Augmentin/Augmentin ES

Augmentin/Augmentin ES Dosage/Direction for Use

amoxicillin + clavulanic acid

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Augmentin tablet and suspension 228 mg/5 mL and 457 mg/5 mL: Dosage depends on the age, weight and renal function of the patient and the severity of the infection.
Dosages are expressed throughout in terms of amoxicillin/clavulanate content except when doses are stated in terms of an individual component.
To minimise potential gastrointestinal intolerance, administer at the start of a meal.
The absorption of Augmentin is optimised when taken at the start of a meal.
Treatment should not be extended/not exceed beyond 14 days without review.
Therapy can be started parenterally and continued with an oral preparation.
Augmentin tablet: Tablets should be swallowed whole without chewing. If required, tablets may be broken in half and swallowed without chewing.
Augmentin tablets are not recommended in children of 12 years and under.
Adults and children over 12 years: One Augmentin 1 g tablet every 12 hours.
One Augmentin 1 g tablet every 8 hours for severe infection.
Dosage in dental infections: Adults and children over 12 years: Augmentin 1 g tablet 2 times a day (or every 12 hours) for five to seven days.
Renal Impairment: No adjustment in dose is required in patients with creatinine clearance (CrCl) greater than 30 mL/min. The Augmentin 1g tablet should only be used in patients with a creatinine clearance (CrCl) rate of more than 30 mL/min.
Hepatic Impairment: Dose with caution; monitor hepatic function at regular intervals. Augmentin is contra-indicated in patients with a previous history of Augmentin-associated cholestatic jaundice/hepatic dysfunction.
Augmentin suspension 228 mg/5 mL and 457 mg/5 mL: Augmentin bottle presentations for suspension may be supplied with a plastic dosing device. For preparation of the suspensions see Instructions for use/handling under Cautions for Usage.
The usual recommended daily dosage is: Lower dose: 25/3.6 mg/kg/day in two divided doses for mild to moderate infections (upper respiratory tract infections e.g. recurrent tonsillitis, lower respiratory infections and skin and soft tissue infections).
Higher dose: 45/6.4 mg/kg/day in two divided doses for the treatment of more serious infections (upper respiratory tract infections e.g. otitis media and sinusitis, lower respiratory tract infections e.g. bronchopneumonia and urinary tract infections).
No clinical data are available on doses above 45/6.4 mg/kg/day in children under 2 years.
There are no clinical data for Augmentin suspension 228 mg/5 mL and 457 mg/5 mL to make dosage recommendations for children under 2 months old.
The tables as follows give dosage guidance for children. (See Tables 4 and 5.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Renal impairment: No adjustment in dose is required in patients with creatinine clearance greater than 30 mL/min.
Augmentin suspension 228 mg/5 mL and 457 mg/5 mL are not recommended in patients with a creatinine clearance of less than 30 mL/min.
Hepatic impairment: Dose with caution; monitor hepatic function at regular intervals. There are insufficient data on which to base a dosage recommendation.
Augmentin ES 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 as follows). 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. (See Table 6.)

Click on icon to see table/diagram/image

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 clavulanic acid per 5 ml whereas Augmentin 200 mg/5 ml suspension contains 28.5 mg of clavulanic acid per 5 ml and the 400 mg/5 ml suspension contains 57 mg of clavulanic acid 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: Dose 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: Augmentin ES suspension: 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.
Treatment should not be extended beyond 14 days without review.
Therapy can be started parenterally and continued with an oral preparation.
SHAKE ORAL SUSPENSION WELL BEFORE USING.
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