HEMATOLOGICAL CHANGES- Kab mob sib cais ntawm agranulocytosis (<500/mm3) tau tshaj tawm, feem ntau ntawm lawv tom qab 10 hnub ntawm kev kho mob thiab tom qab tag nrho cov koob tshuaj 20 g lossis ntau dua.

NERVOUS SYSTEM DISORDERS- mob taub hau

LWM HAIV NEEG, Kev tsis zoo tshwm sim- symptomatic nag lossis daus ntawm ceftriaxone calcium ntsev nyob rau hauv lub gallbladder, kernicterus, oliguria, thiab anaphylactic los yog anaphylactoid cov tshuaj tiv thaiv.

Cephalosporin Class Adverse Reactions

Ntxiv nrog rau cov kev tsis zoo uas tau teev tseg saum toj no uas tau pom nyob rau hauv cov neeg mob kho nrog ceftriaxone, cov kev tshwm sim tsis zoo hauv qab no thiab cov txiaj ntsig ntawm kev sim hloov pauv tau raug tshaj tawm rau cov tshuaj tua kab mob cephalosporin:

Kev Tsis Pom Zoo:Kev tsis haum tshuaj, ua npaws tshuaj, cov tshuaj tiv thaiv kab mob zoo li, lub raum tsis ua haujlwm, tshuaj lom nephropathy, thim rov qab hyperactivity, hypertonia, lub siab tsis ua haujlwm xws li cholestasis, aplastic anemia, hemorrhage, thiab superinfection.

Hloov Cov Kev Ntsuas Kev Ntsuas:Kev kuaj pom zoo ncaj qha Coombs, kuaj tsis tseeb-zoo rau cov piam thaj hauv zis, thiab nce LDH (saib COV KEV CEEV FAJ ).

Ob peb cephalosporins tau cuam tshuam rau qhov ua rau qaug dab peg, tshwj xeeb tshaj yog nyob rau hauv cov neeg mob lub raum tsis zoo thaum noj tshuaj tsis txo qis (saib KEV PAB CUAM THIAB KEV PAB CUAM ). Yog tias qaug dab peg cuam tshuam nrog kev kho tshuaj, cov tshuaj yuav tsum tau txiav. Kev kho mob anticonvulsant tuaj yeem muab tau yog tias kho tau.

Kev noj ntau dhau

Nyob rau hauv cov ntaub ntawv ntawm overdosage, tshuaj concentration yuav tsis txo los ntawm hemodialysis los yog peritoneal dialysis. Tsis muaj tshuaj tiv thaiv tshwj xeeb. Kev kho mob ntawm overdosage yuav tsum yog cov tsos mob.

Rocephin Dosage and Administration

Rocephin tej zaum yuav tau txhaj tshuaj intravenously lossis intramuscularly.

Tsis txhob siv cov diluents uas muaj calcium, xws li Ringer's solution los yog Hartmann's solution, kom rov ua dua Rocephin vials los yog ntxiv dilute ib reconstituted vial rau IV kev tswj hwm vim hais tias ib tug precipitate tuaj yeem tsim. Kev nag lossis daus ntawm ceftriaxone-calcium tuaj yeem tshwm sim thaum Rocephin sib xyaw nrog cov tshuaj calcium uas muaj nyob hauv tib txoj kab kev tswj hwm IV. Rocephin yuav tsum tsis txhob noj ib txhij nrog calcium uas muaj IV cov kev daws teeb meem, suav nrog cov calcium uas muaj cov infusions tas li xws li cov khoom noj khoom haus parenteral ntawm Y-site. Txawm li cas los xij, hauv cov neeg mob uas tsis yog neonates, Rocephin thiab calcium uas muaj cov kev daws teeb meem yuav raug muab coj los ua ke ntawm ib leeg yog tias cov kab infusion raug ntxuav kom huv si ntawm cov dej sib xyaw nrog cov kua dej sib xws (saib CEEB TOOM ).

Tsis muaj cov ntaub ntawv qhia txog kev sib cuam tshuam ntawm ceftriaxone thiab cov khoom noj uas muaj calcium hauv qhov ncauj lossis kev sib cuam tshuam ntawm intramuscular ceftriaxone thiab cov khoom uas muaj calcium (IV lossis qhov ncauj).

Neonates

Hyperbilirubinemic neonates, tshwj xeeb tshaj yog ntxov ntxov, yuav tsum tsis txhob kho nrog Rocephin. Rocephin yog contraindicated nyob rau hauv cov me nyuam yug ntxov ntxov (saib CONTRAINDICATIONS ).

Rocephin yog contraindicated nyob rau hauv neonates (≦ 28 hnub) yog hais tias lawv xav tau (los yog xav kom yuav tsum tau) kev kho mob nrog calcium uas muaj IV kev daws teeb meem, nrog rau tas li calcium uas muaj infusions xws li parenteral khoom noj khoom haus vim muaj kev pheej hmoo ntawm nag lossis daus ntawm ceftriaxone-calcium (saib CONTRAINDICATIONS ).

Intravenous koob tshuaj yuav tsum tau muab tshaj 60 feeb nyob rau hauv cov me nyuam mos kom txo tau txoj kev pheej hmoo ntawm bilirubin encephalopathy.

Cov neeg mob menyuam yaus

Rau kev kho mob ntawm daim tawv nqaij thiab cov kab mob ntawm daim tawv nqaij, qhov pom zoo tag nrho cov koob tshuaj txhua hnub yog 50 mus rau 75 mg / kg muab ib hnub ib zaug (lossis sib npaug sib npaug ob zaug ib hnub). Tag nrho cov koob tshuaj txhua hnub yuav tsum tsis pub tshaj 2 grams.

Rau kev kho mob ntawm tus kab mob otitis media, ib koob tshuaj intramuscular ntawm 50 mg / kg (tsis pub tshaj 1 gram) yog pom zoo (saib Kev qhia thiab kev siv ).

Rau kev kho mob ntawm lwm yam kab mob loj uas tsis yog mob meningitis, qhov pom zoo tag nrho cov koob tshuaj txhua hnub yog 50 mus rau 75 mg / kg, muab faib rau hauv koob tshuaj txhua 12 teev. Tag nrho cov koob tshuaj txhua hnub yuav tsum tsis pub tshaj 2 grams.

Hauv kev kho mob meningitis, nws raug pom zoo tias thawj koob tshuaj yog 100 mg / kg (tsis pub tshaj 4 grams). Tom qab ntawd, tag nrho cov koob tshuaj txhua hnub ntawm 100 mg / kg / hnub (tsis pub tshaj 4 grams txhua hnub) raug pom zoo. Cov koob tshuaj txhua hnub yuav raug muab tshuaj ib zaug ib hnub (lossis sib faib cov koob tshuaj sib npaug txhua 12 teev). Lub sijhawm ib txwm ntawm kev kho yog 7 mus rau 14 hnub.

tshwm sim los ntawm verapamil

Cov neeg laus

Cov neeg laus ib txwm noj txhua hnub yog 1 mus rau 2 grams muab ib hnub ib zaug (los yog sib faib sib npaug ob zaug ib hnub) nyob ntawm seb hom thiab qhov hnyav ntawm tus kab mob. Tag nrho cov koob tshuaj txhua hnub yuav tsum tsis pub tshaj 4 grams.

YogChlamydia trachomatisyog ib yam kab mob uas xav tias yuav tsum tau ntxiv cov tshuaj tiv thaiv kab mob, vim tias ceftriaxone sodium tsis muaj kev cuam tshuam rau cov kab mob no.

Rau kev kho mob ntawm cov kab mob gonococcal tsis yooj yim, ib koob tshuaj intramuscular ntawm 250 mg tau pom zoo.

Rau kev siv ua ntej (kev phais prophylaxis), ib koob tshuaj 1 gram tau muab tso rau hauv 1/2 mus rau 2 teev ua ntej kev phais raug pom zoo.

Feem ntau, kev kho Rocephin yuav tsum tau txuas ntxiv rau yam tsawg 2 hnub tom qab cov tsos mob thiab cov tsos mob ntawm tus kab mob tau ploj mus. Lub sijhawm ib txwm ntawm kev kho yog 4 mus rau 14 hnub; nyob rau hauv cov kab mob nyuaj, kev kho mob ntev yuav tsum tau.

Thaum kho kab mob los ntawmStreptococcus pyogenes muaj, kev kho yuav tsum tau txuas ntxiv rau yam tsawg kawg 10 hnub.

Tsis muaj kev hloov kho ntau npaum li cas rau cov neeg mob uas muaj lub raum tsis ua haujlwm lossis lub siab ua haujlwm siab (saib COV KEV CEEV FAJ ).

Cov koob tshuaj pom zoo rau cov neeg laus yuav tsum tsis txhob hloov pauv hauv cov neeg mob laus txog li 2 gm ib hnub twg yog tias tsis muaj lub raum tsis zoo thiab lub siab tsis zoo (saib COV KEV CEEV FAJ ).

Cov lus qhia rau kev siv

Intramuscular Administration

Rov ua dua Rocephin hmoov nrog qhov tsim nyog diluent (saib Kev sib haum xeeb thiab ruaj khov ).

Txhaj tshuaj diluent rau hauv vial, co vial kom huv si los tsim cov tshuaj. Tshem tag nrho cov ntsiab lus ntawm vial rau hauv syringe kom sib npaug tag nrho cov ntawv sau npe.

Tom qab kev kho dua tshiab, txhua 1 mL ntawm cov tshuaj muaj kwv yees li 250 mg lossis 350 mg sib npaug ntawm ceftriaxone raws li tus nqi diluent qhia hauv qab no. Yog tias xav tau, ntau cov tshuaj diluted tuaj yeem siv tau.

Raws li nrog rau tag nrho cov kev npaj intramuscular, Rocephin yuav tsum tau txhaj zoo nyob rau hauv lub cev ntawm ib tug kuj loj cov leeg; aspiration pab kom tsis txhob muaj kev txhaj tshuaj rau hauv cov hlab ntsha.

Vial Dosage Size Tus nqi ntawm Diluent yuav tsum tau ntxiv
250 mg/ml 350 mg/ml
500 mg 1.8ml ib 1.0 ml ib
1gm ua 3.6ml ib 2.1 ml ib
Intravenous Administration

Rocephin yuav tsum tau txhaj tshuaj intravenously los ntawm infusion nyob rau lub sij hawm ntawm 30 feeb, tshwj tsis yog nyob rau hauv neonates qhov twg cov thawj coj tshaj 60 feeb yog pom zoo kom txo tau qhov kev pheej hmoo ntawm bilirubin encephalopathy. Concentration ntawm 10 mg / mL thiab 40 mg / mL raug pom zoo; Txawm li cas los xij, qhov qis dua tuaj yeem siv yog tias xav tau. Rov ua dua vials nrog qhov tsim nyog IV diluent (saib Kev sib haum xeeb thiab ruaj khov ).

Vial Dosage Size Tus nqi ntawm Diluent yuav tsum tau ntxiv
500 mg 4.8ml ib
1gm ua 9.6ml ib

Tom qab rov kho dua, txhua 1 mL ntawm cov tshuaj muaj kwv yees li 100 mg sib npaug ntawm ceftriaxone. Tshem tawm tag nrho cov ntsiab lus thiab dilute mus rau qhov xav tau concentration nrog qhov tsim nyog IV diluent.

Compatibility thiab Stability

Tsis txhob siv cov tshuaj diluents uas muaj calcium, xws li Ringer's solution los yog Hartmann's solution, kom rov tsim dua Rocephin vials los yog ntxiv dilute ib lub vial rau kev tswj hwm IV. Piculate formation tuaj yeem tshwm sim.

Ceftriaxone tau pom tias sib haum nrog Flagyl®IV (metronidazole hydrochloride). Qhov concentration yuav tsum tsis txhob ntau tshaj 5 mus rau 7.5 mg / mL metronidazole hydrochloride nrog ceftriaxone 10 mg / mL raws li kev sib xyaw. Lub admixture ruaj khov rau 24 teev ntawm chav tsev kub tsuas yog hauv 0.9% sodium chloride txhaj lossis 5% dextrose hauv dej (D5W). Tsis muaj kev tshawb fawb txog kev sib raug zoo tau ua nrog Flagyl®IV RTU®(metronidazole) formulation los yog siv lwm yam diluents. Metronidazole ntawm qhov ntau dua 8 mg / mL yuav ua rau poob. Tsis txhob tso cov khoom sib xyaw ua ke vim tias nag lossis daus yuav tshwm sim.

Vancomycin, amsacrine, aminoglycosides, thiab fluconazole yog incompatible nrog ceftriaxone nyob rau hauv cov khoom xyaw. Thaum ib qho ntawm cov tshuaj no yuav tsum tau muab coj los ua ke nrog ceftriaxone los ntawm kev sib tshuam hauv cov hlab ntsha, nws raug nquahu tias lawv yuav tsum tau muab ua ntu zus, nrog rau cov kab hauv cov hlab ntsha (nrog rau ib qho ntawm cov kua dej sib xws) ntawm kev tswj hwm.

Rocephin daws yuav tsumtsis yogmuab lub cev sib xyaw nrog lossis piggybacked rau hauv cov kev daws teeb meem uas muaj lwm cov tshuaj tiv thaiv kab mob los yog rau hauv cov tshuaj diluent uas tsis yog cov teev saum toj no, vim qhov ua tsis tau zoo (saib CEEB TOOM ).

Rocephin sterile hmoov yuav tsum muab cia rau hauv chav sov -77 ° F (25 ° C) - lossis qis dua thiab tiv thaiv los ntawm lub teeb. Tom qab rov kho dua, kev tiv thaiv los ntawm lub teeb ib txwm tsis tsim nyog. Cov xim ntawm cov kev daws teeb meem yog los ntawm lub teeb daj mus rau amber, nyob ntawm qhov ntev ntawm kev cia, concentration thiab diluent siv.

RocephinintramuscularCov kev daws teeb meem nyob ruaj khov (tsis muaj zog tsawg dua 10%) rau lub sijhawm hauv qab no:

Cia
Diluent Nco ntsoov
mg/ml
Chav Temp.
(25 ° C)
Txias
(4 ° C)
Sterile Dej rau Txhaj 100
250, 350 ib
2 hnub
24 teev
10 hnub
3 hnub
0.9% Sodium Chloride Solution 100
250, 350 ib
2 hnub
24 teev
10 hnub
3 hnub
5% Dextrose daws 100
250, 350 ib
2 hnub
24 teev
10 hnub
3 hnub
Bacteriostatic Dej + 0.9% Benzyl Cawv 100
250, 350 ib
24 teev
24 teev
10 hnub
3 hnub
1% Lidocaine daws (tsis muaj epinephrine) 100
250, 350 ib
24 teev
24 teev
10 hnub
3 hnub

Rocephintxhaj tshuajCov kev daws teeb meem, ntawm qhov ntau ntawm 10, 20 thiab 40 mg / mL, nyob ruaj khov (tsis muaj zog tsawg dua 10%) rau lub sijhawm nram qab no khaws cia hauv iav lossis PVC ntim:

Cia
Diluent Chav Temp.
(25 ° C)
Txias
(4 ° C)
*
Cov ntaub ntawv muaj rau 10 mus rau 40 mg / mL concentrations hauv no diluent hauv PVC ntim nkaus xwb.
Dej tsis muaj menyuam 2 hnub 10 hnub
0.9% Sodium Chloride Solution 2 hnub 10 hnub
5% Dextrose daws 2 hnub 10 hnub
10% Dextrose daws 2 hnub 10 hnub
5% Dextrose + 0.9% Sodium Chloride Solution * 2 hnub Tsis sib haum
5% Dextrose + 0.45% Sodium Chloride Solution 2 hnub Tsis sib haum

Cov tshuaj Rocephin cov tshuaj hauv qab no tau ruaj khov ntawm chav sov (25 ° C) rau 24 teev, ntawm qhov siab ntawm 10 mg / mL thiab 40 mg / mL: Sodium Lactate (PVC thawv), 10% Invert Qab Zib ( iav thawv), 5% Sodium Bicarbonate ( iav thawv), Freamine III ( iav thawv), Normosol-M hauv 5% Dextrose ( iav thiab PVC ntim), Ionosol-B hauv 5% Dextrose ( iav thawv), 5% Mannitol ( iav thawv), 10% Mannitol (iav ntim).

Tom qab lub sijhawm ua haujlwm ruaj khov uas tau hais tseg, qhov tsis siv ntawm cov kev daws teeb meem yuav tsum raug muab pov tseg.

CEEB TOOM: Cov khoom siv tshuaj parenteral yuav tsum tau tshuaj xyuas qhov pom ntawm qhov teeb meem ua ntej kev tswj hwm.

Rocephin reconstituted nrog 5% Dextrose los yog 0.9% Sodium Chloride tov ntawm concentrations ntawm 10 mg / mL thiab 40 mg / mL, thiab ces muab cia rau hauv lub xeev khov (-20 ° C) nyob rau hauv PVC los yog polyolefin ntim, nyob ruaj khov rau 26 lub lis piam.

Frozen daws ntawm Rocephin yuav tsum tau thawed ntawm chav tsev kub ua ntej siv. Tom qab thawing, qhov tsis siv yuav tsum muab pov tseg.Tsis txhob REFREEZE.

Tsiaj Pharmacology

Concretions muaj xws li precipitated calcium ntsev ntawm ceftriaxone tau pom nyob rau hauv lub gallbladder bile ntawm dev thiab baboons kho nrog ceftriaxone.

Cov no tau tshwm sim raws li cov khib nyiab hauv cov dev uas tau txais 100 mg / kg / hnub rau 4 lub lis piam. Ib qho tshwm sim zoo sib xws tau pom nyob rau hauv baboons tab sis tsuas yog tom qab lub sij hawm ncua ntev (6 lub hlis) ntawm cov koob tshuaj ntau dua (335 mg / kg / hnub lossis ntau dua). Qhov tshwm sim ntawm qhov tshwm sim no hauv tib neeg yog suav tias yog tsawg, txij li thaum ceftriaxone muaj ntau dua plasma ib nrab-lub neej nyob rau hauv tib neeg, calcium ntsev ntawm ceftriaxone yog ntau soluble nyob rau hauv tib neeg gallbladder bile thiab cov calcium cov ntsiab lus ntawm tib neeg gallbladder bile kuj tsawg.

Rocephin muab tau li cas

Rocephin yog muab los ua cov hmoov dawb crystalline hmoov hauv iav vials. Cov pob khoom hauv qab no muaj:

Vials muaj 500 mg sib npaug ntawm ceftriaxone. Lub thawv 1 (NDC 0004-1963-02) thiab lub thawv 10 (NDC 0004-1963-01).

Vials muaj 1 gm sib npaug ntawm ceftriaxone. Lub thawv 1 (NDC 0004-1964-04) thiab lub thawv 10 (NDC 0004-1964-01).

CEEB TOOM: Rocephin sterile hmoov yuav tsum muab cia rau hauv chav tsev kub, 77 ° F (25 ° C) los yog qis dua, thiab tiv thaiv los ntawm lub teeb.

Kev tshawb fawb soj ntsuam

Kev sim tshuaj nyob rau hauv cov neeg mob menyuam yaus uas muaj kab mob Otitis Media

Hauv ob qhov kev tsim nyog thiab tswj tau zoo hauv Teb Chaws Asmeskas kev sim tshuaj ib zaug ib koob tshuaj IM ntawm ceftriaxone tau muab piv nrog rau 10 hnub ntawm kev siv tshuaj tua kab mob hauv qhov ncauj hauv cov menyuam yaus hnub nyoog 3 hlis thiab 6 xyoo. Cov nqi kho mob thiab cov txiaj ntsig tau tshwm sim tshwm sim hauv cov lus hauv qab no:

Table 7 Clinical Efficacy in Pediatric Patients with Acute Bacterial Otitis Media
Clinical Efficacy in Evaluable Population
Hnub Kawm Ceftriaxone Ib Dose Tus piv –
10 Hnub ntawm
Kev kho qhov ncauj
95%
Kev ntseeg siab
Lub sijhawm
Kev txheeb cais
Qhov tshwm sim
Kawm 1 – US amoxicillin / clavulanate
14

28
74% (220/296)

58% (167/288)
82% (247/302)

67% (200/297)
(-14.4%, -0.5%)

(-17.5%, -1.2%)
Ceftriaxone qis dua kev tswj hwm ntawm hnub kawm 14 thiab 28.
Kawm 2 - US5 TMP-SMZ
14

28
54% (113/210)

35% (73/206)
60% (124/206)

45% (93/205)
(-16.4%, 3.6%)

(-19.9%, 0.0%)
Ceftriaxone yog sib npaug rau kev tswj ntawm hnub kawm 14 thiab 28.

Txoj kev tshawb nrhiav kab mob bacteriologic qhib ntawm ceftriaxone yam tsis muaj tus neeg sib piv tau tso npe rau 108 tus neeg mob menyuam yaus, 79 ntawm cov neeg muaj kab lis kev cai zoo rau ib lossis ntau dua ntawm cov kab mob. Cov txiaj ntsig ntawm qhov kev tshawb fawb no yog tabulated raws li hauv qab no:

Lub Limtiam 2 thiab 4 Cov Kabmob Eradication Rate nyob rau hauv Ib Txoj Cai Kev Ntsuam Xyuas hauv Roche Bacteriologic Study los ntawm cov kab mob:

Table 8 Bacteriologic Eradication Rates los ntawm Pathogen
Hnub Kawm
13-15
Hnub Kawm
30+ 2
Kab mob Tsis txhob.
Kev tshuaj xyuas
Tsis txhob.
Erad. (%)
Tsis txhob.
Kev tshuaj xyuas
Tsis txhob.
Erad. (%)
Streptococcus pneumoniae 38 32 (84) 35 25 (71)
Hemophilus influenzae 33 28 (85) 31 22 (71)
Moraxella catarrhalis kaum tsib 12 (80) kaum tsib 9 (60)

REFERENCES

  1. Clinical and Laboratory Standards Institute (CLSI).Cov txheej txheem rau Dilution Antimicrobial Susceptibility Tests rau cov kab mob uas loj hlob Aerobically; Pom zoo Standard - Kaum Ib Hlis.CLSI document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
  2. Clinical and Laboratory Standards Institute (CLSI).Cov qauv kev ua tau zoo rau kev kuaj tshuaj tua kab mob tiv thaiv kab mob; Nees nkaum tsib Cov Lus Qhia Ntxiv, CLSI document M100-S25. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
  3. Clinical and Laboratory Standards Institute (CLSI).Cov qauv kev ua haujlwm rau Antimicrobial Disk Diffusion Susceptibility Tests; Pom zoo Standard – Kaum ob tsabCLSI document M02-A12, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
  4. Clinical and Laboratory Standards Institute (CLSI).Cov txheej txheem rau Antimicrobial Susceptibility Test of Anaerobic Bacteria; Pom zoo Standard - Yim tsab.CLSI document M11-A8, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, PA 19087 USA, 2012

Rocephin yog lub npe lag luam ntawm Hoffmann - La Roche Inc.

Muab faib los ntawm:
Genentech USA, Inc.
Ib tug tswv cuab ntawm Roche Group
1 DNA Txoj Kev
South San Francisco, CA 94080-4990

RNI_139904_PI_112012_K

Kho tshiab: Lub Rau Hli 2015

© 2015 Genentech, Inc. All rights reserved.

Tus neeg sawv cev qauv ntawm daim ntawv lo (saib daim ntawv YUAV UA LI CAS seem rau tag nrho cov npe):

PRINCIPAL DISPLAY PANEL - 500 mg Vial Carton

NWS 0004-1963-02

Rocephin®
(Ceftriaxone rau Txhaj USP)

500 mg

Rau intramuscular lossis intravenous siv.

Ib leeg-Siv Vial

Txhua lub vial muaj ceftriaxone sodium hmoov
sib npaug rau 500 mg ceftriaxone.

siv sijhawm ntev ntawm lexapro

Rx xwb

500 mg/15 mL Vial
1 Vial

Genentech

PRINCIPAL DISPLAY PANEL - 1 gram Vial Carton

NWS 0004-1964-04

Rocephin®
(Ceftriaxone rau Txhaj USP)

1g ua

Rau intramuscular lossis intravenous siv.

Ib leeg-Siv Vial

Txhua lub vial muaj ceftriaxone sodium hmoov
sib npaug rau 1 gram ceftriaxone.

Rx xwb

1 gram / 15 mL Vial
1 Vial

Genentech

Rocephin
Ceftriaxone sodium txhaj, hmoov, rau kev daws
Cov ntaub ntawv khoom
Yam khoom HUMAN PRESCRIPTION DRUG LABEL Yam khoom Code (Source) NDC: 0004-1963
Txoj kev tswj hwm INTRAVENOUS, INTRAMUSCULAR DEA Teem caij
Cov khoom xyaw nquag / Active Moiety
Cov khoom xyaw npe Lub hauv paus muaj zog Lub zog
Ceftriaxone sodium (Ceftriaxone) ceftriaxone 500 mg
Ntim
# Yam khoom Code Pob piav qhia
ib NDC: 0004-1963-02 1 VIAL, GLASS hauv 1 BOX
ib 1 HLOOV, POWDER, FOR SOLUTION in 1 VIAL, GLASS
ob NDC: 0004-1963-01 10 VIAL, GLASS hauv 1 BOX
ob 1 HLOOV, POWDER, FOR SOLUTION in 1 VIAL, GLASS
Cov ntaub ntawv lag luam
Kev lag luam qeb Daim ntawv thov Number los yog Monograph Citation Hnub pib ua lag luam Hnub Kawg Ua Lag Luam
KOJ TIAB SA 063239 08.13.1993 dr hab 07/31/2015
Rocephin
Ceftriaxone sodium txhaj, hmoov, rau kev daws
Cov ntaub ntawv khoom
Yam khoom HUMAN PRESCRIPTION DRUG LABEL Yam khoom Code (Source) NDC: 0004-1964
Txoj kev tswj hwm INTRAVENOUS, INTRAMUSCULAR DEA Teem caij
Cov khoom xyaw nquag / Active Moiety
Cov khoom xyaw npe Lub hauv paus muaj zog Lub zog
Ceftriaxone sodium (Ceftriaxone) ceftriaxone 1g ib
Ntim
# Yam khoom Code Pob piav qhia
ib NDC: 0004-1964-04 1 VIAL, GLASS hauv 1 BOX
ib 1 HLOOV, POWDER, FOR SOLUTION in 1 VIAL, GLASS
ob NDC: 0004-1964-01 10 VIAL, GLASS hauv 1 BOX
ob 1 HLOOV, POWDER, FOR SOLUTION in 1 VIAL, GLASS
Cov ntaub ntawv lag luam
Kev lag luam qeb Daim ntawv thov Number los yog Monograph Citation Hnub pib ua lag luam Hnub Kawg Ua Lag Luam
KOJ TIAB SA 063239 08.13.1993 dr hab 02/28/2016
Labeler -Genentech, Inc. (080129000)
Kev tsim kho
Lub npe Chaw nyob ID/FEI Kev ua haujlwm
F. Hoffmann-La Roche Ltd 48524961 ib MANUFACTURE(0004-1963, 0004-1964), ANALYSIS(0004-1963, 0004-1964)
Genentech, Inc.