Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2023 Publisher: Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom
Amoxicillin is indicated for the treatment of the following infections in adults and children (see section 4.2, 4.4 and 5.1).
Amoxicillin 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 Amoxicillin 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 | 250mg to 500mg every 8 hours or 750mg to 1g every 12 hours For severe infections 750mg to 1g every 8 hours Acute cystitis may be treated with 3g twice daily for one day |
| Asymptomatic bacteriuria in pregnancy | |
| Acute pyelonephritis | |
| Dental abscess with spreading cellulitis | |
| Acute cystitis | |
| Acute otitis media | 500mg every 8 hours, 750mg to 1g every 12 hours For severe infections 750mg to 1g every 8 hours for 10 days |
| Acute streptococcal tonsillitis and pharyngitis | |
| Acute exacerbations of chronic bronchitis | |
| Community acquired pneumonia | 500mg to 1g every 8 hours |
| Typhoid and paratyphoid fever | 500mg to 2g every 8 hours |
| Prosthetic joint infections | 500mg to 1g every 8 hours |
| Prophylaxis of endocarditis | 2g orally, single dose 30 to 60 minutes before procedure |
| Helicobacter pylori eradication | 750mg to 1g 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: 500mg to 1g 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): 500mg to 2g 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, dispersible tablets, suspensions or sachets.
Amoxicillin Paediatric Suspension is recommended for children under six months of age.
Children weighing 40kg or more should be prescribed the adult dosage.
| 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 ≥40kg | Children <40 kg# |
|---|---|---|
| greater than 30 | No adjustment necessary | No adjustment necessary |
| 10 to 30 | Maximum 500mg twice daily | 15 mg/kg given twice daily (maximum 500mg twice daily) |
| less than 10 | Maximum 500 mg/day | 15 mg/kg given as a single 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 40kg | 500mg every 24h Prior to haemodialysis one additional dose of 500mg should be administered. In order to restore circulating blood levels, another dose of 500mg should be administered after haemodialysis |
| Children under 40kg | 15 mg/kg/day given as a single daily dose (maximum 500mg). Prior to haemodialysis one additional dose of 15 mg/kg should be administered. In order to restore circulating blood levels, another dose of 15 mg/kg should be administered after haemodialysis |
Amoxicillin maximum 500mg/day
Dose with caution and monitor hepatic function at regular intervals (see section 4.4 and 4.8).
Amoxicillin is for oral use.
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 capsule.
Gastrointestinal symptoms (such as nausea, vomiting and diarrhoea) and disturbances 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 (see section 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.
Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see section 4.4).
3 years: Polypropylene/polyethylene containers.
2 years: Blister strips.
Do not store above 25°C. Store in the original package and keep containers tightly closed.
Polypropylene/polyethylene containers and tamper evident closures/1000, 500, 100, 21, 20 and 15 capsules.
Blister strips: 15 and 21 capsules.
Not all pack sizes may be marketed.
Not applicable.
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