ISOCEF ® Ceftibuten

ISOCEF ® 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

Indications ISOCEF ® Ceftibuten

ISOCEF ® is used in the clinical field in the treatment of respiratory and urinary tract infections, sustained by microorganisms sensitive to cephalosporins.

Mechanism of action ISOCEF ® Ceftibuten

ISOCEF ® is an antibiotic widely used in the clinical setting, given the high efficacy demonstrated even against microorganisms generally resistant to penicillins and the ease of use guaranteed by the possibility of using oral administration.

In fact, ceftibuten is an active ingredient belonging to the class of third generation semi-synthetic cephalosporins, whose chemical structure gives it a natural resistance to gastric acidity, such as to allow it to be taken orally.

Absorbed at the intestinal level, the ceftibuten reaches the maximum plasma concentration in about 2-3 hours, subsequently distributing itself among all the biological fluids, where permeating the biological membranes, with the exception of the blood-brain barrier, carries out its therapeutic action.

Like other beta-lactams, ceftibuten also exerts its bactericidal activity, compromising the stability of the bacterial wall, reducing the formation of cross-linking between the peptidoglycan molecules and thus facilitating the lysis of the microorganism by osmotic shock.

After its therapeutic action, which we remember effectively against a wide spectrum of both Gram positive and negative microorganisms, ceftibuten is eliminated unchanged mainly through urine.

Studies carried out and clinical efficacy

1. THE EFFECTIVENESS OF CEFTIBUTEN IN THE TREATMENT OF PYTHONES

J Med Assoc Thai. 2001 Jun; 84 Suppl 1: S61-7.

Oral ceftibuten therapy was effective and safe in the treatment of pyelonephritis in pediatric age, significantly reducing the period of hospitalization and related health costs.

2 . EFFICACY AND SAFETY OF CEFTIBUTEN IN THE TREATMENT OF ACUTE SINUSITIS

Chemotherapy. 1997 Sep-Oct; 43 (5): 352-7.

Work that demonstrates how treatment with ceftibuten for acute sinusitis of bacterial origin, may be as effective as therapy with amoxicillin / clavulanic acid, but is however endowed with better tolerability.

3. PHARMACOCINETIC PROPERTIES OF CEFTIBUTEN

Chemotherapy. 1995 Jul-Aug; 41 (4): 229-33.

Interesting pharmacokinetic study that demonstrates how the oral intake of ceftibuten can guarantee the achievement of antibiotic concentrations in bronchial secretions, such as to effectively carry out its own therapeutic action.

Method of use and dosage

ISOCEF ®

400 mg capsules of ceftibuten;

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

Treatment with 400 mg of ceftibuten daily is generally well tolerated and effective against most of the microorganisms responsible for respiratory and urinary tract infections.

The daily dose could be taken in a single dose or divided into two administrations every 12 hours.

An adjustment of the dosage would also be necessary in pediatric and geriatric patients during renal diseases such as to reduce their clearance.

The entire treatment should always be supervised by your doctor.

Warnings ISOCEF ® Ceftibuten

Antibiotic therapy with ISOCEF ® should be preceded by a careful medical examination to assess the possible presence of conditions incompatible with the administration of cephalosporins and the cultural isolation of the microorganism with consequent sensitivity test to cephalosporins (antibiogram).

These measures are important to limit the spread of microorganisms resistant to antibiotic therapy.

Particular caution should also be reserved for elderly patients or those suffering from renal diseases, given the increased susceptibility to side effects of antibiotic therapy.

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

ISOCEF ® 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 use of ISOCEF ® during pregnancy and in the subsequent period of breastfeeding, should be reserved for cases of real need and always take place under strict specialist medical supervision.

These precautions are linked to the absence of clinical trials able to characterize the safety profile of the drug for fetal health.

Interactions

The intake of ISOCEF ® is generally free from drug interactions capable of altering the pharmacokinetic and pharmacodynamic characteristics of its active ingredient.

However, it would be useful to remember that the presence of food in the gastro-intestinal environment could slow the systemic absorption of ceftibuten by delaying the appearance of the related therapeutic effects.

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

Contraindications ISOCEF ® Ceftibuten

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

Undesirable effects - Side effects

Although oral cephalosporin therapy is generally well tolerated and free of any clinically relevant side effects, various studies and clinical experience have frequently reported adverse reactions such as nausea, diarrhea, dyspepsia, abdominal pain, headache and dizziness.

Only rarely, and generally following long-lasting therapies, have leukopenia, thrombocytosis, anemia, hypertransaminasemia, hyperbilirubinemia, edema, bronchospasm, laryngospasm, dermatological reactions and in more severe cases also systemic anaphylaxis.

The risk of developing these latter reactions is significantly higher in atopic patients or with hypersensitivity to antibiotics.