Doxcef         Powder for Oral Suspension

Cefpodoxime Proxetil   40mg/5ml

Usage and indications:

Cefpodoxime is indicated for the treatment of the following infections caused by cefpodoxime susceptible pathogens in children up to 11 years.

Upper respiratory tract infections: Acute bacterial sinusitis; Tonsillitis; Acute otitis media

Lower respiratory tract infections: Bacterial pneumonia. In case of bacterial pneumonia cefpodoxime might not be suitable option depending on the pathogen involved. Consideration should be given to the official guidance on the appropriate use of antibacterial agents.

Dosage and administration:

Adults and Elderly:

Not applicable for this product.

 

Infants (>28 days), Toddlers, Children (up to 11 years):

The recommended mean dosage for children is 8mg/kg/day, administered in two divided doses at 12-hour intervals. The dose to be taken is indicated on the measuring spoon. The graduations correspond to the child's weight in kg from 5kg (2.5ml) to 25kg (12.5ml), with intermittent graduations of 1kg (0.5ml) each. The dose to be taken is read directly from the spoon.     

Undesirable effects:  

Blood and lymphatic system disorders:

Rare: haematological disorders such as reduction in haemoglobin, thrombocytosis thrombocytopenia, leucopenia and eosinophilia  

Very rare: haemolytic anaemia.

Nervous system disorders:

Uncommon: headache, paraesthesia, dizziness.

Ear and labyrinth disorders:

Uncommon: tinnitus

Gastrointestinal disorders:

Common: gastric pressure, nausea, vomiting, abdominal pain, flatulence, diarrhoea.  

bloody diarrhoea can be seen as signs of enterocollitis. The possibility of a pseudomembranous enterocolitis should be considered if severe or persistent diarrhea occurs during or after treatment.

Metabolic and nutritional disorders:

Common: Loss of appetite

Immune system disorders:  

Hypersensitivity reactions of all degrees of severity have been observed.

Very rare: anaphylactic reactions, bronchospasm, purpura and angioedema.

Renal and urinary disorders:

Very rare: Slight increases in blood urea and creatinine                                                       

Hepatobiliary disorders:

Rare: Transient moderate elevations of ASAT, ALAT and alkaline phosphatases and/or bilirubin. These laboratory abnormalities, which may also be explained by the infection, may rarely exceed twice the upper limit of the named range and elicit a pattern of liver injury, usually cholestatic and most often asymptomatic.

Very rare: liver damage

Skin and subcutaneous tissue disorders:

Uncommon: hypersensitivity mucocutaneous reactions, rash, urticaria, pruritus

Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiform

Infections and infestations:

There can be multiplication of non-sensitive micro-organisms.

General disorders and administration site conditions:

Uncommon: asthenia or malaise

Warnings and precautions:

Special caution is required to determine any other type of previous hypersensitivity reactions to penicillin or to other beta-lactam medicinal products because patients hypersensitive to these medicines may be hypersensitive to (Cefpodoxiem Proxetil) as well (cross- allergy). Cefpodoxime is not a preferred antibiotic for the treatment of staphylococcal pneumonia and should not be used in the treatment of atypical pneumonia caused by organisms such as Legionella, Mycoplasma and Chlamydia. Cefpodoxime is not recommended for the treatment of pneumonia due to S.pneumoniae. 

As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with cefpodoxime must be discontinued immediately and adequate emergency measures must be initiated.  Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to cefpodoxime, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if cefpodoxime is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.

In cases of severe renal insufficiency it may be necessary to reduce the dosage regimen dependent on the creatinine clearance.  

Antibacterial agent-associated colitis and pseudo-membranous colitis have been reported with nearly all anti-bacterial agents, including cefpodoxime, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea during or subsequent to the administration of cefpodoxime. Discontinuation of therapy with cefpodoxime and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given. Cefpodoxime should always be prescribed with caution in patients with a history of gastrointestinal disease, particularly colitis.

As with all beta-lactam antibiotics, neutropenia and more rarely agranulocytosis may develop particularly during extended treatment. For cases of treatment lasting longer than 10 days, the blood count should be monitored and treatment discontinued if neutropenia is found.

Cephalosporins may be absorbed onto the surface of red cell membranes and react with antibodies directed against the drug. This can produce a positive Coomb's test and very rarely, haemolytic anaemia. Cross-reactivity may occur with penicillin for this reaction.

Changes in renal function have been observed with cephalosporin antibiotics, particularly when given concurrently with potentially nephrotoxic drugs such as aminoglycosides and/or potential diuretics. In such cases, renal function should be monitored.

As with other antibiotics, the prolonged use of cefpodoxime may result in the overgrowth of non-susceptible organisms (Candida and Clostridium difficile), which may require interruption of treatment.  

 

Pack: box containing a glass bottle of 50 ml containing dry powder for oral suspension

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