- 375 mg (2:1)
- 625 mg (4:1)
- 1 g (7:1)
Suspensions containing different ratios of Amoxycillin trihydrate to Potassium Calvulanate:
- 156.25 mg / 5 mL (4:1)
- 312.5 mg / 5 mL (4:1)
- 457 mg / 5 mL (7:1)
- Upper Respiratory Tract infections (including ENT): recurrent tonsilitis, sinusitis, otitis media typically caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
- Lower Respiratory Tract infections: acute exacerbations of chronic bronchitis, lobar and bronchopneumonia typically caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis.
- Gentio-urinary Tract infections: cystitis, urethritis, pyelonephritis, female genital infections typically caused by Enterobacteriaceae (mainly Escheria coli), Stayphylococcus saprophyticus and Enterococcus species; and gonorrhoea caused by Neisseria gonorrhoeae.
- Skin and soft tissue infections: typically caused by Staphylococcus aureus, Streptococcus pyogenes and Bacteriodes species.
The paediatric t.i.d. dosing regimen is also indicated for the following infections:
- Other infections: septic abortion, puerperal sepsis, intra-abdominal sepsis.
- Some members of these species of bacteria produce beta-lactamase, rendering them insensitive to amoxycillin alone.
Infections caused by amoxycillin-susceptible organisms are amenable to Augmentin treatment due to its amoxycillin content. Mixed infections caused by amoxycillin-susceptible organisms in conjunction with Augmentin-susceptible beta-lactamase-producing organisms may therefore be treated by Augmentin.
- A moderate rise in AST and/or ALT has been noted in patients treated with beta-lactam class antibiotics
- Skin rase, pruritus and urticaria
- There have been rare findings of Reversible leucopenia (including neutropenia) and thrombocytopenia
- Erthema multiforme and very rarely reversible agranulocytosis and haemolytic anaemia
- Prolongation of bleeding time and prothrombin time
- Anginoneurotic oedema, anaphylaxis, serum sickness-like syndrome, hypersensitivity vasculitis
- Reversible hyperactivity and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.
- Antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis)
- Superficial tooh discoloration has been reported very rarely in children. Good oral hygiene may help to prevent tooth coloration as it can usually be removed by brushing
- Hepatitis and cholestatic jaundice
These events have been noted with other penicillins and cephalosporins. Stevens-Johnson syndrome, toxic empidermal necrolysis, bullous exofoliative-dermatitis, acute generalised exanthemous pustulosis (AGEP) Interstitial nephritis and crsytalluria.Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged treatment.These events have been very rarely reported in children.Sings and symptoms usually occur during or shortly after treatment but in some cases may not become apparent until several weeks after treatment has ceased. These are usually reversible.Hepatic events may be severe and in extremely rare cirumstances, deaths have been reported. These have almost always occurred in patients with serious underlying disease or taking concomintant medications known to have the potential for hepatic effects.
- Dosage should be expressed in terms of the age of the child and either in mg/kg/day or mL of suspension per dose or equivalent for other presentations.
- Children weighing 40 kg and over should be dosed according to the adult recommendations.
- Children up to 12 years:
- t.i.d. (4:1 formulations), b.i.d. (7:1 forumlations)
- Lower dose (mg/kg/day) 20/5 – 40/10 25/3.6 – 45-6.4
- Higher dose (mg/kg/day) 40/10 – 60/15 45/6.4 – 70/10
- The lower dose is recommended for infections such as skin and soft tissue and recurrent tonsillitis.
- The higher dose is recommended for infections such as otitis media, sinusitis, LRTIE and UTI.
- No cilincal data are available on doses of these formulations higher than 40/10 mg/kg/day t.i.d. (4:1) or 45/6.4 mg/kg/day b.i.d. (7:1) in children under 2 years. There are no clinical data for the 7:1 formulation for patients under 2 months of age. Dosing recommendations in this population therefore cannot be made.
- For administration to children up to 2 years old, Augmentin suspensions may be diluted to half-strength using water.
- Creatinine clearance >30 ml/min: No adjustment necessary
- Creatnine clearance 10-30 ml/min: 15/3.75 mg/kg given b.i.d.
- Creatinine clearance <10 ml/min: 15/3.75 mg/kg given as a single daily dose
- In the majority of cases, parenteral therapy, where available, may be preferred.
- Dosing adjustments are based on the maximum recommended level of amoxycillin
- 15/3.75/kg/day given as a single daily dose
- Prior to haemodialysis one additional dose of 15/2.75 mg/kg should be administered. In order to restore circulating drug levels, another dose of 15/3.75 mg/kg should be administered after haemodialysis
- Mild to moderate infections: 375 mg given t.i.d. or 625 mg given b.i.d. or t.i.d. or 1 g given b.i.d.
- Severe infections: (including chronic and recurrent urinary tract infections and those of the lower respiratory tract) 2 times 375 mg given t.i.d. or 1-2 times 625 mg given t.i.d. or 1 g given t.i.d.
- 2 Augmentin 375 mg should not be substitiuted for one Augmentin 625 mg since they are not equivalent
- In case of renal impairment, dosing adjustments are based on the maximum recommended level of amoxycillin
- Creatinine clearance >30 ml/min: no adjustment necessary
- Creatnine clearance >10-30 ml/min: 1 times 625 given b.i.d. or 1-2 times 375 mg, depending upon severity of infections, given b.i.d.
- Creatnine clearance <10 ml/min: 1 times 625 given o.d; or 1-2 times 375 gm, depending upong severity of infections, given o.d.- Haemodialysis.
- 1 times 625 mg or 2 times 375 mg every 24 hours, PLUS 1 dose during dialysis, to be repeated at the end of dialysis (as serum concentrations of both amoxycillin and clavulanic acid are decreased). The 1 g presentation should only be used in patients with a creatinine clearance of >30 ml/min.
- Dose with caution; monitor hepatic function at regular intervals
- There are insufficient data on which to base a dosage recommendation
Method of Administration
- Oral route
- Administer at the start of a meal, in order to minimize potential gastrointestinal intolerance
- The absorption of Augmentin is optimised when taken at the start of a meal
- Treatment should not be extended beyond 14 days without review
- Therapy can be started parenterally and continued with an oral preparation