AUGMENTIN ES POWDER FOR ORAL SUSPENSION [SIN13201P]

Product Info

AUGMENTIN ES POWDER FOR ORAL SUSPENSION

[SIN13201P]

Indications

AUGMENTIN ES should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data.

AUGMENTIN ES is indicated for the treatment of paediatric patients with acute otitis media due to Streptococcus pneumoniae (penicillin minimum inhibitory concentration (MIC) less than or equal to ≤ 2 mcg/mL), Haemophilus influenzae (including beta-lactamase producing strains) and Moraxella catarrhalis (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.

Susceptibility to AUGMENTIN ES will vary with geography and time. Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary.

Dosage and Administration

Pharmaceutical form: Powder for oral suspension.

Paediatric patients 3 months and older:

The recommended dose for AUGMENTIN ES 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 AUGMENTIN ES in children under 3 months of age.

AUGMENTIN ES does not contain the same amount of clavulanate (as the potassium salt) as any of the other AUGMENTIN suspensions. AUGMENTIN ES contains 42.9 mg of clavulanate per 5 mL whereas AUGMENTIN 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, AUGMENTIN 200 mg/5 mL and 400 mg/5 mL suspensions should not be substituted for AUGMENTIN ES, as they are not interchangeable.

Hepatic Impairment

Administer with caution; monitor hepatic function at regular intervals.
There are insufficient data on which to base a dosage recommendation.

Renal Impairment

There are no dosing recommendations for AUGMENTIN ES in patients with renal impairment.

Method of Administration

To minimise the potential for gastrointestinal intolerance, AUGMENTIN ES should be taken at the start of a meal. The absorption of AUGMENTIN is optimised when taken at the start of a meal.

Note: SHAKE ORAL SUSPENSION WELL BEFORE USING.

Contraindications

AUGMENTIN ES is contraindicated in patients with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins.

AUGMENTIN ES is contraindicated in patients with a previous history of AUGMENTIN-associated jaundice/hepatic dysfunction.