http___www.krenizdravo.com_korisno_upute_cefaleksin-upute-o-lijeku_1.xml
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Ospexin tablets 500mg/Tenkorex tablets 500mg/Cefalexin tablets 500mg/Kiflone tablets 500mg Each tablet contains Cefalexin BP equivalent to 500 mg anhydrous cefalexin. For the full list of excipients, see section 6.1. Film-coated tablets. Oblong, biconvex, white to yellowish. Scored on both sides. Odour - slightly peppermint to characteristic of the active ingredient. Ospexin/Tenkorex/Cefalexin/Kiflone tablets 500 mg is indicated for the treatment of respiratory tract infections (RTI's), urinary tract infections (UTI's), skin and soft tissue infections, otitis media and other infections due to sensitive organisms. Ospexin/Tenkorex/Cefalexin/Kiflone tablets 500 mg are for oral use. Each tablet should be swallowed whole with water. DOSAGE Adults The dosage is 1-4 g daily in divided doses. Most infections will respond to 500 mg every 8 hours. For skin and soft tissue infections, streptococcal pharyngitis and mild uncomplicated UTI's, the usual dosage is 250 mg every 6 hours or 500 mg every 12 hours. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. Older people The dosage is as for adults. The dosage should be reduced if renal function is markedly impaired. Use in children and adolescents The usual recommended daily dosage for children is 25-50 mg/kg in divided doses. For skin and soft tissue infections, streptococcal pharyngitis and mild, uncomplicated urinary tract infections, the total daily dose may be divided and administered every 12 hours. For most infections the following schedule is suggested: In severe infections the dosage may be doubled. In the therapy of otitis media, clinical studies have shown that a dosage of 75-100mg/kg/day in 4 divided doses is required. In the treatment of beta-haemolytic streptococcal infections, a therapeutic dose should be administered for at least 10 days. Cefalexin is contra-indicated in patients with known allergy to the cephalosporin group of antibiotics Severe systemic infections, which require parenteral cephalosporin treatment, should not be treated orally during the acute stage. Cefalexin should be given cautiously to patients who have shown hypersensitivity to other drugs. Cephalosporins should be given with caution to penicillin-sensitive patients, as there is some evidence of partial cross-allergenicity between the penicillins and cephalosporins. Patients have had severe reactions (including anaphylaxis) to both drugs. Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics, including macrolides, semisynthetic penicillins and cephalosporins. It is important, therefore, to consider its diagnosis in patients who develop diarrhoea in association with the use of antibiotics. Such colitis may range in severity from mild to life-threatening. Mild cases of pseudomembranous colitis usually respond to drug discontinuance alone. In moderate to severe cases, appropriate measures should be taken. If the patient experiences an allergic reaction cefalexin should be discontinued and treatment with the appropriate agents initiated. Prolonged use of cefalexin may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. Cefalexin should be administered with caution in the presence of markedly impaired renal function as it is excreted mainly by the kidneys. Careful clinical and laboratory studies should be made because the safe dosage may be lower than that usually recommended. Positive direct Coombs' tests have been reported during treatment with cephalosporin antibiotics. For haematological studies, or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side, or in Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognised that a positive Coombs' test may be due to the drug. A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets. Tests based on glucose oxidation reactions may be safely used. As cephalosporins like cefalexin are only active against proliferating microorganisms, they should not be combined with bacteriostatic antibiotics. Concomitant use of uricosuric drugs (e.g. probenicid) suppresses renal drug elimination. As a result, cefalexin plasma levels are increased and sustained for longer periods. If associated with highly potent diuretics (ethacrynic acid, furosemide) or other potentially nephrotoxic antibiotics (aminoglycosides, polymyxin, colistin), cephalosprins may show higher nephrotoxicity. Combined use of cephalosporins and oral anticoagulants may prolong prothrombin time. Cefalexin may reduce the effects of oral contraceptives. A potential interaction between cefalexin and metformin may result in an accumulation of metformin and could result in fatal lactic acidosis. Hypokalaemia has been described in patient taking cytotoxic drugs for leukaemia when they were given gentamicin and cefalexin. Pregnancy Although laboratory and clinical studies have shown no evidence of teratogenicity, caution should be exercised when prescribing for the pregnant patient. Breastfeedings The excretion of cefalexin in human breast milk increased up to 4 hours following a 500mg dose. The drug reached a maximum level of 4 micrograms/ml, then decreased gradually and had disappeared 8 hours after administration. Caution should be exercised when cefalexin is administered to a nursing woman. There are no effects on ability to drive or to operate machinery. Side effects of cefalexin include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea and abdominal discomfort. The most common of these effects is diarrhoea, but this is rarely severe enough to warrant cessation of therapy. Dyspepsia has also occurred. Transient hepatitis and cholestatic jaundice have rarely been reported. Allergic reactions have been reported such as rash, urticaria, angioedema and rarely erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis (exanthematic necrolysis). These reactions usually subsided upon discontinuation of the drug, although in some cases supportive therapy may be necessary. Anaphylaxis has also been reported. Other side effects such as genital and anal pruritus, genital candidiasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis and joint disorders have been reported. As with other cephalosporins interstitial nephritis has rarely been reported. Eosinophilia, neutropenia, thrombocytopenia, haemolytic anaemia and slight elevations in AST and ALT have been reported. As with other broad-spectrum antibiotics prolonged use may result in the overgrowth of non-susceptible organisms, e.g. candida. This may present a vulvo-vaginitis. There is a possibility of development of pseudomembranous colitis and it is therefore important to consider its diagnosis in patients who develop diarrhoea while taking cefalexin. It may range in severity from mild to life threatening with mild case usually responding to cessation of therapy. Appropriate measures should be taken with moderate to severe cases. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product, Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard. Symptoms of oral overdose include nausea, vomiting, epigastric distress, diarrhoea and haematuria. General management consists of close clinical and laboratory monitoring of haematological, renal and hepatic functions and coagulation status until the patient is stable. Serum levels of Ospexin/Tenkorex/Cefalexin/Kiflone can be reduced by haemodialysis or peritoneal dialysis. Unless 5 to 10 times the normal total daily dose has been ingested, gastro-intestinal decontamination should not be necessary. There have been reports of haematuria without impairment of renal function in children accidentally ingesting more than 3.5g of cefalexin in a day. Treatment has been supportive (fluids) and no sequelae have been reported. Cefalexin is an oral broad-spectrum antibiotic belonging to the group known as cephalosporins. In adequate concentrations it is bactericidal for sensitive proliferating microorganisms by inhibiting the biosynthesis of the cell wall. It is active against the following pathogens: Gram Positive Staphylococci (coagulase positive as well as penicillinase-producing strains), Streptococci, pneumococci, Corynebacterium diphtheriae, Baccillus anthracis, Clostridia, Listeria monocytogenes, Bacillus subtilis and Bacteroides melaninogenicus. Gram Negative Escherichia coli, Salmonellae, Shigellae, Neisseria, Proteus mirabilis, Haemophilus influenzae (some strains), Brucellae, Klebsiella species, Treponema pallidum and actinomycetes. Cefalexin is almost completely absorbed from the gastrointestinal tract and produces peak plasma concentrations about 1 hour after administration. A dose of 500 mg produces a peak plasma concentration of about 18 µg per ml; doubling the dose doubles the peak concentration. Cefalexin readily diffuses into tissues, including bone, joints and the pericardial as well as pleural cavities. Only 10-15% of the dose is bound to plasma proteins. Elimination is mainly renal with 80% of the dose, recovered from the urine, therapeutically active, in the first 6 hours. Cefalexin does not enter cerebrospinal fluid in significant quantities. Cefalexin crosses the placenta and small quantities are found in the milk of nursing mothers. Therapeutically effective concentrations may be found in the bile and some may be excreted by this route. The half-life has been reported to range from 0.5 to 2 hours and this increases with reduced renal function. Core Magnesium stearate Povidone (E1201) Sodium starch glycollate Macrogol 6000 Lactose Saccharin sodium (E954) Peppermint oil Talc (E553b) Coat Titanium dioxide (E171) Hypromellose (E464) There are no known incompatibilities. The shelf life of Ospexin tablets 500mg/Tenkorex tablets 500mg/Cefalexin tablets 500 mg/Kiflone tablets 500 mg is 48 months. The following applies to the storage of Ospexin tablets 500mg/Tenkorex tablets 500mg/Cefalexin tablets 500mg/Kiflone tablets; - Do not store above 25°C. - Store in the original packaging (blister pack presentations only). - Keep the container tightly closed (securitainer presentations only). Containers of Ospexin tablets 500 mg/Tenkorex tablets 500 mg/Cefalexin tablets 500 mg/Kiflone tablets 500 mg are polypropylene containers with lids (Securitainers) or blister packs with duplex foil consisting of aluminium hard foil backing and PVC/PVDC blisters. Each securitainer contains 12 or 15 or 20 or 21 or 24 or 28 or 50 or 100 or 250 or 500 tablets. Each blister pack with duplex foil contains 14 or 15 or 20 or 21 or 28 or 30 or 56 tablets. Handling There are no particular handling procedures. Administration Ospexin tablet 500 mg/Tenkorex tablets 500 mg/Cefalexin tablets 500 mg/Kiflone tablets 500 mg are to be administered as given under method of administration (Section 4.2). Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria.
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Cefaleksin – upute o lijeku Proizvođač: Belupo Samo na recept? DA Primjena: CEFALOSPORINSKI ANTIBIOTIK Skoči na » opis » primjena » doziranje » mjere opreza » napomene Opis Sastav Cefaleksin kapsule 500 mg: jedna kapsula sadržava 500 mg cefaleksina u obliku monohidrata. Cefaleksin prašak za oralnu suspenziju 250 mg/5 ml: jedna bočica s praškom sadržava 5 g cefaleksina u obliku monohidrata; 5 ml pripremljene suspenzije sadržava 250 mg cefaleksina u obliku monohidrata. Pomoćne tvari: saharoza, natrij-benzoat, natrij-edetat. Priprema otopine: sadržaj bočice suspendira se u 60 ml vode. Farmakoterapijska skupina i djelovanje Cefaleksin je beta-laktamski antimikrobni lijek iz skupine cefalosporina za sustavnu primjenu. Način i mjesto izdavanja Na recept , samo u ljekarnama. Rok valjanosti Otisnut je na pakovanju. Pripremljena suspenzija je valjana 7 dana. Lijek se ne smije primijeniti nakon isteka roka valjanosti! Način čuvanja lijeka Čuvati pri temperaturi do 25ºC. Lijek treba čuvati izvan dohvata djece! Primjena Terapijske indikacije Cefaleksin se primjenjuje u liječenju sljedećih bolesti: - infekcija mokraćno-spolnog sustava (cistitis, akutni prostatitis, asimptomatska bakteriurija, akutni i kronični pijelonefritis, ginekološke infekcije), uzrokovanih osjetljivim uzročnicima (E. coli, Proteus mirabilis, Klebsiella pneumoniae); - infekcija gornjeg i donjeg dijela dišnog sustava (uključujući faringitis, tonzilitis, peritonzilarni apsces, sinusitis, akutnu egzacerbaciju kroničnog bronhitisa, bronhopneumoniju, pneumoniju, empijem i apsces pluća) uzrokovanih osjetljivim uzročnicima (Streptococcus pneumoniae, Streptococcus pyogenes); - upala srednjeg uha uzrokovanih osjetljivim uzročnicima (Streptococcus pneumoniae, Haemophilus influenzae, stafilokoki, streptokoki, Moraxella catarrhalis); - infekcija kože i mekih tkiva uzrokovanih stafilokokima i/ili streptokokima (furunkuloza, erizipel, apsces, piodermije, inficirane rane, limfangitis i dr.); - infekcija kostiju i zglobova uzrokovanih stafilokokima i/ili Proteus mirabilisom. Doziranje Odrasli Uobičajena doza u odraslih iznosi 500 mg do 1 g (1-2 kapsule) svakih 12 sati ili 500 mg (1 kapsula) svakih 6 sati. U slučajevima težih infekcija, odnosno infekcija uzrokovanih manje osjetljivim uzročnicima mogu biti potrebne doze do 4 g na dan. Maksimalna dnevna doza iznosi 6 g. Djeca Uobičajena doza cefaleksina u djece iznosi 25 do 50 mg/kg/dan, podijeljeno u dvije do četiri pojedinačne doze. U slučaju težih infekcija doza se može udvostručiti. Preporučena doza cefaleksina u liječenju upale srednjeg uha iznosi 75-100 mg/ /kg/dan, podijeljeno u dvije do četiri pojedinačne dnevne doze. Maksimalna dnevna doza iznosi 4 g. Doziranje oralne suspenzije vrši se pomoću priložene žličice, baždarene 1,25 ml (1/4 žličice), na 2,5 ml (pola žličice) i 5 ml (1 žličica). Prije primjene suspenziju valja dobro promućkati! DOB – DOZA CEFALEKSINA (u mg) – DOZA CEFALEKSINA (u žličicama ili kapsulama) 0-3 mjeseca 62,5-125 mg svakih 12 sati 1/4 -1/2 žličice svakih 12 sati 4 mjeseca- 2 god. 125 -250 mg svakih 12 sati ili 62,5- 125 mg svakih 6 sati 1/2- 1 žličica svakih 12 sati ili 1/4- 1/2 žličice svakih 6 sati 3- 6 godina 250- 500 mg svakih 12 sati ili 125- 500 mg svakih 6 sati 1- 2 žličice svakih 12 sati ili 1/2- 2 žličice svakih 6 sati 7- 12 godina 500 mg- 1 g svakih 12 sati ili 250- 500 mg svakih 6 sati 2- 4 žličice ili 1-2 kapsule svakih 12 sati ili 1- 2 žličice ili 1 kapsula svakih 6 sati Bolesnici s oštećenom funkcijom bubrega U bolesnika s klirensom kreatinina većim od 50 ml/min nije potrebno prilagođavanje doze cefaleksina. U bolesnika s jače oštećenom funkcijom, odnosno s insuficijencijom bubrega (klirens kreatinina manji od 50 ml/min), potrebno je smanjiti dozu cefaleksina, odnosno produžiti razdoblja izmedu doza. Bolesnici na hemodijalizi U bolesnika na hemodijalizi preporučena doza cefaleksina iznosi 500 mg (1 kapsula) svaka 24 sata, plus dodatnih 500 mg cefaleksina (1 kapsula) na kraju svakog postupka hemodijalize. Bolesnicima na kontinuiranoj ambulantnoj peritonealnoj dijalizi doza cefaleksina mora biti prilagođena na isti način kao i u bolesnika s insuficijencijom bubrega. Trajanje liječenja Liječenje Cefaleksin kapsulama ili oralnom suspenzijom potrebno je nastaviti najmanje 48-72 sata nakon nestanka simptoma infekcije. U slučaju infekcije uzrokovane beta-hemolitičkim streptokokom grupe A potrebno je provesti liječenje u trajanju od najmanje 10 dana, kako bi se smanjio rizik od pojave reumatske groznice ili glomerulonefritisa. Ako propustite uzeti jednu dozu lijeka, valja je uzeti što je prije moguće. Ako je vrijeme za uzimanje sljedeće doze blizu, pričekajte i tada uzmite lijek. U tom slučaju ne trebate udvostručiti dozu. Predoziranje Simptomi predoziranja javljaju se pri uzimanju vrlo velikih doza cefaleksina, mnogo većih od terapijskih. Simptomi oralnog predoziranja cefaleksinom uključuju mučninu, povraćanje, epigastrične smetnje, proljev i hematuriju. Vrlo rijetko, uglavnom pri parenteralnoj primjeni, mogu se javiti epileptički napadi, posebice u bolesnika s oštećenom funkcijom bubrega. Terapija kod predoziranja je simptomatska, uz uobičajene mjere za održavanje normalne funkcije organizma. Odmah valja prekinuti primjenu Cefaleksin kapsula, odnosno oralne suspenzije, te se hitno javiti liječniku. Mjere opreza U slučaju pojave alergijske reakcije pri primjeni Cefaleksina treba odmah prekinuti primjenu lijeka, te se hitno javiti liječniku. Zbog moguće djelomične križne preosjetljivosti između cefalosporina i penicilina, potreban je oprez pri primjeni Cefaleksina u osoba s prethodno poznatom preosjetljivošću na peniciline, stoga što može doći do teških reakcija preosjetljivosti, uključujući i anafilaksiju. Kao i uz ostale antibiotike, i pri primjeni Cefaleksina može doći do pojave pseudomembranoznog kolitisa, uzrokovanog bakterijom Clostridium difficile, čiji oblik može varirati od blagog do po život opasnog. Tu činjenicu treba imati na umu pri pojavi proljeva u bolesnika koji uzimaju Cefaleksin. Treba imati na umu kako pri primjeni svih antibiotika, pa tako i Cefaleksina, može doći do pojave superinfekcije rezistentnim sojevima bakterija i gljivica, naročito pri dugotrajnom liječenju. U bolesnika s nekom bolešću probavnog sustava, posebice kolitisom, antibiotike široka spektra, pa tako i Cefaleksin, treba primjenjivati s oprezom. Kontraindikacije Cefaleksin se ne smije primjenjivati u osoba preosjetljivih na cefaleksin i druge cefalosporine, odnosno na neki od pomoćnih sastojaka lijeka. Posebna upozorenja Trudnoća Primjena Cefaleksina u trudnica dozvoljena je samo u slučajevima kada, prema procjeni liječnika, moguća korist za trudnicu prevladava moguće rizike po fetus. Dojenje Cefaleksin se u malim količinama izlučuje u majčinu mlijeku, te je moguća pojava neželjenih učinaka u dojenčeta. Prema odluci liječnika Cefaleksin se smije primjenjivati u dojilja. Bolesnici s poremećenom funkcijom bubrega Cefaleksin treba oprezno koristiti u bolesnika sa značajno poremećenom funkcijom bubrega (klirens kreatinina manji od 50 ml/min), zbog moguće nefrotoksičnosti cefaleksina, pri čemu je potrebno prilagođavanje doze. Djeca Prije primjene Cefaleksin oralne suspenzije u dojenčeta, liječnik mora procijeniti odnos moguće koristi spram mogućih neželjenih učinaka. Pri primjeni cefalosporinskih antibiotika u novorođenčadi opažena je njihova akumulacija, s rezultirajućim produženjem poluživota lijeka. Stoga je pri primjeni Cefaleksin oralne suspenzije u toj dobnoj skupini potreban oprez i pažljivo praćenje. Nuspojave Probavni sustav – nuspojave u probavnom sustavu predstavljaju najčešći oblik nuspojava koje se javljaju pri uporabi cefaleksina. U spomenute nuspojave ubrajaju se: proljev, mučnina, povraćanje, bol u trbuhu, dispepsija. U težim slučajevima potreban je prekid terapije cefaleksinom. Ponekad se mogu javiti i anoreksija, promjene okusa, glositis, flatulencija, žgaravica i kolestaza. Kao i pri liječenju drugim antibioticima, tako i pri primjeni cefaleksina može doći do pojave pseudomembranoznog kolitisa uzrokovanog bakterijom Clostridium difficile koja proizvodi endotoksin. Reakcije preosjetljivosti, odnosno alergijske reakcije – češće su izražene u atopičara, a obično se smiruju nakon prekida primjene cefaleksina. Moguća je pojava urtikarije, svrbeža, morbiliformnog osipa, vrućice, angioedema, bolova u zglobovima i mišićima, erythema multiforme, eksfolijativnog dermatitisa, Stevens-Johnsonova sindroma, zatim dispneje, teškog bronhospazma, sve do razvoja anafilaktičkog šoka, te reakcije poput serumske bolesti. Hematopoetski sustav – ponekad se mogu javiti eozinofilija, prolazna neutropenija, limfocitoza, leukocitoza, leukopenija, trombocitopenija, trombocitoza, agranulocitoza, granulocitopenija, hemolitička anemija, depresija koštane srži, pancitopenija, aplastična anemija, krvarenje povezano s hipoprotrombinemijom. Hepatobilijarni sustav – ponekad se može uočiti porast vrijednosti AST, ALT, ukupnog bilirubina, alkalne fosfataze, LDH, te hepatomegalija i hepatitis. Urogenitalni sustav – može se javiti prolazni porast vrijednosti ureje i kreatinina, piurija, dizurija, reverzibilni intersticijski nefritis, hematurija, toksička nefropatija, a vrlo se rijetko može javiti akutno zatajenje bubrega. Središnji živčani sustav – ponekad se mogu javiti glavobolja, vrtoglavica, letargija, umor, parestezije, konfuzija, dijaforeza, generalizirani kloničko-tonički napadaji, uglavnom pri parenteralnoj terapiji. U slučaju nuspojave, potrebno je obratiti se liječniku ili ljekarniku! Interakcije Prije početka primjene Cefaleksina izvijestite liječnika o svim lijekovima koje koristite! Istovremena primjena cefaleksina i sljedećih lijekova može uzrokovati klinički značajne interakcije: aminoglikozidi (pojačana nefrotoksičnost), bakteriostatski lijekovi (smanjenje učinka cefaleksina), probenecid (pojačani učinak cefaleksina, povećanje toksičnosti), kolestiramin (smanjeni učinak cefaleksina). Za vrijeme terapije cefaleksinom može doći do promjena u nekim laboratorijskim testovima. Tako je npr. u nekih bolesnika opažen lažno pozitivan direktan Coombsov test, a mogu se javiti i lažno pozitivni rezultati ispitivanja glukoze u mokraći. Isto tako, cefaleksin može lažno povećati vrijednosti 17-ketosteroida u mokraći. Prisustvo hrane usporava apsorpciju cefaleksina, međutim, to nema veći klinički značaj, stoga se Cefaleksin može uzimati neovisno o obroku. Napomene IME I ADRESA NOSITELJA ODOBRENJA / PROIZVOĐAČA Belupo, lijekovi i kozmetika, d.d. Ulica Danica 5 48 000 Koprivnica, Hrvatska