Cefdinir (Page 7 of 8)
HOW SUPPLIED
Cefdinir for Oral Suspension, USP 125 mg/5 mL is a off-white to yellowish — white colored granular powder, on constitution with water, forming an off-white to yellowish-white colored suspension with strawberry and cream flavors.
60 mL Bottle NDC 65862-218-60
100 mL Bottle NDC 65862-218-01
Cefdinir for Oral Suspension, USP 250 mg/5 mL is a off-white to yellowish — white colored granular powder, on constitution with water, forming an off-white to yellowish-white colored suspension with strawberry and cream flavors.
60 mL Bottle NDC 65862-219-60
100 mL Bottle NDC 65862-219-01
Store dry powder at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Once reconstituted, the oral suspension can be stored at controlled room temperature for 10 days.
CLINICAL STUDIES
Community-Acquired Bacterial Pneumonia
In a controlled, double-blind study in adults and adolescents conducted in the U.S., cefdinir BID was compared with cefaclor 500 mg TID. Using strict evaluability and microbiologic/clinical response criteria 6 to 14 days posttherapy, the following clinical cure rates, presumptive microbiologic eradication rates, and statistical outcomes were obtained:
Cefdinir BID | Cefaclor TID | Outcome | |
Clinical Cure Rates | 150/187 (80%) | 147/186 (79%) | Cefdinir equivalent to control |
Eradication Rates | |||
Overall | 177/195 (91%) | 184/200 (92%) | Cefdinir equivalent to control |
S. pneumoniae | 31/31 (100%) | 35/35 (100%) | |
H. influenzae | 55/65 (85%) | 60/72 (83%) | |
M. catarrhalis | 10/10 (100%) | 11/11 (100%) | |
H. parainfluenzae | 81/89 (91%) | 78/82 (95%) |
In a second controlled, investigator-blind study in adults and adolescents conducted primarily in Europe, cefdinir BID was compared with amoxicillin/clavulanate 500/125 mg TID. Using strict evaluability and clinical response criteria 6 to 14 days posttherapy, the following clinical cure rates, presumptive microbiologic eradication rates, and statistical outcomes were obtained:
Cefdinir BID | Amoxicillin/ Clavulanate TID | Outcome | |
Clinical Cure Rates | 83/104 (80%) | 86/97(89%) | Cefdinir not equivalent to control |
Eradication Rates | |||
Overall | 85/96 (89%) | 84/90 (93%) | Cefdinir equivalent to control |
S. pneumoniae | 42/44 (95%) | 43/44 (98%) | |
H. influenzae | 26/35 (74%) | 21/26 (81%) | |
M. catarrhalis | 6/6 (100%) | 8/8 (100%) | |
H. parainfluenzae | 11/11 (100%) | 12/12 (100%) |
Streptococcal Pharyngitis/Tonsillitis
In four controlled studies conducted in the United States, cefdinir was compared with 10 days of penicillin in adult, adolescent, and pediatric patients. Two studies (one in adults and adolescents, the other in pediatric patients) compared 10 days of cefdinir QD or BID to penicillin 250 mg or 10 mg/kg QID. Using strict evaluability and microbiologic/clinical response criteria 5 to 10 days posttherapy, the following clinical cure rates, microbiologic eradication rates, and statistical outcomes were obtained:
Study | Efficacy Parameter | Cefdinir QD | Cefdinir BID | Penicillin QID | Outcome |
Adults/ Adolescents | Eradication of S. pyogenes | 192/210 (91%) | 199/217 (92%) | 181/217 (83%) | Cefdinir superior to control |
Clinical Cure Rates | 199/210 (95%) | 209/217 (96%) | 193/217 (89%) | Cefdinir superior to control | |
Pediatric Patients | Eradication of S. pyogenes | 215/228 (94%) | 214/227 (94%) | 159/227 (70%) | Cefdinir superior to control |
Clinical Cure Rates | 222/228 (97%) | 218/227 (96%) | 196/227 (86%) | Cefdinir superior to control |
Two studies (one in adults and adolescents, the other in pediatric patients) compared 5 days of cefdinir BID to 10 days of penicillin 250 mg or 10 mg/kg QID. Using strict evaluability and microbiologic/clinical response criteria 4 to 10 days posttherapy, the following clinical cure rates, microbiologic eradication rates, and statistical outcomes were obtained:
Study | Efficacy Parameter | Cefdinir BID | Penicillin QID | Outcome |
Adults/ Adolescents | Eradication of S. pyogenes | 193/218 (89%) | 176/214 (82%) | Cefdinir equivalent to control |
Clinical Cure Rates | 194/218 (89%) | 181/214 (85%) | Cefdinir equivalent to control | |
Pediatric Patients | Eradication of S. pyogenes | 176/196 (90%) | 135/193 (70%) | Cefdinir superior to control |
Clinical Cure Rates | 179/196 (91%) | 173/193 (90%) | Cefdinir equivalent to control |
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