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Augmentin® 625 mg Tablets Each film-coated tablet contains amoxicillin trihydrate equivalent to 500 mg amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid. For a full list of excipients, see section 6.1. Film-coated tablet White to off-white, oval film-coated tablets debossed with 'AC' and a score line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Augmentin is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1): • Acute bacterial sinusitis (adequately diagnosed) • Acute otitis media • Acute exacerbations of chronic bronchitis (adequately diagnosed) • Community acquired pneumonia • Cystitis • Pyelonephritis • Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis. • Bone and joint infections, in particular osteomyelitis. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component. The dose of Augmentin that is selected to treat an individual infection should take into account: • The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4) • The severity and the site of the infection • The age, weight and renal function of the patient as shown below. The use of alternative presentations of Augmentin (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary (see sections 4.4 and 5.1). For adults and children ≥ 40 kg, this formulation of Augmentin provides a total daily dose of 1500 mg amoxicillin/375 mg clavulanic acid, when administered as recommended below. For children < 40 kg, this formulation of Augmentin provides a maximum daily dose of 2400 mg amoxicillin/600 mg clavulanic acid, when administered as recommended below. If it is considered that a higher daily dose of amoxicillin is required, it is recommended that another preparation of Augmentin is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid (see sections 4.4 and 5.1). The duration of therapy should be determined by the response of the patient. Some infections (e.g. osteomyelitis) require longer periods of treatment. Treatment should not be extended beyond 14 days without review (see section 4.4 regarding prolonged therapy). Adults and children ≥ 40 kg One 500 mg/125 mg dose taken three times a day. Children < 40 kg 20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day given in three divided doses. Children may be treated with Augmentin tablets, suspensions or paediatric sachets. As the tablets cannot be divided, children weighing less than 25 kg must not be treated with Augmentin tablets. The table below presents the received dose (mg/kg body weight) in children weighing 25 kg to 40 kg upon administering a single 500/125 mg tablet. Children aged 6 years and below or weighing less than 25 kg should preferably be treated with Augmentin suspension or paediatric sachets. No clinical data are available on doses of Augmentin 4:1 formulations higher than 40 mg/10 mg/kg per day in children under 2 years. Elderly No dose adjustment is considered necessary. Renal impairment Dose adjustments are based on the maximum recommended level of amoxicillin. No adjustment in dose is required in patients with creatinine clearance (CrCl) greater than 30 ml/min. Adults and children ≥ 40 kg Children < 40 kg Hepatic impairment Dose with caution and monitor hepatic function at regular intervals (see sections 4.3 and 4.4). Method of administration Augmentin is for oral use. Administer at the start of a meal to minimise potential gastrointestinal intolerance and optimise absorption of amoxicillin/clavulanic acid. Therapy can be started parenterally according the SPC of the IV-formulation and continued with an oral preparation. Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients. History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam). History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid (see section 4.8). Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam agents (see sections 4.3 and 4.8). 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 penicillin hypersensitivity and in atopic individuals. If an allergic reaction occurs, amoxicillin/clavulanic acid therapy must be discontinued and appropriate alternative therapy instituted. In the case that an infection is proven to be due to an amoxicillin-susceptible organisms(s) then consideration should be given to switching from amoxicillin/clavulanic acid to amoxicillin in accordance with official guidance. This presentation of Augmentin is not suitable for use when there is a high risk that the presumptive pathogens have reduced susceptibility or resistance to beta-lactam agents that is not mediated by beta-lactamases susceptible to inhibition by clavulanic acid. This presentation should not be used to treat penicillin-resistant S. pneumoniae Convulsions may occur in patients with impaired renal function or in those receiving high doses (see section 4.8). Amoxicillin/clavulanic acid should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin. Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. Prolonged use may occasionally result in overgrowth of non-susceptible organisms. The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthemous pustulosis (AGEP) (see Section 4.8). This reaction requires Augmentin discontinuation and contra-indicates any subsequent administration of amoxicillin. Amoxicillin/clavulanic acid should be used with caution in patients with evidence of hepatic impairment (see section 4.2). Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged treatment. These events have been very rarely reported in children. In all populations, signs and symptoms usually occur during or shortly after treatment but in some cases may not become apparent until several weeks after treatment has ceased. These are usually reversible. Hepatic events may be severe and, in extremely rare circumstances, deaths have been reported. These have almost always occurred in patients with serious underlying disease or taking concomitant medications known to have the potential for hepatic effects (see section 4.8). Antibiotic-associated colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life threatening (see section 4.8). Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of any antibiotics. Should antibiotic-associated colitis occur, amoxicillin/clavulanic acid should immediately be discontinued, a physician be consulted and an appropriate therapy initiated. Anti-peristaltic medicinal products are contra-indicated in this situation. Periodic assessment of organ system functions, including renal, hepatic and haematopoietic function is advisable during prolonged therapy. Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin/clavulanic acid. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation (see section 4.5 and 4.8). In patients with renal impairment, the dose should be adjusted according to the degree of impairment (see section 4.2). 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. In patients with bladder catheters, a regular check of patency should be maintained (see section 4.9). During treatment with amoxicillin, enzymatic glucose oxidase methods should be used whenever testing for the presence of glucose in urine because false positive results may occur with non-enzymatic methods. The presence of Clavulanic acid in Augmentin may cause a non-specific binding of IgG and albumin by red cell membranes leading to a false positive Coombs test. There have been reports of positive test results using the Bio-Rad Laboratories Platelia Aspergillus EIA test in patients receiving amoxicillin/clavulanic acid who were subsequently found to be free of Aspergillus infection. Cross-reactions with non-Aspergillus polysaccharides and polyfuranoses with Bio-Rad Laboratories Platelia Aspergillus EIA test have been reported. Therefore, positive test results in patients receiving amoxicillin/clavulanic acid should be interpreted cautiously and confirmed by other diagnostic methods. Oral anticoagulants Oral anticoagulants and penicillin antibiotics have been widely used in practice without reports of interaction. However, in the literature there are cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin. Moreover, adjustments in the dose of oral anticoagulants may be necessary (see sections 4.4 and 4.8). Methotrexate Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity. Probenecid Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin but not of clavulanic acid. Mycophenolate mofetil In patients receiving mycophenolate mofetil, reduction in pre-dose concentration of the active metabolite mycophenolic acid (MPA) of approximately 50% has been reported following commencement of oral amoxicillin plus clavulanic acid. The change in pre-dose level may not accurately represent changes in overall MPA exposure. Therefore, a change in the dose of mycophenolate mofetil should not normally be necessary in the absence of clinical evidence of graft dysfunction. However, close clinical monitoring should be performed during the combination and shortly after antibiotic treatment. Pregnancy Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Limited data on the use of amoxicillin/clavulanic acid during pregnancy in humans do not indicate an increased risk of congenital malformations. In a single study in women with preterm, premature rupture of the foetal membrane it was reported that prophylactic treatment with amoxicillin/clavulanic acid may be associated with an increased risk of necrotising enterocolitis in neonates. Use should be avoided during pregnancy, unless considered essential by the physician. Lactation Both substances are excreted into breast milk (nothing is known of the effects of clavulanic acid on the breast-fed infant). Consequently, diarrhoea and fungus infection of the mucous membranes are possible in the breast-fed infant, so that breast-feeding might have to be discontinued. Amoxicillin/clavulanic acid should only be used during breast-feeding after benefit/risk assessment by the physician in charge. No studies on the effects on the ability to drive and use machines have been performed. However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines (see section 4.8). The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and vomiting. The ADRs derived from clinical studies and post-marketing surveillance with Augmentin, sorted by MedDRA System Organ Class are listed below. The following terminologies have been used in order to classify the occurrence of undesirable effects. Very common (≥1/10) Not known (cannot be estimated from the available data) Symptoms and signs of overdose Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see section 4.4). Convulsions may occur in patients with impaired renal function or in those receiving high doses. Amoxicillin has been reported to precipitate in bladder catheters, predominantly after intravenous administration of large doses. A regular check of patency should be maintained (see section 4.4). Treatment of intoxication Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance. Amoxicillin/clavulanic acid can be removed from the circulation by haemodialysis. Pharmacotherapeutic group: Combinations of penicillins, incl. beta-lactamase inhibitors; ATC code: J01CR02. Mode of action Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death. Amoxicillin is susceptible to degradation by beta-lactamases produced by resistant bacteria and therefore the spectrum of activity of amoxicillin alone does not include organisms which produce these enzymes. Clavulanic acid is a beta-lactam structurally related to penicillins. It inactivates some beta-lactamase enzymes thereby preventing inactivation of amoxicillin. Clavulanic acid alone does not exert a clinically useful antibacterial effect. PK/PD relationship The time above the minimum inhibitory concentration (T>MIC) is considered to be the major determinant of efficacy for amoxicillin. Mechanisms of resistance The two main mechanisms of resistance to amoxicillin/clavulanic acid are: • Inactivation by those bacterial beta-lactamases that are not themselves inhibited by clavulanic acid, including class B, C and D. • Alteration of PBPs, which reduce the affinity of the antibacterial agent for the target. Impermeability of bacteria or efflux pump mechanisms may cause or contribute to bacterial resistance, particularly in Gram-negative bacteria. Breakpoints MIC breakpoints for amoxicillin/clavulanic acid are those of the European Committee on Antimicrobial Susceptibility Testing (EUCAST) The prevalence of resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable. Absorption Amoxicillin and clavulanic acid, are fully dissociated in aqueous solution at physiological pH. Both components are rapidly and well absorbed by the oral route of administration. Absorption of amoxicillin/clavulanic acid is optimised when taken at the start of a meal. Following oral administration, amoxicillin and clavulanic acid are approximately 70% bioavailable. The plasma profiles of both components are similar and the time to peak plasma concentration (Tmax ) in each case is approximately one hour. The pharmacokinetic results for a study, in which amoxicillin/clavulanic acid (500 mg/125 mg tablets three times daily) was administered in the fasting state to groups of healthy volunteers are presented below. Amoxicillin and clavulanic acid serum concentrations achieved with amoxicillin/clavulanic acid are similar to those produced by the oral administration of equivalent doses of amoxicillin or clavulanic acid alone. Distribution About 25% of total plasma clavulanic acid and 18% of total plasma amoxicillin is bound to protein. The apparent volume of distribution is around 0.3-0.4 l/kg for amoxicillin and around 0.2 l/kg for clavulanic acid. Following intravenous administration, both amoxicillin and clavulanic acid have been found in gall bladder, abdominal tissue, skin, fat, muscle tissues, synovial and peritoneal fluids, bile and pus. Amoxicillin does not adequately distribute into the cerebrospinal fluid. From animal studies there is no evidence for significant tissue retention of drug-derived material for either component. Amoxicillin, like most penicillins, can be detected in breast milk. Trace quantities of clavulanic acid can also be detected in breast milk (see section 4.6). Both amoxicillin and clavulanic acid have been shown to cross the placental barrier (see section 4.6). Biotransformation Amoxicillin is partly excreted in the urine as the inactive penicilloic acid in quantities equivalent to up to 10 to 25% of the initial dose. Clavulanic acid is extensively metabolized in man and eliminated in urine and faeces and as carbon dioxide in expired air. Elimination The major route of elimination for amoxicillin is via the kidney, whereas for clavulanic acid it is by both renal and non-renal mechanisms. Amoxicillin/clavulanic acid has a mean elimination half-life of approximately one hour and a mean total clearance of approximately 25 l/h in healthy subjects. Approximately 60 to 70% of the amoxicillin and approximately 40 to 65% of the clavulanic acid are excreted unchanged in urine during the first 6 h after administration of single Augmentin 250 mg/125 mg or 500 mg/125 mg tablets. Various studies have found the urinary excretion to be 50-85% for amoxicillin and between 27-60% for clavulanic acid over a 24 hour period. In the case of clavulanic acid, the largest amount of drug is excreted during the first 2 hours after administration. Concomitant use of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid (see section 4.5). Age The elimination half-life of amoxicillin is similar for children aged around 3 months to 2 years and older children and adults. For very young children (including preterm newborns) in the first week of life the interval of administration should not exceed twice daily administration due to immaturity of the renal pathway of elimination. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Gender Following oral administration of amoxicillin/clavulanic acid to healthy males and female subjects, gender has no significant impact on the pharmacokinetics of either amoxicillin or clavulanic acid. Renal impairment The total serum clearance of amoxicillin/clavulanic acid decreases proportionately with decreasing renal function. The reduction in drug clearance is more pronounced for amoxicillin than for clavulanic acid, as a higher proportion of amoxicillin is excreted via the renal route. Doses in renal impairment must therefore prevent undue accumulation of amoxicillin while maintaining adequate levels of clavulanic acid (see section 4.2). Hepatic impairment Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. Nonclinical data reveal no special hazard for humans based on studies of safety pharmacology, genotoxicity and toxicity to reproduction. Repeat dose toxicity studies performed in dogs with amoxicillin/clavulanic acid demonstrate gastric irritancy and vomiting, and discoloured tongue. Carcinogenicity studies have not been conducted with Augmentin or its components. Tablet core Magnesium stearate Sodium starch glycolate, Type A Colloidal anhydrous silica Microcrystalline cellulose Tablet film-coat Titanium dioxide (E171) Hypromellose Dimeticone 2 years in cold formed aluminium blisters (CFB) and desiccated pouch packs (DPP) Tablets in desiccated pouch packs should be used within 30 days of opening. Store in the original package in order to protect from moisture. Do not store above 25°C. PVC/Aluminium/Polyamide laminate with aluminium lidding foil referred to as a cold formed aluminium blister (CFB) containing 4, 10, 12, 14, 16, 20, 24, 30, 100 or 500 tablets. Aluminium PVC/PVdC blister enclosed within an aluminium laminate pouch containing a desiccant sachet, referred to as a desiccated pouch (DPP) containing 14, 20 or 21 tablets. Not all pack sizes may be marketed. Beecham Group Ltd 980 Great West Road Brentford Middlesex TW8 9GS Trading as: GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT
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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