Hypersensitivity to the active substance cefpodoxime proxetil or to any of the excipients listed in section 6.1.
Hypersensitivity to any other cephalosporin antibacterial agent.
Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. penicillins or carbapenems).
Cefpodoxime proxetil should be administered with caution in patients with previous hypersensitivity reactions to cefpodoxime, cephalosporins, penicillins or other drugs and penicillin sensitivity (for contraindications due to known hypersensitivity reactions see section 4.3).
Hypersensitivity/anaphylaxis reactions observed with beta-lactam antibiotics.
Antibiotics should be administered with caution to any patient who has demonstrated some form of allergy, particularly to drugs. If an allergic reaction to cefpodoxime proxetil occurs, the drug should be discontinued. Serious sensitivity reactions may require emergency measures.
Cefpodoxime proxetil should not be prescribed in the absence of a proven or strongly suspected bacterial infection.
Cefpodoxime should be discontinued if severe and/or bloody diarrhoea occurs during treatment and appropriate therapy instituted. Antibiotic-associated diarrhoea, colotis and psuedomembranous colitis linked to Clostridium difficile can all be reported with the use of cefpodoxime proxetil. Anti-peristaltics are contraindicated.
As with other cephalosporins, prolonged use of cefpodoxime may result in the overgrowth of nonsusceptible organisms (e.g. perianal, oral or vaginal candidiasis; pseudomembranous colitis; superinfection). In these cases, specific treatment should be initiated.
During long-treatment (>7 days) with high-dose cefpodoxime, blood counts and liver/kidney function must be monitored.
Cephalosporins may be absorbed onto the surface of red cell membranes and react with antibodies directed against the drug. This can produce a positive Coombs' test and very rarely, haemolytic anaemia. Cross-reactivity may occur with penicillin for this reaction.
Regular renal function monitoring is also indicated, if aminoglycosides or potent diuretics such as furosemide are administered concomitantly. If cefpodoxime alone was given, neither nephrotoxicity nor totoxicity was observed.
Cefpodoxime proxetil should be administered with caution in patients with renal insufficiency, the daily dose should be adjusted in terms of creatinine clearance (see section 4.2).
The product should not be used in infants less than 15 days old as no clinical trial data in this age group yet exists.
Cefpodoxime-Lupin 40 mg/5 mL powder for oral suspension contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Patients who cannot tolerate or digest some sugars or with diabetes mellitus should not take this medicine.
Cefpodoxime-Lupin 40 mg/5 mL powder for oral suspension contains aspartame, which is a source of phenylalanine. May be harmful for people with phenylketonuria.
High-dose treatment of parenterally administered Cephalosporins and concomitant administration of strong-acting diuretics (e.g. Furosemide) or potentially nephrotoxic drugs (e.g. Aminoglycoside antibiotics) causing impairment of renal function cannot be excluded. However, pharmacological data and clinical experience show that this is unlikely with the oral cefpodoxime proxetil at the recommended applicable dose.
With concomitant administration of drugs that increase the pH in the stomach, the bioavailablity of cefpodoxime in fasting subjects is reduced to about 30%. These preparations should therefore be taken 2-3 hours before or after cefpodoxime proxetil.
Cefpodoxime proxetil should not be combined with bacteriostatic antibiotics (e.g chloramphenicol, erythromycin, sulfonamides and tetracyclines) since the effect of cefpodoxime proxetil can be reduced.
During treatment with Cephalosporins, Coombs' test and non-enzymatic methods for the determination of glucose in the urine may show false positive results.
For cefpodoxime proxetil no clinical data on exposed pregnancies are available. In rat, cefpodoxime proxetil reaches the embryo/fetus via the placenta. Animal data reveal no undesirable effects on reproduction (see section 5.3 preclinical data). As a precautionary measure, Cefpodoxime-Lupin 40 mg/5 mL powder for oral suspension should only be used during pregnancy after benefit/risk assessment by the doctor in charge, especially during the first trimester.
Cefpodoxime is excreted in maternal milk. Diarrhoea and fungus infections of the mucous membranes could occur in the breast-fed infant, so that nursing might have to be discontinued during treatment with Cefpodoxime-Lupin 40 mg/5 mL powder for oral suspension. The possibility of sensitisation should be borne in mind.
No untoward effects on fertility or reproduction were noted when 100 mg/kg/day or less (2 times the human dose based on mg/m² sup) was administered orally to rats.
Attention should be drawn to the risk of dizzy sensations.
The following adverse reactions have been reported (organised by organ system). The following frequencies are defined in the evaluation of side effects:
very common (more than 1 in 10 people);
common (up to 1 in 10 people);
uncommon (up to 1 in 100 people);
rare (up to 1 in 1,000 people);
very rare (up to 1 in 10,000 people),
not known (frequency cannot be estimated from the available data).
Uncommon: Haemolytic anaemia.
Very rare: In some cases, blood disorders (thrombocytosis, thrombocytopenia, leukopenia, neutropenia, agranulocytosis, eosinophilia, decreased haemoglobin values) were observed. These very rare changes are reversible upon discontinuation of therapy.
Uncommon: Headache, tinnitus, paresthesias and dizziness were observed.
Common: Stomach upset, nausea, vomiting, loss of appetite, bloating or diarrhoea. Bloody diarrhoea may occur as a symptom of enterocolitis.
Rare: If severe or persistent diarrhoea during or after therapy thought to be Pseudomembranous enterocolitis (rare in children), diagnosis should be confirmed. In these rare cases, cephalosporins should be discontinued immediately and appropriate therapy initiated. Peristalsis agents are contraindicated.
Very rare: Single cases of acute pancreatitis have been reported.
Very rare: Single cases of acute renal failure have been reported.
Common: Allergic reactions have been observed, mostly in the form of skin lesions with or without itching (erythema, rash, urticaria, purpura).
Very rare: Individual cases of bullous skin reactions (erythema multiforme, Stevens-Johnson syndrome, Lyell’s syndrome) have been reported. The mediciation should be discontinued if such symptoms occur.
Hypersensitivity reactions of any severity (e.g. angioedema, bronchospasm to life threatening shock) have been observed. Severe acute hypersensitivity reactions may require appropriate emergency measures. With hypersensitivity to other beta-lactam antibiotics, cross reactions with cefpodoxime proxetil may occur (see Section 4.3 Contraindications).
Uncommon: Asthenia, fatigue and discomfort (malaise). Hepato-biliary disorders
Very rare: Single cases of acute hepatitis have been reported.
Uncommon: Elevation of liver enzymes (transaminases, alkaline phosphate) and/or bilirubin as a sign of liver cell damage (cholestatic) as a sign of liver cell damage.
Very rare: In some cases, an increase of uremic substance (creatinine and urea) in serum
Proliferation of non-susceptible organisms, especially with prolonged use
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Not applicable.
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