Cefprozil description, usages, side effects, indications, overdosage, supplying and lots more!

Cefprozil

Northstar Rx LLC
Aurobindo Pharma Limited


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION


DESCRIPTION




6R, 7RRp
DESCRIPTION
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
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   
4.7
(1.57)
3.99
(1.24)
0.91
(0.3)
0.23a
(0.13)
0.94
(0.32)
   adults
   (n=12)
250 mg
4.82
(2.13)
4.92
(1.13)
1.7b
(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)
1d
(0.24)
1.29
(0.14)
   children
   (n=10)
   30 mg/kg   
16.69
(4.26)
17.61
(6.39)
8.66
(2.7)

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

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 Infections
Staphylococcus aureus Streptococcus pyogenes

CONTRAINDICATIONS


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

ADVERSE REACTIONS






Gastrointestinal:


Hepatobiliary:


Hypersensitivity:


CNS:


Hematopoietic:


Renal:


Other:


Cephalosporin class paragraph






DOSAGE AND ADMINISTRATION OVERDOSAGE

OVERDOSAGE




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 q24h
10a
     Acute Sinusitis
     (For moderate to severe infections, the higher dose should be used)
250 q12h or
500 q12h
10
     LOWER RESPIRATORY TRACT
 
 
     Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of 
     Chronic Bronchitis
500 q12h
10
     SKIN AND SKIN STRUCTURE
 
 
     Uncomplicated Skin and Skin Structure Infections
250 q12h or
500 q24h or
500 q12h
10
  CHILDREN (2 years to 12 years)
 
 
     UPPER RESPIRATORY TRACTb
 
 
     Pharyngitis/Tonsillitis
7.5 mg/kg q12h
10a
     SKIN AND SKIN STRUCTUREb
 
 
     Uncomplicated Skin and Skin Structure Infections
20 mg/kg q24h
10
  INFANTS & CHILDREN (6 months to 12 years)                                                                  
 
 
     UPPER RESPIRATORY TRACTb
 
 
     Otitis Media
     (See INDICATIONS AND USAGE and CLINICAL STUDIES )
15 mg/kg q12h
10
     Acute Sinusitis
     (For moderate to severe infections, the higher dose should be used)
  7.5 mg/kg q12h or 
15 mg/kg q12h
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 for Oral Suspension, USP 125 mg/5 mL:





Cefprozil for Oral Suspension, USP 250 mg/5 mL:
Each 5 mL of reconstituted suspension contains cefprozil USP equivalent to anhydrous cefprozil 250 mg.







Reconstitution Directions for Oral Suspension


Total Amount of Water Required for Reconstitution

   Bottle Size   
   Final Concentration   
125 mg/5 mL
   Final Concentration   
250 mg/5 mL
     50 mL
35 mL
35 mL
     75 mL
52 mL
52 mL
   100 mL
70 mL
70 mL



Store dry powder at

CLINICAL STUDIES

Study One:


acute otitis media


U.S. Acute Otitis Media Study 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%
  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 to 2 years  
21%
41%
  3 to 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%
   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%
   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: 12/2012 

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 125 mg/5 mL (50 mL Bottle)

Rx only
NDC 16714-396-01

Cefprozil for Oral Suspension, USP
125 mg/5 mL
50 mL
when reconstituted
Northstar Rx LLC

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 125 mg/5 mL (50 mL Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/5 mL (50 mL Bottle)


Rx only
NDC 16714-397-01

Cefprozil for Oral Suspension, USP
250 mg/5 mL
50 mL
when reconstituted
Northstar Rx LLC

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/5 mL (50 mL Bottle)

Cefprozil

Cefprozil POWDER, FOR SUSPENSION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:16714-396
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CEFPROZIL CEFPROZIL ANHYDROUS 125 mg

Inactive Ingredients

Ingredient Name Strength
ASPARTAME
cellulose, microcrystalline
CARBOXYMETHYLCELLULOSE SODIUM
CITRIC ACID MONOHYDRATE
COLLOIDAL SILICON DIOXIDE
FD&C RED NO. 3
glycine
polysorbate 80
DIMETHICONE
SILICON DIOXIDE
SODIUM BENZOATE
SODIUM CHLORIDE
SUCROSE

Product Characteristics

Color
PINK (Light Pink)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:16714-396-01 50 in 1 BOTTLE
2 NDC:16714-396-02 75 in 1 BOTTLE
3 NDC:16714-396-03 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065381 2007-01-30


Cefprozil

Cefprozil POWDER, FOR SUSPENSION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:16714-397
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
ASPARTAME
cellulose, microcrystalline
CARBOXYMETHYLCELLULOSE SODIUM
CITRIC ACID MONOHYDRATE
COLLOIDAL SILICON DIOXIDE
FD&C RED NO. 3
glycine
polysorbate 80
DIMETHICONE
SILICON DIOXIDE
SODIUM BENZOATE
SODIUM CHLORIDE
SUCROSE

Product Characteristics

Color
PINK (Light Pink)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:16714-397-01 50 in 1 BOTTLE
2 NDC:16714-397-02 75 in 1 BOTTLE
3 NDC:16714-397-03 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065381 2007-01-30


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