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Cefprozil

Northstar Rx LLC
Aurobindo Pharma Limited


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

CEFPROZIL DESCRIPTION




RRRp
Cefprozil
1819352



CLINICAL PHARMACOLOGY








*Data represent mean values of 12 healthy volunteers
Dosage
(mg)
  
Mean Plasma Cefprozil Concentrations
(mcg/mL)*
  
8-hour Urinary Excretion
(%)
 
Peak appx. 1.5 h
 4 h
 8 h
  
250 mg
 6.1
 1.7
 0.2
 60%
500 mg
 10.5
 3.2
 0.4
 62%
1000 mg
 18.3
 8.4
 1.0
 54%



maxmax







PRECAUTIONS DOSAGE AND ADMINISTRATION







an=11; bn=5; cn=9; dn=11.
 
Mean (SD) Plasma Cefprozil Concentrations (mcg/mL)
  
   Population
Dose
 1 h
 2 h
 4 h
 6 h
 T1/2 (h)
   children (n=18)
 7.5 mg/kg
 4.70 (1.57)
 3.99 (1.24)
 0.91 (0.30)
 0.23a (0.13)
 0.94 (0.32)
    adults (n=12)
 250 mg
 4.82 (2.13)
 4.92 (1.13)
 1.70b (0.53)
 0.53 (0.17)
 1.28 (0.34)
   children (n=19)
 15 mg/kg
 10.86 (2.55)
 8.47 (2.03)
 2.75 (1.07)
 0.61c (0.27)
 1.24 (0.43)
   adults (n=12)
 500 mg
 8.39 (1.95)
 9.42 (0.98)
 3.18d (0.76)
 1.00d (0.24)
 1.29 (0.14)
   children (n=10)
 30 mg/kg
 16.69 (4.26)
 17.61 (6.39)
 8.66 (2.70)
 —
 2.06 (0.21)
   adults (n=12)
 1000 mg
 11.99 (4.67)
 16.95 (4.07)
 8.36  (4.13)
 2.79 (1.77)
 1.27 (0.12)

Microbiology


in vitroin vitro INDICATIONS AND USAGE
Aerobic gram-positive microorganisms: Aerobic gram-negative microorganisms:
   Staphylococcus aureus (including β-lactamase-producing strains)
    Haemophilus influenzae (including β-lactamase-producing strains)
   NOTE: Cefprozil is inactive against methicillin-resistant staphylococci.
   Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains)
   Streptococcus pneumoniae
 
   Streptococcus pyogenes
 

in vitroin vitro

Aerobic gram-positive microorganisms:

         Enterococcus durans                                          Staphylococcus warneri
         Enterococcus faecalis                                        Streptococcus agalactiae
         Listeria monocytogenes                                    
         Staphylococcus epidermidis                              
         Staphylococcus saprophyticus

NOTE:Enterococcus faecium

Aerobic gram-negative microorganisms:

         Citrobacter diversus                                          Proteus mirabilis
         Escherichia coli                                                  Salmonella
         Klebsiella pneumoniae                                       Shigella .
         Neisseria gonorrhoeae                                       Vibrio


NOTE: AcinetobacterEnterobacterMorganella morganiiProteus vulgarisProvidenciaPseudomonasSerratia

Anaerobic microorganisms:

         Prevotella (Bacteroides) melaninogenicus        Fusobacterium
         Clostridium difficile                                           Peptostreptococcus
         Clostridium perfringens                                     Propionibacterium acnes

NOTE: Bacteroides fragilis

Susceptibility Tests

Dilution Techniques: 1,2                           
MIC (mcg/mL) Interpretation
≤8
 Susceptible (S)
16
Intermediate (I)
≥32
Resistant (R)



            
Microorganism MIC (mcg/mL)
   Enterococcus faecalis ATCC 29212
 4–16
   Escherichia coli ATCC 25922
1–4
   Haemophilus influenzae ATCC 49766
1–4
   Staphylococcus aureus ATCC 29213
0.25–1
   Streptococcus pneumoniae ATCC 49619
0.25–1
Diffusion Techniques: 3


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




Microorganism Zone diameter (mm)
   Escherichia coli ATCC 25922
 21–27
   Haemophilus influenzae ATCC 49766
20–27
   Staphylococcus aureus ATCC 25923
27–33
   Streptococcus pneumoniae ATCC 49619
25–32

CEFPROZIL INDICATIONS AND USAGE








Pharyngitis/tonsillitis Streptococcus pyogenes

Streptococcus pyogenes

Otitis Media Streptococcus pneumoniaeHaemophilus influenzaeMoraxella (Branhamella) catarrhalis CLINICAL STUDIES



Acute Sinusitis Streptococcus pneumoniaeHaemophilus influenzae Moraxella (Branhamella) catarrhalis



Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis Streptococcus pneumoniaeHaemophilus influenzae Moraxella (Branhamella) catarrhalis



Uncomplicated Skin and Skin-Structure InfectionsStaphylococcus aureus Streptococcus pyogenes

CEFPROZIL CONTRAINDICATIONS

Cefprozil tablets are contraindicated in patients with known allergy to the cephalosporin class of antibiotics.

WARNINGS


BEFORE THERAPY WITH CEFPROZIL IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFPROZIL, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-SENSITIVITY AMONG β-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFPROZIL OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

Clostridium difficile C. difficile

C. difficile C. difficile

C. difficile C. difficile

PRECAUTIONS

General




DOSAGE AND ADMINISTRATION





Information for Patients




Drug Interactions




Drug/Laboratory Test Interactions


®®

Carcinogenesis, Mutagenesis, Impairment of Fertility


in vivo

Salmonella E. coli in vitro2

2

Pregnancy

Teratogenic Effects. Pregnancy Category B


2

Labor and Delivery


Nursing Mothers


Pediatric Use


(See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.)
 
 CLINICAL STUDIES





Geriatric Use


CLINICAL PHARMACOLOGY

DOSAGE AND ADMINISTRATION

CEFPROZIL ADVERSE REACTIONS






Gastrointestinal:

Hepatobiliary:

Hypersensitivity:

CNS:

Hematopoietic:

Renal:

Other:

Cephalosporin class paragraph






DOSAGE AND ADMINISTRATION OVERDOSAGE

OVERDOSAGE




CEFPROZIL DOSAGE AND ADMINISTRATION



Population/Infection Dosage
(mg)		 Duration
(days)
a In the treatment of infections due to Streptococcus pyogenes, cefprozil should be administered for at least 10 days.
b Not to exceed recommended adult doses.
   ADULTS (13 years and older)
 
 
      UPPER RESPIRATORY TRACT
 
 
         Pharyngitis/Tonsillitis
500 q 24 h
10a
         Acute Sinusitis
         (For moderate to severe infections, the higher dose should be used)
 250 q 12 h or
500 q 12 h
 10
      LOWER RESPIRATORY TRACT
 
 
         Secondary Bacterial Infection of Acute Bronchitis and 
         Acute Bacterial Exacerbation of Chronic Bronchitis
 500 q 12 h
 10
      SKIN AND SKIN STRUCTURE
 
 
         Uncomplicated Skin and Skin Structure Infections
250 q 12 h or
500 q 24 h or
500 q 12 h
 10
   CHILDREN (2 years–12 years)
 
 
      UPPER RESPIRATORY TRACTb
 
 
         Pharyngitis/Tonsillitis
7.5 mg/kg q 12 h
10a
      SKIN AND SKIN STRUCTUREb
 
 
         Uncomplicated Skin and Skin Structure Infections
20 mg/kg q 24 h
10
   INFANTS & CHILDREN (6 months–12 years)     
 
 
      UPPER RESPIRATORY TRACTb
 
 
         Otitis Media
         (See INDICATIONS AND USAGE and CLINICAL STUDIES )
 15 mg/kg q 12 h
 10
         Acute Sinusitis
         (For moderate to severe infections, the higher dose should be used)
7.5 mg/kg q 12 h or
15 mg/kg q 12 h
 10

Renal Impairment



Creatinine Clearance
(mL/min)		 Dosage
(mg)		 Dosing Interval
* Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis.
30–120
0–29*
 standard
50% of standard
 standard
 standard

Hepatic Impairment


HOW SUPPLIED


Cefprozil Tablets, USP 250 mg



Cefprozil Tablets, USP 500 mg



Store at

CLINICAL STUDIES

Study One:


acute otitis media

U.S. Acute Otitis Media Stud Cefprozil vs β-lactamase inhibitor-containing control drug
   EFFICACY:
Pathogen
% of Cases with Pathogen
(n=155)
Outcome
   S. pneumoniae
48.4%
 cefprozil success rate 5% better than control
   H. influenzae
35.5%
 cefprozil success rate 17% less than control
   M. catarrhalis
13.5%
 cefprozil success rate 12% less than control
   S. pyogenes
2.6%
 cefprozil equivalent to control
   Overall
100.0%
 cefprozil success rate 5% less than control
SAFETY:



Age Group Cefprozil Control
*The majority of these involved the diaper area in young children.
   6 months–2 years
21%
 41%
   3–12 years
 10%
 19%

Study Two:


acute otitis media

European Acute Otitis Media Study Cefprozil vs β-lactamase inhibitor-containing control drug
   EFFICACY:
Pathogen
% of Cases with Pathogen (n=47)
Outcome
   S. pneumoniae
51.0%
    cefprozil equivalent to control
   H. influenzae
29.8%
    cefprozil equivalent to control
   M. catarrhalis
6.4%
    cefprozil equivalent to control
   S. pyogenes
12.8%
    cefprozil equivalent to control
   Overall
100.0%
    cefprozil equivalent to control

SAFETY:

REFERENCES


  • National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically-Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25, NCCLS, Villanova, PA, December 1993.
  • National Committee for Clinical Laboratory Standards. Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria-Third Edition. Approved Standard NCCLS Document M11-A3, Vol. 13, No. 26, NCCLS, Villanova, PA, December 1993.
  • National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests–Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24, NCCLS, Villanova, PA, December 1993.

 


Clinitest® and Clinistix® are registered trademarks of the Bayer HealthCare LLC.


Manufactured for: Northstar Rx LLC
                                Memphis, TN 38141
                                 Toll Free: 1-800-206-7821

Manufactured by: Aurobindo Pharma Limited
                                Chitkul (V)-502 307, A.P., India

M.L.No.: 78/MD/AP/96/F/B/R

Issued: 11/2012

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg (100 Tablet Bottle)


Rx only
NDC 16714-398-01
Cefprozil Tablets, USP
250 mg
100 Tablets
Northstar Rx LLC


Cefprozil

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg (50 Tablet Bottle)


Rx only
NDC 16714-399-01
Cefprozil Tablets, USP
500 mg
50 Tablets
Northstar Rx LLC
Cefprozil

Cefprozil

Cefprozil TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:16714-398
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CEFPROZIL CEFPROZIL ANHYDROUS 250 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
polyethylene glycol 400
polysorbate 80
titanium dioxide
FD&C YELLOW NO. 6
SHELLAC
FERROSOFERRIC OXIDE
propylene glycol
AMMONIA

Product Characteristics

Color Size Imprint Code Shape
ORANGE 14 mm C16 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:16714-398-01 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065340 2007-05-24


Cefprozil

Cefprozil TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:16714-399
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CEFPROZIL CEFPROZIL ANHYDROUS 500 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Hypromellose 2910 (5 Mpa.s)
polyethylene glycol 400
polysorbate 80
titanium dioxide
SHELLAC
FERROSOFERRIC OXIDE
propylene glycol
AMMONIA

Product Characteristics

Color Size Imprint Code Shape
WHITE 18 mm C17 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:16714-399-01 50 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065340 2007-05-24


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