Cepodem 40 mg/5 ml/100 mg/200 mg Film-Coated Tablets

In Adults

Cepodem 100 Tablets and Cepodem 200 Tablets are indicated for use in the short-term treatment of upper and lower respiratory tract infections due to susceptible micro-organisms (sensitivity tests must be performed):

• Acute bronchitis and acute exacerbations of chronic bronchitis due to: Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis.
• Pharyngitis and tonsillitis due to: Streptococcus pyogenes
• Bacterial pneumonia and community-acquired bronchopneumonia due to: Haemophilus influenza, Streptococcus pneumoniae, Moraxella catarrhalis.
• Acute sinusitis due to: Haemophilus influenzae (non-typeable), Streptococcus pneumoniae, Methicillin-sensitive Staphylococcus aureus, Moraxella catarrhalis.

In Children

Cepodem Suspension 40 mg/5 ml is indicated for use in the short-term treatment of infections due to susceptible micro-organisms:

• Upper and lower respiratory tract infections
• Otitis media due to: Haemophilus influenzae (non-typeable), Streptococcus pneumoniae, Moraxella catarrhalis.
• Tonsillitis and pharyngitis due to: Streptococcus pyogenes.
• Pneumonia due to: Haemophilus influenza, Streptococcus pneumoniae, Moraxella catarrhalis.

Posology

In Adults

Each film-coated tablet contains 100 mg or 200 mg of cefpodoxime. The dosage of Cepodem 100 Tablets and Cepodem 200 Tablets depends on the condition being treated.

• Tonsillitis, pharyngitis and acute bronchitis: One Cepodem 100 Tablet (100 mg) every 12 hours with meals (200 mg/day). In the treatment of beta-haemolytic streptococcal infections, a therapeutic dose should be administered for at least 10 days.
• Acute sinusitis, acute exacerbations of chronic bronchitis, pneumonia: One Cepodem 200 Tablet (200 mg) every 12 hours with meals (400 mg/day).

Special populations

Elderly patients: Where renal function is normal, it is not necessary to adjust the dose.

Hepatic insufficiency in adults and children: No dosage adjustment necessary.

Renal insufficiency in adults and children: When the creatinine clearance is above 40 ml/min, it is not necessary to adjust the dose. For values below 40 ml/min, the daily dosage regimen should be reduced by half and administered as a single daily dose for values 10-39 ml/min, every second day for values below 10 ml/min, and after each dialysis session for haemodialysis patients.

In Children

Each 5 ml of the constituted suspension contains 40 mg of cefpodoxime. The dosage depends on the weight of the child being treated. The average dose is 8 mg/kg/day administered in two doses at 12 hourly intervals with meals. Shake the bottle before use.

The following table may be used as a dosage guide:

• Weight (kg) Dose

• Between 10 and 15 kg: 5 ml (40 mg) every 12 hours
• u2265 15 kg: 10 ml (80 mg) every 12 hours

Cepodem Suspension 40 mg/5 ml is currently not indicated for use in children under one year of age since insufficient clinical data is available at present (see section 4.3).

Method of administration

Oral. Cepodem 100/200 film-coated tablet taken with meals. CEPODEM Suspension 40 mg/5 ml administered with meals.

Directions for reconstitution of the suspension: Shake the bottle to loosen the granules. Add 33 ml and 66 ml water for 50 ml and 100 ml packs respectively in two divided portions to the dry mixture in the bottle. Shake well after each addition.

Hypersensitivity to cefpodoxime, the cephalosporin group of antibiotics (see section 4.4) or any of the excipients listed in section 6.1.

Pregnancy and lactation (see section 4.6).

Children below 1 year of age (see section 4.2)

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 u00df-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 pseudomembranous 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 u2013 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 Coombsu2019 test: There may be a positive response to the Coombsu2019 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 Coombsu2019 test have been reported (see section 4.4). A false positive reaction for glucose in the urine may occur with Benedictu2019s or Fehlingu2019s 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

MedDRA System organ class Frequency Adverse reactions

Infections and Infestations Less frequent Superinfections, overgrowth of non-susceptible organisms (see section 4.4).

Blood and lymphatic system disorders Frequent Eosinophilia. Less frequent Leucopenia, thrombocytopenia, reduction of haemoglobin, thrombocytosis, leucopenia, haemolytic anaemia and eosinophilia. Neutropenia and agranulocytosis may occur during treatment with CEPODEM.

Immune system disorders Less frequent Anaphylactic reactions e.g. angioedema, bronchospasm, malaise, possibly culminating in shock may occur (see section 4.4).

Ear and labyrinth disorders Less frequent Tinnitus.

Gastrointestinal disorders Frequent Nausea, vomiting, abdominal pains. Less frequent abdominal disorders, diarrhoea may sometimes be a symptom of enterocolitis, which may, in some cases, be accompanied by blood in stools. A particular form of enterocolitis that can occur with antibiotics is pseudomembranous colitis (in most cases due to Clostridium difficile) (see section 4.4), taste disturbances, stomatitis, dry mouth.

Hepato-biliary disorders Less frequent Elevations of liver enzymes (AST, ALT and alkaline phosphatase), and/or bilirubin. These laboratory abnormalities exceed twice the upper limit of the normal range and elicit a pattern of drug induced hepatitis, usually cholestatic.

Skin and subcutaneous tissue disorders Less frequent Cutaneous eruptions and pruritus, rash, urticaria and purpura. Cases of bullous eruptions (erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis) have been reported.

Renal and urinary disorders Less frequent Increase of blood urea and creatinine. Changes in renal function have been observed with antibiotics from the same group as CEPODEM, particularly when co-prescribed with aminoglycosides and/or potent diuretics (see section 4.4).

General disorders and administrative site conditions Less frequent Asthenia.

Overdosage with Cepodem may manifest in any of the symptoms described under section 4.8. Treatment is symptomatic and supportive. Convulsions and other signs of CNS toxicity have been associated with high doses, especially in patients with renal impairment.