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Curam/Curam Solutab

Curam/Curam Solutab

amoxicillin + clavulanic acid

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Co-amoxiclav (amoxicillin & clavulanic acid). Per 375 mg tab Amoxicillin trihydrate 250 mg, K clavulanate 125 mg. Per 1,000 mg tab Amoxicillin trihydrate 875 mg, K clavulanate 125 mg. Per 457 mg/5 mL susp Amoxicillin trihydrate 400 mg, K clavulanate 57 mg. Per 1,000 mg Solutab Amoxicillin trihydrate 875 mg, K clavulanate 125 mg
Indications/Uses
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.
Dosage/Direction for Use
Max duration of therapy: 14 days. 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 Duration of therapy: At least 10 days for infections w/ β-haemolytic Strep (eg, rheumatic fever, glomerulonephritis). Childn <40 kg 25-45 mg/kg (based on amoxicillin component) divided into 2 equal doses depending on the severity of infection, 7-12 yr weighing 22-40 kg 5 mL bid (for 25 mg/kg/day) or 10 mL bid (for 45 mg/kg/day), 2-6 yr weighing 13-21 kg 2.5 mL bid (for 25 mg/kg/day) or 5 mL bid (for 45 mg/kg/day), 2 mth to 2 yr Dose according to body wt. Solutab Adult & childn >12 yr 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 to 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.
Administration
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.
Contraindications
Hypersensitivity to amoxicillin, clavulanic acid, any penicillins or β-lactam agent (eg, cephalosporin, carbapenem, monobactam). History of hypersensitivity; jaundice/hepatic impairment due to amoxicillin/clavulanic acid. Curam Solutab Infectious mononucleosis or lymphatic leukemia.
Special Precautions
History of hypersensitivity to penicillins, cephalosporins or other β-lactam agents. Serious & occasionally fatal hypersensitivity reactions (including anaphylactoid & severe cutaneous reactions), which can progress to Kounis syndrome. 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. Convulsions in renally impaired patients or those receiving high doses. Overgrowth of non-susceptible organisms w/ prolonged use; prothrombin time prolongation. Crystalluria in patients w/ reduced urine output. 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 in patients 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 breastfeeding when diarrhoea & fungus infection of mucous membranes in breastfed infant occurs. Drug-induced enterocolitis syndrome in childn. Curam 375 mg & 1,000 mg tab Not recommended in childn <12 yr weighing <40 kg. Curam 457 mg/5 mL susp Childn <2 mth. Not recommended in childn w/ GFR <30 mL/min; infants w/ immature renal function.
Adverse Reactions
Diarrhoea. Mucocutaneous candidiasis; nausea, vomiting. Erythema multiforme, SJS, TEN, acute generalized exanthemous pustulosis, DRESS.
Drug Interactions
Increased INR w/ acenocoumarol or warfarin. Reduced excretion of MTX. Decreased renal tubular secretion of amoxicillin w/ probenecid. Concomitant use w/ mycophenolate mofetil.
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
Curam Solutab 1 g dispertab
Packing/Price
2 × 5's
Form
Curam 1 g FC tab
Packing/Price
12's
Form
Curam 375 mg FC tab
Packing/Price
20's
Form
Curam 457 mg/5 mL powd for oral susp
Packing/Price
35 mL x 1's;70 mL x 1's
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/thailand/image/info/curam-457-mg-5-ml-powd-for-oral-susp/457-mg-5-ml-x-35-ml?id=fbdbcae7-56f8-4d20-95a5-a0c200dfbc56
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