RiteMED Co-amoxiclav

RiteMED Co-amoxiclav

amoxicillin + clavulanic acid

Manufacturer:

RiteMED

Distributor:

RiteMED
Concise Prescribing Info
Contents
Co-amoxiclav (amoxicillin & clavulanic acid). Per 625 mg FC tab Amoxicillin 500 mg, clavulanic acid 125 mg. Per 1 g FC tab Amoxicillin 875 mg, clavulanic acid 125 mg
Indications/Uses
625 mg: Common bacterial infections where oral therapy is indicated, eg, URTI (including ENT) eg, sinusitis, tonsillitis, otitis media. Skin & soft tissue infections eg, boils/abscesses, cellulitis, wound infections, intra-abdominal sepsis. Lower resp tract infections eg, acute & chronic bronchitis, pneumonia, lung abscess. GUT eg, cystitis, urethritis, pyelonephritis, septic abortion, pelvic infection, gonorrhea. Osteomyelitis, septicemia, peritonitis, post-op infections. 1 g: Infections in adults & childn eg, 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.
Dosage/Direction for Use
625 mg Adult & childn ≥40 kg One 500 mg/125 mg dose tid. Childn <40 kg 20 mg/5 mg/kg daily to 60 mg/15 mg/kg daily in 3 divided doses. 1 g Adult & childn ≥40 kg Standard dose (for all indications) 875 mg/125 mg bid. Higher dose (particularly for 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 as 2 divided doses, up to 70 mg/10 mg/kg daily given as 2 divided doses may be considered for some infections (eg, otitis media, sinusitis & lower resp tract infections).
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 penicillins. History of severe immediate hypersensitivity reaction (eg, anaphylaxis) to another β-lactam agent eg, cephalosporin, carbapenem or monobactam. History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid.
Special Precautions
Discontinue & institute appropriate alternative therapy if an allergic reaction 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 be used to treat penicillin-resistant S. pneumoniae. Convulsions may occur in patients w/ impaired renal function or in those receiving high doses. Avoid if infectious mononucleosis is suspected. Concomitant use w/ allopurinol; anticoagulants. Acute generalised exanthematous pustulosis (AGEP). Antibiotic-associated colitis. Periodic assessment of organ system functions, including renal, hepatic & haematopoietic function is advisable during prolonged therapy. May affect ability to drive & use machines. Hepatic & renal impairment. Hepatic events in males & elderly. False +ve results in tests for the presence of glucose in urine; false +ve Coombs test. +ve test results using Bio-Rad Lab Platelia Aspergillus EIA test. Pregnancy & lactation. 625 mg: Co-amoxiclav 4:1 formulations higher than 40 mg/10 mg/kg daily in childn < 2 yr. 1 g: Patients w/ CrCl < 30 mL/min (use of amoxicillin to clavulanic acid ratio of 7:1 is not recommended).
Adverse Reactions
Diarrhoea. Mucocutaneous candidiasis; nausea, vomiting.
Drug Interactions
Increased INR in patients maintained on acenocoumarol or warfarin. Reduced excretion of MTX causing a potential increase in toxicity. Decreased renal tubular secretion w/ probenecid. Reduction in pre-dose conc of the active metabolite mycophenolic acid.
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
RiteMED Co-amoxiclav FC tab 1 g
Packing/Price
10's (P587.5/box, P58.75/film-coated tab)
Form
RiteMED Co-amoxiclav FC tab 625 mg
Packing/Price
15's (P36.75/film-coated tab, P551.25/box)
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