CEDAX ® Ceftibuten

CEDAX ® is a Ceftibuten based drug

THERAPEUTIC GROUP: General antimicrobials for systemic use - Cephalosporins

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Directions CEDAX ® Ceftibuten

CEDAX ® is used in the treatment of bacterial infections sustained by organisms sensitive to cephalosporins.

CEDAX ® has proved particularly effective in treating respiratory and urinary tract infections.

Mechanism of action CEDAX ® Ceftibuten

The Ceftibuten, active ingredient of CEDAX ®, is an antibiotic belonging to the beta-lactam category and more precisely of the third generation semi-synthetic cephalosporins, characterized by:

Broad spectrum of action, both against Gram-positive organisms such as Staphylococci and Streptococci and Gram-negative organisms such as Neissieria, Hemophilus influenzae and Enterobacteria;
High stability against plasmid beta-lactamases, resistance enzymes produced by microorganisms capable of neutralizing the antibiotic activity of beta-lactams;
Advantageous pharmacokinetic characteristics.

In fact the Ceftibuten, taken orally, reaches the maximum plasma concentration in 2-3 hours, to be distributed subsequently to the various organs, where permeating the plasma membranes easily, it reaches concentrations similar to those present in the circulation.

At this point the active principle performs its therapeutic activity by inhibiting the transpeptidation reaction, useful for the formation of cross-linking between the peptidoglycan molecules, compromising the stability of the bacterial wall and thus causing the death of the microorganism by osmotic lysis.

Following a half-life of about 2-3 hours, ceftibuten is eliminated unchanged via the kidneys.

Studies carried out and clinical efficacy

1. THE EFFICACY OF CEFTIBUTEN IN THE TREATMENT OF INFINITIES OF URINARY TRACKS

Pediatr Nephrol. 2009 Mar; 24 (3): 521-6. Epub 2008 Sep 26.

Mårild S, Jodal U, Sandberg T.

Work demonstrating that ceftibuten is effective and safe in treating urinary tract infections in small patients, even when complicated by fever and dysuria.

2 . STRIPS OF NESSIERIA GONORREA RESISTANT TO CEFTIBUTEN

Antimicrob Agents Chemother. 2008 Oct; 52 (10): 3564-7. Epub 2008 Jul 28.

Neisseria gonorrhoeae, a causative agent of gonorrhea or blenorrhagia, has long been effectively treated with ceftibuten. In this study, however, the emergence of resistant strains characterized by the expression of genes able to extend the spectrum of antibiotic resistance also to cephalosporins is reported in the eastern population.

In order to limit the spread of these strains, non-chemotherapy prophylaxis is very important.

3. THE CEFTIBUTEN IN THE TREATMENT OF FARINGOTONSILLITI

Fortschr Med Orig. 2001 Jul 19; 119 Suppl 2: 63-70.

Very interested clinical trial which shows that ceftibuten, although effective in the treatment of pharyngotonsillitis sustained by streptococcus, is not able to reach the same eradication rate guaranteed by penicillins.

Method of use and dosage

CEDAX ®

400 mg capsules of ceftibuten;

Granules for oral suspension of 36 mg of ceftibuten per ml of solution.

In most cases the administration of 400 mg daily of ceftibuten is effective in controlling the infection ensuring prompt remission of symptoms.

The dose could be divided into two different daily intakes or taken as a single dose.

An adjustment of the doses used is necessary in pediatric and senile patients or in patients suffering from renal insufficiency.

It is also useful to remember that taking meals could delay the systemic absorption of the drug, without however changing its therapeutic efficacy.

CEDAX ® Ceftibuten warnings

Treatment with CEDAX ® should be preceded by a careful medical examination to evaluate the prescriptive appropriateness and the possible presence of conditions incompatible with antibiotic treatment.

Particular caution should be reserved for elderly patients or those suffering from renal diseases, given the increased susceptibility to adverse reactions to the antibiotic.

The possible appearance of adverse reactions of various nature, even those of a dermatological nature, should alarm the patient, who after consulting his doctor, could consider the possibility of suspending the therapy in progress.

Prolonged and disproportionate use of the antibiotic could facilitate the appearance of resistant microbial strains and simultaneously increase the risk of Clostridium difficile infection, resulting in pseudo-membranous colitis.

CEDAX ® contains sucrose, so it is not suitable for patients with fructose intolerance, saccharase-isomaltasai enzyme deficiency or glucose / galactose malabsorption syndrome.

PREGNANCY AND BREASTFEEDING

The absence of clinical trials able to characterize the therapeutic efficacy and the safety profile on the fetus of the ceftibuten, limits the use of CEDAX ® during pregnancy and in the subsequent period of breastfeeding, exclusively to cases of real need and always under strict specialist medical supervision.

Interactions

The different pharmacokinetic studies performed showed no pharmacological interactions between ceftibuten and other active ingredients worthy of relevance.

However, it would be useful to remember how the presence of food could lengthen the systemic absorption times, delaying the onset of the therapeutic effect.

Increased transaminases, prolonged prothrombin times and potentially false positivity to the direct Coombs test could be observable laboratory artifacts in patients receiving cephalosporins.

Contraindications CEDAX ® Ceftibuten

The use of CEDAX ® is contraindicated in patients hypersensitive to penicillins and cephalosporins or their excipients.

Undesirable effects - Side effects

CEDAX ® therapy was generally well tolerated and only in rare cases associated with time-limited side effects.

Nausea, diarrhea, dyspepsia, abdominal pain and headache were the most frequently documented adverse reactions whereas haematological alterations with leukopenia, thrombocytosis, anemia, hypertransaminasemia and hyperbilirubinemia were observed only in rare cases.

However, the risk of adverse events remains high in patients hypersensitive to antibiotics, which could develop haemorrhage, edema, bronchospasm, laryngospasm, dermatological reactions and in severe cases systemic anaphylaxis following CEDAX ®.