AMOXICILLIN Capsules Ref.[6178] Active ingredients: Amoxicillin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom

Therapeutic indications

Amoxicillin is indicated for the treatment of the following infections in adults and children (see section 4.2, 4.4 and 5.1).

  • Acute bacterial sinusitis.
  • Acute streptococcal tonsillitis and pharyngitis.
  • Acute exacerbations of chronic bronchitis.
  • Community acquired pneumonia.
  • Acute otitis media.
  • Acute cystitis.
  • Acute pyelonephritis.
  • Asymptomatic Bacteriuria in pregnancy.
  • Typhoid and paratyphoid fevers.
  • Dental abscess with spreading cellulitis.
  • Prosthetic joint infections.
  • Helicobacter pylori eradication.
  • Lyme disease.

Amoxicillin is also indicated for the prophylaxis of endocarditis. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Posology and method of administration

The dose of Amoxicillin 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 severity and the site of infection.
  • The age, weight and renal function of the patient; as shown below.

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).

Adults and children ≥40 kg

Indication*Dose*
Acute bacterial sinusitis250mg 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 media500mg 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 pneumonia500mg to 1g every 8 hours
Typhoid and paratyphoid fever500mg to 2g every 8 hours
Prosthetic joint infections500mg to 1g every 8 hours
Prophylaxis of endocarditis2g orally, single dose 30 to 60 minutes before procedure
Helicobacter pylori eradication750mg 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 <40 kg

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.

Recommended doses:

Indication+Dose+
Acute bacterial sinusitis20 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 pharyngitis40 to 90 mg/kg/day in divided doses*
Typhoid and paratyphoid fever100 mg/kg/day in three divided doses
Prophylaxis of endocarditis50 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.

Elderly

No dose adjustment is considered necessary.

Renal impairment

GFR (ml/min)Adults and children ≥ 40kgChildren < 40 kg#
greater than 30No adjustment necessaryNo adjustment necessary
10 to 30Maximum 500mg twice daily15 mg/kg given twice daily (maximum 500mg twice daily)
less than 10Maximum 500 mg/day15 mg/kg given as a single dose (maximum 500 mg)

# In the majority of cases, parenteral therapy is preferred

In patients receiving haemodialysis

Amoxicillin may be removed from the circulation by haemodialysis.

 Haemodialysis
Adults and children over 40kg500mg 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 40kg15 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.

In patients receiving peritoneal dialysis

Amoxicillin maximum 500mg/day.

Hepatic impairment

Dose with caution and monitor hepatic function at regular intervals (see section 4.4 and 4.8).

Method of administration

Amoxicillin is for oral use.

Absorption of amoxicillin is impaired 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.

Overdose

Symptoms and signs of overdose

Problems of overdosage with amoxicillin are unlikely to occur. 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).

Treatment of intoxication

Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance.

Amoxicillin can be removed from the circulation by haemodialysis.

Shelf life

Shelf life

3 years: Polypropylene/polyethylene containers.

2 years: Blister strips.

Special precautions for storage

Do not store above 25°C. Store in original package and keep containers tightly closed.

Nature and contents of container

Polypropylene/polyethylene containers and tamper evident closures/ 1000, 500, 100, 50, 21, 20 and 15 capsules.

Blister strips: 15 and 21 capsules.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Not applicable.

© 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.