Cefdinir (Page 7 of 7)
Streptococcal Pharyngitis/Tonsillitis:
In four controlled studies conducted in the US, 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 |
REFERENCES
- Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard – Tenth Edition. CLSI Document M07-A10 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
- Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Twelfth Edition. CLSI Document M02-A12 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
- Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fifth Informational Supplement, CLSI Document M100-S25 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
- Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16:31-41.
- Schwartz GJ, Haycock GB, Edelmann CM, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics 1976;58:259-63.
- Schwartz GJ, Feld LG, Langford DJ. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatrics 1984;104:849-54.
Lupin Pharmaceuticals, Inc.
Baltimore, Maryland 21202
United States
Manufactured by:
Lupin Limited
Mandideep 462 046
INDIA
Clinistix® and Clinitest® are registered trademarks of Miles Diagnostics.
Tes-tape® is a registered trademark of Lilly.
Revised: February 2016 ID#: 244810
PRINCIPAL DISPLAY PANEL
CEFDINIR FOR ORAL SUSPENSION USP
Rx Only
125 mg/5 mL
NDC 68180-722-20
60 mL
CEFDINIR FOR ORAL SUSPENSION USP
Rx Only
250 mg/5 mL
NDC 68180-723-20
60 mL
CEFDINIR cefdinir powder, for suspension | ||||||||||||||||||||
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CEFDINIR cefdinir powder, for suspension | ||||||||||||||||||||
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Labeler — LUPIN LIMITED (675923163) |
Registrant — LUPIN LIMITED (675923163) |
Establishment | |||
Name | Address | ID/FEI | Operations |
LUPIN LIMITED | 725504448 | manufacture (57297-722), manufacture (57297-723), pack (57297-722), pack (57297-723) |
Revised: 05/2016 LUPIN LIMITED
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