Amoclav Suspension

156.25 mg/5 mL & 312.5 mg/5 mL powd for oral susp: Acute bacterial sinusitis, acute otitis media, acute exacerbations of chronic bronchitis, community acquired pneumonia, cystitis, pyelonephritis, skin & soft tissue infections (particularly cellulitis, animal bites, severe dental abscess w/ spreading cellulitis) & bone & joint infections (particularly osteomyelitis) in adults & childn. 228.5 mg/5 mL & 457 mg/5 mL powd for susp: Short-term treatment of URTI (including ENT infections) eg, tonsillitis, sinusitis, otitis media; lower resp tract infections eg, acute & chronic bronchitis, pneumonia, lung abscess; GUT & abdominal infections eg, cystitis, urethritis, pyelonephritis, female genital infections, septic abortion, pelvic or puerperal sepsis, intra-abdominal sepsis; skin & skin structure infections eg, furuncle & abscess, cellulitis, wound infections; bone & joint infections eg, osteomyelitis; dental infection eg, dentoalveolar abscess; septicemia, peritonitis, post-surgical infections. Step-down treatment for infections due to susceptible organisms, initially given antimicrobial therapy, particularly parenteral co-amoxiclav. 642.9 mg/5 mL powder for oral susp: Short-term treatment of bacterial infections in ped patients eg, URTI (including ENT infections) eg, recurrent or persistent acute otitis media due to Strep pneumoniae, H. influenzae & Moraxella catarrhalis, tonsillopharyngitis & sinusitis typically caused by Strep pneumoniae, H. influenzae, Moraxella catarrhalis & Strep pyogenes; lower resp tract infections (eg, lobar & bronchopneumonia typically caused by Strep pneumoniae, H. influenzae & Moraxella catarrhalis); skin & soft tissue infections typically caused by Staph pyogenes.

Duration: Not to exceed 14 days w/o 1st re-evaluating patient. 156.25 mg/5 mL & 312.5 mg/5 mL powd for oral susp Adult & childn ≥40 kg One 500 mg/125 mg dose tid. Adult & childn ≥40 kg w/ renal impairment CrCl 10-30 mL/min 500 mg/125 mg bid, <10 mL/min 500 mg/125 mg once daily, hemodialysis 500 mg/125 mg every 24 hr + 500 mg/125 mg during dialysis, to be repeated at the end of dialysis. Childn <40 kg 20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day in 3 divided doses. Childn <40 kg w/ renal impairment CrCl 10-30 mL/min 15 mg/3.75 mg/kg bid (max: 500 mg/125 mg bid), <10 mL/min 15 mg/3.75 mg/kg/day as single daily dose (max: 500 mg/125 mg), hemodialysis 15 mg/3.75 mg/kg/day once daily. Give 15 mg/3.75 mg/kg prior to & after hemodialysis. 228.5 mg/5 mL powd for susp Childn >12 yr weighing >40 kg Adult dose. Childn 6-12 yr weighing 18-40 kg Mild to moderate infection 5-10 mL every 12 hr. Severe infection 10-20 mL every 12 hr. Childn 1-6 yr weighing 10-18 kg Mild to moderate infection 2.5-5 mL every 12 hr. Severe infection 5-10 mL every 12 hr. Childn <1 yr weighing <10 kg Mild to moderate & severe infection 2.5 mL every 12 hr. Childn up to 12 yr w/ renal impairment CrCl >30 mL/min No dose adjustment necessary, 10-30 mL/min 15 mg/kg every 12 hr, <10 mL/min 15 mg/kg once daily, hemodialysis 15 mg/kg once daily, w/ additional dose of 15 mg/kg both during & at end of dialysis. 457 mg/5 mL powd for susp Childn >12 yr weighing >40 kg Adult dose. Childn 6-12 yr weighing 18-40 kg Mild to moderate infection 2.5-5 mL every 12 hr. Severe infection 5-10 mL every 12 hr. Childn 1-6 yr weighing 10-18 kg Mild to moderate infections 2.5 mL every 12 hr. Severe infections 2.5-5 mL every 12 hr. Childn up to 12 yr w/ renal impairment CrCl >30 mL/min No dose adjustment necessary, 10-30 mL/min 15 mg/kg every 12 hr, <10 mL/min 15 mg/kg once daily, hemodialysis 15 mg/kg once daily. w/ additional dose of 15 mg/kg both during & at end of dialysis. 642.9 mg/5 mL powder for oral susp Ped patient ≥3 mth weighing 36 kg 13.5 mL bid for 10 days, 32 kg 12 mL bid for 10 days, 28 kg 10.5 mL bid for 10 days, 24 kg 9 mL bid for 10 days, 20 kg 7.5 mL bid for 10 days, 16 kg 6 mL bid for 10 days, 12 kg 4.5 mL bid for 10 days, 8 kg 3 mL bid for 10 days.

May be taken with or without food: Administer at start of meal to minimize potential GI intolerance & to optimize absorption.

Hypersensitivity to amoxicillin, clavulanic acid or penicillin. History of severe immediate hypersensitivity reaction (eg, anaphylaxis or SJS) to another β-lactam antibiotic (eg, cephalosporin, carbapenem or monobactam). Patients w/ previous history of cholestatic jaundice/hepatic impairment associated w/ co-amoxiclav or penicillin. 228.5 mg/5 mL & 457 mg/5 mL powd for susp/642.9 mg/5 mL powd for oral susp: Patients w/ glandular fever or lymphatic lymphoma.

Reports of serious & occasionally fatal hypersensitivity reactions (including anaphylactoid & severe cutaneous adverse reactions). Make careful inquiry concerning previous hypersensitivity to penicillins, cephalosporins, or other drugs before initiating therapy. Avoid use if infectious mononucleosis is suspected. Long-term or repeated use may result in overgrowth of non-susceptible organisms, including fungi. Maintain adequate fluid intake & urinary output during administration of high doses of amoxicillin. Periodically evaluate renal, hepatic, & haematopoietic status of patients on prolonged treatment. Appropriate monitoring should be undertaken in concomitant use w/ anticoagulants. Potential +ve direct antiglobulin (Coombs') test results. May influence ability to drive & use machines. Adjust dose according to degree of impairment in patients w/ renal impairment. Avoid use during pregnancy unless considered essential. Caution when administering to a nursing mother. 156.25 mg/5 mL & 312.5 mg/5 mL powd for oral susp: Discontinue use if a feverish generalised erythema associated w/ pustula or antibiotic-associated colitis occurs. Not suitable for use when there is a high risk that the presumptive pathogens have reduced susceptibility or resistance to β-lactam agents that is not mediated by β-lactamases susceptible to inhibition by clavulanic acid. Not to be used to treat penicillin-resistant S. pneumoniae. False +ve results may occur w/ non-enzymatic methods. Reports of +ve results using Bio-Rad Laboratories Platelia Aspergillus EIA test in patients who were subsequently found to be free of Aspergillus infection. Convulsions may occur in patients w/ renal impairment or those receiving high doses. Caution in patients w/ evidence of hepatic impairment. Reports of hepatic events. 228.5 mg/5 mL & 457 mg/5 mL powd for susp/642.9 mg/5 mL powd for oral susp: Reports of Clostridium difficile-associated disease. Risk of hepatic dysfunction (including hepatitis & cholestatic jaundice); monitor hepatic function at regular intervals in patients w/ hepatic impairment. May result in false +ve reactions when testing for urinary glucose using cupric sulfate (eg, Clinitest, Benedict's soln). Reports of transient decrease in plasma conc of total conjugated estriol, estriol-glucuronide, conjugated estrone, & estradiol following administration to pregnant women. Dose adjustment & renal function monitoring may be necessary in the elderly. 642.9 mg/5 mL powd for oral susp: Contains phenylalanine.

Mucocutaneous candidosis; diarrhoea, nausea, vomiting.

Decreased renal tubular secretion of amoxicillin w/ probenecid. Increased incidence of skin rashes w/ allopurinol. Reports of abnormal prolongation of prothrombin time (increased INR) w/ oral anticoagulants eg, acenocoumarol or warfarin. Decreased renal clearance & subsequently increased toxicity of MTX. Reduced pre-dose conc of the active metabolite (mycophenolic acid) of mycophenolate mofetil. 228.5 mg/5 mL & 457 mg/5 mL powd for susp/642.9 mg/5 mL powd for oral susp: May reduce efficacy of combined OCs & result in lower estrogen absorption. Not to be used in patients receiving disulfiram.

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.

Rx