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The dose of amoxicillin/clavulanic acid 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 amoxicillin/clavulanic acid (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary (see Precautions and Pharmacology: Pharmacodynamics under Actions).
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. 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 (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).
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 pediatric sachets. Children aged 6 years and below should preferably be treated with co-amoxiclav suspension or pediatric 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/imageChildren <40 kg: See Table 7.
Click on icon to see table/diagram/imageHepatic impairment: Dose with caution and monitor hepatic function at regular intervals (see Contraindications and Precautions).
Method of administration: Co-amoxiclav is for oral use.
Administer at the start of a meal to minimise potential gastrointestinal intolerance and optimise absorption of amoxicillin/clavulanic acid.
Therapy can be started parenterally according to 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 (see Instructions for Use and Handling under Cautions for Usage).
228.5 mg/5 mL & 457 mg/5 mL suspension: Administer Co-amoxiclav at the start of a meal to minimize potential gastrointestinal intolerance and to optimize absorption.
Drink plenty of water to ensure proper state of hydration and adequate urinary output.
Treatment should not exceed 14 days without first re-evaluating the patient.
Usual Oral Dosage in Children up to 12 years old: Co-amoxiclav is dosed based on the amoxicillin component and is given in divided doses every 12 hours.
Children below 1 year old: 30 mg/kg body weight/day.
For Mild to Moderate Infections: 25 mg/kg body weight/day.
For Severe Infections: 45 mg/kg body weight/day. (See Tables 8 and 9.)
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Click on icon to see table/diagram/imageDosage in Children up to 12 years old on Hemodialysis: 15 mg/kg body weight once daily. Patients should receive an additional dose of 15 mg/kg body weight both during and at the end of dialysis.
Dosage in Children up to 12 years old with Hepatic Impairment: Dose with caution and monitor hepatic function regularly.
Directions for Reconstitution: See Table 10.
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