EDAMOX Hard capsule Ref.[28244] Active ingredients: Amoxicillin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

4.1. Therapeutic indications

Edamox is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1):

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

Edamox is also indicated for the prophylaxis of endocarditis.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2. Posology and method of administration

Posology

The dose of Edamox 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 the 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 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 pneumonia500 mg to 1 g every 8 hours
Typhoid and paratyphoid fever500 mg to 2 g every 8 hours
Prosthetic joint infections500 mg to 1 g every 8 hours
Prophylaxis of endocarditis2 g orally, single dose 30 to 60 minutes before procedure
Helicobacter pylori eradication750 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 <40 kg

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 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 ≥40 kgChildren <40 kg#
greater than 30 no adjustment necessaryno adjustment necessary
10 to 30 maximum 500 mg twice daily15 mg/kg given twice daily (maximum 500 mg twice daily)
less than 10 maximum 500 mg/day15 mg/kg given as a single daily 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 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.

In patients receiving peritoneal dialysis

Amoxicillin maximum 500 mg/day.

Hepatic impairment

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

Method of administration

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.

4.9. Overdose

Symptoms and signs of overdose

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).

Treatment of intoxication

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

Amoxicillin may be removed from the circulation by haemodialysis.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C. Protect from light and moisture.

6.5. Nature and contents of container

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.

6.6. Special precautions for disposal and other handling

No special instructions.

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