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Concise Prescribing Info
Contents
Amoxicillin trihydrate 500 mg, clavulanate K 125 mg
Indications/Uses
Adult & childn w/ acute bacterial sinusitis (adequately diagnosed), otitis media & exacerbations of chronic bronchitis (adequately diagnosed), community acquired pneumonia, cystitis, pyelonephritis, skin & soft tissue infections (particularly cellulitis, animal bites, severe dental abscess w/ spreading cellulitis), bone & joint infections (particularly osteomyelitis).
Dosage/Direction for Use
Duration: Not to extend beyond 14 days. Adult & childn ≥40 kg One 500 mg/125 mg tid. Renal impairment CrCl 10-30 mL/min 500 mg/125 mg bid, <10 mL/min 500 mg/125 mg once daily, haemodialysis 500 mg/125 mg every 24 hr + 500 mg/125 mg during dialysis, to be repeated at end of dialysis. Childn <40 kg 20 mg/5 mg/kg-60 mg/15 mg/kg daily in 3 divided doses. 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 as single daily dose (max: 500 mg/125 mg), haemodialysis 15 mg/3.75 mg/kg once daily. 15 mg/3.75 mg/kg prior & after haemodialysis.
Administration
May be taken with or without food: Best taken at the start of meals for better absorption & to reduce GI discomfort.
Contraindications
Hypersensitivity to co-amoxiclav or to any of the penicillins. History of severe immediate hypersensitivity reaction (eg, anaphylaxis) to another β-lactam agent; jaundice/hepatic impairment due to amoxicillin/clavulanic acid.
Special Precautions
Hypersensitivity (including anaphylactoid & severe cutaneous adverse reactions). Not to be used to treat penicillin-resistant S. pneumoniae. Convulsions may occur in patients w/ renal impairment or those receiving high doses. Increase allergic skin reactions in concomitant use of allopurinol. Prolonged use may occasionally result in overgrowth of non-susceptible organisms. Discontinue use in the occurrence of feverish generalized erythema associated w/ pustula. Hepatic events predominantly in males & elderly & may be associated w/ prolonged treatment. Antibiotic-associated colitis. Crystalluria has been observed in patients w/ reduced urine output. False +ve results may occur w/ non-enzymatic methods of testing for presence of glucose in urine; Coombs test; Bio-Rad laboratories Platelia Aspergillus EIA test. void use during pregnancy. Breast-feeding should be discontinued due to the possibility of sensitization.
Adverse Reactions
Diarrhea. Mucocutaneous candidosis; nausea, vomiting.
Drug Interactions
Increased INR w/ acenocoumarol or warfarin. May reduce excretion of MTX causing a potential increase in toxicity. Decreased renal tubular secretion & may result in increased & prolonged blood levels of amoxicillin w/ probenecid. Reduced pre-dose conc of the active metabolite of mycophenolate mofetil.
MIMS Class
Penicillins
ATC Classification
J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
Presentation/Packing
Form
Janclav FC tab 625 mg
Packing/Price
20's
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