Moxifloxacin - litaelo tsa semmuso bakeng sa tšebeliso

Tlhaloso e amanang le 30.01.2015

• Lebitso la Latin: Moxifloxacine
• Khoutu ea ATX: J01MA14
• Lintho tse sebetsang: Moxifloxacin (Moxifloxacin)
• Moetsi: Vertex (Russia), Macleods Pharmaceutical (India).

Letlapa le le leng moxifloxacin hydrochloride 400 mg

Cellulose, lactose monohydrate, hydroxypropyl cellulose, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, talc, iron oxide e khubelu, joalo ka baeti.

Pharmacodynamics le pharmacokinetics

Pharadodynamics

Setlhare se thibelang likokoana-hloko sehlopheng sa IVin quinolones (trifluoroquinolone), se sebetsa ka bactericidal. E kenella ka seleng ea pathogen ebe e thibela tse peli ka nako e le 'ngoe enzymeho kenya letsoho phetolelong ea DNA le ho laola thepa ea DNA, e lebisang ho phetoho e kholo leboteng la sele, ho senyeha ha sebopeho sa DNA le lefu la pathogen.

Lipontšo tsa Moxifloxacin bactericidalketso e amanang le likokoana-hloko tse kenang ka hare, gram-positive le gram-negative microorganisms. E sebetsa hantle khahlanong le anaerobes, acid e hananang le acid le libaktheria tsa atypical. Ke e 'ngoe ea tse sebetsang khahlanong le staphylococci, ho kenyelletsa le staphylococci e nang le methicillin. Ketso ea Mycoplasmas e phahame Levofloxacinle chlamydia - Ofloxacin.

Ha ho na khanyetso le penicillin, aminoglycosides, macrolidesle cephalosporins. Khafetsa ea khatello ea lithethefatsi e tlase, ho hanyetsa ho hola butle. Setlhare ha se na ts'ebetso ea ho bala. Matla a sethethefatsi a lekana hantle le ho ts'oaroa ha ona ho madi le lisele tsa 'mele' me e tsamaea le ho nyehloloa hanyane chefoka hona ha ho na kotsi ea nts'etsopele botaoa Khahlano le semelo sa kalafo.

Mofumahali

Moxifloxacin kamora tsamaiso ea molomo e kenelletse ka botlalo. Bioavailability ke 91%. Khokahano e phahameng ea lithethefatsi e bonoa ka mor'a lihora tse 0.5-4, mme kamora matsatsi a mararo a ho ja kamehla, boemo ba eona bo tsitsitseng boa fihlella. Setlhare sena se ajoa ka har'a lisele tsa sona. Nako T 1/2 - lihora tse 12. E pepesoa ke liphio le ka tsela ea tšilo ea lijo.

Matšoao a ho sebelisoa

• Lefuba (hammoho le litlhare tse ling tsa anti-TB, joalo ka moriana oa mola oa bobeli),
• mafu a ho phefumoloha: hr bronchitis maemong a hlobaetsang, sinusitis, pneumonia,
• tšoaetso ea mpa le ka mpeng le ka har'a urogenital,
• tšoaetso ea letlalo le lisele tse bonolo.

Contraindication

• boima ho hloleha ha sebete,
• hypersensitivity
• pseudomembranous colitis,
• lilemo tse 18
• tloaelo ea ho tsubella,
• boimana.

C e khethoa ka hloko ha e letsa nako ea Q-T, myocardial ischemia, bradycardia ea bohlokoa haholo, hypokalemia, ha e ntse e nka li-corticosteroids.

Litlamorao

• Bohloko ba ka mpeng botlaela, ho hlatsa, ho sokela,maemo a eketsehang a transaminase, molomo o omeletseng, anorexia, candidiasis molomong oa molomogastritis, dysphagia,leqhubu la leleme,
• kizunguzungu, asthenia, ho hloka boroko, hlooho e bohloko, maikutlo matšoenyeho, paresthesia. Ka seoelo - mathata a puo, hallucinations, cramp,pherekano,
• ho fetola tatso kapa ho lahleheloa ke maikutlo a tatso,
• tachycardiabohloko ba sefuba, eketsa HELLQaletso ea nako ea Q-T,
• ho hema hanyaneka seoelo - tsietsing asthma ea lefu la bronchial,
• arthralgiabohloko ba morao
• botšehali candidiasismosebetsi o sa sebetseng oa renal,
• lekhopho, urticaria,
• leukopenia, eosinophilia, anemia, thrombocytosis, hyperglycemia.

Tšebelisano

Li-antacids, li-multivitamineka liminerale le Ranitidine ho sitisa ho monya le ho fokotsa khatello ea lithethefatsi ho plasma. Li tlameha ho fuoa lihora tse 2 kamora ho sebelisa moriana o moholo. Litokisetso tsa tšepe, sucralfate haholo fokotsa bioavailability, li tlameha ho sebelisoa kamora lihora tse 8.

Ts'ebeliso e tšoanang ea ba bang quinolonese eketsa kotsi ea ho lelefatsa nako ea Q-T ka makhetlo a 'maloa. Moxifloxacin o ama hanyane pharmacokinetics Digoxin.

Ha a ntse a nka Warfarin o hloka ho laola matšoao a coagulation. Moketeng oa kamohelo corticosteroids kotsi e eketsehileng ea ho phatloha ha tendon le ponahalo ea tendovaginitis.

Melemo ea pharmacological

Pharadodynamics

Moxifloxacin ke sethethefatsi se thibelang likokoana-hloko ka bongata ba li-bactericidal, 8-methoxyphoroquinolone. Matla a bactericidal a moxifloxacin a bakoa ke ho thibeloa ha libaktheria topoisomerases II le IV, tse lebisang ho sitiseng lits'ebetso tsa ho pheta-pheta, ho lokisa le ho hatisa DNA biosynthesis ea lisele tse likokoana-hloko, ka lebaka leo, lefung la lisele tse likokoana-hloko.
Metsotso e nyane ea bactericidal ea moxifloxacin hangata e bapisoa le botebo ba eona bo fokolang ba inhibitory (MICs).
Mekhoa ea ho hanyetsa

Mechine e isang nts'etsopele ea ho hanyetsa li-penicillin, cephalosporins, aminoglycosides, macrolides le tetracyclines ha e ame mosebetsi oa antibacterial oa moxifloxacin. Ha ho na khanyetso pakeng tsa lihlopha tsena tsa lithethefatsi tsa antibacterial le moxifloxacin. Ho fihlela hajoale, ha ho e-so be le maemo a hanyetsano ea plasmid. Khafetsa e akaretsang ea ntlafatso ea khanyetso e nyane haholo (10 -7 -10 -10). Khanyetso ea Moxifloxacin e tsoela pele butle butle ka liphetoho tse ngata. Tšusumetso e pheta-phetoang ea moxifloxacin ho likokoana-hloko tse ngata tse ka tlas'a MIC e tsamaisana le keketseho e nyane ho MIC. Ho hlokomeleha maemo a ho hanyetsoa ha quinolones. Le ha ho le joalo, likokoana-hloko tse ling tse ntle tsa gram le anaerobic tse hananang le li-quinolones tse ling li lula li tsotella moxifloxacin.
Ho ile ha thehoa hore kenyelletso ea sehlopha sa methoxy maemong a C8 ho moxifloxacin molek'huleng ea molek'hule e eketsa ts'ebetso ea moxifloxacin le ho fokotsa sebopeho sa mefuta e sa sebetseng ea libaktheria tse ntle tsa gram. Ho eketsoa ha sehlopha sa libaesekele maemong C7 ho thibela nts'etsopele ea li-efflux tse sebetsang, mochini oa ho hanyetsa fluoroquinolones.
Moxifloxacin in vitro e sebetsa khahlano le likokoana-hloko tse fapaneng tsa gram-negative le gram-positive, anaerobes, libaktheria tse thibelang acid le libaktheria tsa atypical joalo ka Mycoplasma spp., Chlamydia spp., Legionella $ pp.hammoho le libaktheria tse hananang le lithibela-mafu tsa ß-lactam le macrolide.
Matla a teng ka microflora ea mala

Lithutong tse peli tse entsoeng ho baithaopi, liphetoho tse latelang tsa microflora ea mala li ile tsa bonoa kamora ho tsamaisoa ha molomo ka moxifloxacin. Ho fokotsehile ha likakanyo tsa maikutlo ho ile ha bonoa. Escherichia coli, Bacillus spp., Bacteroides vulgatus, Enterococcus spp., Klebsiella spp.hammoho le anaerobes Bifidobacterium spp., Eubacterium spp., Peptostreptococcus spp. Liphetoho tsena li ile tsa fetoha hape kamora libeke tse peli. Chefo Clostridium Hardile ha e fumanoe.
Tlhahlobong ea Vitro Sensitivity

Kakaretso ea mesebetsi ea antibacterial ea moxifloxacin e kenyelletsa likokoana-hloko tse latelang:

E nahanela	Ka hloko	Ho hana
E ntle
Gardnerella vaginalis
Streptococcus pneumonia (ho kenyeletsoa mefuta e meng e hananang le penicillin le mathata a hanyetsanang le meriana e thibelang likokoana-hloko tse ngata), le likarolo tse hanyetsanang le lithibela-mafu tse peli kapa ho feta, tse kang penicillin (MIC> 2 mg / ml), II moloko oa cephalosporins (mohlala, cefuroxime), macrolides, tetracyclines, trimethoprim / sulfamethoxazole
Streptococcus pyogene (sehlopha A) *
Sehlopha Streptococcus milleri (S. anginosus * S. constellatus * le interrnedius *)
Sehlopha Li-virreans tsa Streptococcus (S. viridans, S. mutans, S. mitis, S. sanguinis, S. salivarius, S. thermophilics, S. constellatus)
Streptococcus agalactiae
Streptococcus dysgalactiae
Staphylococcus aureus (ho kenyeletsoa likarolo tsa methapo ea methapo ea methapo ea methapo) *	Staphylococcus aureus (methicillin / ofloxacin makhooa a manganga) *
Coagulonegative Staphylococci (S .. cohnii, S. epidermic! Ke, S. haemolyticus, S. Hominis, S. saprophytic us, S s ​​imulans)Metsoako ea methapo ea methapo	Coagul e sebetsang staphylococci (S.cohnii, S. epidermic / ke, S. haemolyticus, S. Horn in is, S.saprophytics, S. simulans)Metsoako ea methicillin
Enterococcus faecalis* ((ke mathata feela a anngoeng ke vancomycin le glamicin)
Enterococcus avium *
Enterococcus faecium *
Gram hampe
Haemophilus influenzae (ho kenyelletsa mefuta e hlahisang le e sa hlahiseng ß-lactamase) *
Haemophillus parainfluenzae*
Moraxella catarrhalis (ho kenyelletsa mefuta e hlahisang le e sa hlahiseng ß-lactamase) *
Bordetella pertussis
Legionella pneumophila	Escherichia coli *
Acinetobacter baumanii	Klebsiella pneumoniae *
Klebsiella oxetoca
Cyprobacter freundii *
Enterо bader spp. (E.aerogenes, E.intermedins, E.sakazakii)
Enterobacter cloacae *
Pantoea babuelli ba litaba
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 / is * B. Distasoni * Ho thetaiotaomicron *, B. ovatus *, B. junifomo ke *, B. vulgaris *)
Fusobacterium spp.
Peptos treptococcus spp. *
Porphyromonas spp.
Prevotella spp.
Propionibacterium spp.
Clostridium spp. *
Mohlolo
Chlamydia pneumoniae *
Chiamydia trachomatis *
Mycoplasma pneumoniae *
Mycoplasma hominis
Mycoplasma genitalium
CoxieIla burnettii
Legionella pneumohila

* Sensitivity ho moxifloxacin e netefatsoa ke data ea kliniki.

Ts'ebeliso ea moxifloxacin ha e khothaletsoe bakeng sa kalafo ea tšoaetso e bakoang ke methapo ea methapo ea methicillin ea S. aureus (MRSA). Tabeng ea ts'oaetso e belaelloang kapa e netefalitsoeng e bakoang ke MRSA, kalafo ka lithethefatsi tse nepahetseng tsa antibacterial e lokela ho laeloa.
Bakeng sa likhathatso tse itseng, ho ata ha khanyetso e fumanoeng ho ka fapana ka sebaka le ka nako. Ntlheng ena, ha ho hlahlojoa maikutlo a methapo, ho hotle ho ba le tlhaiso-leseling ea lehae mabapi le ho hanyetsa, haholo kalafo ea ts'oaetso e matla.
Haeba ho bakuli ba ntseng ba phekoloa sepetlele, sebaka se tlas'a khatello ea nako ea pharmacokinetic curve (AUC) / MHK₉₀ e feta 125, 'me boholo ba mahloriso a plasma (Cmax) / MIC₉₀ e maemong a 8-10 - sena se bontša ntlafatso ea bongaka. Litlalehong tsa nako e fetileng, litekanyetso tsena tsa surrogate hangata li tlase: AUC / MIC₉₀>30-40.

Paramente (boleng bo mahareng)	AUIC * (h)	Cmax / MIC90 (infusion bakeng sa 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 - sebaka se ka tlasa sekoaelo sa inhibitory (ratio (AUC) / MMK)₉₀).

Mofumahali
Suction
Kamora ho ts'oaroa ha moxifloxacin e le 'ngoe ka tekanyetso ea 400 mg bakeng sa 1 h, max a C a fihlella qetellong ea infusion mme e ka ba 4.1 mg / l, e lumellanang le keketseho ea hoo e ka bang 26% ha e bapisoa le boleng ba letšoao lena ha u nka moxifloxacin ka molomo. Pontšo ea moxifloxacin, e khethiloeng ke letšoao la AUG, e feta hanyane ho feta ea tsamaiso ea molomo ea moxifloxacin. Boaoavailability e felletseng e ka ba 91%. Kamora ho kenella kahare ho infravenous infusions ea moxifloxacin ka tekanyetso ea 400 mg bakeng sa hora e le 'ngoe, boholo ba maemo a tlase le a tlase a ho ema a tloha ho 4.1 mg / L ho isa ho 5.9 mg / L le ho tloha ho 0.43 mg / L ho isa ho 0.84 mg / L, ho latela. Kakaretso e tsitsitseng ea 4.4 mg / L e fihlella qetellong ea infusion.
Tsamaiso
Moxifloxacin e ajoa ka potlako ho lithane le litho mme e tlama liprotheine tsa mali (haholo albin) ke hoo e ka bang 45%. Bophahamo ba thomello ke hoo e ka bang 2 l / kg.
Mehopolo e phahameng ea moxifloxacin, e fetisang e leng plasma ea mali, e entsoe ka liseleng tsa matšoafo (ho kenyelletsa mokelikeli oa li-epithelial, li-alveolar macrophages, li-sinuse (maxillary le ethmoid sinuses), ka li-polyps tsa nasal, tse mabapi le ho ruruha (ka har'a litaba tsa marang-rang le maqeba a letlalo). Ho mokelikeli oa mahareng le matheong, moxifloxacin e ikemiselitsoe ka foromo e sa lefelloeng, e se nang protheine, ntlheng ea mahloriso a phahametseng plasma ea mali. Ntle le moo, ho bonahala lintho tse tebileng tsa moxifloxacin lisele tsa litho tsa ka mpeng, mokelikeli oa peritoneal le litho tsa botšehali tsa basali.
Metabolism
Moxifloxacin e feta tlhahisong ea biotransformation ea karolo ea bobeli mme e tsoa 'meleng ke liphio le mala, ka bobeli e sa fetoloe hape ka sebopeho sa metsoako e sa sebetseng ea Sfofo (Ml) le glucuronides (M2).
Moxifloxacin ha e ea biotransformed ke microsomal cytochrome P450 system. Metabolites Ml le M2 li teng ka har'a plasma ea mali maemong a tebileng a tlase ho potoloho ea motsoali. Ho latela sephetho sa lithuto tsa pele, ho ile ha netefatsoa hore li-metabolites tsena ha li na phello e mpe 'meleng mabapi le polokeho le mamello.
Ho tsala
Bophelo ba halofo ea moxifloxacin ke hoo e ka bang lihora tse 12. Karolelano ea ho hlakisoa ka botlalo ka mor'a tekanyetso ea 400 mg ke 1 79-246 ml / min. Ho hlakoloa ha molao ke 24-53 ml / min. Sena se bontša ho khutlisetsoa ka leqhubu la mothapo oa moxifloxacin.
Tekanyo ea metabolite ea ho qala le karolo ea 2 ke hoo e ka bang 96-98%, e bontšang ho ba sieo ha metabolism ea oxidative. Hoo e ka bang 22% ea lethal dose le le leng (400 mg) e hlahisoa e sa fetoloe ke liphio, e ka bang 26% - ke mala.
Pharmacokinetics ka lihlopha tse fapaneng tsa bakuli
Age, bong le morabe
Phuputso e entsoeng ka pharmacokinetics ea moxifloxacin ho banna le basali e hlahisitse phapang ea 33% ho latela AUC le Cmax. Ho tlosoa ha moxifloxacin ho ne ho sa itšetleha ka bong. Phapang e teng ho AUC le Cmax e ne e bakoa haholo ke phapang ea boima ba 'mele ho fapana le bong mme ha e bohlokoa ka tliliniki.
Ho ne ho se na phapang e kholo litabeng tsa pharmacokinetics ea moxifloxacin ho bakuli ba merabe e fapaneng le ba lilemo tse fapaneng.
Bana
Pharmacokinetics ea moxifloxacin ho bana ha e e-so ithutoe.
Ho hloleha hape
Ha ho na liphetoho tse kholo litabeng tsa pharmacokinetics tsa moxifloxacin ho bakuli ba nang le ts'ebetso ea mokokotlo ea mokokotlo (ho kenyelletsa le bakuli ba nang le tumello ea creatinine 2) le ho bakuli ba ntseng ba tsoela pele ka hemodialysis le nako e telele ea peritoneal dialysis.
Ts'ebetso ea sebete e sa sebetseng
Ha ho na phapang e kholo phapusing ea moxifloxacin ho bakuli ba nang le ts'ebetso ea sebete e sa sebetseng (lihlopha tsa classified tsa bana le A) ha li bapisoa le baithaopi ba phetseng hantle le bakuli ba nang le ts'ebetso e tloaelehileng ea sebete (ho sebelisoa ho bakuli ba lefu la cirrhosis, bona le karolo "Litaelo tse ikhethang" )

Tekanyetso le tsamaiso

Motsoako o khothalelitsoeng oa moxifloxacin: 400 mg (250 ml ea tharollo ea infusion) nako e le 1 ka letsatsi le ts'oaetso e bontšitsoeng kaholimo. Se ke oa feta tekanyetso e khothalletsoang.
Nako ea kalafo

Nako ea kalafo e khethoa ke sebaka le ho teba ha ts'oaetso, hammoho le phello ea kliniki.

• Pneumonia e fumanoeng ke sechaba: nako eohle ea kalafo e qapiloeng ka moxifloxacin (tsamaiso ea methapo e lateloang ke tsamaiso ea molomo) ke matsatsi a 7-14,
• Ts'oaetso e rarahaneng ea letlalo le likarolo tse poteletseng: Nako eohle ea kalafo e qapiloeng le moxifloxacin ke matsatsi a 7-21,
• Tšoaetso e rarahaneng ea ka mpeng: nako eohle ea kalafo e nang le moxifloxacin ke matsatsi a 5- 14.

Se ke oa feta kalafo e khothalelitsoeng. Ho latela lithuto tsa tliliniki, nako ea kalafo e nang le moxifloxacin e ka fihla matsatsi a 21.
Bakuli ba baholo

Ho fetola mofuta oa litekanyetso ho bakuli ba tsofetseng ha ho hlokahale.
Bana

Ho sebetsa hantle le polokeho ea tšebeliso ea moxifloxacin ho bana le lilemong tsa bocha ha e e-so thehoe.
Ts'ebetso ea sebete e sa sebetseng (Sehlopha sa bana le sa Pugh L le B)

Bakuli ba nang le ts'ebetso ea sebete e sa sebetseng ha ho hlokahale hore ba fetole mofuta oa kalafo (hore e sebelisoe ho bakuli ba lefu la ho ferekana kelellong, bona karolo ea "Litaelo tse Khethehileng").
Ho hloleha hape

Bakeng sa bakuli ba nang le ts'ebetso ea renal e sa sebetseng (ho kenyelletsa le ba nang le bothata bo matla ba ho hlaba ba le hantle ka 30 ml / min / 1.73 m 2), hammoho le ho bakuli ba ntseng ba tsoela pele ka hemodialysis le tsoelo-pele ea nako e telele ea peritoneal dialysis, tlhahlobo ea dosing ha e hlokehe. .
Sebelisa ho bakuli ba merabe e fapaneng

Ho fetola moriana oa litekanyetso ha ho hlokahale.
Mokhoa oa kopo

Lithethefatsi li fanoa kahare ka mokhoa oa infusion o nkang bonyane metsotso e 60, ka bobeli li sa qhekelloa ebile li kopantsoe le tharollo e latelang e lumellanang le eona (ho sebelisa adapta ea sebopeho sa T:

• metsi bakeng sa ente
• 0,9% sodium chloride tharollo,
• Tharollo ea sodium chloride,
• Tharollo ea dextrose 5%
• Tharollo ea dextrose 10%
• 40% dextrose tharollo,
• 20% xylitol tharollo,
• Tharollo ea ringer
• Tharollo ea ringer

Haeba lithethefatsi moxifloxacin, tharollo ea infusion, e sebelisoa hammoho le lithethefatsi tse ling, joale lithethefatsi ka mong li lokela ho tsamaisoa ka thoko.
Motsoako oa tharollo ea lithethefatsi le tharollo ea infusion e kaholimo o lula o tsitsitse lihora tse 24 ka mocheso oa kamore.
Kaha tharollo e ke ke ea hoamisoa kapa ea koaheloa, e ke ke ea bolokoa ka sehatsetsing. Ha le pholile, pula e ka 'na ea theoha, ea qhibiliha ka mocheso oa kamore. Tharollo e lokela ho bolokoa ka pokellong ea eona. Ke tharollo feela e hlakileng e lokelang ho sebelisoa.

Litla-morao

U ke ke ua kenya tharollo ea infusion ea moxifloxacin ka nako e le ngoe le litharollo tse ling tse sa tsamaelaneng le eona, tse kenyeletsang:

• 10% tharollo ea sodium chloride,
• 20% tharollo ea sodium chloride,
• Tharollo ea bicarbonate ea sodium 4,2%,
• Tharollo ea sodium bicarbonate ea 8.4%.

Litaelo tse khethehileng

Tšusumetso ho bokhoni ba ho khanna makoloi le mekhoa

Fluoroquinolones, ho kenyelletsa moxifloxacin, e ka nyenyefatsa bokhoni ba bakuli ba ho khanna makoloi le ho etsa lintho tse ling tse ka bang kotsi tse hlokang tlhokomelo e eketsehileng le lebelo la karabelo ea psychomotor ka lebaka la ts'ebetso ea tsamaiso ea methapo e kholo le ho senyeha ha pono.

Moetsi

Setifikeiti sa ho ingolisa
LLC PROMOMED RUS, Russia,
101000, Moscow, Arkhangelsky Lane, 1, moaho 1

Aterese ea molao:
Russia, Rephaboliking ea Mordovia,
430030, Saransk, st. Vasenko, 1 5A.

Aterese ea sebaka sa tlhahiso:
Russia, Rephaboliking ea Mordovia,
430030, Saransk, st. Vasenko, 15A.

Lebitso, aterese le nomoro ea mohala ea mokhatlo o ngolisitsoeng bakeng sa mabitso (o romela litletlebo le litletlebo):
LLC PROMOMED RUS, Russia,
129090, Moscow, Prospect Mira, d. 13, leq. 1.

Sebopeho le mofuta oa tokollo

Moxifloxacin e fumaneha ka mefuta e meraro: tharollo ea infusion, matlapa a tsamaiso ea molomo le marotholi a mahlo. Sebopeho sa bona:

Biconvex lipilisi tse mosehla

Khatello ea moxifloxacin hydrochloride, mg

Yellow iron oxide, calcium stearate, titanium dioxide, poone starch, talc, croscarmellose sodium, macrogol, joala ba polyvinyl, mannitol, opadra, cellulose ea microcrystalline, povidone, hydroxypropyl cellulose, hypromellose, polyethylene glycol

Sodium Chloride, Sodium Hydroxide, Hydrochloric acid, Metsi

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

Lithutsoana tsa likhomphutha tse 5., 1 kapa 2 lithutsoana ka paketeng

Li-botlolo tse 250 ml

Li-botlolo tse 5 tsa polyethylene e tlohang

Tekanyetso le tsamaiso

Mefuta e fapaneng ea ho lokolloa ha moriana e fapana ka mekhoa ea ts'ebeliso. Matlapa a reretsoe ho tsamaisoa ka molomo, tharollo e fanoa ka mokhoa oa botsoali, 'me marotholi a kenngoe mahlong ka mafu a tšoaetsanoang a tšoaetsanoang. Litekanyetso li itšetleha ka boima ba lefu lena, mofuta oa lona, ​​litšobotsi tsa motho ka mong. Tlhahisoleseling e fanoa ka litaelo.

Nakong ea kemolo

Nakong ea tlhaho ea ngoana, ho nka meriana e loantšang likokoana-hloko ea tšoaetsanoa, ntle le haeba molemo ho 'm'a o sa fetise kotsi ho lesea. Lithuto mabapi le polokeho ea moriana nakong ea kemolo ha li e-so tšoaroe. Ha ho fanoa ka moriana nakong ea lebone, ho anyesa lesea ho lokela ho hlakoloa, hobane ntho e sebetsang ea motsoako e kenella ka lebeseng la mpa mme e ama bophelo bo botle ba lesea.

Ho sebelisana le lithethefatsi

Pele o qala kalafo le Moxifloxacin, ho sebelisana le lithethefatsi le lithethefatsi tse ling ho lokela ho ithutoa. Motsoako le litlamorao:

1. Li-antacids tse thehiloeng ho magnesium kapa aluminium hydroxide, sucralfate, zinc le litokisetso tsa tšepe li liehisa ho kenngoa ha lithethefatsi.
2. Moriana o eketsa khatello ea "digoxin" e phahameng, o fokotsa katleho ea glibenclamide.
3. Ranitidine e fokotsa ho kenella ha moriana o thibelang mali maling, e ka baka candidiasis.
4. Ho kopana ha sethethefatsi le fluoroquinolones tse ling, Penicillin e eketsa karabelo ea lifoto.

Bongata

Ho eketsa tekanyetso ea lithibela-mafu ho bontšoa ke litla-morao tse eketsehang. Ha overdose e etsahala, o hloka ho hlatsoa mpa, ho emisa ho sebelisa lithethefatsi, ho sebelisa litlolo ho tlosa chefo (Smecta, khabone e kentsoeng, Enterosgel, Sorbex). Ka taolo, taolo e kenelletseng ea tharollo ea detoxification, ts'ebeliso ea lithethefatsi tse nang le matšoao, li-multivitamine li lumelloa.

Ketso ea pharmacological

Moxifloxacin ke sethethefatsi se thibelang likokoana-hloko se nang le lisele tse ngata tsa fluoroquinolone. Moxifloxacin e bonts'a ts'ebetso ea vitro khahlanong le likokoana-hloko tse fapaneng tsa gram tse ntle le gram-negative, anaerobic, acid e hanyetsanang le acid le mohlala oa Chlamidia spp. Mycoplasma spp. le Legionella spp. Tšusumetso ea "bactericidal" ea lithethefatsi e bakoa ke ts'oaetso ea baktheria topoisomerases II le IV, tse lebisang tlolong ea biosynthesis ea DNA ea sele ea microbial mme ka lebaka leo, lefung la lisele tse likokoana-hloko. Tekanyo e nyane ea bactericidal ea lithethefatsi hangata e bapisoa le botebo ba eona bo fokolang ba ho inhibitory.

Moxifloxacin e na le phello ea bactericidal ho libaktheria tse hananang le lithibela-mafutsana tsa p - lactam le macrolides.

Mechine e isang nts'etsopele ea ho hanela li-penicillin, cephalosporins, aminoglycosides, macrolides le tetracyclines ha e senye mosebetsi oa antibacterial oa moxifloxacin. Ha ho na khanyetso pakeng tsa lihlopha tsena tsa lithethefatsi tsa antibacterial le moxifloxacin. Khanyetso e pakeng tsa plasmid ha e e-so bonoe. Keketseho e akaretsang ea ho hanana e nyane haholo (10 '- 10 ") Ho hanyetsa moxifloxacin ho hlaha butle butle ka liphetoho tse ngata. Ho pepesetsoa khafetsa moxifloxacin ho likokoana-hloko tse kenang ka botebo ka tlase ho bonyane ba inhibitory mahloriso (MIC) ho tsamaisana le keketseho e nyane haholo ea MIC. Ho na le maemo a ho hanyetsa li-quinolones. Le ha ho le joalo, likokoana-hloko tse ling tse ntle tsa gram le anaerobic tse hananang le li-quinolones tse ling li lula li tsotella moxifloxacin.

Kakaretso ea mesebetsi ea antibacterial ea moxifloxacin e kenyelletsa likokoana-hloko tse latelang:

1. a mob mobile ea HIV - Streptococcus pneumoniae (ho akarelletsa le mefuta e itoanelang ho penicillin e le macrolides le mefuta le ho hanyetsa tse ngata ho lithibela-mafu) *, Streptococcus pyogenes (Group A) *, Streptococcus milleri, Streptococcus mitis, Streptococcus agalactiae *, Streptococcus dysgalactiae, Streptococcus anginosus *, Streptococcus constellatus *, Staphylococcus aureus (ho kenyelletsa le methapo ea methapo ea methapo ea methapo) *, Staphylococcus cohnii, Staphylococcus epidermidis (ho kenyeletsoa le methicillin e tsepamisang maikutlo), Staphylococcus haemolyticus, Staphylocococecocococcusocinocococococico o nahanne ka vancomycin le gentamicin) *.

2. Gram-negative - Haemophillus influenzae (ho kenyelletsa le mefuta e hlahisang le e sa hlahiseng (3-lactamases) *, Haemophillus parainfluenzae *, Klebsiella pneumoniae *, Moraxella catarrhalis (ho kenyelletsa le mefuta e hlahisang le e sa hlahiseng (3-lactamases) *, Escherobacteria coli * , Bordetella pertussis, Klebsiella oxytoca, Enterobacter aerogene, 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, .... Propionibacterium spp., Clostridium perfringens *, Clostridium ramosum.

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

Legionella pneumophila *, Coxiella bumetti.

* - Boitlhotlhollo ba moxifloxacin bo tiisoa ke datha ea kliniki.

Moxifloxacin ha e sebetse khahlano le Pseudomonas aeruginosa, Pseudomonas fluorescens, Burkholderia cepacia, Stenotrophomonas maltophilia.

Mofumahali

Kamora ho ts'oaroa ho le leng ha moxifloxacin ka tekanyetso ea 400 mg bakeng sa hora e le ngoe, khatello e phahameng ea lithethefatsi (C_tlhokomeliso) e fihlella qetellong ea infusion mme e ka ba 4.1 mg / l, e tsamaellanang le keketseho ea hoo e ka bang 26% ha e bapisoa le boleng ba letšoao lena ha u kenya moriana kahare. Ho pepesetsoa ha sethethefatsi, se ikemiselitsoeng ke AUC (sebaka se tlas'a khefu ea nako ea mahloriso), se feta seo hanyane ha o sebelisa moriana kahare. Boaoavailability e felletseng e ka ba 91%.

Kamora ho kenella kahare ho infusions kahare ho tharollo ea moxifloxacin ka tekanyetso ea 400 mg bakeng sa hora e le ngoe, tlhoko ea litheko le bonyane ba plasma maemong a tsitsitseng (400 mg hang ka letsatsi) li fihlela boleng ho tloha ho 4.1 ho isa ho 5.9 mg / l le ho tloha ho 0,43 ho isa ho 0.84 mg / l, ka ho latellana. Boemong bo tsitsitseng, phello ea tharollo ea moxifloxacin kahare ho karohano ea litekanyetso e batla e le 30% e phahame ho feta ka mor'a tekanyetso ea pele. Karolelano ea likhakanyo tse tsitsitseng tsa 4,4 mg / L li fihlella qetellong ea infusion.

Moxifloxacin e ajoa ka potlako ho lithane le litho mme e tlama liprotheine tsa mali (haholo albin) ke hoo e ka bang 45%. Bophahamo ba thomello ke hoo e ka bang 2 l / kg.

Moxifloxacin e feta tlhahisong ea biotransformation ea karolo ea bobeli mme e tsoa 'meleng ke liphio, hammoho le makhopho, a sa fetoheng le ka sebopeho sa metsoako e sa sebetseng ea sirapo le glucuronides. Moxifloxacin ha e ea biotransformed ke microsomal cytochrome P450 system. Bophelo ba halofo ea lithethefatsi ke lihora tse ka bang 12. Kakaretso e hlakileng ea kamora ho qeta ka nako ea tsamaiso ka tekanyetso ea 400 mg e tsoa ho 179 ho isa ho 246 ml / min. Ekaba 22% ea tekanyetso e le 'ngoe (400 mg) ha e sa fetoloe ka har'a moroto, e ka ba 26% - e nang le makhopho.

Litlhokahalo tsa polokeho

Maemong a mang, kamora ts'ebeliso ea pele ea moxifloxacin, hypersensitivity le allergic reaction li ka hlaha. Ke ka seoelo, ts'oaetso ea anaphylactic e ka tsoelang pele ho sokela bophelo ba lefu la anaphylactic, le kamora ts'ebeliso ea pele ea lithethefatsi. Maemong ana, moxifloxacin e lokela ho khaoloa mme mehato ea kalafo e hlokahalang e nkuoa (ho kenyelletsa anti-shock).

Ka ts'ebeliso ea moxifloxacin ho bakuli ba bang, keketseho ea nako ea QT e ka hlokomeleha.

Kaha basali ba tloaetse ho lelefatsa nako ea QT ha e bapisoa le banna, ba kanna ba ameha haholo ka lithethefatsi tse eketsang nako ea QT. Bakuli ba tsofetseng ba boetse ba ela hloko lithethefatsi tse amang nako ea QT.

Tekanyo ea ho lelefatsa nako ea QT e ka eketseha ka bongata ba lithethefatsi, ka hona ha ua lokela ho feta tekanyo e khothalletsoang le tekanyo ea infusion (400 mg ka metsotso e 60). Leha ho le joalo, ho bakuli ba lefu la pneumonia ho ne ho se na kamano pakeng tsa khatello ea moxifloxacin maling a mali le ho lelefatsa nako ea QT. Ho eketsa nako ea QT ho amana le kotsi e eketsehang ea li-ventricular arrhythmias, ho kenyelletsa polymorphic ventricular tachycardia. Ha ho na bakuli ba 9,000 ba tšoaroang ke moxifloxacin ea nang le mathata a pelo kapa a bolaeang a amanang le ho lelefatsa nako ea QT. Leha ho le joalo, ho bakuli ba nang le maemo a rerang ho tloahela ho kopana, tšebeliso ea moxifloxacin e kanna ea eketsa kotsi ea li-ventricular arrhythmias.

Mabapi le sena, tsamaiso ea moxifloxacin e lokela ho qojoa ho bakuli ba nang le nako e telele ea QT, hypokalemia e sa hlophisitsoeng, hammoho le ba fumanang lithethefatsi tsa antiarrhythmic tsa sehlopha sa IA (quinidine, procainamide) kapa sehlopha sa III (amiodarone, sotalol), kaha boiphihlelo ba ho sebelisa moxifloxacin ho tsena bakuli ba manyolo.

Moxifloxacin e lokela ho khethoa ka hloko, ho tloha

phello e tlatsetsang ea moxifloxacin e ke ke ea qheleloa ka thoko maemong a latelang:

- ho bakuli ba fumanang kalafo e tšoanang ea lithethefatsi e holofatsang nako ea QT (cosapride, erythromycin,

li-antipsychotic lithethefatsi, li-antidepressants tsa trousclic),

- ho bakuli ba nang le maemo a rerang ho kopana le liketsahalo tsa kalafo, joalo ka "bradycardia" e bohlokoa haholo, ischemia e matla,

- ho bakuli ba lefu la cirrhosis, kaha ho ba teng ha nako ea katiso ea QT ho bona ho ke ke ha qheleloa ka thoko,

- ho basali kapa bakuli ba seng ba tsofetse, ba ka bang leihlo la lithethefatsi tse atisang nako ea QT. Ho tlalehiloe maemo a ho ntlafatsoa ha lefu la hepatitis e phethahetseng, le ka 'nang la baka khaello ea bophelo ba sebete, ho kenyeletsa le lefu. Haeba matšoao a ho hloleha ha sebete a hlaha, bakuli ba lokela ho ea ngakeng hang-hang pele ba tsoela pele kalafo.

Ho tlalehoa ha ho na le maemo a mangata a bakileng letlalo a ileng a fetoha ha a bapisoa le letlalo, ka mohlala, Stevens-Johnson syndrome kapa lefu le kotsi la chefo e ka fokotsang bophelo ba motho. Haeba karabelo e hlaha karolong ea letlalo le / kapa li-membrous tsa mucous, o boetse o lokela ho etela ngaka hang-hang pele a tsoela pele kalafo. Ts'ebeliso ea lithethefatsi tsa quinolone e amahanngoa le kotsi e ka ba teng ea ho ts'oaroa. Moxifloxacin e lokela ho sebelisoa ka hloko ho bakuli ba nang le mafu a methapo ea methapo e kholo le ka maemo a belaetsang ho kenella ha methapo ea methapo e kholo, ho rera esale pele hore ho na le ho ts'oaroa ka tšohanyetso, kapa ho theola monyako oa ts'ebetso e tsitsipanyang.

Ts'ebeliso ea lithethefatsi tsa antibacterial tse pharalletseng, ho kenyeletsa moxifloxacin, e amahanngoa le kotsi ea ho ba le pseudomembranous colitis e amanang le ho nka lithibela-mafu. Tlhahlobo ena e lokela ho lula e hopoloa ho bakuli ba nang le lets'ollo le matla nakong ea kalafo le moxifloxacin. Tabeng ena, kalafo e loketseng e lokela ho fuoa hang-hang. Bakuli ba nang le lets'ollo le matla ba kopantsoe le lithethefatsi tse thibelang matla a ka mpeng.

Moxifloxacin e lokela ho sebelisoa ka hloko ho bakuli ba nang le Gravis myasthenia gravis, kaha lithethefatsi li ka mpefatsa matšoao a lefu lena.

Nakong ea phekolo e nang le fluoroquinolones, ho kenyelletsa moxifloxacin, haholo-holo ho batho ba tsofetseng le bakuli ba fumanang li-glucocorticosteroids, nts'etsopele ea tendonitis le ho phatloha ha tendon ho ka etsahala. Letšoao la pele la bohloko kapa ho ruruha setsing sa likotsi, setlhare se lokela ho emisoa 'me leoto le amehang le imolohe.

Bakeng sa bakuli ba nang le mafu a rarahaneng a ruruhileng ea litho tsa pelvic (ka mohlala, a amanang le li-tubo-ovarian kapa pelvic abscesses) bao ho bonahatsoang kalafo ea methapo, tšebeliso ea moxifloxacin matlapeng a 400 mg ha e khothalletsoe.

Ha u sebelisa li-quinolones, ho bonoa ka mokhoa oa photosensitivity ho bonoang. Leha ho le joalo, nakong ea boithuto ba pelehi, lithupelo tsa bongaka, le ts'ebeliso ea moxifloxacin ts'ebetsong, ha ho lits'oaetso tsa photosensitivity tse boneng. Leha ho le joalo, bakuli ba fumanang moxifloxacin ba lokela ho qoba khanya ea letsatsi le mahlaseli a kotsi a letsatsi.

Bakeng sa bakuli ba jang lijo tse nang le sodium e nyane (bakeng sa ho nyekeloa ke pelo, ho se sebetse hantle ha masapo, le nephrotic syndrome), tlatsetso e eketsehileng ea sodium e nang le tharollo ea infusion e lokela ho tsotelloa.