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CEFOTAXIME

Wockhardt USA LLC.

Prescribing information Cefotaxime for Injection, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotaxime for injection and other antibacterial drugs, cefotaxime for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

CEFOTAXIME DESCRIPTION

2
CEFOTAXIME
1616572

CLINICAL PHARMACOLOGY


1423

Microbiology



Aerobes, Gram-positive:
Enterococcus
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus


Aerobes, Gram-negative:
Acinetobacter
Citrobacter
Enterobacter
Escherichia
Haemophilus influenzae
Haemophilus parainfluenzae
Klebsiella
Morganella morganii
Neisseria gonorrhoeae
Neisseria meningitidis
Proteus mirabilis
Proteus vulgaris
Providencia rettgeri
Providencia stuartii
Serratia marcescens
NOTE: Pseudomonas aeruginosa

Anaerobes:
BacteroidesBacteroidesfragilis
Note: Clostridium difficile
FusobacteriumFusobacterium nucleatum
Peptococcus
Peptostreptococcus

in vitro but the clinical significance is unknown. in vitro

Aerobes, Gram-negative:
Providencia
Salmonella Salmonella typhi
Shigella
in vitro1
in vitroPseudomonas aeruginosa

Susceptibility Tests

Dilution techniques:

1

organismsaHaemophilus Neisseria gonorrhoeaeStreptococcus
MIC (mcg/mL)
 Interpretation
≤8
16-32
≥64
Susceptible (S)
Intermediate (I)
Resistant (R)
Haemophilusb
MIC (mcg/mL) Interpretationc
≤2 Susceptible (S)
Streptococcusd
MIC (mcg/mL) Interpretation
≤0.5
1
≥2
 Susceptible (S)
Intermediate (I)
Resistant (R)
Neisseria gonorrhoeae
MIC (mcg/mL) Interpretationc
≤0.5 Susceptible (S)
in vitro
2


2





Microorganism
 MIC (mcg/mL)
Escherichia coli ATCC 25922
Staphylococcus aureus ATCC 29213
Pseudomonas aeruginosa ATCC 27853
Haemophilus influenzae a ATCC 49247
Streptococcus pneumoniae b ATCC 49619   
Neisseria gonorrhoeae c ATCC 49226		 0.06-0.25   
1-4   
4-16   
0.12-0.5   
0.06-0.25   
0.015-0.06   
2
2
2

Diffusion Techniques:

3

aHaemophilusNeisseria gonorrhoeae Streptococcus
MIC (mcg/mL) Interpretation
≥23
15-22
≤14		 Susceptible (S)
Intermediate (I)
Resistant (R)
Haemophilusb
Zone Diameter (mm)
 Interpretationc
≥26 Susceptible (S)
StreptococcusStreptococcus pneumoniae
Zone Diameter (mm) Interpretation
≥28
26-27
≤25		 Susceptible (S)
Intermediate (I)
Resistant (R)
Neisseria gonorrhoeaed
Zone Diameter (mm) Interpretationc
≥31 Susceptible (S)
in vitro
3

3




Microorganism Zone Diameter (mm)
Escherichia coli ATCC 25922               
Staphylococcus aureus ATCC 25923           
Pseudomonas aeruginosa ATCC 27853           
Haemophilus influenzae a ATCC 49247           
Neisseria gonorrhoeae b ATCC 49226
 29-35
25-31
18-22
31-29
38-48
3
3

Anaerobic Techniques:
4
MIC (mcg/mL) Interpretation
≤16
32
≥64		 Susceptible (S)
Intermediate (I)
Resistant (R)



Microorganism MIC (mcg/mL)
Bacteroides fragilis a ATCC 25285       
Bacteroides thetaiotaomicron ATCC 29741       
Eubacterium lantem ATCC 43055
 8-32
16-64
64-256

CEFOTAXIME INDICATIONS AND USAGE


Treatment


  • Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes* (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens*, Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa).
  • Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus*, (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella  species, Proteus mirabilis, Proteus vulgaris*, Providencia stuartii, Morganella morganii*, Providencia rettgeri*, Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria  gonorrhoeae , including penicillinase producing sjtrains.    
  • Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species*, Klebsiella species*, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis*), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. Nucleatum*). Cefotaxime, like other cephalosporins, has no activity against Chlamydia trachomatis.
    Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added.    
  • Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus andStreptococcus species (including S. pneumonia).    
  • Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing),Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species,         Acinetobacter species*, Escherichia coli, Citrobacter species (including C. freundii*), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Morganella morganii, Providencia rettgeri*, Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus species).
  • Intra-abdominal infections including peritonitis caused by Streptococcus species*, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus * species) Proteus mirabilis*, and Clostridium species*.    
  • Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes*), Pseudomonas species (including P. aeruginosa*), and Proteus mirabilis*.    
  • Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae,    Streptococcus pneumoniae, Klebsiella pneumoniae* and Escherichia coli*.   

faecalisPseudomonas in vitro




Prevention


DOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATION


CEFOTAXIME CONTRAINDICATIONS

WARNINGS


DOSAGE AND ADMINISTRATION

Clostridium difficileC. difficile.

C. difficileC. difficile

C. difficile C. difficile

PRECAUTIONS


General





2
5

Weight (kg) x (140 - age)





Information for Patients



Drug Interactions





Drug/Laboratory Test Interactions



Carcinogenesis, Mutagenesis

22

Pregnancy Teratogenic Effects Pregnancy Category B:

22

Nonteratogenic Effects


Nursing Mothers

Pediatric Use

Geriatric Use



PRECAUTIONSGeneral

CEFOTAXIME ADVERSE REACTIONS


Clinical Trials Experience


The most frequent adverse reactions (greater than 1%) are











Less frequent adverse reactions (less than 1%) are:











Post-Marketing Experience
















Cephalosporin Class Labeling


DOSAGE AND ADMINISTRATION OVERDOSAGE

OVERDOSAGE

CEFOTAXIME DOSAGE AND ADMINISTRATION


Adults



GUIDELINES FOR DOSAGE OF CEFOTAXIME FOR INJECTION   
Type of Infection
 Daily Dose grams)
 Frequency and Route
Gonococcal urethritis/cervicitis in males and females
Rectal gonorrhea in females
Rectal gonorrhea in males
Uncomplicated infections
Moderate to severe infections
Infections commonly needing antibiotics in higher dosage (e.g., septicemia)
Life-threatening infections		 0.5
0.5
1
2
3-6
6-8
up to 12
 0.5 gram IM (single dose)
0.5 gram IM (single dose)
1 gram IM (single dose)
1 gram every 12 hours IM or IV   
1-2 grams every 8 hours IM or IV
2 grams every 6-8 hours IV
2 grams every 4 hours IV
trachomatis

Cesarean Section Patients

Neonates, Infants, and Children











Geriatric Use

RECAUTIONS, GeneralPRECAUTIONS, Geriatric Use

Impaired Renal Function

PRECAUTIONS, General.

NOTE:

Preparation of Cefotaxime for injection Sterile



Strength Diluent
(mL)
 Withdrawable Volume
(mL)		 Approximate Concentration
(mg/mL)
500 mg vial (IM)
1 g vial (IM)
2 g vial (IM)
500 mg vial (IV)
1 g vial (IV)
2 g vial (IV)		 2
3
5
10
10
10
 2.2
3.4
6
10.2
10.4
11
 230
300
330
50
95
180


For intramuscular use:

For intravenous use:

NOTE:


IM Administration:

IV Administration:




Compatibility and Stability

(Preparation of Cefotaxime for injection)
Strength

 Reconstituted Concentration mg/mL

 Stability at or below 220C

 Stability under Refrigeration (at or below 50C)
Original Containers
 Plastic Syringes
500 mg vial IM
1 g vial IM
2 g vial IM
500 mg vial IV
1 g vial IV
2 g vial IV		 230
300
330
50
95
180
 12 hours
12 hours
12 hours
24 hours
24 hours
12 hours
 7 days
7 days
7 days
7 days
7 days
7 days
 5 days
5 days
5 days
5 days
5 days
5 days


00®

NOTE:

HOW SUPPLIED


















NOTE:


REFERENCES
  • Richmond, M. H. and Sykes R. B.: The ß-Lactamases of Gram-Negative Bacteria and their Possible Physiological Role, Advances in Microbial Physiology 9:31-88, 1973.
  • 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. Performance Standard for Antimicrobial Disk Susceptibility Tests - Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24, 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, NCCLS, Villanova, PA, December, 1993.
  • Cockcroft, D.W. and Gault, M.H.: Prediction of Creatinine Clearance from Serum Creatinine, Nephron 16:31-41, 1976.
Manufactured by:



Distributed by:






CEFOTAXIME
CEFOTAXIME
CEFOTAXIME

CEFOTAXIME

CEFOTAXIME INJECTION, POWDER, FOR SOLUTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:64679-947
Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CEFOTAXIME SODIUM CEFOTAXIME 500 mg

Product Characteristics

Color
yellow (Off-white to pale yellow crystalline powder)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64679-947-01 1 in 1 CARTON
2 NDC:64679-947-02 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065197 2008-06-20


CEFOTAXIME

CEFOTAXIME INJECTION, POWDER, FOR SOLUTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:64679-986
Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CEFOTAXIME SODIUM CEFOTAXIME 1 g

Product Characteristics

Color
yellow (Off-white to pale yellow crystalline powder)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64679-986-01 1 in 1 CARTON
2 NDC:64679-986-01 1 in 1 CARTON
3 NDC:64679-986-01 1 in 1 CARTON
4 NDC:64679-986-04 50 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065197 2006-08-29


CEFOTAXIME

CEFOTAXIME INJECTION, POWDER, FOR SOLUTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:64679-948
Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CEFOTAXIME SODIUM CEFOTAXIME 2 g

Product Characteristics

Color
yellow (Off-white to pale yellow crystalline powder)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64679-948-01 1 in 1 CARTON
2 NDC:64679-948-02 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065197 2008-06-20


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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