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CEFADROXIL

STAT Rx USA LLC

Cefadroxil Capsules, USP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION


CEFADROXIL DESCRIPTION


1617352
CEFADROXIL

Cefadroxil capsules contain the following inactive ingredients: Lactose monohydrate, magnesium stearate, FD&C Blue No.1, D&C Red No.28, FD&C Red No. 40, titanium dioxide, gelatin, sodium lauryl sulphate, and edible black ink (black iron oxide).

CLINICAL PHARMACOLOGY


Microbiology


In vitroin vitro INDICATIONS AND USAGE

Beta-hemolytic streptococci

Staphylococci,
Streptococcus (Diplococcus) pneumoniae
Escherichia coli
Proteus mirabilis

Klebsiella species
Moraxella (Branhamella) catarrhalis

Note:
Enterococcus faecalisStreptococcus faecalisEnterococcus faeciumStreptococcus faeciumEnterobacterMorganella morganiiProteus morganiiP. vulgarisPseudomonasAcinetobacter calcoaceticusMimaHerellea

Susceptibility tests

Diffusion Techniques

1


   Zone diameter (mm)       Interpretation   
≥ 18
(S) Susceptible
15–17
(I) Intermediate
≤ 14
(R) Resistant




Organism    Zone Diameter (mm)   
  Staphylococcus aureus ATCC 25923   
29–37
  Escherichia coli ATCC 25922
17–22
Dilution Techniques

2

Staphylococcus aureusEscherichia coliStreptococcus faecalis

CEFADROXIL INDICATIONS AND USAGE




E. coli, P. mirabilis, Klebsiella



Streptococcus pyogenes

Note:


Note:


CEFADROXIL CONTRAINDICATIONS


WARNINGS






Clostridium difficile
C. difficile

C. difficile
C. difficile

C. difficileC. difficile

PRECAUTIONS

General


2 DOSAGE AND ADMINISTRATION





Information for Patients




Drug/Laboratory Test Interactions


Carcinogenesis, Mutagenesis, Impairment of Fertility


Pregnancy




Labor and Delivery


Nursing Mothers


Pediatric Use


DOSAGE AND ADMINISTRATION

Geriatric Use




DOSAGE AND ADMINISTRATION: Renal Impairment

CEFADROXIL ADVERSE REACTIONS

Gastrointestinal


WARNINGS

Hypersensitivity


Other








DOSAGE AND ADMINISTRATION OVERDOSAGE

OVERDOSAGE




CEFADROXIL DOSAGE AND ADMINISTRATION


Adults


Urinary Tract Infections:  



Skin and Skin Structure Infections: 


Pharyngitis and Tonsillitis: 

Children


Renal Impairment


2
   Creatinine Clearances       Dosage Interval   
 0-10 mL/min
36 hours
10-25 mL/min
24 hours
25-50 mL/min
12 hours

HOW SUPPLIED


Cefadroxil Capsules, USP 500 mg

                
              

Store at

REFERENCES


  • National Committee for Clinical Laboratory Standards, Approved Standard, Performance Standards for Antimicrobial Disk Susceptibility Test, 4th Edition. Vol. 10 (7): M2-A4, Villanova, PA, April, 1990.
  • National Committee for Clinical Laboratory Standards, Approved Standard: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, 2nd Edition, Vol. 10(8): M7-A2, Villanova, PA, April, 1990.

 



Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited


PACKAGE LABEL

CEFADROXIL 500 MG LABEL IMAGE

CEFADROXIL

CEFADROXIL

CEFADROXIL CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:16590-043(NDC:65862-085)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CEFADROXIL CEFADROXIL 500 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
MAGNESIUM STEARATE
FD&C BLUE NO. 1
D&C RED NO. 28
FD&C RED NO. 40
titanium dioxide
GELATIN
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE

Product Characteristics

Color Size Imprint Code Shape
white (WHITE OPAQUE) 21 mm C;97 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:16590-043-05 5 in 1 BOTTLE
2 NDC:16590-043-10 10 in 1 BOTTLE
3 NDC:16590-043-14 14 in 1 BOTTLE
4 NDC:16590-043-15 15 in 1 BOTTLE
5 NDC:16590-043-20 20 in 1 BOTTLE
6 NDC:16590-043-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065352 2007-01-25


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