cefdinir and Diarrhea

Short-course therapy for acute otitis media (AOM) improves adherence and may reduce secondary bacterial resistance.. In this multicenter, prospective, investigator-blinded study, patients between the ages of 6 months and 6 years with a clinical diagnosis of AOM were randomized to receive cefdinir oral suspension 7 mg/kg q12h for 5 days or azithromycin oral suspension 10 mg/kg once daily on day 1 and 5 mg/kg once daily on days 2 through 5. Clinical response was assessed at the end-of-therapy (EOT) visit (days 7-9) and the follow-up visit (days 20-25).. Three hundred fifty-seven patients were enrolled in the study. The treatment groups were similar at baseline with respect to demographic characteristics (mean [SD] age, 3.0 [1.7] years; 55% male), incidence of bilateral AOM (45%), and presenting signs and symptoms. The majority of evaluable children (77%) had previously received conjugated heptavalent pneumococcal vaccine (PCV7) against Streptococcus pneumoniae. At the EOT visit, clinical cure rates were comparable for cefdinir and azithromycin (87% [151/174] and 85% [149/176], respectively; 95% CI, -5.5 to 9.8). In addition, clinical cure rates at the EOT visit in the children who had been vaccinated with PCV7 were comparable between cefdinir and azithromycin (86% vs 83%; 95% CI, -6.5 to 11.8). No significant difference in clinical cure rates was observed at the follow-up visit (76% and 86%; 95% CI, -18.9 to 0.0). Parental satisfaction was similar between treatment groups with regard to ease of use, taste, compliance, health care resource utilization, and missed days of work and day-care. Both antibiotics were well tolerated; diarrhea and abnormal stools were the most common antibiotic-related adverse events (< or = 7% each).. Short courses (5 days) of therapy with cefdinir or azithromycin were comparable in these children with AOM based on clinical end points, parental preferences, and health care utilization.

Topics: Acoustic Impedance Tests; Acute Disease; Administration, Oral; Analgesics; Analgesics, Non-Narcotic; Anti-Infective Agents; Anti-Inflammatory Agents; Azithromycin; Cefdinir; Cephalosporins; Child, Preschool; Diarrhea; Drug Administration Schedule; Female; Heptavalent Pneumococcal Conjugate Vaccine; Humans; Male; Meningococcal Vaccines; Otitis Media; Pneumococcal Vaccines; Prospective Studies; Single-Blind Method; Streptococcus pneumoniae; Time Factors; Treatment Outcome; Tympanic Membrane

An investigator-blinded, randomized, multicenter study was conducted to compare the efficacy and safety of cefdinir and amoxicillin/clavulanate (amoxicillin/CA) in the treatment of pediatric patients with acute suppurative otitis media. Patients 6 months to 12 years of age were randomized in a 1:1:1 ratio to receive cefdinir 14 mg/kg once-daily, cefdinir 7 mg/kg b.i.d., or amoxicillin/CA 13.3 mg/kg t.i.d. Test-of-cure was determined 11 to 16 days post therapy. Of the 752 patients who entered the study, 665 (88%) completed treatment and 595 (79%) were evaluable. Response rates in the three treatment groups were similar. Overall rates of adverse events were statistically lower in the cefdinir once-daily group than in the amoxicillin/CA group. Diarrhea was the most common adverse event in all treatment groups. Cefdinir given either once-daily or twice-daily is a safe and effective treatment for pediatric patients with acute suppurative otitis media.

Topics: Amoxicillin; Anti-Bacterial Agents; Cefdinir; Cephalosporins; Child; Child, Preschool; Clavulanic Acid; Clavulanic Acids; Diarrhea; Female; Humans; Infant; Male; Otitis Media, Suppurative; Penicillins

Topics: Administration, Oral; Adult; Antacids; Anti-Infective Agents; Candidiasis, Vulvovaginal; Cefdinir; Cephalosporins; Child; Child, Preschool; Controlled Clinical Trials as Topic; Diarrhea; Dose-Response Relationship, Drug; Drug Interactions; Fees, Pharmaceutical; Female; Humans; Iron