http___www.krenizdravo.com_korisno_upute_amoksicilin-prasak-i-kapsule-uputa-o-lijeku_2.xml
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top top Amoxicillin Sodium 250mg Powder for Solution for Injection Amoxicillin Sodium 500mg Powder for Solution for Injection Amoxicillin Sodium 1g Powder for Solution for Injection top Sodium Amoxicillin equivalent to Amoxicillin Ph Eur 250mg Sodium Amoxicillin equivalent to Amoxicillin Ph Eur 500mg Sodium Amoxicillin equivalent to Amoxicillin Ph Eur 1g toptop Powder for solution for injection. top Amoxicillin is a broad-spectrum aminopenicillin and is indicated in the treatment of bacterial infections such as actinomycosis, biliary-tract infections, bone and joint infections, acute exacerbations of chronic bronchitis, gastroenteritis, (including Escherichia coli enteritis and Salmonella enteritis, but not shigellosis), gonorrhoea, mouth infections, sinusitis, otitis media, pneumonia (except where Mycoplasma suspected), typhoid and paratyphoid fever, urinary-tract infections, bacterial meningitis and the prophylaxis of endocarditis. It is also used in the treatment of Lyme disease. top Treatment of Infections in Adults and the Elderly Treatment of Infection in Children up to 10 years Renal impairment It may be necessary to reduce the total daily dosage depending on the degree of renal impairment. As amoxicillin is removed by haemodialysis, patients receiving haemodialysis may require another dose of amoxicillin at the end of their dialysis. Endocarditis prophylaxis Method of Administration Amoxicillin Sodium for Injection BP, when diluted may be injected slowly into a vein or infusion line over three to four minutes. Intravenous Infusion: Prepare as above and add to an iv solution in a minibag or in-line burette. Administer over 30 to 60 minutes. Alternatively the appropriate volume of iv fluid may be transferred from the infusion bag into the vial, using a suitable reconstitution device, and drawn back into the bag after dissolution. top Amoxicillin should not be given to patients with a history of hypersensitivity to the beta-lactam antibiotics (e.g. penicillins, cephalosporins). Bacterial resistance to amoxicillin or ampicillin. top Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity to beta-lactam antibiotics. If a hypersensitivity reaction is reported, treatment with amoxicillin must be discontinued. Discontinue treatment if skin rash appears. Amoxicillin-induced flare of DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) has been reported. Amoxicillin should be given with caution to patients with a history of allergy, especially to drugs. Desensitisation may be necessary if treatment is essential. Amoxicillin should not be used for long-term treatment of recurrent urinary tract infection, as resistance may develop in the enteric flora. Prolonged use of penicillins may occasionally result in overgrowth of non-susceptible organisms. Amoxicillin should not be used in patients with glandular fever. Care is necessary if very high doses of amoxicillin are given, especially if renal function is poor, because of the risk of nephrotoxicity and/or neurotoxicity. Adequate fluid intake and urinary output must be maintained during high dose parenteral administration of amoxicillin in order to minimise the occurrence of crystalluria. The intrathecal route should be avoided. Care is also necessary if large doses of sodium (as amoxicillin sodium) are given to patients with impaired renal function or heart failure. Renal and haematological status should be monitored during prolonged and high-dose therapy. Care is required when treating some patients with spirochaete infections such as syphilis or leptospirosis because the Jarisch-Herxheimer reaction may occur shortly after treatment with a penicillin is started. Contact with amoxicillin should be avoided since skin sensitisation may occur. Amoxicillin should preferably not be given to patients with undiagnosed pharyngitis (who may have mononucleosis) or patients with lymphatic leukaemia or possibly HIV infection who may also be at increased risk of developing skin rashes with amoxicillin. In case of severe and persistent diarrhoea, the possibility of pseudomembranous colitis should be considered; amoxicillin therapy should be discontinued. Prolonged use of penicillins may occasionally result in overgrowth of non-susceptible organisms. There is a potential for increased serum levels of amoxicillin in the newborn or in young infants due to reduced renal excretion. Amoxicillin sodium 250mg, 500mg and 1g powder for solution for injection contains 0.65mmol (14.9mg), 1.3mmol (29.7mg) and 2.6mmol (59.4mg) of sodium per dose, respectively. To be taken into consideration by patients on a controlled sodium diet. top Broad spectrum antibiotics including amoxicillin may increase the effects of oral anticoagulants or they may reduce the effects of oral anticoagulants. Amoxicillin may decrease the efficacy of oestrogen-containing oral contraceptives. Plasma concentrations of amoxicillin are enhanced if probenecid is given concurrently. There is reduced excretion of methotrexate (increased risk of toxicity). There may be antagonism between amoxicillin and bacteriostatic agents such as chloramphenicol. An increased frequency of skin rashes has been reported in patients receiving amoxicillin together with allopurinol, compared to those receiving amoxicillin alone. Tetracyclines may reduce the effectiveness of penicillins particularly in the treatment of infections such as pneumococcal meningitis and scarlet fever. Penicillins may produce false-positive results with the direct antiglobulin (Coombs') test. Penicillins may produce falsely high urinary glucose results with the copper sulphate test. Glucose enzymatic tests such as the glucose oxidase test are not affected by penicillins. Penicillins may produce falsely high urinary protein results. Bromophenol blue reagent test strips are not affected by penicillins. toptop Amoxicillin crosses the placenta, however, there has been no evidence of a teratogenic effect in animals or untoward effect in humans. When antibiotic therapy is required during pregnancy, Amoxicillin may be considered appropriate when the potential benefits outweigh the potential risks associated with treatment. Reproduction studies in mice and rats, at doses up to ten times the human dose of amoxicillin, have shown no evidence of impaired fertility. Trace quantities of amoxicillin can be detected in breast milk. Modification of bowel flora in breast-fed infants resulting in diarrhoea. Hypersensitivity may occur in infants breast-fed by mothers taking penicillins. top The most common adverse effects are sensitivity reactions including urticaria, maculo- papular rashes (often appearing more than seven days after commencing treatment), fever, joint pains and angioedema. Anaphylaxis occasionally occurs and has sometimes been fatal. Late sensitivity reactions may include serum sickness-like reactions (featuring symptoms such as arthralgia, rash, urticaria, fever, angioedema, lymphadenopathy), haemolytic anaemia and acute interstitial nephritis. Other skin disorders include morbilliform rash, fixed drug eruption,erythema nodosum, pemphigoid reactions, non-thrombocytopenic purpura, vasculitis, acute generalized exanthematous pustulosis, baboon syndrome. Other skin disorders include pruritus. Other adverse effects are generally associated with large intravenous doses of amoxicillin or impaired renal function. These include bronchospasm, acute, severe dyspnoea, allergic pneumonitis, agranulocytosis, eosinophilia, transient leucopenia and thrombocytopenia, haemolytic anaemia and neutropenia (which might have some immunological basis); prolongation of bleeding time and defective platelet function; nephropathy, convulsions and other signs of central nervous system toxicity (encephalopathy has been reported following intrathecal administration and can be fatal); hallucinations, electrolyte disturbances such as hypokalaemia, due to administration of large amounts of sodium. A coma may develop with high doses of amoxicillin. In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. Most patients with infectious mononucleosis develop a maculopapular rash when treated with amoxicillin, and patients with other lymphoid disorders such as lymphatic leukaemia or HIV infection also appear to be at higher risk. Some patients with spirochaete infections such as syphilis or leptospirosis may experience a Jarisch-Herxheimer reaction shortly after treatment with a penicillin is started. Symptoms include fever, chills, headache and reaction at the site of lesions. The reaction can be dangerous in cardiovascular syphilis or where there is a serious risk of increased local damage such as with optic atrophy. Gastrointestinal effects (vomiting, sore mouth or tongue, diarrhoea and nausea, candida infection) reported with amoxicillin commonly occur after oral administration, not parenteral administration. Pseudomembranous colitis has been reported with most antibiotics. These gastrointestinal effects may occur with parenteral administration. Erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, hepatitis and cholestatic jaundice have been reported in association with amoxicillin alone and with combined amoxicillin and clavulanic acid therapy. Reversible changes in liver function test results can occur during treatment with beta-lactam antibiotics. 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 at www.mhra.gov.uk/yellowcard. toptop Symptoms: gross overdosage will produce very high urinary concentrations, particularly after parenteral administration. Problems are unlikely if adequate fluid intake and urinary output are maintained but crystalluria is a possibility. Treatment: is symptomatic. More specific measures may be necessary in patients with impaired renal function. Amoxicillin is removed by haemodialysis. top Amoxicillin is a member of the penicillin family. The penicillin nucleus consists of a thiazolidine ring connected to a B-lactam ring to which is attached a side-chain. The side-chain determines most of the pharmacological and antibacterial properties of the penicillin in question. In the case of amoxicillin the benzyl ring in the side chain extends the range of antimicrobial activity into the Gram-negative bacteria. Amoxicillin kills bacteria by interfering with the synthesis of the bacterial cell wall. As a result the bacterial cell wall is weakened, the cell swells and then ruptures. Amoxicillin is readily hydrolysed by the staphylococcal penicillinase. Its spectrum of activity is extended by administration with the beta-lactamase inhibitor clavulanic acid. top After the equivalent of 500mg intramuscular amoxicillin, given as amoxicillin sodium, the serum level peaks at one hour at approximately 14mg L-1 Amoxicillin is rapidly distributed throughout the body but penetrates the uninflamed meninges poorly. Its distribution into the cerebrospinal fluid is known to be less efficient than that of ampicillin. Amoxicillin concentrations in interstitial fluid peak around one hour after the serum peak, according to skin window tests. Concentrations in umbilical cord blood have been found to be a fraction of those in maternal blood. Concentrations in amniotic fluid are variable but less than 50% of maternal blood levels. The volume of blood distribution is 0.3 Lkg-1 bodyweight. Plasma protein binding is around 20%. Only small amounts of the drug are excreted in breast-milk. Elimination of amoxicillin occurs via the kidneys by glomerular filtration and tubular secretion. After parenteral administration, 75% of the dose is excreted via the kidneys within the following six hours. High concentrations have been recorded in the bile, but in the presence of biliary tract obstruction amoxicillin may be undetectable. A small amount (10-20%) of the drug is metabolised by hydrolysis of the B-lactam ring to penicilloic acid, which is excreted in the urine. There is limited enterohepatic circulation of the antibiotic. toptoptop There are no pre-clinical data of relevance to the prescriber which are additional to those included in other sections. toptop If amoxicillin is prescribed concurrently with an aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid container or giving set because under these conditions, loss of activity of the aminoglycoside can occur. Amoxicillin and aminoglycoside injections should be administered at separate sites. Amoxicillin should not be mixed with blood products or other proteinaceous fluids (eg protein hydrolysates) or with intravenous lipid emulsions. Amoxicillin should not be mixed with ciprofloxacin. top Store below 25°C Reconstituted solutions should be administered immediately after preparation. top Vials containing 250mg or 500mg of amoxicillin sodium for injection in packs of 10 vials. Vials containing 1g of amoxicillin sodium for injection in single packs. top The vials are not suitable for multidose use. top Wockhardt UK Ltd Ash Road North, Wrexham LL13 9UF UK toptop Amoxicillin Sodium 250mg Powder for Solution for Injection - PL 29831/0010 Amoxicillin Sodium 500mg Powder for Solution for Injection - PL 29831/0012 Amoxicillin Sodium 1g Powder for Solution for Injection - PL 29831/0011
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Amoksicilin prašak i kapsule – Uputa o lijeku Proizvođač: Belupo Samo na recept? DA Opis Sastav Amoksicilin prašak za oralnu suspenziju 250 mg/5 ml: jedna bočica s praškom sadržava 5 g amoksicilina u obliku trihidrata; 5 ml pripremljene suspenzije sadržava 250 mg amoksicilina u obliku trihidrata. Pomoćne tvari: saharoza. Priprema suspenzije: sadržaj bočice suspendira se u 59 ml vode. Amoksicilin kapsule 375 mg: jedna kapsula sadržava 375 mg amoksicilina u obliku trihidrata. Amoksicilin kapsule 500 mg: jedna kapsula sadržava 500 mg amoksicilina u obliku trihidrata. Pomoćne tvari: boje: kinolin žuta (E104), sunset žuta FCF (E110), eritrozin (E127), titan-dioksid (E171). Farmakoterapijska skupina Amoksicilin je polusintetički beta-laktamski antibakterijski lijek široka spektra djelovanja za sustavnu primjenu. Način i mjesto izdavanja Izdaje se na recept , samo u ljekarnama. Pakovanje - Prašak za pripremu 100 ml oralne sus-penzije (250 mg/5 ml) - 12 kapsula od 375 mg - 16 kapsula od 500 mg Primjena Terapijske indikacije Amoksicilin se primjenjuje u liječenju infekcija uzrokovanih bakterijama osjetljivim na amoksicilin: - infekcije dišnog sustava: upale bronha, upale ždrijela, upale sinusa, upale pluća uzrokovane pneumokokom, streptokokom i stafilokokom koji ne producira betalaktamazu; - akutne upale srednjeg uha uzrokovane pneumokokom, streptokokom, stafilokokom koji ne producira betalaktamazu te one koje su uzrokovane Haemophilus influenzae; - infekcije genitalnog sustava koje uzrokuju: E. coli, Proteus mirabilis, Streptococcus faecalis; - infekcije kože i mekih tkiva ,uključujući infekcije opeklina, koje uzrokuje streptokok, stafilokok koji ne producira betalaktamazu, E. coli, Proteus mirabilis; - Lymeova bolest; - trbušni tifus (Salmonella typhi); - gastritis i peptički ulkus uzrokovan infekcijom s Helicobacter pylori u kombinaciji s antiulkusnim lijekom (inhibitorom protonske pumpe) i drugim antibakterijskim lijekom (npr. metronidazol, klaritromicin). Amoksicilin se primjenjuje u profilaksi bakterijskog endokarditisa. Doziranje i način primjene Doziranje amoksicilina ovisi o uzročniku, težini bolesti, dobi te bubrežnoj funkciji. Amoksicilin se u pravilu uzima svakih 8 sati, na prazan ili pun želudac. Odrasli i djeca teža od 20 kg Uobičajena peroralna doza je, ovisno o težini infekcije i uzročniku, 250-500 mg amoksicilina svakih 8 sati. U slučaju potrebe za dozom od 250 mg daje se suspenzija (5 ml odnosno 1 žličica), u ostalim slučajevima primjenjuje se 1 kapsula od 375, odnosno 500 mg svakih 8 sati. U liječenju gastritisa i peptičkog ulkusa uzrokovanih infekcijom s Helicobacter pylori amoksicilin se primjenuje u dozi od 1 g svakih 12 sati tijekom 7 dana u kombinaciji s antiulkusnim lijekom (inhibitorom protonske pumpe) i još jednim antibakterijskim lijekom (npr. metronidazol). Srčanim bolesnicima koji idu kod zubara ili u bolnicu na kirurški zahvat, ponekad je potreban antibiotik u svrhu sprečavanja bakterijskog endokarditisa. Bolesnici koji podliježu invazivnim dentalnim postupcima bez opće anestezije trebaju uzeti 3 g amoksicilina peroralno prije zahvata. Ukoliko se smatra potrebnim, moguće je dati drugu dozu 6 sati poslije. Bolesnici koji su primili opću anesteziju trebaju uzeti 3 g amoksicilina peroralno 4 sata prije anestezije te 3 g odmah nakon obavljenog zahvata. Kod bolničkih kirurških zahvata amoksicilin se obično primjenjuje parenteralno (iv. ili im.) prije zahvata te 500 mg peroralno ili parenteralno 6 sati poslije. Doza amoksicilina za djecu mlađu od 10 g. iznosi polovicu doze za odrasle, dok doza amoksicilina za djecu mlađu od 5 g. iznosi četvrtinu doze za odrasle. Djeca do 20 kg tjelesne mase U djece do 20 kg tjelesne mase doza amoksicilina se određuje prema tjelesnoj masi, a primjenjuje se u obliku suspenzije. Uobičajene doze su, ovisno o težini infekcije i uzročniku, 20-40 mg/kg na dan podijeljeno u 3 doze (odnosno svakih 8 sati). Prema ovoj shemi doziranja daje se 1,25-5 ml suspenzije svakih 8 sati. Suspenziju valja promućkati prije primjene! Doziranje se provodi pomoću priložene žličice. Žličica je namijenjena za odmjeravanje pojedinačnih doza jednakih ili većih od 62,5 mg amoksicilina, odnosno 1,25 ml suspenzije. Trajanje terapije Duljina terapije ovisi o uzročniku i težini bolesti. Za većinu infekcija terapiju valja nastaviti 48-72 sata nakon prestanka simptoma bolesti ili nakon što se bakteriološki dokazalo odsustvo bakterija. Kod infekcija beta-hemolitičkim streptokokom terapija mora trajati najmanje 10 dana radi smanjenja rizika od reumatske groznice i glomerulonefritisa. Kod težih oštećenja bubrežne funkcije povećava se interval doziranja. U liječenju kroničnih infekcija potrebno je povremeno raditi testove osjetljivosti zbog mogućnosti pojave rezistentnih sojeva bakterija. Perzistentne i teške infekcije zahtijevaju dulju terapiju. Predoziranje Toksičnost penicilina pri predoziranju očituje se tek primjenom vrlo velikih doza, znatno većih od terapijskih i vrlo rijetko pri peroralnoj primjeni. Akutno predoziranje penicilinima može izazvati mučninu, povraćanje, dijareju i abdominalnu bol, u teškim slučajevima neuromuskularnu preosjetljivost koja se može očitovati npr. uzbuđenošcu, razdražljivošću te rijetko konvulzijama. U slučaju predoziranja valja odmah prestati uzimati Amoksicilin i obratiti se liječniku! Interakcije Prije početka primjene AMOKSICILINA, izvijestite liječnika o svim lijekovima koje uzimate! Amoksicilin može smanjiti učinkovitost oralnih kontraceptiva. Tijekom terapije amoksicilinom preporučuje se primjena i drugih oblika kontracepcije. Pri istovremenoj primjeni amoksicilina i alopurinola povećava se učestalost kožnih osipa, dok se s kortikosteroidima povećava mogućnost hematoloških i bubrežnih nuspojava. Istovremeno primijenjeni penicilini mogu smanjiti klirens metotreksata i povećati mogućnost nuspojava ovog lijeka te se bolesnici na kombiniranoj terapiji moraju pažljivo pratiti. Ukoliko je indicirana kombinirana terapija amoksicilinom i aminoglikozidima, preporučuje se da vremenski razmak između uzimanja ova dva lijeka bude najmanje jedan sat. Amoksicilin se ne preporučuje primjenjivati istovremeno s tetraciklinima, kloramfenikolom i sulfonamidom jer bakteriostatsko djelovanje ovih lijekova može onemogućiti baktericidno djelovanje amoksicilina. Izlučivanje amoksicilina putem bubrega može se usporiti djelovanjem probenecida. Mjere opreza Amoksicilin može izazvati reakciju preosjetljivosti do anafilaktičkog šoka. Ukoliko postoje anamnestički podaci o preosjetljivosti na druge beta-laktamske antibiotike, uključujući cefalosporine i cefamicine te druge peniciline, potreban je poseban oprez zbog moguće parcijalne unakrsne preosjetljivosti na amoksicilin. Tijekom liječenja amoksicilinom, naročito tijekom dugotrajne ili opetovane primjene, postoji mogućnost superinfekcije gljivicama i drugim patogenim bakterijama. U tom slučaju se primjena amoksicilina mora odmah prekinuti. Pri duljoj primjeni lijeka potrebno je provjeriti funkciju bubrega, jetre i hematološkog sustava. Kontraindikacije Amoksicilin se ne smije primijeniti u slučaju preosjetljivosti na penicilin te u bolesnika s infektivnom mononukleozom i limfatičkom leukemijom zbog učestale pojave osipa. Posebna upozorenja Lijek je potrebno pažljivo dozirati u starijih osoba i djece, ovisno o njihovoj tjelesnoj masi. Nije pogodan za primjenu u bolesnika s učestalim proljevima. U bolesnika s poremećajem bubrežne funkcije preporučuje se, zbog usporene eliminacije lijeka, smanjiti dozu ili povećati vremenski razmak izmedu dvije doze. Trudnoća Amoksicilin prolazi kroz posteljicu. U trudnoći je dozvoljena primjena samo kada, prema procjeni liječnika, moguća korist za trudnicu prevladava moguće rizike za fetus. Dojenje Amoksicilin se izlučuje u majčinu mlijeku te postoji mogućnost senzibilizacije, proljeva, kandidijaze i kožnog osipa u dojenčeta. Primjena amoksicilina je dozvoljena samo kada, prema procjeni liječnika, moguća korist za dojilju prevladava moguće rizike za dojenče. Nuspojave Amoksicilin može izazvati reakciju preosjetljivosti koja u najtežem slučaju može dovesti do anafilaktičkog šoka. Reakcija preosjetljivosti se pojavljuje u 0,7-10% bolesnika, a očituje najčešće kožnim reakcijama, rjeđe poremećajima disanja, vrućicom i angioneurotskim edemom. U nekim slučajevima može se razviti serumska bolest. Anafilakticki šok je rijedak i malo vjerojatan kod peroralne primjene. Najčešće kožne reakcije preosjetljivosti su osip, naročito makulopapularni te urtikarija i svrbež. U slučaju reakcije preosjetljivosti valja prekinuti primjenu amoksicilina. Amoksicilin može dovesti do supresije normalne crijevne flore i na taj način izazvati proljev i druge probavne smetnje (mučnina, povraćanje, abdominalna bol). Zbog navedenog može doći do rasta rezistentnih mikroorganizama te postoji mogućnost superinfekcije. Opisane su i izuzetno rijetke nuspojave amoksicilina: poremećaj jetrene ili bubrežne funkcije, intersticijski nefritis, pseudomembranozni kolitis, hematološke promjene (trombocitopenija, leukopenija, neutropenija). U slučaju pojave nuspojava, potrebno je obratiti se liječniku ili ljekarniku! Ulje divljeg origana Najdjelotvorniji prirodni antibiotik. Akcijska cijena! Citrofit Jak podizač imuniteta. od 68 kn