Bactoclav

Bactoclav

amoxicillin + clavulanic acid

Manufacturer:

Micro Labs

Distributor:

Atlanta Medicare
Concise Prescribing Info
Contents
Per 375 mg tab Amoxicillin 250 mg, clavulanic acid 125 mg. Per 625 mg tab Amoxicillin 500 mg, clavulanic acid 125 mg. Per 1000 mg tab Amoxicillin 875 mg, clavulanic acid 125 mg
Indications/Uses
Infections caused by susceptible organisms: Acute bacterial sinusitis, acute otitis media, pharyngitis & tonsillitis; acute exacerbations of chronic bronchitis; community acquired pneumonia; cystitis, pyelonephritis; skin & soft tissue infections in particular cellulitis, boils, abscesses, wound infections, animal bites, severe dental infections w/ spreading cellulitis; bone & joint infections, in particular osteomyelitis; septic abortion, puerperal & intra-abdominal sepsis.
Dosage/Direction for Use
Adult & childn ≥40 kg 375 mg every 8 hr or 625 mg every 12 hr, in more severe infections every 8 hr. Severe infections 1 g every 12 hr. Severe renal impairment CrCl <10 mL/min Adult 325 mg or 625 mg once daily. Childn <40 kg 15 mg/3.75 mg/kg as a single daily dose. Max: 500 mg/125 mg. Moderate renal impairment CrCl 10-30 mL/min Adult 375 mg or 625 mg bid. Childn <40 kg 15 mg/3.75 mg/kg bid. Max: 500 mg/125 mg bid. Haemodialysis Adult 2 doses of 375 mg every 24 hr + 2 doses of 375 mg during dialysis, to be repeated at the end of dialysis. Childn <40 kg 15 mg/3.75 mg/kg once daily. Administer 15 mg/3.75 mg/kg after haemodialysis to restore circulating drug levels.
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 or any of the penicillins. History of cholestatic jaundice/hepatic dysfunction.
Special Precautions
Hepatic & renal impairment. Perform careful enquiry concerning previous hypersensitivity reactions to penicillin, cephalosporins or other β-lactam agents prior to therapy initiation. History of penicillin hypersensitivity & atopic individuals; discontinue & institute appropriate alternative therapy if allergic reactions occur. Do not use to treat penicillin-resistant S. pneumoniae. Impaired renal function or receiving high Bactoclav dose. Avoid use if infectious mononucleosis is suspected. Concomitant use w/ allopurinol & anticoagulants. Prolonged use. Acute generalized exanthemous pustulosis (discontinue). Consider antibiotic-associated colitis in patients who present w/ diarrhea during therapy; discontinue if this occurs. Ensure periodic assessment of organ system functions, including renal, hepatic & hematopoietic function during prolonged therapy. Maintain adequate fluid intake & urinary output to reduce possibility of crystalluria. False positive results in glucose presence testing in urine may occur w/ non-enzymatic methods, & in Coombs' test. Pregnancy (avoid use especially during 1st trimester) & lactation.
Adverse Reactions
Diarrhoea. Mucocutaneous candidosis; nausea, vomiting.
Drug Interactions
Increased INR w/ acenocoumarol or warfarin. Reduced efficacy & reabsorption of combined OCs. Potential increase in toxicity w/ methotrexate. Decreased renal tubular secretion w/ probenecid. Reduce pre-dose conc of active metabolite mycophenolic acid.
MIMS Class
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
Bactoclav tab 625 mg
Packing/Price
3 × 10's
Form
Bactoclav tab 375 mg
Packing/Price
3 × 10's
Form
Bactoclav tab 1 g
Packing/Price
2 × 7's
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