Concise Prescribing Info
Contents
Co-amoxiclav (amoxicillin & clavulanic acid). Per 312.5 mg/5 mL powd for susp Amoxicillin 250 mg, clavulanic acid 62.5 mg. Per 457 mg/5 mL powd for susp Amoxicillin 400 mg, clavulanic acid 57 mg
Indications/Uses
312.5 mg: Infections due to β-lactamase-producing strains including resp tract, skin & skin structure & UTI; otitis media & sinusitis. 457 mg: Acute bacterial sinusitis, otitis media, exacerbations of chronic bronchitis; community acquired pneumonia, cystitis, pyelonephritis, skin & soft tissue infections particularly cellulitis, animal bites, severe dental abscess w/ spreading cellulitis.
Dosage/Direction for Use
312.5 mg powd for susp Childn Usual recommended dose: 25 mg/kg/day in divided doses every 8 hr, >6 yr weighing 18-40 kg 5 mL tid, 1-6 yr weighing 10-18 kg 5 mL of 156.25 mg/5 mL susp tid, <1 yr weighing 7.5 kg 2 mL of 156.25 mg/5 mL susp tid, <1 yr 25 mg/kg/day. Childn <40 kg Renal impairment CrCl 10-30 mL/min 15 mg/3.75 mg/kg bid. Max: 500 mg/125 mg bid, CrCl <10 mL/min 15 mg/3.75 mg/kg as single daily dose. Max: 500 mg/125 mg. Hemodialysis 15 mg/3.75 mg/kg/day once daily given prior to hemodialysis. Another dose may be given after hemodialysis to restore circulating drug levels. 457 mg powd for susp Adults & childn ≥40 kg Use adult formulations of amoxicillin/clavulanic acid. Childn <40 kg Lower dose: 25 mg/3.6 mg/kg/day to 45 mg/6.4 mg/kg/day in 2 divided doses. Max daily dose: 1,000-2,800 mg amoxicillin & 143-400 mg clavulanic acid. Some infections including otitis media, sinusitis & lower resp tract infection 45 mg/6.4 mg/kg/day to 70 mg/10 mg/kg/day in 2 divided doses.
Administration
Should be taken with food: 457 mg/5 mL powd for susp: Take at the start of meal to minimise potential GI intolerance.
Contraindications
Hypersensitivity to amoxicillin, clavulanic acid & penicillins. History of a severe immediate hypersensitivity reaction to another β- lactam agent (eg, cephalosporins, carbapenem or monobactam). Previous history of cholestatic jaundice/liver dysfunction associated w/ penicillins.
Special Precautions
Anaphylactoid reactions; possible allergic skin reaction w/ co-administration of allopurinol. History of penicillin hypersensitivity. Discontinue & initiate alternative therapy if an allergic reaction; suspected acute generalised exanthematous pustulosis (AGEP); antibiotic-associated colitis occurs. Suspected infectious mononucleosis. Overgrowth of nonsusceptible organisms in prolonged use. Perform periodic assessment of organ system functions including renal, hepatic, hematopoietic function during prolonged therapy. Prolonged prothrombin time. Hepatic & renal impairment. Pregnancy & lactation. Elderly.
Adverse Reactions
Mucocutaneous candidiasis; diarrhoea, nausea, vomiting.
Drug Interactions
Decreased renal tubular secretion w/ probenecid. Reduced efficacy of OCs. Possibility of prolonged bleeding time w/ anticoagulants. Reduced excretion of MTX.
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
Orapen-S powd for susp 312.5 mg/5 mL
Packing/Price
60 mL x 1's
Form
Orapen-S powd for susp 457 mg/5 mL
Packing/Price
60 mL x 1's;70 mL x 1's
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