Source: Υπουργείο Υγείας (CY) Revision Year: 2016 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 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 750 mg amoxicillin/375 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).
Treatment should not be extended beyond 14 days without review.
One tablet three times a day.
Clavomid tablets are not recommended in children < 40 kg.
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.
| 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 hours, plus two doses of 250 mg/125 mg during dialysis, to be repeated at the end of dialysis (as serum concentrations of both amoxicillin and clavulanic acid are decreased) |
In children <40 kg with creatinine clearance less than 30 ml/min, the use of Clavomid presentations with an amoxicillin to clavulanic acid ratio of 2:1 is not recommended, as no dose adjustments are available. In such patients, Clavomid formulations with an amoxicillin to clavulanic acid ratio of 4:1 are recommended.
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 Clavomid.
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-size of 20 film-coated tablets.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
