Source: Υπουργείο Υγείας (CY) Revision Year: 2017 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, P. O. Box 51706, 3056 Limassol, Cyprus
Clavomid is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1):
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
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 Clavomid that is selected to treat an individual infection should take into account:
*the expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4).
The use of alternative presentations of Clavomid (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary (see sections 4.4 and 5.1).
For adults and children ≥40 kg, this formulation of Clavomid provides a total daily dose of 1500 mg amoxicillin/375 mg clavulanic acid, when administered as recommended below. For children <40 kg, this formulation of Clavomid provides a maximum daily dose of 2400 mg amoxicillin/600 mg clavulanic acid, when administered as recommended below. If it is considered that a higher daily dose of amoxicillin is required, it is recommended that another preparation of Clavomid is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid (see sections 4.4 and 5.1).
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 section 4.4 regarding prolonged therapy).
One tablet three times a day.
20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day given in three divided doses.
Children may be treated with Clavomid tablets.
As the tablets cannot be divided, children aged 6 years and below or weighing less than 25 kg must not be treated with Clavomid tablets.
The table below presents the received dose (mg/kg body weight) in children weighing 25 kg to 40 kg upon administering a single 500/125 mg tablet.
| Body weight [kg] | 40 | 35 | 30 | 25 | Single dose recommended [mg/kg body weight] (see above) |
| Amoxicillin [mg/kg body weight] per single dose (1 film-coated tablet) | 12.5 | 14.3 | 16.7 | 20.0 | 6.67–20 |
| Clavulanic acid [mg/kg body weight] per single dose (1 film-coated tablet) | 3.1 | 3.6 | 4.2 | 5.0 | 1.67–5 |
No dose adjustment is considered necessary.
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:
| 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 hours, plus 500 mg/125 mg during dialysis, to be repeated at the end of dialysis (as serum concentrations of both amoxicillin and clavulanic acid are decreased) |
Children <40 kg:
| 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. |
Dose with caution and monitor hepatic function at regular intervals (see sections 4.3 and 4.4).
Clavomid is for oral use.
Administer at the start of a meal to minimise potential gastrointestinal intolerance and optimize the absorption of amoxicillin/clavulanic acid.
Therapy can be started parenterally according the SPC of the IV-formulation and continued with an oral preparation.
Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see section 4.4).
Convulsions may occur in patients with impaired renal function or in those receiving high doses.
Amoxicillin has been reported to precipitate in bladder catheters, predominantly after intravenous administration of large doses. A regular check of patency should be maintained (see section 4.4).
Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance. Amoxicillin/clavulanic acid can be removed from the circulation by haemodialysis.
2 years.
Store below 25°C. Protected from light and moisture.
Aluminium/Aluminium blisters. Pack-sizes of 15 and 20 film-coated tablets.
Not all pack-sizes may be marketed.
No special requirements.
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