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The dose of co-amoxiclav that is selected to treat an individual infection should take into account: The expected pathogens and their likely susceptibility to antibacterial agents; 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 co-amoxiclav (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary.
For adults and children ≥40 kg, this formulation of co-amoxiclav provides a total daily dose of 1500 mg amoxicillin/375 mg clavulanic acid, when administered as recommended as follows. For children <40 kg, this formulation of co-amoxiclav provides a maximum daily dose of 2400 mg amoxicillin/600 mg clavulanic acid, when administered as recommended as follows. If it is considered that a higher daily dose of amoxicillin is required, it is recommended that another preparation of co-amoxiclav is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid.
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.
Adults and children ≥40 kg: One 500 mg/125 mg dose taken three times a day.
Children <40 kg: 20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day given in three divided doses.
Children may be treated with co-amoxiclav tablets, suspensions or paediatric sachets.
As the tablets cannot be divided, children weighing less than 25 kg must not be treated with co-amoxiclav tablets.
Table 5 presents the received dose (mg/kg body weight) in children weighing 25 kg to 40 kg upon administering a single 500/125 mg tablet. (See Table 5.)
Click on icon to see table/diagram/imageChildren aged 6 years and below or weighing less than 25 kg should preferably be treated with co-amoxiclav suspension or paediatric sachets.
No clinical data are available on doses of co-amoxiclav 4:1 formulations higher than 40 mg/10 mg/kg per day in children under 2 years.
Elderly: No dose adjustment is considered necessary.
Renal impairment: Dose adjustments are based on the maximum recommended level of amoxicillin.
No adjustment in dose is required in patients with creatinine clearance (CrCl) greater than 30 ml/min.
Adults and children ≥40 kg: See Table 6.
Click on icon to see table/diagram/imageHepatic impairment: Dose with caution and monitor hepatic function at regular intervals.
Method of administration: Co-Amoxiclav is for oral use.
Co-Amoxiclav should be administered with a meal to minimise potential gastrointestinal intolerance.
Therapy can be started parenterally according the SPC of the IV formulation and continued with an oral preparation.
1 g: The usual adult dose is one amoxicillin and potassium clavulanate tablet, 500 mg/125 mg every 12 hours or one amoxicillin and potassium clavulanate tablet, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and potassium clavulanate tablet, 875 mg/125 mg every 12 hours or one amoxicillin and potassium clavulanate tablet, 500 mg/125 mg every 8 hours.
Alclav Kids: Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component.
The dose of Co-Amoxiclav 400/57 mg/5 ml Powder for Oral Suspension that is selected to treat an individual infection should take into account: The expected pathogens and their likely susceptibility to antibacterial agents.
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 Co-amoxiclav 400/57 mg/5 ml Powder for Oral Suspension (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary.
For adults and children ≥40 kg, this formulation of Co-amoxiclav 400/57 mg/5 ml Powder for Oral Suspension provides a total daily dose of 1750 mg amoxicillin/250 mg clavulanic acid with twice daily dosing and 2625 mg amoxicillin/375 mg clavulanic acid with three times daily dosing, when administered as recommended as follows. For children <40 kg, this formulation of Co-amoxiclav 400/57 mg/5 ml Powder for Oral Suspension provides a maximum daily dose of 1000-2800 mg amoxicillin/143-400 mg clavulanic acid, when administered as recommended as follows. If it is considered that a higher daily dose of amoxicillin is required, it is recommended that another preparation of Co-amoxiclav 400/57 mg/5 ml Powder for Oral Suspension is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid.
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.
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 Co-amoxiclav 400/57 mg/5 ml Powder for Oral Suspension tablets, suspensions or paediatric sachets.
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 Co-amoxiclav 400/57 mg/5 ml Powder for Oral Suspension 7:1 formulations regarding doses higher than 45 mg/6.4 mg/kg per day in children under 2 years.
There are no clinical data for Co-amoxiclav 400/57 mg/5 ml Powder for Oral Suspension 7:1 formulations for patients under 2 months of age. Dosing recommendations in this population therefore cannot be made.
Elderly: No dose adjustment is considered necessary.
Renal impairment: No adjustment in dose 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 Co-amoxiclav 400/57 mg/5 ml Powder for Oral Suspension presentations with an amoxicillin 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.
Method of administration: Co-amoxiclav 400/57 mg/5 ml Powder for Oral Suspension is for oral use.
Co-amoxiclav 400/57 mg/5 ml Powder for Oral Suspension should be administered with a meal to minimise potential gastrointestinal intolerance.
Therapy can be started parenterally according the SPC of the IV-formulation and continued with an oral preparation.
Shake to loosen powder, add water as directed, invert and shake.
Shake the bottle before each dose.
Alclav Hospi: Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component.
The dose of Co-amoxiclav that is selected to treat an individual infection should take into account: The expected pathogens and their likely susceptibility to antibacterial agents; 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 Co-amoxiclav (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary.
This Co-amoxiclav powder for solution for injection or infusion provides a total daily dose of 3000 mg amoxicillin and 600 mg clavulanic acid when administered as recommended as follows. If it is considered that a higher daily dose of amoxicillin is required it is recommended that an alternative intravenous formulation of Co-amoxiclav is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid.
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. Consideration should be given to local guidelines on appropriate dosing frequencies for amoxicillin/clavulanic acid.
Adults and children ≥40kg: For treatment of infections as indicated in section 4.1: 1000 mg/200 mg every 8 hours. (See Table 7.)
Click on icon to see table/diagram/imageChildren <40 kg: Recommended doses: Children aged 3 months and over: 25 mg/5 mg per kg every 8 hours.
Children aged less than 3 months or weighing less than 4 kg: 25 mg/5 mg per kg every 12 hours.
Elderly: No dose adjustment is considered necessary.
Renal impairment: Dose adjustments are based on the maximum recommended level of amoxicillin.
No dose adjustment is required in patients with creatinine clearance (CrCl) greater than 30 mL/min.
Adults and children ≥40kg: See Table 8.
Click on icon to see table/diagram/imageChildren <40 kg: See Table 9.
Click on icon to see table/diagram/imageHepatic impairment: Dose with caution and monitor hepatic function at regular intervals.
