- Approval Id
- 3fd4bc14b847ca9c
- Drug Name
- AUGMENTIN ES POWDER FOR ORAL SUSPENSION
- Product Name
- AUGMENTIN ES POWDER FOR ORAL SUSPENSION
- Approval Number
- SIN13201P
- Approval Date
- 2006-04-20
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- POWDER, FOR SUSPENSION
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p>Pharmaceutical form: Powder for oral suspension.</p>
<p><strong>Paediatric patients 3 months and older:</strong></p>
<p>The recommended dose for <em>AUGMENTIN ES</em> is 90/6.4 mg/kg/day in 2 divided doses at 12-hourly intervals for 10 days (see chart below). There is no experience in paediatric patients weighing more than 40 kg, or in adults. There are no clinical data on <em>AUGMENTIN ES</em> in children under 3 months of age.</p>
<img src="/TGIF/AugmentinES-Table1_250722.png" alt="Augmentin ES Dosage Table 1" /><br><br>
<p><em>AUGMENTIN ES</em> does not contain the same amount of clavulanate (as the potassium salt) as any of the other <em>AUGMENTIN</em> suspensions. <em>AUGMENTIN ES</em> contains 42.9 mg of clavulanate per 5 mL whereas <em>AUGMENTIN</em> 200 mg/5 mL suspension contains 28.5 mg of clavulanate per 5 mL and the 400 mg/5 mL suspension contains 57 mg of clavulanate per 5 mL. Therefore, <em>AUGMENTIN</em> 200 mg/5 mL and 400 mg/5 mL suspensions should not be substituted for <em>AUGMENTIN ES</em>, as they are not interchangeable.</p>
<p><em>Hepatic Impairment</em></p>
<p>Administer with caution; monitor hepatic function at regular intervals.<br>
There are insufficient data on which to base a dosage recommendation.</p>
<p><em>Renal Impairment</em></p>
<p>There are no dosing recommendations for <em>AUGMENTIN ES</em> in patients with renal impairment.</p>
<p><strong>Method of Administration</strong></p>
<p>To minimise the potential for gastrointestinal intolerance, <em>AUGMENTIN ES</em> should be taken at the start of a meal. The absorption of <em>AUGMENTIN</em> is optimised when taken at the start of a meal.</p>
<p><strong>Note:</strong> SHAKE ORAL SUSPENSION WELL BEFORE USING.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indications</strong></p>
<p><em>AUGMENTIN ES</em> should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data.</p>
<p><em>AUGMENTIN ES</em> is indicated for the treatment of paediatric patients with acute otitis media due to <em>Streptococcus pneumoniae</em> (penicillin minimum inhibitory concentration (MIC) less than or equal to ≤ 2 mcg/mL), <em>Haemophilus influenzae</em> (including beta-lactamase producing strains) and <em>Moraxella catarrhalis</em> (including beta-lactamase producing strains). Such patients are often characterised by antibiotic exposure for acute otitis media within the preceding 3 months, and are either aged ≤ 2 years or attend daycare.</p>
<p>Susceptibility to <em>AUGMENTIN ES</em> will vary with geography and time. Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p><em>AUGMENTIN ES</em> is contraindicated in patients with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins.</p>
<p><em>AUGMENTIN ES</em> is contraindicated in patients with a previous history of <em>AUGMENTIN</em>-associated jaundice/hepatic dysfunction.</p>
- Atc Code
- J01CR02
- Atc Item Name
- amoxicillin and beta-lactamase inhibitor
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
- Company Detail Path
- /organization/glaxosmithkline-pte-ltd
