Augmentin/Augmentin ES

Augmentin/Augmentin ES

amoxicillin + clavulanic acid

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Co-amoxiclav (amoxicillin & clavulanic acid). Per Augmentin 1 g tab Amoxicillin trihydrate 875 mg, K clavulanate 125 mg. Per Augmentin 228 mg/5 mL susp Amoxicillin trihydrate 200 mg, K clavulanate 28.5 mg. Per Augmentin 457 mg/5 mL susp Amoxicillin trihydrate 400 mg, K clavulanate 57 mg. Per Augmentin ES 642.9 mg/5 mL susp Amoxicillin trihydrate 600 mg, K clavulanate 42.9 mg
Indications/Uses
Augmentin: Short-term treatment of susceptible bacterial infections of upper resp tract (including ENT) eg, tonsillitis, sinusitis, otitis media; lower resp tract eg, acute exacerbation of chronic bronchitis, lobar & bronchopneumonia; GUT eg, cystitis, urethritis, pyelonephritis due to E. coli, Proteus mirabilis or Enterococcus faecalis; skin & soft tissue eg, boils, abscesses, cellulitis, wound infections; bone & joint eg, osteomyelitis; dental eg, dentoalveolar abscess; septic abortion, puerperal & intra-abdominal sepsis. Augmentin susp 228 mg/5 mL & 457 mg/5 mL: Short term treatment of bacterial infections of upper resp tract (including ENT) eg, recurrent tonsillitis, sinusitis, otitis media; lower resp tract eg, acute exacerbations of chronic bronchitis, lobar & bronchopneumonia; urinary tract eg, cystitis, urethritis, pyelonephritis; skin & soft tissue eg, cellulitis, animal bites; dental eg, severe dental abscess w/ spreading cellulitis. Augmentin ES: Short-term treatment of bacterial infections in paed patients w/ URTI (including ENT) (eg, recurrent or persistent acute otitis media or tonsillo-pharyngitis & sinusitis), & lower resp tract infections eg, lobar & bronchopneumonia typically caused by Strep pneumoniae, H. influenzae, Moraxella catarrhalis & Strep pyogenes (for tonsillo-pharyngitis & sinusitis); skin & soft tissue infections typically caused by Staph aureus, Strep pyogenes & Bacteroides spp.
Dosage/Direction for Use
Tab Max duration: 14 days. Adult & childn >12 yr 1 g every 12 hr. Severe infection 1 g every 8 hr. Dental infection 1 g bid (or every 12 hr) for 5-7 days. Susp 228 mg/5 mL & 457 mg/5 mL Max duration: 14 days. Recommended dose: Mild to moderate infection 25/3.6 mg/kg daily in 2 divided doses. More serious infection 45/6.4 mg/kg daily in 2 divided doses. Childn ≥2 yr weighing 36 to <40 kg 10 mL or 12.5 mL every 12 hr of 457 mg/5 mL susp, 27-35 kg 7.5 mL or 10 mL every 12 hr of 457 mg/5 mL susp, 17-26 kg 5 mL or 7.5 mL every 12 hr of 457 mg/5 mL susp, or 10 mL or 15 mL every 12 hr of 228 mg/5 mL susp, 12-16 kg 2.5 mL or 5 mL every 12 hr of 457 mg/5 mL susp, or 5 mL or 10 mL every 12 hr of 228 mg/5 mL susp. Susp 457 mg/5 mL Childn 2 mth to 2 yr weighing 15 kg 2.3 mL or 4.2 mL every 12 hr, 14 kg 2.2 mL or 3.9 mL every 12 hr, 13 kg 2 mL or 3.7 mL every 12 hr, 12 kg 1.9 mL or 3.4 mL every 12 hr, 11 kg 1.7 mL or 3.1 mL every 12 hr, 10 kg 1.6 mL or 2.8 mL every 12 hr, 9 kg 1.4 mL or 2.5 mL every 12 hr, 8 kg 1.3 mL or 2.3 mL every 12 hr, 7 kg 1.1 mL or 2 mL every 12 hr, 6 kg 0.9 mL or 1.7 mL every 12 hr, 5 kg 0.8 mL or 1.4 mL every 12 hr, 4 kg 0.6 mL or 1.1 mL every 12 hr, 3 kg 0.5 mL or 0.8 mL every 12 hr, 2 kg 0.3 mL or 0.6 mL every 12 hr. ES Susp Max duration: 14 days. Paed ≥3 mth Recommended dose: 90/6.4 mg/kg daily in 2 divided doses at 12 hr intervals for 10 days. Childn weighing 36 kg 13.5 mL bid, 32 kg 12 mL bid, 28 kg 10.5 mL bid, 24 kg 9 mL bid, 20 kg 7.5 mL bid, 16 kg 6 mL bid, 12 kg 4.5 mL bid, 8 kg 3 mL bid.
Administration
Should be taken with food: Take at the start of meals for better absorption & to reduce GI discomfort. 1-g tab: May be divided into halves. Do not chew/crush.
Contraindications
History of hypersensitivity to β-lactams eg, penicillins & cephalosporins. History of Augmentin-associated jaundice/hepatic dysfunction.
Special Precautions
Hypersensitivity which may progress to Kounis syndrome; history of penicillin & cephalosporin hypersensitivity; serious anaphylactic reactions. Discontinue therapy if allergic reaction occurs; if prolonged or significant diarrhoea occurs or patient experiences abdominal cramps. Avoid use if infectious mononucleosis is suspected. Superinfection/overgrowth of non-susceptible organisms w/ prolonged use. Pseudomembranous colitis; abnormal prolongation of prothrombin time (increased INR); changes in LFTs; cholestatic jaundice; crystalluria in patients w/ reduced urine output. Patients w/ phenylketonuria. Assess organ system functions including renal & hepatic function & blood count before & during prolonged therapy. Monitor hepatic function at regular intervals. Maintain adequate fluid intake & urinary output. Concomitant use w/ oral anticoagulants. Hepatic dysfunction & renal impairment. Lactation. Augmentin tab: Use only in patients w/ CrCl >30 mL/min. Avoid use in pregnancy (especially during 1st trimester). Not recommended in childn ≤12 yr. Augmentin susp 228 mg/5 mL & 457 mg/5 mL: Not recommended in patients w/ renal impairment or CrCl <30 mL/min. Childn <2 mth. Augmentin ES: Paed patients >40 kg; childn <3 mth. Adults.
Adverse Reactions
Diarrhoea. Mucocutaneous candidiasis; nausea, vomiting. Erythema multiforme. SJS, TEN, acute generalised exanthematous pustulosis, DRESS.
Drug Interactions
Decreased renal tubular secretion of amoxicillin w/ probenecid. Increased allergic skin reactions w/ allopurinol. Reduced oestrogen reabsorption & efficacy of combined OCs. Increased INR w/ oral anticoagulants, acenocoumarol or warfarin. Reduced pre-dose conc of active metabolite mycophenolic acid.
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
Augmentin FC tab 1 g
Packing/Price
14's
Form
Augmentin ES powd for oral susp 642.9 mg/5 mL
Packing/Price
100 mL x 1's;50 mL x 1's
/thailand/image/info/augmentin es powd for oral susp 642-9 mg-5 ml/50 ml?id=7b1f9312-31f6-4b61-80c9-aa0d009f6b6b
/thailand/image/info/augmentin es powd for oral susp 642-9 mg-5 ml/100 ml?id=795d309b-3af9-46a2-b005-aa0d009f6b6b
Form
Augmentin powd for oral susp 228 mg/5 mL
Packing/Price
70 mL x 1's
Form
Augmentin powd for oral susp 457 mg/5 mL
Packing/Price
35 mL x 1's;70 mL x 1's
/thailand/image/info/augmentin powd for oral susp 457 mg-5 ml/457 mg-35 ml?id=06dfcb5a-1c94-4346-91c9-aff7010cfee9
/thailand/image/info/augmentin powd for oral susp 457 mg-5 ml/457 mg-70 ml?id=3869c10f-000a-4965-8dee-aff701068d20
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