Alclav Neo/Alclav Kids/Alclav Hospi

Alclav Neo 625 mg FC tab/Alclav Kids/Alclav Hospi Acute exacerbations of chronic bronchitis, community acquired pneumonia, cystitis, pyelonephritis; skin & soft tissue infections in particular cellulitis, animal bites, severe dental abscess w/ spreading cellulitis; bone & joint infections, in particular osteomyelitis. Alclav Neo 625 mg FC tab/Alclav Kids Acute bacterial sinusitis, acute otitis media. Alclav Neo 1 g FC tab UTI due to susceptible organisms; otitis media or sinusitis due to resistant microorganism (eg, H. influenzae, Strep pneumoniae, M. catarrhalis); lower resp tract & skin infections due to susceptible organism; polymicrobial infections w/ mixed aerobic & anaerobic eg, diabetic foot. Alclav Neo 1 g FC tab/Alclav Hospi Gynecologic/female genital infections, intraabdominal infections. Alclav Hospi Severe infections of ENT (eg, mastoiditis, peritonsillar infections, epiglottitis & sinusitis when accompanied by severe systemic signs & symptoms). Prophylaxis against infections associated w/ major surgical procedures in adults involving GIT, pelvic cavity, head & neck, biliary tract surgery.

Alclav Neo 625 mg FC tab Adult & childn ≥40 kg 1 tab tid. Childn <40 kg 20 mg/5 mg/kg daily to 60 mg/15 mg/kg daily in 3 divided doses. Renal impairment in adult & childn ≥40 kg CrCl 10-30 mL/min 15 mg/3.75 mg/kg bid. Max: 1 tab bid, <10 mL/min 15 mg/3.75 mg/kg as single daily dose. Max: 1 tab once daily, haemodialysis 15 mg/3.75 mg/kg once daily. Additional dose prior to & after haemodialysis. Alclav Neo 1 g FC tab Adult 500 mg/125 mg every 12 hr or 250 mg/125 mg every 8 hr. More severe infections & infections of resp tract 875 mg/125 mg (1 tab) every 12 hr or 500 mg/125 mg every 8 hr. Alclav Kids Adult & childn ≥40 kg All indications 875 mg/125 mg bid. Infections eg, otitis media, sinusitis, lower resp tract infections & UTI 875 mg/125 mg tid. Childn <40 kg 25 mg/3.6 mg/kg daily to 45 mg/6.4 mg/kg daily given as 2 divided doses. Otitis media, sinusitis & lower resp tract infections Up to 70 mg/10 mg/kg daily given as 2 divided doses. Alclav Hospi Adult & childn ≥40 kg All indication 1000 mg/200 mg every 8 hr. Surgical prophylaxis 1,000 mg/200 mg to 2,000 mg/200 mg given at induction of anaesth for procedures <1 hr in duration; 1,000 mg/200 mg to 2,000 mg/200 mg given at induction anaesth w/ up to 3 doses of 1,000 mg/200 mg in 24 hr for procedures >1 hr in duration. Childn ≥3 mth 25 mg/5 mg/kg every 8 hr, <3 mth or <4 kg 25 mg/5 mg/kg every 12 hr. Renal impairment in adult & childn ≥40 kg CrCl 10-30 mL/min Initially 1,000 mg/200 mg & then 500 mg/100 mg bid, <10 mL/min Initially 1,000 mg/200 mg & then 500 mg/100 mg every 24 hr, haemodialysis Initially 1,000 mg/200 mg followed by 500 mg/100 mg every 24 hr + 500 mg/100 mg at the end of dialysis. Childn <40 kg CrCl 10-30 mL/min 25 mg/5 mg/kg every 12 hr, <10 mL/min 25 mg/5 mg/kg every 24 hr, haemodialysis 25 mg/5 mg/kg every 24 hr + 12.5 mg/2.5 mg/kg at the end of dialysis.

Should be taken with food.

Hypersensitivity to amoxicillin trihydrate, clavulanic acid, or any penicillins. History of severe immediate hypersensitivity reaction (eg, anaphylaxis) to another β-lactam agent (eg, cephalosporin, carbapenem or monobactam). History of jaundice/hepatic impairment.

Drugs that delay peristalsis eg, opiates & diphenoxylate w/ atropine, may prolong &/or worsen condition & should not be used. Hepatic impairment. Pregnancy & lactation. Alclav Neo 625 mg FC tab/Alclav Kids/Alclav Hospi Careful inquiry concerning previous hypersensitivity reactions to penicillins, cephalosporins or other β-lactam agents before initiating therapy. Anaphylactoid & severe cutaneous adverse reactions in individuals w/ history of penicillin hypersensitivity & in atopic individuals. Discontinue & institute appropriate alternative therapy if allergic reaction occurs. Not suitable for use when high risk presumptive pathogens have reduced susceptibility or resistance to β-lactam agents. Not to be used to treat penicillin-resistant Strep pneumoniae. Convulsions in patients w/ impaired renal function or receiving high doses. Avoid if infectious mononucleosis is suspected. Concomitant use of allopurinol during treatment w/ amoxicillin can increase likelihood of allergic skin reactions. Prolonged use may result in overgrowth of non-susceptible organisms. Discontinue if acute generalised exanthemous pustulosis occurs. Hepatic events in males & elderly associated w/ prolonged treatment; patients w/ serious underlying disease or taking concomitant medications known to have potential for hepatic effects. Consider antibiotic-associated colitis in patients who present w/ diarrhoea during or subsequent to administration; discontinue immediately should this occurs. Periodic assessment of organ system functions, including renal, hepatic & haematopoietic function during prolonged therapy. Appropriate monitoring of prothrombin time when anticoagulants are prescribed concomitantly. Adjust dose according to degree of impairment in patients w/ renal impairment. Crystalluria in patients w/ reduced urine output. Maintain adequate fluid intake & urinary output. Check patency regularly in patients w/ bladder catheters. Use enzymatic glucose oxidase methods whenever testing for presence of glucose in urine because false +ve results may occur w/ non-enzymatic methods during treatment. False +ve Coombs test. Interpret +ve test results using Bio-Rad Laboratories Platelia Aspergillus EIA test in patients found to be free of Aspergillus infection cautiously & should be confirmed by other diagnostic methods since cross-reactions w/ non-Aspergillus polysaccharides & polyfuranoses w/ Bio- Rad Laboratories Platelia Aspergillus EIA test can occur. Alclav Neo 1 g FC tab Provide fluids, electrolytes & protein replacement therapy when indicated. Alclav Neo 1 g FC tab/Alclav Kids Contains aspartame; patients w/ phenylketonuria. Alclav Kids Contains sorbitol; not to be taken by patients w/ rare glucose-galactose malabsorption. Contains benzyl alcohol that may cause allergic reactions. Patients w/ CrCl <30 mL/min. Childn <2 yr. Alclav Hospi Patients w/ reduced kidney function or on controlled K diet.

Diarrhoea, nausea, vomiting. Alclav Neo 625 mg FC tab/Alclav Kids/Alclav Hospi Mucocutaneous candidosis. Alclav Neo 1 g FC tab Gastritis, stomatitis, glossitis, black "hair" tongue, indigestions, enterocolitis, pseudomembranous colitis & candidiasis; skin rashes & urticaria; serious & occasional fatal hypersensitivity (anaphylactic) reactions & angioneurotic oedema in patients on penicillin therapy, cross-sensitivity w/ other β-lactam antibiotics eg, cephalosporins, may occur; transient hepatitis & cholestatic jaundice; anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia & agranulocytosis; phlebitis at site of inj.

Alclav Neo/Alclav Hospi Amoxicillin: Decreased renal tubular secretion that may result in increased & prolonged blood levels w/ probenecid. Alclav Neo 625 mg FC tab/Alclav Hospi Reduction in predose conc of active metabolite mycophenolic acid in patients receiving mycophenolate mofetil. Amoxicillin: Increased INR w/ acenocoumarol or warfarin. May reduce excretion of MTX causing potential increase in toxicity. Alclav Neo 1 g FC tab Decrease in plasma conc of total conjugated estriol, estradiol. Increased incidence of rashes w/ allopurinol. May precipitate disulfiram (antabuse) like reaction w/ alcohol.

Penicillins

J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.

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