Cov tshuaj Moxifloxacin: cov lus qhia rau kev siv > Kev khomob thiab kev tiv thaiv

Kev piav qhia cuam tshuam rau 30.01.2015

Lub npe Latin: Moxifloxacine
ATX Code: J01MA14
Yam tshuaj muaj sia: Moxifloxacin (Moxifloxacin)
Chaw tsim tshuaj paus: Vertex (Russia), Macleods Tshuaj (Is Nrias teb).

1 ntsiav tshuaj moxifloxacin hydrochloride 400 mg

Cellulose, lactose monohydrate, hydroxypropyl cellulose, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, talc, hlau oxide liab, raws li cov neeg muaj mob.

Pharmacodynamics thiab pharmacokinetics

Cov Tshuaj Hauv Tshuaj

Cov tshuaj tua kab mob los ntawm pab pawg ntawm IV tiam quinolones (trifluoroquinolone), ua cov kab mob bactericidal. Daws li nkag mus rau hauv lub cell ntawm lub pathogen thiab block ib txhij ob enzymemuab kev koom tes hauv DNA replication thiab tswj cov khoom ntawm DNA, uas ua rau muaj kev hloov pauv ntau hauv cov xovtooj ntawm tes, cuam tshuam DNA tsim thiab tuag ntawm cov kab mob.

Moxifloxacin cov khoom pov thawj tua kab mobkev cuam tshuam hauv kev cuam tshuam rau cov kab mob intracellular, kab mob gram-zoo thiab gram-tsis zoo. Ua tau zoo tiv thaiv anaerobes, tiv thaiv cov kab mob acid thiab atypical. Nws yog ib qho ntawm nquag tiv thaiv staphylococci, suav nrog methicillin-resistant staphylococci. Hauv kev nqis tes ua ntawm mycoplasmas superior Levofloxacinthiab ntawm Chlamydia - Ofloxacin.

Tsis kam tiv nrog tshuaj penicillins, aminoglycosides, macrolidesthiab cephalosporinsCov. Qhov zaus ntawm kev tawm tsam cov tshuaj muaj peev xwm tsawg, kev tawm tsam qeeb zuj zus. Cov tshuaj tsis muaj qhov ntxim nyiam photosensitizing. Cov nyhuv ntawm cov tshuaj yog ncaj qha sib luag rau nws cov concentration hauv ntshav thiab cov ntaub so ntswg thiab nrog nws los ntawm kev tso tawm me ntsis co toxinsyog li tsis muaj kev pheej hmoo ntawm kev nthuav dav qaug cawv tawm tsam keeb kwm ntawm kev kho mob.

Cov Tshuaj Pharmacokinetics

Moxifloxacin tom qab kev tswj hwm ntawm qhov ncauj yog kiag li yaim. Bioavailability yog 91%. Qhov siab tshaj plaws ntawm cov tshuaj yog pom tom qab 0.5-4 teev, thiab tom qab peb hnub ntawm kev ua kom tsis tu ncua, nws theem ruaj khov tiav. Cov tshuaj tau muab faib rau hauv cov ntaub so ntswg, thiab qhov tseem ceeb ntawm nws yog txiav txim siab hauv lub ntsws ua pa thiab tawv nqaij. Lub Sijhawm T 1/2 - 12 teev. Nws yog tawm los ntawm lub raum thiab los ntawm kev zom zaub mov.

Kev ntsuas rau siv

Tub Ntshaw (hauv kev sib xyaw nrog lwm cov tshuaj tiv thaiv TB, zoo li tshuaj thib ob),
Kab mob ua pa: hr mob ntsws nyob rau theem mob, mob hlab ntsws, mob ntsws,
mob plab thiab mob urogenital,
kis tau ntawm daim tawv nqaij thiab cov nqaij mos.

Cov Yuav Tsum Muaj

hnyav daim siab ua hauj lwm,
kev tiv thaiv tsis haum
mob plab pseudomembranous,
hnub nyoog txog 18 xyoo
ib tug nyiam los tsim qaug dab peg,
cev xeeb tub.

C raug ceeb toom nrog kev ceev faj thaum mus ntev Q-T luv, myocardial ischemia, thaj chaw tseem ceeb bradycardia, hypokalemia, thaum noj corticosteroids.

Sab sij huam

Mob plab flatulence, ntuav, cem quav,nce qib ntawm transaminases, qhov ncauj qhuav, tsis nco qab, candidiasis lub qhov ncauj kab noj hniavmob plab, dysphagia,discoloration ntawm tus nplaig
kiv tob hau, asthenia, pw tsis tsaug zog, mob taub hau, kev xav ntxhov siab, paresthesia. Tsis tshua muaj heev - hais lus tsis meej, cov lus qhia, cramps,tsis meej pem,
saj hloov lossis poob ntawm qhov tsis hnov tsw,
tachycardiamob hauv siab, nce ntxiv HUAB TAISQ-T luv ntu ua ntev,
txog siavtsis tshua muaj - qaug dab peg bronchial hawb pob,
arthralgiarov qab mob
pojniam lub paum candidiasislub raum tsis ua hauj lwm zoo,
xoo pob, urticaria,
leukopenia, eosinophilia, anemia, thrombocytosis, hyperglycemia.

Kev sib txuam

Antacids, multivitaminsnrog cov ntxhia thiab Ranitidine ua rau qhov nqus tsis tau thiab txo qhov kev xav ntawm cov tshuaj hauv ntshav. Lawv yuav tsum tau xaj sijhawm 2 teev tom qab noj cov tshuaj tseem ceeb. Hlau npaj, hauv siab me me txo qis bioavailability, lawv yuav tsum siv tom qab 8 teev.

Siv lub sib txig ntawm lwm tus quinolonesnce kev pheej hmoo ntawm lub sijhawm Q-T ncua sijhawm los ntawm ntau lub sijhawm. Moxifloxacin me ntsis cuam tshuam cov tshuaj pharmacokinetics Digoxin.

Thaum noj Warfarin koj yuav tsum tswj cov ntsuas kev coagulation. Ntawm kev txais tos corticosteroids nce kev pheej hmoo ntawm kev sib tawg ntawm cov leeg thiab cov tsos ntawm tendovaginitis.

Cov chaw muag tshuaj

Cov Tshuaj Hauv Tshuaj

Moxifloxacin yog qhov tshuaj tiv thaiv kab mob loj tshaj plaws, 8-methoxyphoroquinolone. Cov kab mob muaj txiaj ntsig ntawm moxifloxacin yog vim kev thaiv cov kab mob topoisomerases II thiab IV, uas ua rau muaj kev cuam tshuam ntawm cov txheej txheem ntawm kev rov ua dua, kho thiab hloov pauv ntawm DNA biosynthesis ntawm microbial hlwb thiab, vim li ntawd, ua rau kev tuag ntawm microbial hlwb.
Cov kab mob tsawg kawg ntawm cov kab mob moxifloxacin feem ntau yog piv rau nws qhov tsawg kawg yog inhibitory ntau (MICs).
Lub tshuab ua haujlwm tiv thaiv

Cov txheej txheem ua rau muaj kev txhim kho kev tiv thaiv ntawm penicillins, cephalosporins, aminoglycosides, macrolides thiab tetracyclines tsis cuam tshuam rau cov tshuaj tiv thaiv kab mob ntawm moxifloxacin. Tsis muaj ib qho kev rov qab tiv thaiv ntawm cov pab pawg ntawm cov tshuaj tua kab mob thiab moxifloxacin. Txog tam sim no, tseem muaj tsis muaj kev cuam tshuam ntawm plasmid tsis kam. Zuag qhia tag nrho cov kev txhim kho ntawm kev tiv thaiv yog qhov tsawg heev (10 -7 -10 -10). Moxifloxacin tsis kam pib maj mam dhau los ntawm ntau yam kev sib hloov. Cov nyhuv rov ua dua ntawm moxifloxacin ntawm cov kab mob me me hauv cov ntsiab lus hauv qab MIC yog cov los ntawm tsuas yog nce me ntsis hauv MIC. Cov xwm txheej ntawm cov ntoo khaub lig-tiv thaiv rau quinolones raug sau tseg. Txawm li cas los xij, qee cov kab mob gram-zoo thiab anaerobic cov kab mob tiv taus rau lwm cov quinolones tseem muaj lub siab moxifloxacin.
Nws tau tsim tsa hais tias qhov sib ntxiv ntawm cov pab pawg methoxy nyob hauv C8 txoj hauj lwm mus rau moxifloxacin qauv qauv tsim cov kev ua haujlwm ntawm moxifloxacin thiab txo cov kev tsim ntawm cov kev hloov pauv ntawm cov kab mob gram-positive. Qhov sib ntxiv ntawm pab pawg bicycloamine ntawm txoj hauj lwm C7 tiv thaiv kev txhim kho ntawm nquag efflux, ib lub tshuab los tiv thaiv fluoroquinolones.
Moxifloxacin hauv vitro nquag tawm tsam ntau cov kab mob gram-negative thiab kab mob gram-zoo, anaerobes, cov kab mob tiv thaiv acid thiab cov kab mob atypical xws li Mycoplasma spp., Chlamydia spp., Legionella $ pp.ntxiv rau cov kab mob tiv thaiv to-lactam thiab tshuaj tua kab mob macrolide.
Ua rau tib neeg cov hnyuv microflora

Hauv ob txoj kev tshawb nrhiav los ntawm cov neeg ua haujlwm pub dawb, cov kev hloov pauv hauv qab no hauv cov hnyuv microflora tau pom tom qab kev tswj hwm ntawm moxifloxacin. Ib qho kev txo qis hauv ntau yog tau sau tseg. Escherichia coli, Bacillus spp., Bacteroides vulgatus, Enterococcus spp., Klebsiella spp.as Well as anaerobes Bifidobacterium spp., Eubacterium spp., Peptostreptococcus spp. Cov kev hloov no tau thim rov qab tsis pub dhau ob lub lim tiam. Txha Clostridium difficile tsis pom.
Hauv Kev Tshuaj Ntsuam Kev Puas Ntsuam Lub Zog

Lub spectrum ntawm kev ua haujlwm ntawm moxifloxacin suav nrog cov kab mob hauv qab no:

Rhiab	Yooj yim nkag siab	Txom Nyem
Gram zoo
Gardnerella vaginalis
Kab mob ntsws dej ntsws (suav nrog cov kab mob uas tiv taus penicillin thiab cov kab mob uas muaj ntau yam tshuaj tua kab mob tiv thaiv kab mob), nrog rau cov kab mob uas tiv taus ob lossis ntau hom tshuaj tua kab mob, xws li penicillin (MIC> 2 mg / ml), II tiam cephalosporins (piv txwv li cefuroxime), macrolides, tetracyclines, trimethoprim / sulfamethoxazole
Cov kab mob Streptococcus pyogenes (pawg A) *
Cov pab pawg Cov kab mob Streptococcus milleri (S. anginosus S. constellatus * thiab interrnedius )
Cov pab pawg Cov kab mob Streptococcus viridans (S. viridans, S. mutans, S. mitis, S. sanguinis, S. salivarius, S. thermophilics, S. constellatus)
Tus kab mob Streptococcus agalactiae
Tus kab mob Streptococcus dysgalactiae
Dab Tsi Staphylococcus aureus (suav nrog methicillin-rhiab cov leeg) *	Dab Tsi Staphylococcus aureus (cov kab mob methicillin / ofloxacin tiv thaiv tsis tau) *
Coagulonegative Staphylococci (S .. cohnii, S. epidermic! Is, S. haemolyticus, S. hominis, S. saprophytic us, S s imulans)methicillin-sensitive hom	Kev sib xyaw coagul staphylococci (S.cohnii, S. epidermic / yog, S. haemolyticus, S. horn nyob hauv yog, S.saprophytics, S. simulans)methicillin leeg hnyav
Enterococcus faecalis* (tsuas mob rhiab rau vancomycin thiab gentamicin)
Enterococcus avium *
Enterococcus faecium *
Gram tsis zoo
Haemophilus mob npaws (suav nrog kev lim kev lag luam thiab cov uas tsis ua-act-lactamases) *
Haemophillus parainfluenzae*
Moraxella catarrhalis (suav nrog kev lim kev lag luam thiab cov uas tsis ua-act-lactamases) *
Bordetella mob hnoos qhuav
Legionella pneumophila	Escherichia coli *
Acinetobacter baumanii	Klebsiella pneumoniae *
Klebsiella oxytoca
Citrobacter freundii *
(E. Qerogenes, E.intermedins, E.sakazakii)
Cov kab mob qa
Pantoea agglomerans
Pseudomonas aeruginosa
Pseudomonas fluorescens
Burkholderia cepacia
Stenotrophomonas maltophilia
Proteus mirabilis *
Proteus vulgaris
Morganella morganii
Neisseria gonorrhoeae *
Providencia spp. (P. rettgeri, P. Stuartii)
Anaerobes
Bacteroides spp. (B.fragi / yog B. Distasoni * Hauv thetaiotaomicron , B. ovatus , B. khaub ncaws yog , B. vulgaris )*
Fusobacterium spp.
Peptos treptococcus spp. *
Porphyromonas spp.
Prevotella spp.
Propionibacterium spp.
Clostridium spp. *
Atypical
Chlamydia mob ntsws *
Chiamydia trachomatis *
Mycoplasma mob ntsws *
Mycoplasma hominis
Mycoplasma genitalium
CoxieIla burnettii
Legionella pneumohila

* Qhov rhiab heev rau moxifloxacin yog paub tseeb los ntawm cov ntaub ntawv soj ntsuam.

Kev siv moxifloxacin tsis pom zoo rau kev kho mob los ntawm kev kis mob los ntawm methicillin tiv thaiv cov leeg ntawm S. aureus (MRSA). Yog hais tias tsam raug tus mob los yog tus kab mob MRSA kho, yuav tsum tau siv tshuaj kho mob kom tsim nyog.
Rau qee hom kab mob, kev kis tau ntawm kev tawm tsam kuj yuav txawv raws cheeb tsam chaw thiab dhau sijhawm. Hauv qhov no, thaum kuaj qhov rhiab heev ntawm hom, nws yog ntshaw kom muaj cov ntaub ntawv hauv zos ntawm kev tawm tsam, tshwj xeeb hauv kev kho mob ntawm cov mob hnyav.
Yog tias nyob hauv cov neeg mob tau txais kev kho mob hauv tsev kho mob, thaj chaw nyob rau hauv qhov chaw cia tshuaj khov-sijhawm ntau lub khw muag tshuaj (AUC) / MHK₉₀ tshaj 125, thiab qhov siab tshaj plaws ntshav plasma concentration (Cmax) / MIC₉₀ yog nyob rau hauv thaj tsam ntawm 8-10 - qhov no qhia pom kev txhim kho mob. Hauv cov neeg mob sab nrauv, cov kev ntsuas surrogate feem ntau qis dua: AUC / MIC₉₀>30-40.

Parameter (qhov nruab nrab tus nqi)	*AUIC (h)**	Cmax / MIC₉₀ (Txoj kev lis ntshav rau 1 h)
MIC₉₀ 0.125 mg / ml	313	32,5
MIC₉₀ 0.25 mg / ml	156	16,2
MIC₉₀ 0.5 mg / ml	78	8,1

* AUIC - thaj chaw hauv qab qhov nkhaus (ntu (AUC) / MMK₉₀).

Cov Tshuaj Pharmacokinetics
Xuas
Tom qab ib qho kev sib xyaw ntawm moxifloxacin ntawm koob tshuaj 400 mg rau 1 h, C max tau mus txog thaum kawg ntawm Txoj kev lis ntshav thiab muaj kwv yees li 4.1 mg / l, uas sib raug rau qhov nce ntxiv ntawm kwv yees li 26% piv nrog tus nqi ntawm qhov ntsuas no thaum noj moxifloxacin los ntawm qhov ncauj. Kev cuam tshuam ntawm moxifloxacin, txiav txim siab los ntawm AUG qhov ntsuas, me ntsis dhau ntawm kev tswj hwm qhov ncauj ntawm moxifloxacin. Kev tsis raug cai ntawm qhov tsis raug cai yog kwv yees li 91%. Tom qab rov ua kom tso cov tshuaj tua kab mob ntawm moxifloxacin ntawm koob tshuaj 400 mg rau 1 teev, qhov siab tshaj plaws thiab qhov tsawg kawg nkaus nyob ruaj ruaj ntawm thaj tsam ntawm 4.1 mg / L txog rau 5,9 mg / L thiab txij li 0.43 mg / L txog 0.84 mg / L, raws li. Qhov ntsuas nruab nrab ruaj khov ntawm 4.4 mg / L yog ua tiav thaum xaus ntawm Txoj kev lis ntshav.
Kev xa Khoom
Moxifloxacin tau faib sai sai hauv cov ntaub so ntswg thiab cov plab hnyuv siab raum thiab khi rau cov ntshav protein (feem ntau albumin) kwv yees li 45%. Qhov ntim ntawm kev faib tawm yog kwv yees li 2 l / kg.
Cov ntsiab lus siab ntawm moxifloxacin, ntau dua cov neeg hauv cov ntshav ntshav, yog tsim nyob rau hauv cov hlab ntsws (nrog rau cov kua epithelial, alveolar macrophages), hauv cov hlab (maxillary thiab ethmoid sinuses), hauv qhov ntswg polyps, hauv foci ntawm o (hauv cov ntsiab lus ntawm cov hlwv nrog daim tawv nqaij mob). Hauv cov kua dej interstitial thiab hauv cov qaub ncaug, moxifloxacin yog txiav txim siab dawb, tsis muaj protein-khi daim ntawv, ntawm qhov siab tshaj ntawm ntshav ntshav. Tsis tas li ntawd, muaj kev kub siab ntawm moxifloxacin raug tshawb pom nyob rau hauv cov ntaub so ntswg ntawm lub plab, cov kua dej peritoneal, thiab cov poj niam lub cev.
Kev zom zaub mov
Moxifloxacin yauv raug biotransformation ntawm theem ob thiab raug ntiab tawm ntawm lub cev los ntawm lub raum thiab hnyuv, ob qho tib si tsis hloov thiab hauv daim ntawv ntawm cov tsis muaj zog sulfo teb (Ml) thiab glucuronides (M2).
Moxifloxacin tsis yog biotransformed los ntawm microsomal cytochrome P450 system. Metabolites Ml thiab M2 nyob rau hauv ntshav ntshav hauv cov ntshav ntau dua li niam txiv cov lus sib txuas. Raws li cov txiaj ntsig ntawm kev tshawb fawb preclinical, nws tau ua pov thawj tias cov metabolites no tsis muaj lub cev tsis zoo hauv lub cev ntawm kev nyab xeeb thiab tiv taus.
Chaw Sau Ntawv
Ib nrab-lub neej ntawm moxifloxacin yog kwv yees li 12 teev. Qhov nruab nrab tag nrho kev pom zoo tom qab muab tshuaj rau ntawm 400 mg yog 1 79-246 ml / min. Kev hlais pob zeb yog 24-53 ml / min. Qhov no qhia tau tias ib nrab tubular reabsorption ntawm moxifloxacin.
Qhov sib npaug rau qhov pib ua haujlwm thiab theem 2 metabolites yog kwv yees li 96-98%, uas qhia tau tias tsis muaj cov metabolism oxidative. Txog 22% ntawm ib koob tshuaj (400 mg) raug nthuav tawm tsis hloov pauv los ntawm lub raum, li 26% - los ntawm txoj hnyuv.
Pharmacokinetics hauv ntau pab pawg neeg mob
Lub hnub nyoog, poj niam txiv neej thiab haiv neeg
Kev kawm txog cov tshuaj pharmacokinetics ntawm moxifloxacin hauv cov txiv neej thiab cov poj niam tau qhia qhov sib txawv ntawm 33% hauv AUC thiab Cmax. Qhov sib txawv ntawm AUC thiab Cmax yog vim muaj ntau qhov sib txawv ntawm lub cev qhov hnyav dua li poj niam txiv neej thiab tsis yog qhov tseem ceeb hauv tsev kho mob.
Tsis muaj qhov sib txawv hauv kev kho mob hauv cov chaw muag tshuaj ntawm moxifloxacin hauv cov neeg mob ntawm cov neeg sib txawv thiab cov hnub nyoog sib txawv.
Cov menyuam
Cov tshuaj pharmacokinetics ntawm moxifloxacin hauv cov menyuam yaus tsis tau kawm.
Tsis hlauv
Tsis muaj kev hloov pauv ntau hauv cov chaw muag tshuaj ntawm moxifloxacin hauv cov neeg mob uas lub raum tsis ua haujlwm (suav nrog cov neeg mob creatinine tshem tawm 2) thiab hauv cov neeg mob tau kho hemodialysis tas mus li thiab kev mob siab ntev los ntawm tus neeg mob lub cev.
Lub siab ua haujlwm tsis zoo
Tsis muaj qhov sib txawv tseem ceeb hauv kev saib xyuas ntawm moxifloxacin hauv cov neeg mob uas muaj lub siab tsis ua hauj lwm (Cov me nyuam Pugh kev faib chav A thiab B) piv nrog cov neeg tuaj yeem noj qab haus huv thiab cov neeg mob ua lub siab ua haujlwm (rau kev siv rau cov neeg mob qog ntshav siab, saib hauv tshooj "Cov lus qhia tshwj xeeb" )

Tsuas tshuaj thiab tswj hwm

Cov tshuaj pom zoo muab cov tshuaj moxifloxacin: 400 mg (250 ml ntawm kev daws rau Txoj kev lis ntshav) 1 zaug nyob rau ib hnub nrog rau cov kis tau hais saum toj no. Tsis pub tshaj qhov pom zoo koob tshuaj.
Lub sijhawm kho

Lub sijhawm kho yog txiav txim los ntawm qhov chaw thiab qhov mob sib kis tau, nrog rau kev kuaj mob.

Kev mob ntsws hauv zej zog: lub sijhawm tag nrho ntawm kev kho mob nrog moxifloxacin (kev tso ntshav tawm raws li kev tswj hwm ntawm lub qhov ncauj) yog 7-14 hnub,
Cov mob sib xyaw ua ke ntawm cov tawv nqaij thiab cov tawv nqaij subcutaneous: tag nrho lub sijhawm ntawm kev kho mob nrog moxifloxacin yog 7-21 hnub,
Qhov mob hnyav hauv plab: tag nrho lub sijhawm ntawm kev kho mob nrog moxifloxacin yog 5-14 hnub.

Tsis pub tshaj qhov pom zoo ntawm lub sijhawm kho mob. Raws li kev tshawb fawb hauv chav kho mob, lub sijhawm ua haujlwm nrog moxifloxacin tuaj yeem ncav cuag 21 hnub.
Cov neeg laus cov neeg mob

Hloov txoj kev noj tshuaj ntxiv rau hauv cov neeg laus yog tsis xav tau.
Cov menyuam

Qhov ua tau zoo thiab kev nyab xeeb ntawm kev siv moxifloxacin hauv cov menyuam yaus thiab cov tub ntxhais hluas tsis tau tsim.
Lub siab ua haujlwm tsis zoo (Menyuam thiab Pugh chav kawm L thiab B)

Cov neeg mob uas lub siab tsis ua haujlwm tsis tas yuav hloov cov tshuaj ntau ntxiv (rau kev siv rau cov neeg mob qog ntshav, saib "Cov Lus Qhia Tshwj Xeeb").
Tsis hlauv

Hauv cov neeg mob uas lub raum lub raum tsis ua haujlwm (suav nrog cov neeg lub raum tsis ua haujlwm nrog creatinine tshem tawm ntawm 30 ml / min / 1,73 m 2), ib yam nkaus li hauv cov neeg mob kho mob txuas ntxiv mus thiab cov neeg mob qog ua lub cev tiv thaiv kab mob peritoneal lim ntshav, tsis tas yuav tsum tau txais kev noj tshuaj. Cov.
Siv rau hauv cov neeg mob ntawm ntau pab pawg

Hloov cov tshuaj rau tshuaj yog tsis tas yuav tsum tau ua.
Txoj kev ntawm daim ntawv thov

Cov tshuaj yog muab tshuaj rau hauv daim ntawv ntawm txoj kev lis ntshav ntev li ntawm 60 feeb, ob qho tib si tsis muaj tshuaj tiv thaiv thiab kev sib xyaw nrog cov kev daws teeb meem hauv qab no tau tshaj nws (siv lub T-puab lub adapter):

dej rau kev txhaj tshuaj
0.9% kev daws sodium chloride,
1M sodium tshuaj dawb
5% dextrose tov,
10% dextrose tov,
40% dextrose tov,
20% xylitol tov,
lub nplhaib kev daws teeb meem
lub tov lub nplhaib lactate,

Yog tias cov tshuaj moxifloxacin, ib qho kev daws teeb meem rau Txoj kev lis ntshav, siv nrog rau lwm cov tshuaj, tom qab ntawd txhua cov tshuaj yuav tsum muab tshuaj cais.
Qhov sib xyaw ntawm cov tshuaj daws nrog cov kev hais daws teeb meem saum toj no tseem nyob ruaj khov rau 24 teev ntawm chav tsev kub.
Vim tias cov tshuaj no tsis tuaj yeem khov lossis txias, nws tsis tuaj yeem khaws cia rau hauv tub yees. Thaum txias, ib qho nag lossis daus yuav nag lossis daus uas yaj ntawm chav sov. Kev daws yuav tsum muab cia rau hauv nws ntim. Tsuas yog ib qho tseeb daws yuav tsum tau siv.

Sab sij huam

Koj tsis tuaj yeem nkag mus rau Txoj kev lis ntshav ntawm moxifloxacin ib txhij nrog lwm cov kev daws teeb meem tsis haum nrog nws, uas suav nrog:

10% sodium tshuaj dawb tov,
20% sodium tshuaj dawb tov,
4.2% sodium bicarbonate daws,
8.4% kev daws sodium bicarbonate.

Cov lus qhia tshwj xeeb

Muaj feem xyuam rau kev muaj peev xwm tsav tsheb thiab cov txheej txheem

Cov tshuaj fluoroquinolones, suav nrog moxifloxacin, tuaj yeem ua rau lub peev xwm ntawm cov neeg mob tsav tsheb thiab koom nrog lwm yam kev phom sij uas xav tau kev nce siab thiab ceev ntawm psychomotor cov kev cuam tshuam vim qhov cuam tshuam rau hauv nruab nrab lub paj hlwb thiab qhov muag tsis zoo.

Chaw tsim tshuaj paus

Daim Ntawv Tso Npe Sau Npe
LLC TXOJ LUS RUS, Russia,
101000, Moscow, Arkhangelsky Txoj Kev, 1, lub tsev 1

Chaw nyob raug cai:
Russia, Koom pheej ntawm Mordovia,
430030, Saransk, st. Vasenko, 1 5A.

Chaw nyob ntawm qhov chaw ntau lawm:
Russia, Koom pheej ntawm Mordovia,
430030, Saransk, st. Vasenko, 15A.

Npe, chaw nyob thiab naj npawb xov tooj ntawm cov koom haum muaj cai rau kev tiv toj (xa cov ntawv yws thiab tsis txaus siab):
LLC TXOJ LUS RUS, Russia,
129090, Moscow, Prospect Mira, d. 13, p. 1.

Kev Sib Sau thiab daim ntawv ntawm kev tso tawm

Moxifloxacin muaj nyob rau hauv peb hom ntawv: kev daws teeb meem rau Txoj kev lis ntshav, ntsiav tshuaj rau qhov ncauj tswj hwm thiab qhov muag pom. Lawv muaj pes tsawg leeg:

Biconvex daj tshuaj ntsuab

Cov concentration ntawm moxifloxacin hydrochloride, mg

Daj hlau oxide, calcium stearate, titanium dioxide, pob kws hmoov txhuv, talc, croscarmellose sodium, macrogol, cawv polyvinyl, mannitol, opadra, microcrystalline cellulose, povidone, hydroxypropyl cellulose, hypromellose, polyethylene glycol

Cov Sodium Chloride, Sodium Hydroxide, Hydrochloric Acid, Dej

Sodium hydroxide, sodium chloride, hydrochloric acid, boric acid, dej

Blisters rau 5 pcs., 1 lossis 2 blisters ua ib pob

250 ml fwj

5 ml polyethylene dropper fwj

Tsuas tshuaj thiab tswj hwm

Txawv xa cov tshuaj sib txawv ntawm cov txheej txheem kev siv. Cov ntsiav tshuaj yog npaj rau cov thawj coj ntawm qhov ncauj, kev daws teeb meem yog tswj hwm niam txiv, thiab cov tee tau tso rau hauv qhov muag nrog cov kabmob sib kis. Dosage nyob ntawm qhov mob hnyav ntawm tus kab mob, nws hom, tus yam ntxwv ntawm tus neeg mob. Cov ntaub ntawv raug muab rau hauv cov lus qhia.

Thaum cev xeeb tub

Thaum lub sijhawm yug menyuam, kev siv tshuaj tiv thaiv kab mob yog siv sib kis, tshwj tsis yog cov txiaj ntsig rau leej niam tsis pub dhau qhov kev pheej hmoo rau tus menyuam hauv plab. Cov kev tshawb fawb txog kev nyab xeeb ntawm cov tshuaj thaum cev xeeb tub tsis tau ua. Thaum sau tshuaj rau thaum lub sijhawm lactation, kev pub mis niam ntawm tus menyuam yuav tsum tau muab tshem tawm, vim tias cov khoom ua kom lub cev muaj zog nkag mus rau hauv niam mis thiab muaj kev cuam tshuam tsis zoo rau kev noj qab haus huv ntawm tus menyuam.

Yeeb tshuaj sib cuam tshuam

Ua ntej pib txoj kev kho nrog Moxifloxacin, kev sib txuam tshuaj nrog lwm cov tshuaj yuav tsum tau kawm. Kev sib txuas ua ke thiab cuam tshuam:

Cov tshuaj tiv thaiv kab mob raws li cov tshuaj magnesium lossis aluminium hydroxide, ua tiav, zinc thiab hlau npaj qeeb yuav tsis nqus cov tshuaj.
Cov tshuaj tsub kom qhov siab tshaj plaws ntawm digoxin, txo qhov ua haujlwm ntawm glibenclamide.
Ranitidine txo qis kev nqus ntawm cov tshuaj tua kab mob mus rau hauv cov ntshav, tuaj yeem ua rau mob hnyuv siab.
Kev sib xyaw ntawm cov tshuaj nrog lwm cov fluoroquinolones, Penicillin tsub kom cov tshuaj tiv thaiv phototoxic.

Noj ntau dhau

Tshaj dhau cov koob tshuaj ntawm cov tshuaj tua kab mob tau pom los ntawm kev mob tshwm sim ntau dua. Thaum kev siv tshuaj ntau dhau, koj yuav tsum ntxuav lub plab, tso tseg tsis noj tshuaj, siv sorbents tshem tawm cov co toxins (Smecta, ua kom cov pa roj carbon, Enterosgel, Sorbex). Nrog rau kev qaug cawv, tswj kev siv tshuaj ntawm kev daws teeb meem, kev siv cov tshuaj tiv thaiv cov tsos mob, multivitamins raug tso cai.

Pharmacological kev txiav txim

Moxifloxacin yog ib hom tshuaj tua kab mob bactericidal nrog cov tshuaj lom dav dav fluoroquinolone. Moxifloxacin cov khoom pov thawj hauv cov dej num hauv vitro tiv thaiv ntau yam ntawm cov kab mob gram-positive thiab gram-tsis zoo, tus kab mob tsis haum, acid-resistant thiab atypical kab mob, piv txwv li Chlamidia spp., Mycoplasma spp. thiab Legionella spp. Cov kab mob bactericidal ntawm cov tshuaj yog vim qhov inhibition ntawm cov kab mob topoisomerases II thiab IV, uas ua rau kev ua txhaum ntawm biosynthesis ntawm DNA ntawm microbial cell thiab, vim li ntawd, ua rau kev tuag ntawm microbial cell. Tsawg kawg ntawm cov kab mob bactericidal ntau ntawm cov tshuaj feem ntau piv rau nws qhov tsawg kawg nkaus inhibitory ntau.

Moxifloxacin muaj cov kab mob bactericidal ua rau cov kab mob tiv thaiv p - lactam tshuaj tua kab mob thiab macrolides.

Cov kev ua uas ua rau muaj kev txhim kho kev tiv thaiv rau penicillins, cephalosporins, aminoglycosides, macrolides thiab tetracyclines tsis ua txhaum kev tua kabmob ntawm moxifloxacin. Tsis muaj ib qho kev rov qab tiv thaiv ntawm cov pab pawg ntawm cov tshuaj tua kab mob thiab moxifloxacin. Plasmid-mediated tsis tau pom zoo. Cov xwm txheej tag nrho ntawm kev tawm tsam yog tsawg heev (10 '- 10 "). Kev tawm tsam moxifloxacin muaj kev maj mam dhau los ntawm ntau yam kev sib hloov.Qhov raug ntawm moxifloxacin rau microorganisms nyob rau hauv cov ntsiab lus qis dua qhov tsawg kawg nkaus hauv kev tiv thaiv (MIC) yog nrog tsuas yog nce me ntsis hauv MIC. Txawm li cas los xij, qee cov kab mob gram-zoo thiab anaerobic cov kab mob tiv taus rau lwm cov quinolones tseem muaj lub siab moxifloxacin.

Lub spectrum ntawm kev ua haujlwm ntawm moxifloxacin suav nrog cov kab mob hauv qab no:

1. Gram-zoo - tus kab mob Streptococcus pneumoniae (xws li hom resistant rau penicillin thiab macrolides thiab lim nrog ntau yam kuj mus tshuaj tua kab mob) *, tus kab mob Streptococcus pyogenes (Group A) *, tus kab mob Streptococcus milleri, tus kab mob Streptococcus mitis, tus kab mob Streptococcus agalactiae *, tus kab mob Streptococcus dysgalactiae, tus kab mob Streptococcus anginosus *, Tus kab mob Streptococcus constellatus *, Staphylococcus aureus (suav nrog rau cov kab mob hu ua methicillin-rhiab), Staphylococcus cohnii, Staphylococcus epidermidis (suav nrog methicillin-sensitive strains), Staphylococcus haemolyticus, Staphylocococecococococcus hom rhiab rau vancomycin thiab gentamicin) *.

2. Gram-negative - Haemophillus influenzae (suav nrog cov kab mob ua tawm thiab tsis tsim (3-lactamases) *, Haemophillus parainfluenzae *, Klebsiella pneumoniae *, Moraxella catarrhalis (suav nrog rau cov leeg mob thiab tsis tsim (3-lactamases) *, Escherobacteria coli * , Bordetella pertussis, Klebsiella oxytoca, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter intermedius, Enterobacter sakazaki, Proteus mirabilis *, Proteus vulgaris, Morganella morganii, Providencia rettgeri, Providencia stuartii.

3. anaerobes - Bacteroides distasonis, Bacteroides eggerthii, Bacteroides fragilis *, Bacteroides ovatum, Bacteroides thetaiotaomicron *, Bacteroides uniformis, Fusobacterium spp, Peptostreptococcus spp *, Porphyromonas spp, Porphyromonas anaerobius, Porphyromonas asaccharolyticus, Porphyromonas Magnus, Prevotella spp, .... Cov tshuaj Propionibacterium spp., Clostridium perfringens *, Clostridium ramosum.

4. Atypical - Chlamydia mob ntsws *, Mycoplasma pneumoniae *,

Legionella pneumophila *, Coxiella bumetti.

* - rhiab heev rau moxifloxacin yog paub tseeb los ntawm cov ntaub ntawv soj ntsuam.

Moxifloxacin tsis tshua muaj feem ua rau Pseudomonas aeruginosa, Pseudomonas fluorescens, Burkholderia cepacia, Stenotrophomonas maltophilia.

Cov Tshuaj Pharmacokinetics

Tom qab ib zaug tshuaj ntawm moxifloxacin ntawm koob tshuaj 400 mg rau 1 teev, qhov siab tshaj plaws ntawm cov tshuaj (C_tah) tau tiav ntawm qhov kawg ntawm Txoj kev lis ntshav thiab yog kwv yees li 4.1 mg / l, uas sib raug rau qhov nce ntxiv ntawm kwv yees li 26% piv nrog tus nqi ntawm qhov ntsuas no thaum noj cov tshuaj hauv. Kev cuam tshuam ntawm cov tshuaj, txiav txim siab los ntawm AUC (thaj chaw hauv qab qhov tsom-lub sijhawm nkhaus), me ntsis tshaj tias thaum noj cov tshuaj hauv. Kev tsis raug cai ntawm qhov tsis raug cai yog kwv yees li 91%.

Tom qab rov ua kom tso ntshav tso rau ntawm kev daws moxifloxacin ntawm koob tshuaj 400 mg rau 1 teev, qhov siab thiab tsawg kawg ntshav ntau nyob hauv lub xeev ruaj khov (400 mg ib hnub ib zaug) nce mus txog qhov tseem ceeb ntawm 4.1 txog 5.9 mg / l thiab txij li 0.43 txog 0.84 mg / l, ntsig txog. Hauv lub xeev ruaj khov, cov nyhuv ntawm moxifloxacin kev daws teeb meem nyob hauv qhov ntau npaum li cas yog kwv yees li 30% siab dua li tom qab txhaj thawj koob. Qhov nruab nrab ruaj khov ntau ntawm 4.4 mg / L yog ua tiav thaum xaus ntawm Txoj kev lis ntshav.

Moxifloxacin tau faib sai sai hauv cov ntaub so ntswg thiab cov plab hnyuv siab raum thiab khi rau cov ntshav protein (feem ntau albumin) kwv yees li 45%. Qhov ntim ntawm kev faib tawm yog kwv yees li 2 l / kg.

Moxifloxacin yauv raug biotransformation ntawm ntu 2 thiab yog tawm hauv lub cev los ntawm lub raum, nrog rau cov quav, ob qho tib si tsis pauv thiab ua rau lub cev tsis muaj zog sulfo thiab glucuronides. Moxifloxacin tsis yog biotransformed los ntawm microsomal cytochrome P450 system. Ib nrab-lub neej ntawm cov tshuaj yog kwv yees li 12 teev. Qhov nruab nrab tag nrho kev ua kom pom tseeb tom qab kev tswj hwm ntawm ib koob ntawm 400 mg yog los ntawm 179 txog 246 ml / min. Txog 22% ntawm ib koob tshuaj (400 mg) raug nthuav tawm tsis hloov hauv cov zis, li 26% - nrog quav.

Kev tiv thaiv kev nyab xeeb

Qee qhov xwm txheej, tom qab siv moxifloxacin thawj zaug, kev tiv thaiv tsis haum thiab ua xua tuaj yeem tshwm sim. Tsis tshua muaj, kev siv tshuaj tiv thaiv kab mob tuaj yeem hloov mus rau lub neej muaj kev phom sij anaphylactic, txawm tias tom qab siv thawj zaug ntawm cov tshuaj. Hauv cov rooj plaub no, moxifloxacin yuav tsum tsis ua ntxiv thiab muaj kev kho mob tsim nyog (suav nrog kev cuam tshuam los tiv thaiv).

Nrog kev siv moxifloxacin hauv qee cov neeg mob, ncua sijhawm ntxiv QT.

Muab hais tias poj niam nyiam ua ntev QT ntu sib piv piv rau txiv neej, lawv yuav nkag siab zoo txog cov tshuaj uas txuas ntxiv QT luv. Cov neeg laus cov neeg mob tseem yoog cov tshuaj uas cuam tshuam nrog QT ntu.

Qib ntev ntawm QT ncua sij hawm tuaj yeem nce nrog qhov nce ntxiv ntawm cov tshuaj, yog li koj yuav tsum tsis txhob tshaj qhov pom zoo koob tshuaj thiab rab phom sij (400 mg hauv 60 feeb). Txawm li cas los xij, hauv cov neeg mob ntsws muaj kab mob ntsws tsis muaj kev cuam tshuam ntawm kev sib xyaw ntawm moxifloxacin nyob rau hauv cov ntshav ntshav thiab lub caij nyoog QT luv. Ntev lub sijhawm QT cuam tshuam nrog kev pheej hmoo siab ntawm ventricular arrhythmias, suav nrog polymorphic ventricular tachycardia. Tsis muaj ib leeg ntawm 9,000 tus neeg mob kho nrog moxifloxacin muaj mob hlab plawv lossis mob tuag uas cuam tshuam nrog ncua sijhawm QT luv. Txawm li cas los xij, hauv cov neeg mob uas mob ua ntej rau mob tsis xwm yeem, kev siv moxifloxacin tuaj yeem ua rau muaj kev pheej hmoo ntawm ventricular arrhythmias.

Hauv qhov no, kev tswj hwm ntawm moxifloxacin yuav tsum zam nyob rau hauv cov neeg mob nrog ncua QT, tsis raug mob hypokalemia, nrog rau cov uas tau txais tshuaj antiarrhythmic ntawm chav kawm IA (quinidine, procainamide) lossis chav kawm III (amiodarone, sotalol), txij li cov kev paub siv moxifloxacin hauv cov no Cov neeg mob yog cov organic.

Moxifloxacin yuav tsum yog daim ntawv ceeb toom nrog ceev faj, txij li thaum

cov nyhuv ntxiv ntawm moxifloxacin tsis tuaj yeem raug tshem tawm hauv cov xwm txheej hauv qab no:

- nyob rau hauv cov neeg mob uas tau txais kev kho mob sib xyaw tshuaj kho qhov ntev QT ntu (cisapride, erythromycin,

tshuaj tiv thaiv kev puas tsuaj, tricyclic antidepressants),

- nyob rau hauv cov neeg mob uas muaj mob predisposing rau arrhythmias, xws li thaj chaw tseem ceeb bradycardia, mob myocardial ischemia,

- nyob rau hauv cov neeg mob uas mob ntsws, vim tias muaj sijhawm txuas QT ntxiv mus rau hauv lawv tsis tuaj yeem suav nrog,

- hauv cov poj niam lossis cov neeg laus laus, leej twg yuav nkag siab txog cov tshuaj uas txuas ntxiv QT ntu. Cov kab mob kev loj hlob ntawm tus kab mob siab txaus, uas ua rau lub siab ua rau tuag taus, nrog rau kev tuag, tau hais qhia. Yog tias pom tias daim siab ua haujlwm tshwm sim, cov neeg mob yuav tsum sab laj nrog tus kws kho mob tam sim ntawd ua ntej txuas ntxiv kev kho mob.

Cov neeg muaj mob rau cov tawv nqaij tawv nqaij piv txwv, piv txwv li Stevens-Johnson syndrome lossis mob ua paug lom (muaj feem ua rau tuag taus), tau tshaj tawm. Yog tias muaj qhov tsis haum ntawm daim tawv nqaij thiab / lossis cov leeg mob, koj yuav tsum tau sab laj nrog kws kho mob ua ntej yuav kho ntxiv. Kev siv cov tshuaj quinolone cuam tshuam nrog kev pheej hmoo ntawm kev txhim kho qhov chua leeg. Moxifloxacin yuav tsum tau siv nrog ceev faj hauv cov neeg mob uas muaj kab mob hauv lub hauv nruab nrab thiab nrog cov xwm txheej uas tsis txaus ntseeg txog kev koom tes ntawm lub hauv nruab nrog hauv lub nruab nrog, ua kom tshwm sim rau qhov tshwm sim ntawm qhov mob nriaj, lossis txo qis tshaj qhov qub rau qhov kev ua ub no.

Kev siv cov tshuaj tiv thaiv kab mob sab nrauv, suav nrog moxifloxacin, cuam tshuam nrog kev pheej hmoo ntawm kev txhim kho pseudomembranous colitis cuam tshuam nrog kev siv tshuaj tua kab mob. Qhov kev kuaj mob no yuav tsum tau muab khaws cia hauv lub siab rau cov neeg mob uas mob plab zawv loj thaum kho moxifloxacin. Hauv qhov no, txoj kev kho tsim nyog yuav tsum tau hais tawm tam sim ntawd. Cov neeg mob uas mob plab zawv plab heev yog sib kis hauv cov tshuaj uas thaiv txoj hnyuv kom zoo.

Moxifloxacin yuav tsum siv nrog ceev faj hauv cov neeg mob nrog Gravis myasthenia gravis, vim tias cov tshuaj yuav ua rau cov tsos mob ntawm tus kab mob no hnyav dua.

Thaum kho nrog fluoroquinolones, suav nrog moxifloxacin, tshwj xeeb tshaj yog nyob rau cov neeg laus thiab cov neeg mob uas tau txais glucocorticosteroids, kev tsim kho cov leeg nqaij thiab leeg txhaws tau. Nyob rau ntawm thawj cov tsos mob ntawm mob los yog mob rau ntawm qhov chaw raug mob, cov tshuaj yuav tsum nres thiab cuam tshuam povtseg relieved.

Rau cov neeg mob uas muaj mob ua mob ntawm cov mob plab hauv plab (piv txwv, cuam tshuam nrog tubo-ovarian lossis pelvic abscesses) rau leej twg txoj kev kho tus mob tau qhia, kev siv moxifloxacin hauv 400 mg ntsiav tshuaj tsis pom zoo.

Thaum siv quinolones, kev tsis haum tshuaj lub ntsej muag raug sau tseg. Txawm li cas los xij, thaum lub sijhawm preclinical, kev tshawb fawb soj ntsuam, nrog rau kev siv moxifloxacin hauv kev coj ua, tsis muaj kev cuam tshuam qhov muag yoog tau pom. Txawm li cas los xij, cov neeg mob tau txais moxifloxacin yuav tsum zam kev tiv thaiv tshav ntuj thiab duab hluav taws xob ultraviolet.

Rau cov neeg mob noj cov zaub mov sodium tsawg (rau lub plawv tsis ua haujlwm, lub raum tsis ua haujlwm, thiab mob nephrotic), ntxiv cov tshuaj sodium ntxiv nrog kev daws teeb meem yuav tsum tau siv rau hauv tus lej.