Sumetrolim - sirop

Prospect

Prospect produs: SUMETROLIM®








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SUMETROLIM®
, sirop


combinatii









Prezentare farmaceutica: Comprimate continand 400 mg sulfametoxazol si 80 mg trimetoprim. Sirop – 100 ml continand 2500 mg sulfametoxazol si 500 mg trimetoprim.


Actiune terapeutica: Sulfametoxazolul si trimetoprimul,substantele active din Sumetrolim, blocheaza doua niveluri succesive ale aceluiasi proces biochimic si isi potenteaza reciproc efectele; inhiba sinergic biosinteza de acid folic de la nivelul enzimelor microbiene. In competitie cu acidul para-amino-benzoic, sulfametoxazolul inhiba sinteza acidului dihidrofolic. Trimetoprimul inhiba selectiv enzima de conversie a acidului dihidrofolic in acid tetrahidrofolic. In acest fel cele doua componente bacteriostatice devin bactericide atunci cand se folosesc in combinatie. Sumetrolimul are un larg spectru antimicrobian si este mai putin susceptibil de a induce rezistenta decat sulfametoxazolul sau trimetoprimul luate separat.


Indicatii: Infectii de cai respiratorii superioare si inferioare, bronsiectazie, pneumonii inclusiv cea cu Pneumocystis carinii, sinuzite, faringite, otite medii, amigdalite. Infectii de tract urinar: pielonefrite acute si cronice, cistite, uretrite. Infectii gastrointestinale: salmoneloze, dizenterie bacilara, enterocolite, colecistite, colangite. Infectii ale pielii si ale partilor moi ; piodermite, furunculoza, abcese. Infectii ale sferei genitale: uretrite gonococice, prostatite, anexite. Alte infectii bacteriene: osteomielite acute si cronice, bruceloza acuta, nocardioza.


Contraindicatii Hepatita acuta, insuficienta hepatica grava, insuficienta renala severa, discrazii sanguine, sensibilitate cunoscuta la sulfonamide sau trimetoprim, sarcina (in primul trimestru si cu cateva saptamani inainte de nastere), alaptare.


Mod de administrare: Adulti: doza de atac este de 2, maximum 3 tablete de doua ori pe zi (la 12 ore interval), iar doza de intretinere este de 2 tablete x 2/zi. Copii: in virsta de 1 an: 1/4 tb sau 4 ml sirop x 2/zi; intre 2 si 6 ani: 1/4 tableta sau 1/2 tableta sau 6 - 8 ml sirop x 2/zi; intre 7 si 12 ani:1/2 sau 1 tableta sau 8 - 16 ml sirop x2/zi. Doza recomandata este de 6 mg/kg corp/zi trimetoprim si 30 mg/kg corp/zi sulfametoxazol. In cazul afectarii renale: poate fi administrata doza uzuala in cazul in care clearence-ul la creatinina endogena depaseste valoarea de 30 ml/min Se va administra 1/2 din doza uzuala daca clearence-ul la creatinina este intre 15 si 30 ml/min Terapia cu Sumetrolim nu este recomandata la un clearence de creatinina sub 15 ml/min in pneumonia cu Pneumocystis carinii: dozele zilnice recomandate sunt semnificativ mai mari, 20 mg/kg corp trimetoprim si 100 mg/kg corp sulfametoxazol divizate in 4 prize egale.


Efecte secundare: La nivelul tractului gastrointestinal; disconfort abdominal, varsaturi, diaree, stomatite, glosite, pancreatite, afectari hepatice, tranzitoriu niveluri crescute ale transaminazelor si bilirubinei. Manifestari alergice: exantem, conjunctivite, fotofobie, dermatita exfoliativa, eritem multiform, sindrom Stevens-Johnson, miocardita alergica, foarte rar epidermoliza toxica (sdr. Lyell). Manifestari neurologice: cefalee, slabiciune, insomnie, ataxie. Manifestari hematologice: trombocitopenie, neutropenie, leucopenie, agranulocitoza, anemie aplastica, anemie hemolitica. Reactiile adverse hematologice sunt rare si reversibile. Manifestari de afectare renala: nefrotoxicitatea medie a preparatului care poate aparea la pacienti cu afectare renala anamnestica se atribiue sulfametoxazolului. Alte simptome: artralgii, mialgii.


Interactiuni medicamentoase: Anticoagulante orale (potentarea efectului anticoagulant); fenitoina (nivelurile plasmatice ale fenitoinei pot creste pana la nivelul toxic); antidiabetice orale (riscul aparitiei hipoglicemiei); metotrexat (nivelurile plasmatice ale metotrexatului pot atinge valori toxice); salicilati, fenilbutazona, naproxen (nivelurile plasmatice ale sulfametoxazolului pot atinge valori toxice).


Precautii: La prematurii sub varsta de 1 an se va administra numai in mod exceptional. Nu se dministreaza la nou-nascuti si sugari sub varsta de 6 saptamani. Tratamentul cu Sumetrolim se va administra in mod exceptional sub varsta de 3 luni (risc de hiperbilirubinemie).

A.P.P.: Producator: EGIS
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