Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Edamox is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1):
Edamox is also indicated for the prophylaxis of endocarditis.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The dose of Edamox that is selected to treat an individual infection should take into account:
The duration of therapy should be determined by the type of infection and the response of the patient, and should generally be as short as possible. Some infections require longer periods of treatment (see section 4.4 regarding prolonged therapy).
| Indication* | Dose* |
|---|---|
| Acute bacterial sinusitis Asymptomatic bacteriuria in pregnancy Acute pyelonephritis Dental abscess with spreading cellulitis Acute cystitis | 250 mg to 500 mg every 8 hours or 750 mg to 1 g every 12 hours For severe infections 750 mg to 1 g every 8 hours Acute cystitis may be treated with 3 g twice daily for one day |
| Acute otitis media Acute streptococcal tonsillitis and pharyngitis Acute exacerbations of chronic bronchitis | 500 mg every 8 hours, 750 mg to 1 g every 12 hours For severe infections 750 mg to 1 g every 8 hours for 10 days |
| Community acquired pneumonia | 500 mg to 1 g every 8 hours |
| Typhoid and paratyphoid fever | 500 mg to 2 g every 8 hours |
| Prosthetic joint infections | 500 mg to 1 g every 8 hours |
| Prophylaxis of endocarditis | 2 g orally, single dose 30 to 60 minutes before procedure |
| Helicobacter pylori eradication | 750 mg to 1 g twice daily in combination with a proton pump inhibitor (e.g. omeprazole, lansoprazole) and another antibiotic (e.g. clarithromycin, metronidazole) for 7 days |
| Lyme disease (see section 4.4) | Early stage: 500 mg to 1 g every 8 hours up to a maximum of 4 g/day in divided doses for 14 days (10 to 21 days) Late stage (systemic involvement): 500 mg to 2 g every 8 hours up to a maximum of 6 g/day in divided doses for 10 to 30 days |
* Consideration should be given to the official treatment guidelines for each indication
Children may be treated with amoxicillin capsules or other suitable pharmaceutical forms.
For children under six months of age the pharmaceutical form of suspension should be used.
Children weighing 40 kg or more should be prescribed the adult dosage.
Recommended doses:
| Indication+ | Dose+ |
|---|---|
| Acute bacterial sinusitis Acute otitis media Community acquired pneumonia Acute cystitis Acute pyelonephritis Dental abscess with spreading cellulitis | 20 to 90 mg/kg/day in divided doses* |
| Acute streptococcal tonsillitis and pharyngitis | 40 to 90 mg/kg/day in divided doses* |
| Typhoid and paratyphoid fever | 100 mg/kg/day in three divided doses |
| Prophylaxis of endocarditis | 50 mg/kg orally, single dose 30 to 60 minutes before procedure |
| Lyme disease (see section 4.4) | Early stage: 25 to 50 mg/kg/day in three divided doses for 10 to 21 days Late stage (systemic involvement): 100 mg/kg/day in three divided doses for 10 to 30 days |
+ Consideration should be given to the official treatment guidelines for each indication.
*Twice daily dosing regimens should only be considered when the dose is in the upper range.
No dose adjustment is considered necessary.
| GFR (ml/min) | Adults and children ≥40 kg | Children <40 kg# |
|---|---|---|
| greater than 30 | no adjustment necessary | no adjustment necessary |
| 10 to 30 | maximum 500 mg twice daily | 15 mg/kg given twice daily (maximum 500 mg twice daily) |
| less than 10 | maximum 500 mg/day | 15 mg/kg given as a single daily dose (maximum 500 mg) |
# In the majority of cases, parenteral therapy is preferred.
Amoxicillin may be removed from the circulation by haemodialysis.
| Haemodialysis | |
|---|---|
| Adults and children over 40 kg | 500 mg every 24 h Prior to haemodialysis one additional dose of 500 mg should be administered. In order to restore circulating drug levels, another dose of 500 mg should be administered after haemodialysis. |
| Children under 40 kg | 15 mg/kg/day given as a single daily dose (maximum 500 mg). Prior to haemodialysis one additional dose of 15 mg/kg should be administered. In order to restore circulating drug levels, another dose of 15 mg/kg should be administered after haemodialysis. |
Amoxicillin maximum 500 mg/day.
Dose with caution and monitor hepatic function at regular intervals (see sections 4.4 and 4.8).
Oral administration.
Absorption of amoxicillin is unimpaired by food.
Therapy can be started parenterally according to the dosing recommendations of the intravenous formulation and continued with an oral preparation.
Swallow with water without opening the capsule.
Gastrointestinal symptoms (such as nausea, vomiting and diarrhoea) and disturbance of the fluid and electrolyte balances may be evident. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed. Convulsions may occur in patients with impaired renal function or in those receiving high doses (see sections 4.4 and 4.8).
Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance.
Amoxicillin may be removed from the circulation by haemodialysis.
5 years.
Store below 25°C. Protect from light and moisture.
PVC/Aluminium blisters. Pack sizes of 20 and 1000 hard capsules.
PP/PE containers with PE closure. Pack size of 1000 hard capsules.
Not all sizes may be marketed.
No special instructions.
© 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.
