Cefalexin, capsule

Prospect

Compozitie
cefalexin 250 mg; cefalexin Forte 500 mg - capsule continand cantitatea echivalenta de monohidrat de cefalexin corespunzatoare la 250, respectiv 500 mg cefalexina baza. cefalexin 125 mg/5 ml; cefalexin 250 mg/5 ml; cefalexin 375 mg/5 ml - pulbere suspendabila pentru prepararea a 60 ml suspensie orala, continand 1,5 g, 3 g, respectiv 4,5 g cefalexin anhidru sub forma de monohidrat si excipienti pana la 30 g. O lingurita dozatoare (5 ml suspensie) contine 125 mg, 250 mg, respectiv 375 mg cefalexin anhidra sub forma de monohidrat. Suspensia reconstituita are gust dulce aromat de banane, vanilie si caramel.

Actiune terapeutica
cefalexina este un antibiotic bactericid din clasa cefalosporinelor din prima generatie. Actioneaza prin acilarea unor transpeptidaze care intervin in sinteza polimerului peptoglicanic din structura peretelui celular bacterian. bacteriile care se divid rapid sunt mai susceptibile la actiunea cafalexinului.
Spectrul de actiune cuprinde: coci gram pozitivi- staphylococcus aureus si epidermidis, streptococcus alfa- si beta-haemoliticus, streptococcus pyogenes, streptococcus pneumoniae, bacili gram negativi - Escherichia coli, Klebsiella sp., Proteus indol negativ, Salmonella sp., Shigella sp.; coci gram negativi - Neisseria sp. Germeni rezistenti la actiunea cefalexinului: Staphylococcus aureus meticilin-rezistent, Streptococcus epidermidis meticilin-rezistent, Streptococcus faecalis grup D, Haemophyllus influenzae (majoritatea tulpinilor), Enterobacter sp., Proteus sp. indol pozitiv, Serratia sp., Clostridium dificile. Cefalexina prezinta o absorbtie digestiva buna fata de substantele recomandate pe cale orala, asigurand realizarea de nivele plasmatice comparabile cu cele obtinute prin administrare injectabila i.m. Absorbtia este rapida si totala la nivelul duodenului. Nu este modificata nici in cazul afectiunilor gastro-intestinale, rezectie gastrica, icter, suferinte ale colonului. Prezenta alimentelor intarzie, dar nu diminueaza absorbtia. Dupa administrarea la adulti a 250 mg, 500 mg, 1 g, nivelul plasmatic mediu de 8-10 g/ml, 18-20 g/ml respectiv 32 - 40 g/ml este atins dupa 1 ora. Timpul de injumatatire este de 50 la 70 min. Putin legata de proteinele serice, aproximativ 6 - 10 %, cefalexina are difuziune buna in tesuturi si organe, regasindu-se in plamani, ficat, inima si mai ales in rinichi. Difuziunea in lichidul cefalo-rahidian este slaba. Traverseaza placenta si se excreta in cantitati mici in laptele matern. Nu se metabolizeaza in organism. Excretia cefalexinei se produce in mare parte pe cale renala (filtrare glomerulara si secretie tubulara), sub forma activa, 80 - 100% in 24 ore. Dupa administrarea a 250 mg si a 1 g substanta, se atinge concentratia de 1 000 g/ml respectiv 4 000 g/ml in urina. Excretia biliara este foarte slaba.

Indicatii
Cefalexina este indicata in tratamentul afectiunilor cu germeni sensibili: otita medie cauzata de Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes; infectii ale tractului respirator inferior, inclusiv pneumonia cauzata de Streptococcus pneumoniae, Haemophilus influenzae, Streptococcus pyogenes, stafilococi; infectiile tractului respirator superior, inclusiv faringita si amigdalita, cauzate de Streptococcus pyogenes; infectiile tractului urinar - pielonefrite si cistite; infectiile pielii si ale tesuturilor moi determinate de staphylococcus aureus si streptococcus pyogenes; sinuzita. Nu exista dovezi suficiente in prezent pentru a stabili eficacitatea cefalexinei in profilaxia reumatismului articular acut si a endocarditei bacteriene.

Mod de administrare
Adulti:1 - 2 g/zi (in 4 prize la 6 ore); doza maxima 4 g/zi.
Copii: 25 - 50mg/kg corp/zi fractionat la 8 -12 ore; doza maxima 4 g/zi.
Nou-nascuti:25 mg - 50 mg/kg corp/24 ore. in cazuri grave: 75 - 100 mg/kg corp/24ore fractionat la 6 ore.

Contraindicatii

Hipersensibilitate la cefalosporine. Prudenta la cei cu alergie la peniciline (sensibilizarea incrucisata 20%). Se evita in timpul alaptarii. Prudenta in insuficienta renala. In cazul asocierii cu antibiotice aminoglicozidice sau cu diuretice foarte active (furosemid, acid etacrinic), se recomanda supravegherea functiei renale.

Precautii
Administrarea la pacientii sensibili la penicilina se va face cu precautie deoarece au fost inregistrate si cazuri de soc anafilactic. Nu se administreaza in primele luni de sarcina.

Reactii adverse
Uneori greata, voma, dispepsie, dureri abdominale, rareori diaree, colita; ocazional reactii alergice cum ar fi eruptii cutanate, urticarie, edem angioneurotic, rareori fenomene anafilactice acute; eozinofilie, leucopenie, cresterea trecatoare a transaminazelor.


 

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