Source: Υπουργείο Υγείας (CY) Revision Year: 2017 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Amoxapen is indicated for the treatment of the following infections in adults and children (see section 4.2, 4.4, 5.1):
Amoxapen is also indicating for the prophylaxis of endocarditis.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology
The dose of Amoxapen 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 | 250 mg to 500 mg every 8 hours or 750 mg to 1 g every 12 hours |
| Asymptomatic bacteriuria in pregnancy | |
| Acute pyelonephritis | |
| Dental abscess with spreading cellulitis | For severe infections 750 mg to 1 g every 8 hours |
| Acute cystitis | Acute cystitis may be treated with 3 g twice daily for one day |
| Acute otitis media | 500 mg every 8 hours, 750 mg to 1 g every 12 hours |
| Acute streptococcal tonsillitis and pharyngitis | For severe infections 750 mg to 1 g every 8 hours for 10 days |
| Acute exacerbations of chronic bronchitis | |
| 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, etronidazole) 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 Amoxapen capsules and powder for oral suspension.
Amoxapen 125 mg/5 ml powder for oral suspension is recommended for children under six months of age.
Children weighing 40 kg or more should be prescribed the adult dosage.
Recommended doses:
| Indication+ | Dose+ |
|---|---|
| Acute bacterial sinusitis | 20 to 90 mg/kg/day in divided doses* |
| Acute otitis media | |
| Community acquired pneumonia | |
| Acute cystitis | |
| Acute pyelonephritis | |
| Dental abscess with spreading cellulitis | |
| 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 ≥40 kg | 15 mg/kg/day given as a single daily dose. 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).
Amoxapen is for oral use.
Absorption of Amoxapen 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.
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 can be removed from the circulation by haemodialysis.
5 years.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label or carton after ‘EXP’. The expiry date refers to the last day of that month.
Store below 25°C. Protect from light and moisture.
Amoxapen 250 mg film-coated tablets:
PVC/Aluminium blisters. Pack-sizes of 20 film-coated tablets.
PP containers with PE closure. Pack-sizes of 100 and 1000 film-coated tablets.
Amoxapen 500 mg film-coated tablets:
PVC/Aluminium blisters. Pack-sizes of 20, 100 and 1000 film-coated tablets.
PP containers with PE closure. Pack-sizes of 100, 500 and 1000 film-coated tablets.
Not all pack sizes may be marketed.
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.
