Moxiclav BIS

Per 5 mL powd for oral susp Amoxicillin trihydrate 400 mg, K clavulanate 57 mg

Short-term treatment of upper & lower resp tract, skin & soft tissue infections & UTI; mixed infections (susceptible organisms including β-lactamase producing organisms).

Max treatment duration: 14 days. Mild to moderate upper & lower resp tract, skin & soft tissue infection 25/3.6 mg/kg daily (lower dose). More serious upper & lower resp tract infection & UTI 45/6.4 mg/kg daily (higher dose). Childn 7-12 yr weighing 22-40 kg 5 mL bd at lower dose or 10 mL bd at higher dose, 2-6 yr weighing 13-21 kg 2.5 mL bd at lower dose or 5 mL bd at higher dose. Childn 2 mth to <2 yr weighing 15 kg 2.3 mL every 12 hr at lower dose or 4.2 mL every 12 hr at higher dose, 14 kg 2.2 mL every 12 hr at lower dose or 3.9 mL every 12 hr at higher dose, 13 kg 2 mL every 12 hr at lower dose or 3.7 mL every 12 hr at higher dose, 12 kg 1.9 mL every 12 hr at lower dose or 3.4 mL every 12 hr at higher dose, 11 kg 1.7 mL every 12 hr at lower dose or 3.1 mL every 12 hr at higher dose, 10 kg 1.6 mL every 12 hr at lower dose or 2.8 mL every 12 hr at higher dose, 9 kg 1.4 mL every 12 hr at lower dose or 2.5 mL every 12 hr at higher dose, 8 kg 1.3 mL every 12 hr at lower dose or 2.3 mL every 12 hr at higher dose, 7 kg 1.1 mL every 12 hr at lower dose or 2 mL every 12 hr at higher dose, 6 kg 0.9 mL every 12 hr at lower dose or 1.7 mL every 12 hr at higher dose, 5 kg 0.8 mL every 12 hr at lower dose or 1.4 mL every 12 hr at higher dose, 4 kg 0.6 mL every 12 hr at lower dose or 1.1 mL every 12 hr at higher dose, 3 kg 0.5 mL every 12 hr at lower dose or 0.8 mL every 12 hr at higher dose, 2 kg 0.3 mL every 12 hr at lower dose or 0.6 mL every 12 hr at higher dose.

May be taken with or without food: Best taken at the start of meal to reduce GI intolerance.

Hypersensitivity to amoxicillin trihydrate, K clavulanate, or to any penicillins. History of hypersensitivity to β-lactams (eg, cephalosporins). History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid.

Serious & occasionally fatal hypersensitivity (including anaphylactoid & severe cutaneous AR) reactions most likely in patients w/ history of penicillin hypersensitivity & in atopic individuals. Discontinue use & institute appropriate alternative therapy if allergic reaction occurs. Consider switching from amoxicillin/clavulanic acid to amoxicillin in case the infection is proven to be due to an amoxicillin-susceptible organism. Not for treatment of treat penicillin-resistant S. pneunomiae. Convulsions may occur in patient w/ impaired renal function or in those receiving high doses. Avoid use if infectious mononucleosis is suspected. Potential overgrowth of non-susceptible organisms during prolonged use. Discontinue use if there is an occurrence of feverish generalised erythema associated w/ pustula at treatment initiation. Mild to life-threatening pseudomembranous colitis; immediately discontinue if prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps; anti-peristaltic drugs are contraindicated in this situation. Periodically assess organ system functions including renal, hepatic & haematopoietic function is advisable during prolonged therapy. Possible prolonged prothrombin time; monitor during concomitant use of anticoagulants. Crystalluria may be observed in patients w/ reduced urine output; maintain adequate fluid intake & urinary output; regularly check patency in patient w/ bladder catheters. False +ve results w/ non-enzymatic methods; Coombs test. Possible cross-reactions w/ non-Aspergillus polysaccharides & polyfuranoses w/ Bio-Rad Laboratories Platelia Aspergillus EIA test. Patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Not recommended in patient w/ CrCl <30 mL/min. Possible cholestatic jaundice; signs & symptoms may not become apparent for up to 6 wk after treatment. Patients w/ evidence of hepatic impairment; monitor hepatic function at regular intervals; patients w/ serious underlying disease or concomitantly taking medications w/ potential hepatic effects. Avoid use during pregnancy. Not for administration in patient w/ sensitisation risk during lactation period.

Mucocutaneous candidosis; diarrhoea, nausea, vomiting.

Increased INR w/ oral anticoagulants (eg, acenocoumarol or warfarin). Possible reduced MTX excretion; potential increase in toxicity. May increase & prolong amoxicillin blood levels by probenecid. May increase risk of amoxicillin-related allergic skin reactions w/ allopurinol. May lower oestrogen reabsorption & reduce efficacy of combined OCs. Reduced pre-dose conc of mycophenolic acid.

Penicillins

J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.

POM