Augmentin/Augmentin ES

Augmentin/Augmentin ES Dosage/Direction for Use

amoxicillin + clavulanic acid

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
Full Prescribing Info
Dosage/Direction for Use
Augmentin: Tablet/Powder Suspension: 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 co-amoxiclav content except when doses are stated in terms of an individual component.
Therapy can be started parenterally and continued with an oral preparation. (See Table 4.)

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Two co-amoxiclav 250/125 mg tablets should not be substituted for one co-amoxiclav 500/125 mg tablet since they are not equivalent.
Children: Dosage should be expressed in terms of the age of the child and either in mg/kg/day (given in 2 or 3 divided doses) 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. (See Table 5.)

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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, lower respiratory tract infections and urinary tract infections.
No clinical data are available on doses of these formulations higher than 40/10 mg/kg/day (4:1) or 45/6.4 mg/kg/day (7:1) in children under 2 years.
There are no clinical data for the 7:1 formulation in patients under 2 months of age. Dosing recommendations in this population therefore cannot be made.
The 8:1 ratio formulation is recommended for dosing at 40/50 to 80/10 mg/kg/day (in three divided doses) in children aged 1 to 30 months, depending upon severity of infection.
Premature: No dosage recommendation can be made for this category.
Elderly: No adjustment needed; dose as for adults. If there is evidence of renal impairment, dose should be adjusted as for renally impaired adults.
Haemodialysis: Adults: 1 times 500/125 mg or 2 times 250/125 mg every 24 hours, plus 1 dose during dialysis, to be repeated at the end of dialysis (as serum concentrations of both amoxicillin and clavulanic acid are decreased)(+).
(+)The 875/125 mg and 1000/125 mg presentations should only be used in patients with a creatinine clearance of more than 30 mL/min.
Children: 15/3.75 mg/kg/day given as a single daily dose.
Prior to haemodialysis one additional dose of 15/3.75 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.
Injection: Treatment of Infection: Adults and Children over 12 Years: Usually 1.2 g eight hourly. In more serious infections, increase frequency to six-hourly intervals.
Children 3 months-12 years: Usually 30 mg/kg* Co-amoxiclav (Augmentin) eight hourly. In more serious infections, increase frequency to six-hourly intervals.
0-3 months: 30 mg/kg* Co-amoxiclav (Augmentin) every 12 hours in premature and in full term infants during the perinatal period, increasing to eight hours thereafter.
*Each 30 mg Co-amoxiclav (Augmentin) contains 25 mg amoxicillin and 5 mg clavulanate.
Adult Dosage for Surgical Propyhlaxis: The usual dose is 1.2 g Co-amoxiclav (Augmentin) intravenous given at the induction of anaesthesia.
Operations where there is a high risk of infection e.g. colorectal surgery, may require three, and up to four doses of 1.2 g Co-amoxiclav (Augmentin) intravenous in a 24-hour period. These doses are usually given at 0, 8, 16 (and 24) hours. This regimen can be continued for several days if the procedure has a significantly increased risk of infection.
Clear clinical signs of infection at operation will require a normal course of intravenous or oral Co-amoxiclav (Augmentin) therapy post-operatively.
Renal Impairment: Tablet/Powder for Suspension: Dosage adjustments are based on the maximum recommended level of amoxicillin. (See Tables 6 and 7.)

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In the majority of cases, parenteral therapy, where available, may be preferred.
Injection: See Table 8.

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Children: Similar reduction in dosage should be made for children.
Infant Drops: Dosage in Renal Impairment: Mild Impairment (Creatinine clearance >30 mL/min): No change in dosage, ie The recommended dose given three times daily.#
Moderate Impairment (Creatinine clearance 10-30 mL/min): The recommended dose given twice daily instead of three times per day.#
Severe Impairment (Creatinine clearance <10 mL/min): The recommended dose given once daily instead of three times per day.#
#In more serious cases this dose may be doubled.
Hepatic Impairment: Tablet: Dose with caution; monitor hepatic function at regular intervals. There are insufficient data on which to base a dosage recommendation.
Injection: Each 1.2 g vial of Co-amoxiclav (Augmentin) contains 1.0 mmoL of potassium and 3.1 mmoL of sodium (approx.).
Administration: Tablet/Powder for Suspension: To minimise potential gastrointestinal intolerance, administer at the start of a meal.
The absorption of Co-amoxiclav (Augmentin) is optimised when taken at the start of a meal.
Treatment should not be extended beyond 14 days without review.
Injection: Co-amoxiclav (Augmentin) intravenous may be administered either by intravenous injection or by intermittent infusion. It is not suitable for intramuscular administration.
Augmentin ES: Paediatric patients 3 months and older: The recommended dose for Co-amoxiclav (Augmentin ES) is 90/6.4 mg/kg/day in 2 divided doses at 12-hourly intervals for 10 days (see Table 9). There is no experience in paediatric patients weighing > 40 kg, or in adults. There are no clinical data on Co-amoxiclav (Augmentin ES) in children under 3 months of age. (See Table 9.)

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Co-amoxiclav (Augmentin ES) does not contain the same amount of clavulanate (as the potassium salt) as any of the other Co-amoxiclav (Augmentin) suspensions. Co-amoxiclav (Augmentin ES) contains 42.9 mg of clavulanic acid per 5 mL whereas Co-amoxiclav (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, Co-amoxiclav (Augmentin) 200 mg/5 mL and 400 mg/5 mL suspensions should not be substituted for Co-amoxiclav (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 Co-amoxiclav (Augmentin ES) in patients with renal impairment.
Method of Administration: To minimise the potential for gastrointestinal intolerance, Co-amoxiclav (Augmentin ES) should be taken at the start of a meal. The absorption of Co-amoxiclav (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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