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Comxicla

Comxicla

amoxicillin + clavulanic acid

Manufacturer:

Indchemie Health Specialities

Distributor:

Suhitas
Concise Prescribing Info
Contents
Amoxicillin 500 mg, clavulanic acid 125 mg
Indications/Uses
Adults & childn w/ acute otitis media, adequately diagnosed acute bacterial sinusitis & 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
Duration: Not to extend >14 days. Adult & childn ≥40 kg One 500 mg/125 mg dose tid. Renal impairment CrCl 10-30 mL/min 500 mg/125 mg bid, CrCl <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 20/5 mg/kg to 60/15 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), CrCl <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, w/ 15 mg/3.75 mg/kg administered prior to & after haemodialysis.
Administration
May be taken with or without food: Preferably taken at the start of meals for better absorption & to reduce GI discomfort.
Contraindications
Hypersensitivity to amoxicillin, clavulanic acid or any of the penicillins. History of a 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 use if an allergic reaction, symptoms of acute generalised exanthemous pustulosis, or antibiotic-associated colitis occurs. Avoid use if infectious mononucleosis is suspected. Not to be used for penicillin-resistant S. pneumoniae. Convulsions may occur in patients w/ renal impairment or those receiving high doses. Overgrowth of non-susceptible organisms in prolonged use. Perform periodic assessment of organ system functions including renal, hepatic & haematopoietic function in prolonged therapy. Maintain adequate fluid intake & urinary output during administration of high doses. Regularly check patency in patients w/ bladder catheters. False +ve results may occur w/ non-enzymatic methods. False +ve Coombs test. +ve test results using Bio-Rad Laboratories Platelia Aspergillus EIA test. Monitor for prolongation of prothrombin time in concomitant use w/ anticoagulants. Concomitant use w/ allopurinol. Hepatic & renal impairment. Avoid use during pregnancy. Lactation. Not to be used in childn <25 kg.
Adverse Reactions
Diarrhoea. Mucocutaneous candidosis; nausea, vomiting.
Drug Interactions
Increased INR w/ oral anticoagulants eg, acenocoumarol or warfarin. May reduce excretion of MTX. Decreased renal tubular secretion of amoxicillin w/ probenecid. Reduced pre-dose conc of active metabolite of mycophenolate mofetil (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
Comxicla FC tab 625 mg
Packing/Price
20's
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