Concise Prescribing Info
Contents
Co-amoxiclav (amoxicillin & clavulanic acid). Per 375 mg tab Amoxicillin 250 mg, clavulanic acid 125 mg. Per 625 mg tab Amoxicillin 500 mg, clavulanic acid 125 mg. Per 1,000 mg tab Amoxicillin 875 mg, clavulanic acid 125 mg. Per 156.25 mg/5 mL susp Amoxicillin 125 mg, clavulanic acid 31.25 mg
Indications/Uses
Tab Short-term treatment of upper resp tract infections (including ENT) eg, tonsillitis, sinusitis, otitis media; lower resp tract infections eg, acute & chronic bronchitis, lobar & bronchopneumonia; GUT infections eg, cystitis, urethritis, pyelonephritis; skin & soft tissue infections eg, boils, abscesses, cellulitis, wound infections; bone & joint infections eg, osteomyelitis; dental infections eg, dentoalveolar abscess; other infections eg, septic abortion, puerperal & intra-abdominal sepsis. Susp UTI; other gram -ve aerobic & gram -ve anaerobic infections; resp tract infections; skin & soft tissue infections; gonorrhea; chancroid.
Dosage/Direction for Use
Tab Adult & childn >12 yr Mild to moderate infections 625 mg bd, or 375 mg tds 8 hrly. Do not extend treatment for >14 days w/o review. Severe infections 1,000 mg bd. Do not extend treatment for >14 days w/o review. Therapy can be started parenterally & continued PO. Dental infections (eg, dentoalveolar abscess) 625 mg bd for 5 days. Do not extend treatment for >14 days w/o review. Renal impairment in adult Do not extend treatment for >14 days w/o review. Mild (CrCl >30 mL/min) 625 mg bd or 1,000 mg bd. Moderate (CrCl 10-30 mL/min) 625 mg bd. Severe (CrCl <10 mL/min) Max: 625 mg 24 hrly. Do not extend treatment for >14 days w/o review. Susp Mild to moderate infections 25/3.6 mg/kg/day. Serious infections 45/6.4 mg/kg/day. Childn 2-12 yr (13-40 kg) 25 mg/kg/day. Childn 2 mth-2 yr dosed according to body wt.
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 penicillin. Possible cross-sensitivity w/ other β-lactam antibiotics eg, cephalosporins; history of penicillin-associated jaundice/hepatic dysfunction.
Special Precautions
Serious & occasionally fatal anaphylactoid reactions may occur more likely in individuals w/ history of penicillin hypersensitivity. Erythematous rashes associated w/ glandular fever may occur; avoid if glandular fever is suspected. Overgrowth of nonsusceptible organisms may occur in prolonged use. Moderate or severe renal impairment. 1,000 mg tab should only be used in patient w/ GFR >30 mL/min. Hepatic impairment (dose w/ caution) & regularly monitor hepatic function. Liver function test changes in some patients may occur. Patients w/ evidence of hepatic dysfunction. Cholestatic jaundice may occur. Avoid use in pregnancy, especially during the 1st trimester. Childn ≤12 yr (625- & 1,000-mg doses are not recommended).
Adverse Reactions
Diarrhea, indigestion, nausea & vomiting; urticaria, anaphylaxis, erythematosus rashes. Candidiasis; antibiotic-associated colitis; interstitial nephritis; reversible thrombocytopenia & haemolytic anemia; convulsions; behavioral changes; lab test abnormalities. May be severe & may continue for several mth, hepatitis & cholestatic jaundice. Potentially, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis.
Drug Interactions
Prolonged bleeding & prothrombin time w/ anticoagulants. May reduce the efficacy of OCs. Decreased renal tubular secretion, increased & prolonged amoxicillin blood levels w/ concomitant use of probenecid. May increase likelihood of allergic skin reactions w/ allopurinol.
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
Indclav FC tab 625 mg
Packing/Price
2 × 10's
Form
Indclav FC Tab 1000 mg
Packing/Price
1 × 10's
Form
Indclav FC tab 375 mg
Packing/Price
2 × 10's
Form
Indclav dry syr 156.25/5 mL
Packing/Price
100 mL x 1's
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