CEPODEM Film-coated tablet / Suspension Ref.[51081] Active ingredients: Cefpodoxime

Anaphylactic reactions

Preliminary enquiry as to an allergic diathesis and particularly hypersensitivity of beta-lactam antibiotics should precede treatment with CEPODEM.

The use of CEPODEM is strictly contraindicated in subjects with a previous history of immediate type hypersensitivity to cephalosporins. CEPODEM should be used with extreme caution in patients sensitive to penicillin and other β-lactam antibiotics as cross-allergy may develop. Strict medical supervision is required throughout the treatment.

Hypersensitivity reactions (anaphylaxis) observed with CEPODEM can be serious and occasionally fatal.

If an allergic reaction occurs, treatment should be stopped immediately.

Prolonged use may result in overgrowth of non-susceptible organisms and, as with other broad spectrum antibiotics, pseudomembranous colitis may develop. It is important to consider its diagnosis in patients who develop diarrhoea in association with the use of antibiotics. Such colitis may range in severity from mild to life threatening. Treatment should be discontinued if symptoms suggestive of psuedomembranous colitis arise. Mild cases of pseudomembranous colitis usually respond to drug discontinuance alone. When the colitis does not improve after the medicine has been discontinued, or when it is severe, oral vancomycin is the medicine of choice for antibiotic associated pseudomembranous colitis produced by C. difficile.

Clostridium difficile – associated disease

Diarrhoea, particularly if severe and/or persistent, occurring during treatment or in the initial weeks following treatment with CEPODEM, may be symptomatic of Clostridium difficile-associated disease, the most severe form of which is pseudomembranous colitis. The diagnosis of this possibly fatal condition is confirmed by endoscopy and/or histology. Screening of faeces for this pathogen, and its cytotoxin is the best way to diagnose Clostridium difficile associated disease.

If a diagnosis of pseudomembranous colitis is suspected, CEPODEM should be stopped immediately and appropriate specific therapy should be started without delay (e.g. vancomycin or metronidazole). Clostridium difficile-associated disease can be favoured by faecal stasis.

Superinfection

The use of CEPODEM, especially if prolonged, may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient’s condition is essential. If superinfection occurs during therapy, appropriate measures should be taken (see section 4.8: Infections and Infestations).

Renal impairment

Cephalosporins should be given with caution to patients with renal impairment. Changes in renal function have been observed with antibiotics of the same class as CEPODEM, particularly when given concurrently with potentially nephrotoxic agents such as aminoglycosides and/or potent diuretics. In such cases, renal function should be monitored.

Positive Coombs' test

There may be a positive response to the Coombs' test during treatment with cephalosporins. CEPODEM may be absorbed onto the surface of red cell membranes and react with antibiotics directed against the medicine. This can produce a positive antiglobulin test and haemolytic anaemia. Cross-reactivity may occur with penicillin for this reaction.

Paediatrics

No paediatrics-specific problems have been documented with the use of cefpodoxime proxetil to date. The safety and efficacy of Cepodem have not been established in children under one year of age (see section 4.3).

Geriatrics

Cepodem may be used at the normal recommended dosage in elderly patients even with mild to moderate renal impairment; however, appropriate modification in dosage is advised in patients with severe renal impairment (See section 4.2).

Excipients

Sucrose/Lactose

Cepodem 100 Tablets, 200 Tablets and Suspension 40 mg/5 ml contain lactose. Cepodem Suspension 40 mg/5 ml also contains sucrose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take Cepodem.

Absorption of cefpodoxime is decreased by antacids or histamine H₂-receptor antagonists.

Probenecid reduces the renal excretion of cefpodoxime.

The bioavailability of CEPODEM is increased if the product is administered during meals (acid pH). CEPODEM potentially enhances the anticoagulant effect of warfarin and reduces the contraceptive effect of oestrogens.

Cases showing development of a positive Coombs' test have been reported (see section 4.4).

A false positive reaction for glucose in the urine may occur with Benedict’s or Fehling’s solution or with copper sulphate test tablets, but not with tests based on enzymatic glucose oxidase reactions.

Pregnancy

Safety in pregnancy has not been established (see section 4.3).

Lactation

Safety in Lactation has not been established (see section 4.3).

Dizziness may occur, which should be taken into account when driving a vehicle or operating machines. Patients should therefore be advised not to drive or operate machinery until their individual susceptibility is known.

Tabulated list of adverse reactions

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.

Not applicable.