Curam/Curam Solutab

Co-amoxiclav (amoxicillin & clavulanic acid). Per 375 mg tab Amoxicillin trihydrate 250 mg, K clavulanate 125 mg. Per 625 mg tab Amoxicillin trihydrate 500 mg, K clavulanate 125 mg. Per 1,000 mg tab Amoxicillin trihydrate 875 mg, K clavulanate 125 mg. Per 156.25 mg/5 mL susp Amoxicillin trihydrate 125 mg, K clavulanate 31.25 mg. Per 312.5 mg/5 mL susp Amoxicillin trihydrate 250 mg, K clavulanate 62.5 mg. Per 457 mg/5 mL susp Amoxicillin trihydrate 400 mg, K clavulanate 57 mg. Per 1,200 mg vial Amoxicillin Na 1,000 mg, K clavulanate 200 mg. Per 1,000 mg Solutab Amoxicillin trihydrate 875 mg, K clavulanate 125 mg

Bacterial infections induced by gm -ve & +ve amoxicillin-resistant microorganisms whose resistance is caused by β-lactamases which are sensitive to combination of amoxicillin & clavulanic acid. Upper & lower resp tract infections (including ENT), GUT, skin & soft tissue, bone & joint, & dental/odontogenic infections. Curam: Septicaemia, peritonitis, post-op infections. Curam 457 mg/5 mL: Abdominal infections. Curam Solutab: Intra-abdominal sepsis.

Tab Adult & childn >12 yr weighing >40 kg Mild to moderate infection 375 mg tid or every 8 hr, or 625 mg bid or every 12 hr. Severe infection 625 mg (or as two 375-mg tab) tid or every 8 hr, or 1,000 mg bid or every 12 hr. Moderate renal insufficiency w/ CrCl 10-30 mL/min 375 mg or 625 mg bid or every 12 hr in adult, or 18.75 mg/kg bid (max: 625 mg bid) in childn. Severe renal insufficiency w/ CrCl <10 mL/min Not >1 tab 375 mg every 12 hr or 625 mg every 24 hr in adult, or 18.75 mg/kg as single dose daily (max: 625 mg) in childn. Susp Childn <12 yr 25-50 mg/kg daily (based on amoxicillin component), 7-12 yr 10 mL of 156.25 mg/5 mL or 5 mL of 312.5 mg/5 mL tid, 2-7 yr 5 mL of 156.25 mg/5 mL tid, 9 mth to 2 yr 2.5 mL of 156.25 mg/5 mL tid. Susp 457 mg/5 mL Childn <40 kg 25-45 mg/kg (based on amoxicillin component) divided into 2 equal doses, 7-12 yr weighing 22-40 kg 5 mL bid (for 25 mg/kg daily) or 10 mL bid (for 45 mg/kg daily), 2-6 yr weighing 13-21 kg 2.5 mL bid (for 25 mg/kg daily) or 5 mL bid (for 45 mg/kg daily), 2 mth to 2 yr Dose according to body wt. Vial To be given IV. Adult & childn >50 kg Non-serious infection Amoxicillin/clavulanic 1,000/200 mg 8 hrly. Childn 3 mth to 12 yr Amoxicillin/clavulanic acid 25/5 mg/kg 8 hrly, 0-3 mth 25/5 mg/kg 12 hrly. Surgical prophylaxis Adult 1,000/200 mg at the induction of anesth. Solutab Adult & childn >12 yr 625 mg every 8 hr or 1 g every 12 hr. Renal impairment weighing 70 kg w/ GFR 10-30 mL/min & plasma creatinine 2.5-5.5 250/62.5 mg-500/125 mg every 12 hr, GFR <10 mL/min & plasma creatinine >5.5 250/62.5 mg every 12 hr or 500/125 mg every 24 hr.

May be taken with or without food: Best taken at the start of meals for better absorption & to reduce GI discomfort. Solutab: Stir into ½ glass of water (approx 30 mL). Mix thoroughly before taking. Alternatively, place in the mouth to disperse then swallow. Do not chew/cut.

Hypersensitivity to amoxicillin, clavulanic acid, any penicillins or β-lactam agent (eg, cephalosporin, carbapenem, monobactam). History of hypersensitivity; jaundice/hepatic impairment. Curam Solutab: Infectious mononucleosis or lymphatic leukemia.

History of penicillin hypersensitivity to penicillins, cephalosporins or other β-lactam agents. Discontinue therapy if allergic reaction; feverish generalised erythema associated w/ pustula at treatment initiation; antibiotic-associated colitis occurs. Not for use when there is high risk that presumptive pathogens have reduced susceptibility or resistance to β-lactam agents not mediated by β-lactamases susceptible to inhibition by clavulanic acid; to treat penicillin-resistant Strep pneumoniae. Avoid use if infectious mononucleosis is suspected. Atopic individuals. Patients w/ reduced urine output. Convulsions in renally impaired patients or receiving high doses. Overgrowth of non-susceptible organisms w/ prolonged use; prothrombin time prolongation; crystalluria. Periodically assess organ system functions, including renal, hepatic & haematopoietic function during prolonged therapy. Maintain adequate fluid intake & urinary output during administration of high doses of amoxicillin. Regularly check patency in patients w/ bladder catheters. Monitor liver function regularly. May cause false +ve results w/ non-enzymatic methods in testing for presence of glucose in urine; false +ve Coombs test; +ve test results using Bio-Rad lab Platelia Aspergillus EIA test who were subsequently found to be free of Aspergillus infection. Consider switching to amoxicillin in case infection is proven to be due to amoxicillin-susceptible organism. Concomitant use w/ allopurinol; medications known to have potential hepatic effects; oral anticoagulants. May affect ability to drive & use machines. Renal & hepatic impairment. Avoid use during pregnancy. Discontinue lactation when diarrhoea & fungus infection of mucous membranes in breastfed infant occurs. Curam 375 mg, 625 mg & 1,000 mg tab: Not recommended in childn <12 yr weighing <40 kg. Curam 457 mg/5mL susp: Childn <2 mth. Not recommended in childn w/ GFR <30 mL/min; infants w/ immature renal function.

Mucocutaneous candidiasis; diarrhoea, nausea, vomiting. Erythema multiforme, SJS, TEN.

Increased INR w/ acenocoumarol or warfarin. Reduced excretion of MTX. Decreased renal tubular secretion of amoxicillin w/ probenecid. Concomitant use w/ 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.

FC tab/Susp/Solutab: D; Inj: S