cefdinir and Pharyngitis

Topics: Acute Disease; Administration, Oral; Cefdinir; Cephalosporins; Child; Child, Preschool; Humans; Infant; Otitis Media; Pharyngitis; Streptococcal Infections; Streptococcus pyogenes

The clinical efficacy and safety of clarithromycin (CAM) and cefdinir (CFDN) were evaluated in 65 pediatric outpatients with group A beta-hemolytic streptococcal tonsillopharyngitis. Treatment was "effective" or better in 26 (78.8%) children receiving CAM and in 27 (87.1%) receiving CFDN based on antigen clearance and the "Criteria for Evaluation in Clinical Trials of Antibacterial Agents in Children" proposed by Japan Society of Chemotherapy (p = NS). The causative organisms were eradicated in 94.7% and 93.8% of subjects in the CAM and CFDN groups, respectively (p = NS). Adverse drug reactions were limited to moderate diarrhea in one patient in each group, and subsided during treatment. Causative organisms exhibited good susceptibility to CAM and CFDN. These results suggest excellent efficacy, safety and usefulness of CAM and CFDN in the treatment of group A beta-hemolytic streptococcal tonsillopharyngitsis in children.

Topics: Administration, Oral; Anti-Bacterial Agents; Cefdinir; Cephalosporins; Child; Child, Preschool; Clarithromycin; Drug Administration Schedule; Drug Evaluation; Humans; Pharyngitis; Streptococcal Infections; Streptococcus pyogenes; Tonsillitis

Patients with acute exacerbations of chronic bronchitis were treated with cefdinir 300 mg bd for 5 days or cefprozil 500 mg bd for 10 days in a prospective, randomized, double-blind, multicentre study. Of the 548 patients enrolled, 281 (51%) were evaluable. The clinical cure rates at the test-of-cure visit were 80% (114/142) and 72% (100/139) for the evaluable patients treated with cefdinir and cefprozil, respectively. Respiratory tract pathogens were isolated from 409 (75%) of 548 admission sputum specimens, with the predominant pathogens being Haemophilus parainfluenzae, Haemophilus influenzae, Staphylococcus aureus and Moraxella catarrhalis. The microbiological eradication rates at the test-of-cure visit were 81% (157 of 193 pathogens) and 84% (166 of 198 pathogens) for the evaluable patients treated with cefdinir and cefprozil, respectively. Adverse event rates while on treatment were equivalent between the two treatment groups. The incidence of diarrhoea during therapy was higher for patients treated with cefdinir (17%) than for patients treated with cefprozil (6%) (P < 0.01), but most cases were mild and did not lead to discontinuation of treatment. These results indicate that a 5 day regimen of cefdinir is as effective and safe in the treatment of patients with acute exacerbations of chronic bronchitis as a 10 day regimen of cefprozil.

Topics: Acute Disease; Adolescent; Adult; Aged; Anti-Infective Agents; Bronchitis; Cefdinir; Cefprozil; Cephalosporins; Child; Chronic Disease; Double-Blind Method; Female; Humans; Male; Middle Aged; Patient Compliance; Pharyngitis; Prospective Studies; Tonsillitis

Group A beta-hemolytic streptococcal (GABHS) tonsillopharyngitis continues to be a prevalent pediatric infectious disease that requires prompt treatment for relief of symptoms and to prevent complications.. To compare the efficacy/tolerability of cefdinir and penicillin V in the treatment of pediatric GABHS tonsillopharyngitis as demonstrated in two clinical trials of similar design.. Multicenter, randomized, investigator-blinded trials.. Children < or =12 years of age with sore throat, pharyngeal erythema and positive rapid streptococcal antigen test results.. In Study A patients took cefdinir 7 mg/kg twice daily or 14 mg/kg once daily or penicillin V 10 mg/kg 4 times daily (all regimens for 10 days). In Study B patients took cefdinir 7 mg/kg twice daily for 5 days or penicillin V 10 mg/kg 4 times daily for 10 days.. Clinical and microbiologic evaluations were conducted at multiple times during and after therapy.. Of 1274 patients 1122 were evaluable (679 patients received cefdinir; 443 received penicillin V). Clinical cure and microbiologic eradication rates were superior in the combined cefdinir treatment groups (94.9 and 92.7%, respectively), whether given once or twice daily for 10 days or twice daily for 5 days, compared with the penicillin treatment group (88.5 and 70.9%, respectively; P<0.001 for both). Adverse event rates were comparable in the 2 groups.. Cefdinir is a reliable and well-tolerated drug for the management of GABHS tonsillopharyngitis in children.

Topics: Cefdinir; Cephalosporins; Child; Child, Preschool; Female; Humans; Male; Penicillin V; Penicillins; Pharyngitis; Streptococcal Infections; Streptococcus pyogenes; Tonsillitis; Treatment Outcome

This multicenter, randomized, controlled, investigator-masked study was performed to assess the efficacy and tolerability of cefdinir for the treatment of streptococcal pharyngitis. Children aged 1 through 12 years with signs and symptoms of pharyngitis and a positive result on a rapid screening test for Streptococcus pyogenes were randomly assigned to receive cefdinir 14 mg/kg QD, cefdinir 7 mg/kg BID, or penicillin V 10 mg/kg 4 times daily for 10 days. Seven hundred ninety-two patients were enrolled, and 682 were clinically and microbiologically assessable. All treatment groups had similar demographic characteristics (-50.0% male, predominantly white, median age 7 years). The eradication rates of S pyogenes, determined 4 to 9 days after completion of therapy, were 94.3% in the cefdinir QD group, 94.3% in the cefdinir BID group, and 70.0% in the penicillin V group (95% confidence interval [CI] 17.6%-30.9%, P < 0.001 for cefdinir QD vs penicillin; CI 17.5%-30.9%, P < 0.001 for cefdinir BID vs penicillin). Clinical cure rates were 97.4%, 96.0%, and 86.3% for the cefdinir QD, cefdinir BID, and penicillin groups, respectively (CI 6.1%-15.9%, P = 0.001 for cefdinir QD vs penicillin; CI 4.6%-14.8%, P = 0.001 for cefdinir BID vs penicillin). Adverse reactions occurred in 8.3%, 8.7%, and 7.6% of cefdinir QD, cefdinir BID, and penicillin patients, respectively (P = NS). Treatment with cefdinir, either QD or BID, was associated with higher eradication rates of S pyogenes and higher clinical cure rates. Both cefdinir and penicillin were well tolerated. Three patients, 1 receiving cefdinir BID and 2 receiving penicillin, discontinued the study drug because of adverse reactions.

Topics: Anti-Bacterial Agents; Cefdinir; Cephalosporins; Child; Child, Preschool; Female; Humans; Infant; Male; Penicillins; Pharyngitis; Streptococcal Infections; Streptococcus pyogenes

Cefdinir, an oral cephalosporin active against Streptococcus pyogenes (group A beta-hemolytic streptococci [GABHS]), is also resistant to degradation by most oropharyngeal beta-lactamases. This multicenter, randomized, controlled, double-masked study assessed the tolerability and efficacy of 2 dosing regimens of cefdinir in the treatment of pharyngitis due to GABHS. Adults and adolescents with pharyngitis due to GABHS received cefdinir 600 mg QD, cefdinir 300 mg BID, or penicillin V 250 mg QID each for 10 days. A throat culture and clinical assessment were obtained 4 to 9 days after completion of therapy. Of 919 patients enrolled, 644 (70.1%) were microbiologically assessable. The eradication rates 4 to 9 days after completion of therapy were 91.4% in the cefdinir QD group, 91.7% in the cefdinir BID group, and 83.4% in the penicillin group (P = 0.02 for cefdinir QD vs penicillin, P = 0.01 for cefdinir BID vs penicillin, P = 0.95 for cefdinir QD vs cefdinir BID). Clinical cure rates were also superior with cefdinir QD (94.8%, P = 0.02) and cefdinir BID (96.3%, P < 0.01) compared with penicillin (88.9%). Diarrhea was more common in the cefdinir groups (P < 0.001). Seventeen cefdinir patients and 4 penicillin patients discontinued therapy because of adverse reaction (P = 0.13). Ten days of treatment for streptococcal pharyngitis with cefdinir QD or BID is superior to treatment with penicillin V for the eradication of GABHS from the pharynx, although it is associated with a higher rate of adverse reactions.

Topics: Administration, Oral; Adolescent; Adult; Aged; Anti-Bacterial Agents; Cefdinir; Cephalosporins; Child; Double-Blind Method; Female; Humans; Male; Middle Aged; Penicillin V; Penicillins; Pharyngitis; Streptococcal Infections; Streptococcus pyogenes; Treatment Outcome

A multicenter, randomized, controlled, investigator-blind study was performed to evaluate the safety and efficacy of oral cefdinir versus oral penicillin V for the treatment of pharyngitis due to group A beta-hemolytic streptococci (GABHS). Patients 13 years of age and older were randomized to receive either oral cefdinir (300 mg twice a day) for 5 days followed by placebo for 5 days or oral penicillin V (250 mg four times a day) for 10 days. Throat cultures were obtained, and signs and symptoms of pharyngitis were recorded at study admission and follow-up visits on study days 11 to 15, 16 to 20, and 25 to 31. Patients kept a diary to record medication intake and their assessment of throat pain at admission and at each day of study treatment. Five hundred fifty-eight patients were enrolled, of whom 432 (77.4%) were clinically and microbiologically evaluable. The GABHS eradication rates 5 to 10 days after completion of therapy were 193 of 218 (88.5%) in the cefdinir group and 176 of 214 (82.2%) in the penicillin group (P = 0.053). Clinical cure rates were 89.0 and 84.6%, respectively (P = 0.80). By the time of the long-term follow-up visit, 2 to 3 weeks after completion of treatment, 156 of 191 (81.7%) of the assessable cefdinir patients and 152 of 195 (77.9%) of the penicillin patients remained free of GABHS. Both treatments were well tolerated, with adverse reaction rates of 18.3% in the cefdinir study arm and 15.0% in the penicillin study arm (P = 0.278). Five-day treatment with cefdinir is safe and effective therapy for GABHS pharyngitis. Based on its twice-a-day dosage and shorter course of therapy, leading to potentially greater patient compliance, cefdinir may be considered for use in the treatment of pharyngitis caused by GABHS.

Topics: Administration, Oral; Adolescent; Adult; Aged; Cefdinir; Cephalosporins; Double-Blind Method; Female; Humans; Male; Middle Aged; Pharyngitis; Streptococcal Infections; Streptococcus pyogenes

To compare the safety and efficacy of a 5-day regimen of cefdinir with those a conventional 10-day regimen of penicillin V for the treatment of streptococcal pharyngitis in children.. Investigator-blind, randomized controlled trial.. Primary care, ambulatory.. Children aged 1 to 12 years with signs and symptoms of pharyngitis and a positive result on a rapid screening test for Streptococcus pyogenes (ie, a convenience sample). Four hundred eighty-two patients were enrolled in the study, and 440 were clinically and microbiologically evaluable. The most common reasons patients were nonevaluable were failure to return for specified visits and noncompliance with the administration of the medication; 2 patients receiving penicillin V discontinued use of the drug because of adverse events.. Patients were randomized to receive either 7-mg/kg cefdinir, twice daily, for 5 days or 10-mg/kg penicillin V potassium, 4 times daily, for 10 days.. The eradication of S pyogenes and the clinical cure of the signs and symptoms of pharyngitis, both determined 5 to 10 days after the completion of therapy.. Streptococcus pyogenes was eradicated in 201 (90%) of the 224 patients receiving cefdinir and 155 (72%) of the 216 patients receiving penicillin V (95% confidence interval [CI], 10.7%-25.1%; P < .001). The clinical cure rates were 92% and 91% in the groups receiving cefdinir and penicillin V, respectively (95% CI, -4.5% to 6.1%; P = .80). Adverse events, regardless of the opinion of the investigator about their relationship to the study medication, occurred in 12.5% of the patients receiving cefdinir and 13.6% of the patients receiving penicillin V (P = .69).. A 5-day regimen of cefdinir eradicated a higher proportion of S pyogenes than a 10-day regimen of penicillin V. No difference was noted between the regimens for clinical outcomes or adverse event rates.

Topics: Adolescent; Ambulatory Care; Cefdinir; Cephalosporins; Child; Child, Preschool; Drug Administration Schedule; Female; Humans; Infant; Male; Office Visits; Pharyngitis; Primary Health Care; Single-Blind Method; Streptococcal Infections; Streptococcus pyogenes; Treatment Outcome; Treatment Refusal

Cephalosporins were found to be more effective than penicillins in the eradication of group A beta-hemolytic streptococcal (GABHS) from tonsillar tissues. This study investigated the effect of amoxicillin and cefdinir therapies on the rate of eradication of GABHS from the tonsils of children with acute pharyngo-tonsillitis (PT).. Of 50 children suffering from PT 25 were treated with amoxicillin (40 mg/(kg d) or 250 mg every 8 h) and 25 with cefdinir (14 mg/(kg d) or 600 mg once a day) for 10 days. Pharyngo-tonsillar cultures were obtained from all children before treatment and on the 1st, 2nd, 3rd, 4th, 7th, and 12th days.. GABHS was eradicated more rapidly from children treated with cefdinir as compared to those receiving amoxicillin. A smaller number of patients with GABHS were found in those treated with cefdinir as compared to amoxicillin throughout the treatment period. Eradication of GABHS from 68% (8 of 25 patients) was noted in those treated with cefdinir after 2 days and those treated with amoxicillin after 4 days. The differences between the number of patients who had a bacteriological cure between those receiving cefdinir to those getting amoxicillin was statistical significant at day 4 (32% vs. 8%). At the end of therapy GABHS was recovered from 5 (20%) and 2 (8%) of the patients. The group that received cefdinir, had a more rapid reduction in fever on the first after initiation of therapy as compared to those receiving amoxicillin. The fever reduction in those receiving cefdinir occurred a day earlier than in those getting amoxicillin.. Fever was reduced and GABHS was eradicated more rapidly from children treated with cefdinir as compared to amoxicillin.

Topics: Acute Disease; Amoxicillin; Anti-Bacterial Agents; Cefdinir; Cephalosporins; Child; Child, Preschool; Comorbidity; Drug Therapy, Combination; Female; Fever; Hemolysis; Humans; Male; Pharyngitis; Streptococcal Infections; Streptococcus pyogenes; Time Factors; Tonsillitis

Drug-induced hepatotoxicity is well recognized but can cause some diagnostic problems, particularly if not previously reported. The present case involves a 22-year-old male who presented with jaundice and elevated liver enzymes after a course of cefdinir (Omnicef) for streptococcal pharyngitis. A diagnosis of drug-induced liver injury was suspected but a liver biopsy was required after his jaundice worsened despite cessation of the presumed offending agent. A short course of steroids was initiated and eventually the jaundice resolved. This case highlights the need to suspect medication-induced liver injury in cases of jaundice, even if not previously reported. In addition, it illustrates the potential for adverse outcomes in situations where antibiotics are used inappropriately or where first line antibiotics are not used for routine infections. We report a case of a young male who developed jaundice associated with cefdinir use with pathological confirmation of moderate cholestasis with portal and lobular mixed inflammation and focal bile duct injury consistent with drug-induced liver injury.

Topics: Anti-Bacterial Agents; Cefdinir; Cephalosporins; Chemical and Drug Induced Liver Injury; Humans; Male; Obesity, Morbid; Pharyngitis; Streptococcal Infections; Young Adult

This pooled analysis compared the clinical cure and bacterial eradication rates achieved by cefdinir and penicillin in the treatment of group A beta-hemolytic streptococcal (GABHS) pharngotonsillitis.. Data from 4 multicenter, randomized, controlled, investigator-blinded trials, 2 in children receiving oral suspensions and 2 in adults receiving capsules/tablets, were pooled and analyzed in terms of clinical cure rates, microbiologic eradication rates, and adverse events.. A total of 2751 patients were enrolled (age <13 years, n = 1274; age > or =13 years, n = 1477). Patients were randomized to receive cefdinir once daily (n = 569) or twice daily (n = 1086) for 5 or 10 days, or penicillin 4 times daily (n = 1096) for 10 days. Of the 2751 patients enrolled, 2198 were evaluable for clinical and microbiologic outcomes. Compared with the 10-day penicillin regimens, the cefdinir regimens for 5 or 10 days produced higher clinical cure and microbiologic eradication rates. Combined clinical cure rates were significantly higher for cefdinir compared with penicillin (94% vs 83%, respectively; P < 0.001). Combined microbiologic eradication rates were also significantly higher for cefdinir compared with penicillin (92% vs 77%; P < 0.001). Both cefdinir and penicillin were well tolerated, as >98% of patients completed the course of therapy.. In this pooled analysis of data from 4 multicenter, randomized, controlled, investigator-blinded trials in children and adults, 5- and 10-day regimens of cefdinir achieved significantly higher clinical cure and microbiologic eradication rates compared with 10-day penicillin regimens in the treatment of GABHS pharyngotonsillitis.

Topics: Adolescent; Adult; Anti-Infective Agents; Cefdinir; Cephalosporins; Child; Child, Preschool; Female; Humans; Infant; Male; Multicenter Studies as Topic; Penicillins; Pharyngitis; Randomized Controlled Trials as Topic; Streptococcal Infections; Streptococcus pyogenes; Tonsillitis

A total of 2865 strains of the causative organisms isolated from the patients with acute pharyngitis and tonsillitis at the primary medical institutions were used in this study. The MICs of levofloxacin (LVFX) and other oral antimicrobial drugs were determined and evaluated by the NCCLS guideline. LVFX, cefditoren (CDTR) and cefcapene (CFPN) were potently active against 773 isolates of Hemophilus influenzae, the MIC50S of LVFX being < or = 0.06 microgram/mL and also the same as the MIC90S of LVFX. LVFX was the most active against 496 isolates of Enterobacteriaceae. The MIC50S of LVFX were < or = 0.06 microgram/mL and were lower than those of CDTR, cefdinir (CFDN) and cefpodoxime (CPDX) (MIC50S: 0.5 microgram/mL). The MIC90S of these cephems were markedly higher than the respective MIC50S, whereas MIC50 of LVFX was 0.12 microgram/mL, only twice the MIC50. Against the majority of Streptococcus pyogenes (555 isolates) and Streptococcus spp. (495 isolates), CDTR, CFDN, CPDX and CFPN were highly active (MICs: < or = 0.06 microgram/mL), and clarithromycin (CAM) and azithromycin (AZM) were also active against these organisms (MICs: 0.12 to 0.25 microgram/mL). Against S. pneumoniae (92 isolates), CDTR and CFDN were active (MIC50S: 0.12 and 0.25 microgram/mL, respectively). However, the MIC90S of these drugs were 4-8 times the MIC50S. Against Moraxella (Branhamella) catarrhalis (454 isolates), LVFX was potently active, the MIC90 of LVFX being < or = 0.06 microgram/mL and MIC90S of the other cephems being 0.5 microgram/mL or more. When the susceptibility of these strains to LVFX was evaluated by the NCCLS guideline, about 3% of other Streptococcus spp. were resistant to the drug but no test strains resistant to LVFX were detected in H. influenzae, S. pyogenes or Enterobacteriaceae. On the other hand, the percentages of strains susceptible to the cephems tested were 60-90%, which were quite different according to kinds of drugs and species used. Furthermore, the strains of S. pneumoniae resistant to CFDN and CPDX, and those to CAM and AZM were 21-25% and 50% or more, respectively, whereas no LVFX-resistant strains were detected. The major pathogens isolated from patients with pharyngitis and tonsillitis in the primary institutions were highly susceptible to LVFX. These results suggest that LVFX is a useful drug which is potently active against the strains resistant to oral cephem and macrolide antibiotics.

Topics: Acute Disease; Ampicillin; Anti-Infective Agents; Azithromycin; Cefdinir; Cefpodoxime; Ceftizoxime; Cephalosporins; Clarithromycin; Enterobacteriaceae; Haemophilus influenzae; Humans; Levofloxacin; Ofloxacin; Penicillin G; Pharyngitis; Streptococcus pneumoniae; Streptococcus pyogenes; Tonsillitis

Cefdinir (CFDN) was evaluated for its efficacy and safety. The following results were obtained. 1. Pharmacokinetic study: CFDN was evaluated pharmacokinetically in 4 male children aged 9 to 13. CFDN was given orally to 3 children at a dose of 3 mg/kg. Peak plasma levels of 0.71 microgram/ml, 0.78 microgram/ml and 0.45 microgram/ml were attained in the 3 children, respectively, at 4 hours after dosing. Half-lives of CFDN in serum were 1.78 hours, 1.48 hours and 2.23 hours, respectively. The 12-hour urinary recovery rates of CFDN were 17.4%, 28.1% and 6.2%. When CFDN was given orally to the remaining child at a dose of 6 mg/kg, the peak plasma level was attained at 4 hours after dosing with a level of 1.16 micrograms/ml. T 1/2 was 1.78 hours. The 12-hour urinary recovery rate of CFDN was 15.0%. 2. Clinical study: CFDN 5 percent fine granules were given to 26 patients with infections; 2 with pneumonia, 4 with acute bronchitis, 1 with chronic bronchitis, 12 with pharyngitis, 4 with scarlet fever, 1 with otitis media and 2 with skin and soft tissue infections. Therapeutic responses were "excellent" in 15, "good" in 8, "fair" in 1 and "poor" in 2, with an efficacy rate of 88.5%. 3. Adverse reactions: As for adverse reactions, diarrhea was noted in 1 patient. It was concluded that CFDN is a useful drug for the treatment of the bacterial infections in pediatrics.

Topics: Administration, Oral; Adolescent; Age Factors; Bacterial Infections; Bronchitis; Cefdinir; Cephalosporins; Child; Drug Evaluation; Humans; Male; Pharyngitis

Cefdinir (CFDN), a newly developed oral cephalosporin in 5% fine granular form, was administered to 10 boys at 1 hour before meal (in the fasting state) and concentrations of the drug in plasma and urine and its urinary recovery rates were determined. The subjects were divided into 2 groups of 5 boys each; one group received 3 mg/kg of CFDN, and the other, 6 mg/kg. To 6 of the 10 children the drug was administered in the two different dose levels using the cross-over method. To study clinical and bacteriological effects of this drug, a mean dose of 4.6 mg/kg t.i.d. was administered for 8 days on the average to 40 children with various infections; pharyngitis (4 cases), tonsillitis (2), acute bronchitis (2), pneumonia (8), scarlet fever (6), acute purulent otitis media (1), urinary tract infection (12), impetigo (2), phlegmon (1), lymphadenitis (1) and subcutaneous abscess (1). MICs were determined for 6 drugs including CFDN, cefaclor, cefixime (CFIX), methicillin, cloxacillin (MCIPC), amoxicillin (AMPC) against 13 strains of 6 species freshly isolated from children receiving CFDN. An inoculum size of 10(6) cfu/ml was used in the MIC-determinations. Adverse reactions and abnormal laboratory findings attributable to this drug were also examined in these patients. The results obtained are summarized as follows. 1. Mean plasma peak levels of CFDN were observed at 3 hours after administration in both the 3 mg/kg and 6 mg/kg groups with mean peak values of 0.68 and 1.35 micrograms/ml, respectively. Mean half-lives were 2.06 hours in the 3 mg/kg group and 1.61 hours in the 6 mg/kg group, and mean AUCs were 3.5 in the former and 6.5 micrograms.hr/ml in the latter. Thus, dose-response between the 2 doses was observed in plasma levels and AUCs. 2. To 3 patients, CFDN was given in the two different doses using the cross-over method. Mean plasma peak levels of CFDN were 0.71 and 1.31 micrograms/ml in the doses of 3 mg/kg and 6 mg/kg, respectively. Half-lives were 1.39-2.90 hours in the 3 mg/kg group and 1.21-1.48 hours in the 6 mg/kg group, with AUCs of 3.4-3.7 and 4.1-7.5 micrograms.hr/ml, respectively.(ABSTRACT TRUNCATED AT 400 WORDS)

Topics: Administration, Oral; Age Factors; Bacteria; Bacterial Infections; Cefdinir; Cephalosporins; Child; Child, Preschool; Dosage Forms; Drug Evaluation; Drug Resistance, Microbial; Female; Humans; Infant; Male; Pharyngitis; Pneumonia; Urinary Tract Infections