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Concise Prescribing Info
Contents
Per 625 mg tab Amoxicillin 500 mg, clavulanic acid 125 mg
Indications/Uses
Lower resp tract infections, otitis media & sinusitis caused by β-lactamase-producing strains of H. influenzae & Moraxella catarrhalis; skin & skin structure infections caused by S. aureus, E. coli, Klebsiella spp. & Enterobacter spp; UTI caused by E. coli, Klebsiella spp. & Enterobacter spp.
Dosage/Direction for Use
Adult & childn >12 yr Mild to moderate infection 375 mg every 8 hr. More severe & resp tract infection 625 mg every 8 hr.
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 amoxicillin, clavulanic acid & penicillins. History of severe immediate hypersensitivity reaction to another β-lactam agent (eg, cephalosporin, carbapenem or monobactam. History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid.
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. Avoid if infectious mononucleosis is suspected. Not to be used to treat penicillin-resistant S. pneumoniae. Convulsion may occur in patients w/ renal impairment or receiving high doses. Overgrowth of nonsusceptible organisms in prolonged use. Perform periodic assessment of organ system functions including renal, hepatic, hematopoietic function during prolonged therapy. Concomitant use w/ anticoagulants. Hepatic & renal impairment. False +ve result may occur w/ non-enzymatic methods in testing for the presence of glucose in urine; Coomb's test; Bio-Rad Laboratories Platelia Aspergillus EIA test. Pregnancy & lactation.
Adverse Reactions
Diarrhoea. Mucocutaneous candidiasis; nausea; vomiting.
Drug Interactions
Increased INR w/ acenocoumarol or warfarin. May reduce excretion of MTX causing a potential increase in toxicity. Increased & prolonged blood levels of amoxicillin w/ probenecid.
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 tab 625 mg
Packing/Price
20's
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