CEFODOX Film Coated Tablet 100 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
CEFPODOXIME PROXETIL
Available from:
Sanofi-Aventis Ireland Limited
Dosage:
100 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
1996-10-11
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefodox 100mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Cefodox Tablet contains cefpodoxime proxetil equivalent to 100 mg cefpodoxime.
Excipients: each tablet contains 220mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
A biconvex, cylindrical, practically white tablet, 9mm in diameter, with ‘208’ and beneath ‘A’ engraved on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indications include:
_Upper respiratory tract infections _caused by organisms sensitive to cefpodoxime, including sinusitis. In tonsillitis and
pharyngitis, Cefodox should be reserved for recurrent or chronic infections, where the causative organism is known or
suspected to be resistant to commonly used antibiotics.
_Lower respiratory tract infection_s caused by organisms sensitive to cefpodoxime, including acute bronchitis and
relapses or exacerbations of chronic bronchitis, and bacterial pneumonia, including patients at risk or compromised by
other underlying illnesses.
_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, furuncles, folliculitis, paronychia, carbuncles, burns and ulcers.
Gonorrhoea, uncomplicated gonococcal urethritis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS :_
_Upper Respiratory Tract Infection_
Sinusitis: 200mg twice daily (morning and evening).
Pharyngitis, tonsillitis: 100mg twice daily (morning and evening).
Other upper respiratory tract infections: 100mg twice daily.
Tablets should be taken during meals.
_Lower Respiratory Tract
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