CEFODOX PAEDIATRIC 40MG/5ML GRANULES FOR ORAL SUSP
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
CEFPODOXIME PROXETIL
Available from:
Sanofi-Aventis Ireland Limited
Dosage:
40 Base mg/5ml
Pharmaceutical form:
Granules for Oral Suspension
Authorization date:
1999-07-21
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefodox Paediatric 40mg/5ml Granules for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted each 5ml volume contains 40mg of cefpodoxime, as cefpodoxime proxetil.
Excipients: contains per 5ml:
Aspartame (E951) 20mg
Lactose monohydrate q.s.
Sucrose 601.33mg
Potassium 2.17mg
Sulphites 0.72 micrograms
Glucose 322.2mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral suspension
Pale yellow granules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefodox is a bactericidal cephalosporin antibiotic active against _in vitro _a wide range of gram-negative and gram-
positive organisms. It is indicated for the treatment of the following infections.
Indications include:
_Upper respiratory tract infections _caused by organisms sensitive to cefpodoxime, including acute otitis media,
sinusitis, tonsillitis and pharyngitis.
Cefodox should be reserved for recurrent or chronic infections.
_Lower respiratory tract infection_s caused by organisms sensitive to cefpodoxime.
_Upper and lower urinary tract infections _caused by organisms sensitive to cefpodoxime including cystitis and acute
pyelonephritis.
_Skin and soft tissue infections _caused by organisms sensitive to cefpodoxime such as abscesses, cellulitis, infected
wounds, folliculitis, paronychia, carbuncles, burns and ulcers.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral.
Adults & Elderly:
Not applicable for this product.
Children:
The recommended mean dosage for children is 8mg/kg/day administered in two divided doses at 12 hour intervals.
The following dosage regimen is proposed as a guide to prescribing:
Below 6 months:
8mg/kg/day in 2 divided doses.
6 months-2 years:
5.0 ml twice daily.
3-8 years:
10.0 ml t
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