Augmentin

Augmentin Dosage/Direction for Use

amoxicillin + clavulanic acid

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Dosage/Direction for Use
Posology: Doses are expressed throughout in terms of amoxycillin/clavulanic acid content except when doses are stated in terms of an individual component.
The dose of Augmentin that is selected to treat an individual infection should take into account: The expected pathogens and their likely susceptibility to antibacterial agents (see Precautions); The severity and the site of the infection; The age, weight and renal function of the patient as shown as follows.
The use of alternative presentations of Augmentin (e.g. those that provide higher doses of amoxycillin and/or different ratios of amoxycillin to clavulanic acid) should be considered as necessary (see Precautions and Pharmacology: Pharmacodynamics under Actions).
If it is considered that a higher daily dose of amoxycillin is required, it is recommended that another preparation of Augmentin is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid (see Precautions and Pharmacology: Pharmacodynamics under Actions).
The duration of therapy should be determined by the response of the patient. Some infections (e.g. osteomyelitis) require longer periods of treatment. Treatment should not be extended beyond 14 days without review (see Precautions regarding prolonged therapy).
Elderly: No dose adjustment is considered necessary.
Renal impairment: Dose adjustments are based on the maximum recommended level of amoxycillin.
No dose adjustment is required in patients with creatinine clearance (CrCl) greater than 30 ml/min.
In patients with creatinine clearance less than 30 ml/min, the use of Augmentin presentations with an amoxycillin to clavulanic acid ratio of 7:1 is not recommended, as no recommendations for dose adjustments are available.
Hepatic impairment: Dose with caution and monitor hepatic function at regular intervals (see Contraindications and Precautions).
375 mg tablet: For adults and children ≥40 kg, this formulation of Augmentin provides a total daily dose of 750 mg amoxycillin/375 mg clavulanic acid, when administered as recommended as follows.
Adults and Children ≥40 kg: One 250 mg/125 mg tablet taken 3 times a day.
CrCl 10-30 mL/min: 250 mg/125 mg twice daily.
CrCl <10 mL/min: 250 mg/125 mg once daily.
Haemodialysis: Two doses of 250 mg/125 mg every 24 hrs, plus 2 doses of 250 mg/125 mg during dialysis, to be repeated at the end of dialysis (as serum concentrations of both amoxycillin and clavulanic acid are decreased).
Children <40 kg: Augmentin 250 mg/125 mg film-coated tablets are not recommended in children <40 kg.
CrCl <30 mL/min: The use of Augmentin presentations with an amoxycillin to clavulanic acid ratio of 2:1 is not recommended, as no dose adjustments are available. In such patients, Augmentin formulations with an amoxycillin to clavulanic acid ratio of 4:1 are recommended.
625 mg tablet: Usual Dosages for the Treatment of Infection: Adults and Children >12 years: Mild to Moderate Infections: One 625-mg tablet twice daily.
Dental Infections (eg, dentoalveolar abscess): One 625-mg tablet 2 times a day for 5 days.
Mild Impairment (CrCl >30 mL/min): No change in dosage (ie, one 625-mg tablet twice daily).
Moderate Impairment (CrCl 10-30 mL/min): One 625-mg tablet twice daily. The 1-g tablet should not be administered.
Severe Impairment (CrCl <10 mL/min): One 625-mg tablet every 24 hrs.
1 g tablet: For adults and children ≥40 kg, this formulation of Augmentin provides a total daily dose of 1750 mg amoxycillin/250 mg clavulanic acid with twice daily dosing and 2625 mg amoxycillin/375 mg clavulanic acid with three times daily dosing, when administered as recommended as follows. For children <40 kg, this formulation of Augmentin provides a maximum daily dose of 1000-2800 mg amoxycillin/143-400 mg clavulanic acid, when administered as recommended as follows.
Adults and children ≥40 kg: Recommended doses: Standard dose (for all indications): 875 mg/125 mg two times a day.
Higher dose (particularly for infections such as otitis media, sinusitis, lower respiratory tract infections and urinary tract infections): 875 mg/125 mg three times a day.
Children <40 kg: Children may be treated with Augmentin tablets or suspensions.
Recommended doses: 25 mg/3.6 mg/kg/day to 45 mg/6.4 mg/kg/day given as two divided doses; up to 70 mg/10 mg/kg/day given as two divided doses may be considered for some infections (such as otitis media, sinusitis and lower respiratory tract infections).
As the tablets cannot be divided, children weighing less than 25 kg must not be treated with Augmentin tablets.
The following table presents the received dose (mg/kg body weight) in children weighing 25 kg to 40 kg upon administering a single 875/125 mg tablet. (See Table 5.)

Click on icon to see table/diagram/image

Children weighing less than 25 kg should preferably be treated with Augmentin suspension.
No clinical data are available for Augmentin 7:1 formulations regarding doses higher than 45 mg/6.4 mg per kg per day in children under 2 years.
There are no clinical data for Augmentin 7:1 formulations for patients under 2 months of age. Dosing recommendations in this population therefore cannot be made.
Syrup: For adults and children ≥40 kg, this formulation of Augmentin provides a total daily dose of 1,500 mg amoxycillin/375 mg clavulanic acid, when administered as recommended. For children <40 kg, this formulation of Augmentin provides a maximum daily dose of 2,400 mg amoxycillin/600 mg clavulanic acid, when administered as recommended.
Adults and Children ≥40 kg: One 500 mg/125 mg dose taken 3 times a day.
CrCl 10-30 mL/min: 500 mg/125 mg twice daily.
CrCl <10 mL/min: 500 mg/125 mg once daily.
Haemodialysis: 500 mg/125 mg every 24 hrs, plus 500 mg/125 mg during dialysis, to be repeated at the end of dialysis (as serum concentrations of both amoxycillin and clavulanic acid are decreased).
Children <40 kg: 20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day given in 3 divided doses.
Children may be treated with Augmentin tablets, suspensions or paediatric sachets. Children ≤6 years should preferably be treated with Augmentin suspension or paediatric sachets.
No clinical data are available on doses of Augmentin 4:1 formulations higher than 40 mg/10 mg/kg per day in children <2 years.
CrCl 10-30 mL/min: 15 mg/3.75 mg/kg twice daily (maximum 500 mg/125 mg twice daily).
CrCl <10 mL/min: 15 mg/3.75 mg/kg as a single daily dose (maximum 500 mg/125 mg).
Haemodialysis: 15 mg/3.75 mg/kg per day once daily. Prior to haemodialysis, 15 mg/3.75 mg/kg. In order to restore circulating drug levels, 15 mg/3.75 mg per kg should be administered after haemodialysis.
Suspension: For children <40 kg, this formulation of Augmentin provides a maximum daily dose of 1000-2800 mg amoxycillin/143-400 mg clavulanic acid, when administered as recommended as follows.
Children ≥40 kg: Should be treated with the adult formulations of Augmentin.
Children <40 kg: Children may be treated with Augmentin tablets or suspensions.
Recommended doses: 25 mg/3.6 mg/kg/day to 45 mg/6.4 mg/kg/day given as two divided doses; up to 70 mg/10 mg/kg/day given as two divided doses may be considered for some infections (such as otitis media, sinusitis and lower respiratory tract infections).
No clinical data are available for Augmentin 7:1 formulations regarding doses higher than 45 mg/6.4 mg per kg per day in children under 2 years.
There are no clinical data for Augmentin 7:1 formulations for patients under 2 months of age. Dosing recommendations in this population therefore cannot be made.
Method of administration: Augmentin is for oral use.
Augmentin should be administered with a meal to minimise potential gastrointestinal intolerance and optimise absorption of amoxycillin/clavulanic acid.
Therapy can be started parenterally according to the package insert of the IV-formulation and continued with an oral preparation.
Syrup/Suspension: Shake to loosen powder, add water as directed, invert and shake.
Shake the bottle before each dose (see Special precautions for disposal and other handling under Cautions for Usage).
For instructions on reconstitution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.
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