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Worldwide safety experience with ceftibuten pediatric suspension
1Schering-Plough Research Institute, Kenilworth, NJ 07033, USA.
Insights
Ceftibuten suspension, a once-daily antibiotic for children, showed a low incidence of adverse events like diarrhea and vomiting. Treatment discontinuation due to side effects was rare, indicating good tolerability in pediatric patients.
Area of Science:
- Pediatric Pharmacology
- Infectious Diseases
- Clinical Therapeutics
Background:
- Ceftibuten is a third-generation cephalosporin antibiotic used for bacterial infections.
- Pediatric dosing and safety profiles require specific evaluation.
Purpose of the Study:
- To assess the safety and tolerability of ceftibuten suspension in pediatric patients.
- To document adverse experiences associated with ceftibuten treatment in children.
Main Methods:
- A total of 1312 pediatric patients received ceftibuten suspension (9 mg/kg once daily, max 400 mg).
- Adverse experiences were collected via voluntary reports and elicited data from 1152 and 160 patients, respectively.
- Patients were treated for conditions including otitis media and pharyngitis.
Main Results:
- 10% of patients reported adverse experiences; diarrhea (3-9%) and vomiting (2-3%) were most common.
- Treatment discontinuation due to adverse events occurred in only 0.9% of patients.
- No serious adverse events like Stevens-Johnson syndrome or toxic epidermal necrolysis were observed.
Conclusions:
- Ceftibuten suspension demonstrated a favorable safety profile in pediatric patients.
- The antibiotic is generally well-tolerated, with low rates of adverse events and treatment discontinuation.
Abstract:
Ceftibuten suspension was administered to 1312 pediatric patients in clinical trials at a dosage of 9 mg/kg once daily, with a maximal daily dose of 400 mg. Adverse experiences were collected by voluntary reports by physicians from direct observations, parental and/or patient complaints in 1152 patients. In 160 patients gastrointestinal adverse experiences were elicited at each visit in addition to voluntary reports. Patients had a mean age of 4.9 years, the male: female ratio was 1:1 and 72% were white. Fifty-five percent (719 of 1312) of patients were treated in otitis media studies, 33% (438 of 1312) were treated in a pharyngitis study and 12% (155 of 1312) were treated in other studies. Adverse experiences occurred in 10% (138 of 1312) of all patients receiving ceftibuten suspension. The most common voluntarily reported treatment-related adverse events were diarrhea 3% (34 of 1152) and vomiting 2% (22 of 1152). For elicited adverse events related to treatment, the most common were also diarrhea 9% (14 of 160) and vomiting 3% (5 of 160). There were no deaths and only 0.9% (12 of 1312) patients discontinued treatment because of adverse events. Abnormal laboratory values related to therapy were uncommon and no patient discontinued treatment because of abnormal laboratory values. No cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, serum sickness-like reactions or pseudomembranous colitis have been observed with ceftibuten suspension in research studies to date.(ABSTRACT TRUNCATED AT 250 WORDS)