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:

Pharyngitis/Tonsillitis Studies Cefdinir (10 days) vs Penicillin (10 days)
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:

Pharyngitis/Tonsillitis Studies Cefdinir (5 days) vs Penicillin (10 days)
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

  1. 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.
  2. 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.
  3. 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.
  4. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16:31-41.
  5. 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.
  6. 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.

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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 fos USP, 125 mg/5mL
(click image for full-size original)

CEFDINIR FOR ORAL SUSPENSION USP

Rx Only

250 mg/5 mL

NDC 68180-723-20

60 mL

Cefdinir fos USP, 250 mg/5mL
(click image for full-size original)
CEFDINIR cefdinir powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-722
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFDINIR (CEFDINIR) CEFDINIR 125 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GUAR GUM
SILICON DIOXIDE
SODIUM BENZOATE
SODIUM CITRATE
STRAWBERRY
SUCROSE
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor STRAWBERRY (Strawberry) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-722-20 60 mL in 1 BOTTLE None
2 NDC:57297-722-10 100 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065259 05/01/2007
CEFDINIR cefdinir powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-723
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFDINIR (CEFDINIR) CEFDINIR 250 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GUAR GUM
SILICON DIOXIDE
SODIUM BENZOATE
SODIUM CITRATE
STRAWBERRY
SUCROSE
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor STRAWBERRY (Strawberry) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-723-20 60 mL in 1 BOTTLE None
2 NDC:57297-723-10 100 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065259 05/01/2007
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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