Ceftibuten (Cedax) is indicated for the treatment of the following infections induced when the strains microorganisms were susceptible:
- Infections of the upper respiratory tract, including the following specific infections: pharyngitis, tonsillitis, scarlet fever in adults and/or children, acute sinusitis in adults, otitis media in children.
- Infections of the lower respiratory tract in adults, including acute exacerbation of chronic bronchitis and pneumonia in patients in whom oral therapy is appropriate
- Urinary tract infection in adults and children, complicated and uncomplicated.
Dosage and administration
As with other oral antibiotic therapy generally takes 5 to 10 days. For the treatment of infections caused by the bacterium Streptococcus pyogenes, ceftibuten (Cedax) therapeutic dose should be administered at least 10 days.
The recommended daily dose is 400 mg of ceftibuten (Cedax). For the treatment of the following indications of 400 mg taken once a day: acute bacterial sinusitis, acute exacerbations of chronic bronchitis and complicated or uncomplicated urinary pathways. For the treatment of pneumonia in patients where oral therapy is appropriate, and in which exist non hospital infection, recommended daily dose is 200 mg every 12 hours.
The recommended dose is 9 mg/kg/day (maximum 400 mg/day) of an oral suspension. The above dose is taken once a day for the treatment of the following indications: pharyngitis, with or without tonsillitis, acute otitis media with discharge and complicated or uncomplicated urinary pathways. Children heavier than 45 kg or older than 10 years may receive doses recommended for adults.
Special groups of patients
Adult patients with renal impairment
Renal impairment does not affect the pharmacokinetics of ceftibuten (Cedax) so that it would be necessary to adjust the dose. If creatinine clearance were not lower than 50 ml / min. If a dose adjustment is carried out by changing the frequency of the medicine administration of the medicine , the dose of 400 mg ceftibuten (Cedax) can be given to patients with creatinine clearance 30-49 ml/min every 48h (every 2 days), and patients with creatinine clearance 5-29 ml/min every 96h (every 4 days). Patients who are on hemodialysis, hemodialysis is carried out 2-3 times a week, a single dose of ceftibuten (Cedax) of 400 mg may be administered at the end of each dialysis.
In this group of patients can be used as in the usual dosage for adults.
Method of application
Ceftibuten (Cedax) suspension should be taken 1-2 hours before or after meals.
Warning and precautions
Ceftibuten (Cedax) is contraindicated in patients who are known to be allergic to cephalosporin such as: cefaclor (Raniclor), cefadroxil (Duricef), cefazolin (Ancef), cefdinir (Omnicef), cefditoren (Spectracef), cefpodoxime (Vantin), cefprozil (Cefzil), cefuroxime (Ceftin), cephalexin (Keflex), cephradine (Velosef). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase failure should not take this medicine. In patients with renal impairment and in patients on dialysis may be necessary adjust the dose of ceftibuten (Cedax). Ceftibuten (Cedax) are easily dialyzed. Dialysis patients should be carefully monitored, and ceftibuten (Cedax) administered immediately following dialysis. Ceftibuten (Cedax) should be administered with caution to persons with a complicated history of gastrointestinal disease, especially chronic colitis.Cephalosporin antibiotic should be applied with particular caution in patients with known or suspected allergy to penicillin. Approximately 5 % of patients with an allergy to penicillin determined shows a crossover hypersensitivity to cephalosporin antibiotics. Severe acute hypersensitivity reactions (anaphylactic reactions) have been reported in patients treated with penicillin in patients who received cephalosporin, and there have been cross-linked hypersensitivity reactions with anaphylaxis. In the case of development of allergic reactions to ceftibuten (Cedax) should stop taking the medicine and to implement appropriate treatment. Severe anaphylaxis requires appropriate emergency treatment as clinically indicated. During the therapy with ceftibuten (Cedax) and other broad-spectrum antibiotics changes in the intestinal flora can lead to diarrhea associated with antibiotic administration, including pseudomembranous colitis caused by a Clostridium difficile toxin. Diarrhea may occur during or after the uptake of antibiotics, and the severity may be mild to severe or life-threatening, with or without dehydration. It is important on how to take care of every patient who is known to have persistent diarrhea while taking ceftibuten (Cedax) or any other broad-spectrum antibiotics.
Use with other medicine (Interaction)
Cedax interaction studies were carried out with the following medicines:
- Antacids that contain aluminum or magnesium hydroxide in a high dose, ranitidine and intravenously applied theophylline. There were no significant interactions with this medicines. Ceftibuten (Cedax) effect on plasma levels of theophylline or pharmacokinetics that administered orally is not known. Other significant reaction with the medication have not been known.
- Cephalosporins, including ceftibuten (Cedax), can rarely reduce the prothrombotic activity of which leads to the prolonging the prothrombin time, particularly in patients with oral pre-stabilized anticoagulants. At-risk patients should accompany prothrombin time or International Normalized Ratio (INR) and, if required to give vitamin K. There have not been reported significant interactions with other medicines.
- There are no known interactions of chemical or laboratory tests with ceftibuten (Cedax). When treating with other cephalosporins there have been reported false positive results of direct Coombs test. However, test results of the red blood cells of healthy humans to determine the direct Coombs reaction in vitro do not show a positive reaction even at concentrations of 40 mg/ml.
The speed and amount of absorption of ceftibute (Cedax) suspensions can be changed as a result of the simultaneous intake food.
Pregnancy and lactation
There are not conducted adequate testing on pregnant women. Considering that studies in animals indicate no direct or indirect adverse effects associated with pregnancy, embryonal/fetal development, parturition or postnatal development, the use of ceftibuten (Cedax) during pregnancy recommended only if the potential benefit outweighs the possible risk to the fetus. Ceftibuten (Cedax) is not found in the milk of nursing mothers.
Effects on ability to drive and use machines
The medicine has no effect on the ability to drive and use machines.
In clinical trials conducted in approximately 3000 patients most frequently reported adverse events were nausea (3%), diarrhea (3%), and headache (2%). Within each organ system side effects are classified according to frequency of occurrence of the following categories: Common (>= 1/100 to <1/10), uncommon (>= 1/1000 <1/100), rare (>= 1/10, 000 to < 1/1, 000) and very rare (<1/10, 000).
Rare: transient increase in AST (SGOT), ALT (SGPT) and LDH. Adverse reactions and clinically significant laboratory abnormalities that occur in the application cephalosporin antibiotics, have been reported after putting ceftibuten (Cedax) on the market, including infections and infestations: superimposed infection; disorders of the immune system: allergic reactions, including anaphylaxis, bronchospasm, dyspnea, rash, urticaria, photosensitive reaction, pruritus, angioneurotic edema, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis; gastrointestinal disorders: severe diarrhea, colitis associated with the use of antibiotics, including pseudomembranous colitis;
Blood and lymphatic system
Prolonged prothrombin time/INR. In the application of cephalosporin antibiotics have been reported: aplastic anemia, hemolytic anemia, hemorrhage, renal failure, toxic nephropathy, elevated bilirubin, direct positive Coombs test, glucosuria, pancytopenia, neutropenia and agranulocytosis. There are possibility that these side effects occur with the application of ceftibuten (Cedax).
In case of accidental overdose ceftibuten (Cedax) not observed toxic manifestations. Since there is no specific antidote, it can be done gastric lavage. A significant amount of ceftibuten (Cedax) can remove from the circulation by hemodialysis. It was not established whether the ceftibuten (Cedax) effectively removed from the circulation by peritoneal dialysis. In healthy adult volunteers who received a single dose of up to 2 g of ceftibuten (Cedax) not observed serious adverse events, and all clinical and laboratory findings were within normal limits.