http___www.krenizdravo.com_korisno_upute_amoksicilin-prasak-i-kapsule-uputa-o-lijeku_1.xml
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Amoxicillin 500 mg, Powder for Solution for Injection or Infusion Each 10ml vial contains 500 mg Amoxicillin as Amoxicillin Sodium. Each vial contains approximately 38 mg sodium. Powder for Solution for Injection or Infusion. Glass vial containing white or almost white powder. Treatment of Infection: Amoxicillin is a broad spectrum antibiotic indicated for the treatment of commonly occurring bacterial infections such as: • Upper respiratory tract infections • Otitis media • Acute and chronic bronchitis • Chronic bronchial sepsis • Lobar and bronchopneumonia • Cystitis, urethritis, pyelonephritis • Bacteriuria in pregnancy • Gynaecological infections including puerperal sepsis and septic abortion • Gonorrhoea • Peritonitis • Intra-abdominal sepsis • Septicaemia • Bacterial endocarditis • Typhoid and paratyphoid fever • Skin and soft tissue infections In children with urinary tract infection the need for investigation should be considered. Prophylaxis of endocarditis: Amoxicillin may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis. Adult dosage (including elderly patients): Treatment of infection: Moderate infections: 500 mg via intramuscular injection every 8 hours (or more frequently if necessary). This dose may be given by slow intravenous injection if more convenient. Severe infections: 1 g via intravenous injection every 6 hours. Prophylaxis of endocarditis: Children: Children weighing < 40 kg The daily dosage for children is 40 - 90 mg/kg/day in two to three divided doses* (not exceeding 3 g/day) depending on the indication, severity of the disease and the susceptibility of the pathogen (see special dosage recommendations below and sections 4.4, 5.1 and 5.2). *PK/PD data indicate that dosing three times daily is associated with enhanced efficacy, thus twice daily dosing is only recommended when the dose is in the upper range. Children weighing more than 40 kg should be given the usual adult dosage. Special dosage recommendation Tonsillitis: 50 mg/kg/day in two divided doses. Acute otitis media: In areas with high prevalence of pneumococci with reduced susceptibility to penicillins, dosage regimens should be guided by national/local recommendations. Early Lyme disease (isolated erythema migrans): 50 mg/kg/day in three divided doses, over 14-21days. Prophylaxis for endocarditis: 50 mg amoxicillin/kg body weight given as a single dose one hour preceding the surgical procedure. Dosage in impaired renal function: The dose should be reduced in patients with severe renal function impairment. In patients with a creatinine clearance of less than 30 ml/min an increase in the dosage interval and a reduction in the total daily dose is recommended (see section 4.4 and 5.2). Renal impairment in children under 40 kg: Administration: Intravenous injection, intravenous infusion, intramuscular injection: See Section 6.6, Instructions for use and handling. Amoxicillin is a penicillin and should not be given to patients with a history of hypersensitivity to penicillins or other beta-lactam antibiotics e.g. cephalosporins. 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 (see Section 4.3). Erythematous (morbilliform) rashes have been associated with glandular fever in patients receiving amoxicillin. Prolonged use may also occasionally result in overgrowth of non-susceptible organisms. In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria (See Section 4.9 Overdose). Amoxicillin has been reported to precipitate in bladder catheters after intravenous administration of large doses. A regular check of patency should be maintained. Dosage should be adjusted in patients with renal impairment (see section 4.2). Precautions should be taken in premature children and during the neonatal period: renal, hepatic and haematological functions should be monitored. Amoxicillin injection contains approximately 3.3 mmol sodium per gram. This should be taken into consideration by patients on a sodium controlled diet. In common with other broad spectrum antibiotics, amoxicillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly. Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods. Pregnancy Animal studies with amoxicillin have shown no teratogenic effects. It has been in extensive clinical use since 1972 and its suitability in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, amoxicillin may be considered appropriate when the potential benefits outweigh the potential risks associated with treatment. Lactation Amoxicillin may be given during lactation. With the exception of the risk of sensitisation associated with the excretion of trace quantities of amoxicillin in breast milk, there are no known detrimental effects for the breast-fed infant. Adverse effects on the ability to drive or operate machinery have not been observed. The following convention has been utilised for the classification of undesirable effects:- The majority of side effects listed below are not unique to amoxicillin and may occur when using other penicillins. Blood and lymphatic system disordersVery rare: Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia. Prolongation of bleeding time and prothrombin (see Section 4.5 - Interaction with other Medicaments and other Forms of Interaction) Immune system disordersVery rare: As with other antibiotics, severe allergic reactions, including angioneurotic oedema, anaphylaxis (see Section 4.4 - Special Warnings and Precautions for Use), serum sickness and hypersensitivity vasculitis. If a hypersensitivity reaction is reported, the treatment must be discontinued. (See also Skin and subcutaneous tissue disorders). Nervous system disordersVery rare: Hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses. Gastrointestinal disordersCommon: Diarrhoea and nausea. Uncommon: VomitingVery rare: Mucocutaneous candidiasis and antibiotic associated colitis (including pseudomembraneous colitis and haemorrhagic colitis). Hepato-biliary disordersVery rare: Hepatitis and cholestatic jaundice; a moderate rise in AST and/or ALT (the significance of a rise in AST and/or ALT is unclear). Skin and subcutaneous tissue disordersCommon: Skin rash Uncommon: Urticaria and pruritus Very rare: Skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis and acute generalised exanthematous pustulosis (AGEP) (See also Immune system disorders). Renal and urinary disordersVery rare: Interstitial nephritis, crystalluria (See Section 4.9 Overdose). Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically with attention to the water/electrolyte balance. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special warnings and special precautions for use). Amoxicillin may be removed from the circulation by haemodialysis. ATC code: J01CF05 Pharmacotherapeutic group: Beta-lactamase resistant penicillins Amoxicillin is a broad spectrum antibiotic. It is rapidly bactericidal and possesses the safety profile of a penicillin. The wide range of organisms sensitive to the bactericidal action of Amoxicillin include: Amoxicillin is well absorbed by the oral and parenteral routes. Amoxicillin gives good penetration into bronchial secretions and high urinary concentrations of unchanged antibiotic. In preterm infants with gestational age 26-33 weeks, the total body clearance after intravenous dosing of amoxicillin, day 3 of life, ranged between 0.75 2 ml/min, very similar to the inuline clearance (GFR) in this population. Following oral administration, the absorption pattern and the bioavailability of amoxicillin in small children may be different to that of adults. Consequently, due to the decreased CL, the exposure is expected to be elevated in this group of patients, although this increase in exposure may in part be diminished by decreased bioavailability when given orally. No further information of relevance. Amoxicillin should not be mixed with blood products, other proteinaceous fluids such as protein hydrolysates, or with intravenous lipid emulsions. If Amoxicillin is prescribed concurrently with an aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid container or giving set because loss of activity of the aminoglycoside can occur under these conditions. Unopened vial: 36 months. After opening: To be used immediately. Clear Type III glass vials with chlorobutyl rubber closure, in cartons of 1, 5, 10, 20 or 50 vials. Not all pack sizes may be marketed. Intravenous Injection: Dissolve 500mg in 10 ml Water for Injections BP (final volume 10.4 ml). Amoxicillin injection, suitably diluted, may be injected directly into a vein or the infusion line over a period of three to four minutes. Intravenous Infusion: Solutions may be prepared as described for intravenous injections and then added to an intravenous solution in a minibag or in-line burette and administered over a period of half to one hour. Alternatively, using a suitable reconstitution device, the appropriate volume of intravenous fluid may be transferred from the infusion bag into the vial and then drawn back into the bag after dissolution. Intramuscular injection: Add 2.5 ml Water for Injections BP and shake vigorously (final volume 2.9 ml). A transient pink colouration or slight opalescence may appear during reconstitution. Reconstituted solutions are normally a pale straw colour. Amoxicillin injection may be added to the following intravenous fluids and used immediately. • Water for Injections BP • Sodium Chloride Intravenous Infusion (0.9%) • Potassium Chloride (0.3%) and Sodium Chloride (0.9%) Intravenous Infusion • Glucose Intravenous Infusion • Sodium Chloride (0.18%) and Glucose (4%) Intravenous Infusion • Dextran 40 Intravenous Infusion (10%) in Sodium Chloride Intravenous Infusion (0.9%) • Dextran 40 Intravenous Infusion (10%) in Glucose Intravenous Infusion (5%) • Sodium Lactate Intravenous Infusion (M/6) • Compound Sodium Lactate Intravenous Infusions (Ringer-Lactate: Hartmann's Solution) Bowmed Limited Unit 2, Eastman Way Stevenage Herts SG1 4SZ UK
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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. Citrofit Jak podizač imuniteta. od 68 kn