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Ceftriaxone for Injection, USPPHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION | Ceftriaxone

05:56 EDT 27th August 2014 | BioPortfolio
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IMAGE ceftriaxone-str.jpg
Table 1 Ceftriaxone Plasma Concentrations After Single Dose Administration
* IV doses were infused at a constant rate over 30 minutes.
ND = Not determined.
 Dose/Route
Average Plasma Concentrations (mcg/mL)
 
0.5 hr
1 hr
2 hr
4 hr
6 hr
8 hr
12 hr
16 hr
24 hr
 0.5 g IV*
82
59
48
37
29
23
15
10
5
 0.5 g IM
     250 mg/mL
22
33
38
35
30
26
16
ND
5
 0.5 g IM
     350 mg/mL
20
32
38
34
31
24
16
ND
5
 1 g IV*
151
111
88
67
53
43
28
18
9
 1 g IM
40
68
76
68
56
44
29
ND
ND
 2 g IV*
257
192
154
117
89
74
46
31
15
Table 2 Urinary Concentrations of Ceftriaxone After Single Dose Administration
ND = Not determined.
 Dose/Route
Average Urinary Concentrations (mcg/mL)
 
0-2 hr
2-4 hr
4-8 hr
8-12 hr
12-24 hr
24-48 hr
 0.5 g IV
526
366
142
87
70
15
 0.5 g IM
115
425
308
127
96
28
 1 g IV
995
855
293
147
132
32
 1 g IM
504
628
418
237
ND
ND
 2 g IV
2692
1976
757
274
198
40
Table 3 Average Pharmacokinetic Parameters of Ceftriaxone in Pediatric Patients With Meningitis
 
50 mg/kg IV
75 mg/kg IV
 Maximum Plasma Concentrations (mcg/mL)
216
275
 Elimination Half-life (hr)
4.6
4.3
 Plasma Clearance (mL/hr/kg)
49
60
 Volume of Distribution (mL/kg)
338
373
 CSF Concentration—inflamed meninges (mcg/mL)
5.6
6.4
     Range (mcg/mL)
1.3-18.5
1.3-44
     Time after dose (hr)
3.7 (± 1.6)
3.3 (± 1.4)
Table 4 Average Pharmacokinetic Parameters of Ceftriaxone in Humans
* Creatinine clearance.
 Subject Group
Elimination
Half-Life
(hr)
Plasma
Clearance
(L/hr)
Volume of
Distribution
(L)
 Healthy Subjects
5.8-8.7
0.58-1.45
5.8-13.5
 Elderly Subjects (mean age, 70.5 yr)
8.9
0.83
10.7
 Patients With Renal Impairment
 
 
 
     Hemodialysis Patients (0-5 mL/min)*
14.7
0.65
13.7
     Severe (5-15 mL/min)
15.7
0.56
12.5
     Moderate (16-30 mL/min)
11.4
0.72
11.8
     Mild (31-60 mL/min)
12.4
0.7
13.3
 Patients With Liver Disease
8.8
1.1
13.6
MIC (mcg/mL)
Interpretation
≤1
2
≥4
(S) Susceptible
(I) Intermediate
(R) Resistant
MIC (mcg/mL)
Interpretation
≤2
(S) Susceptible
MIC (mcg/mL)
Interpretation
≤0.25
(S) Susceptible
MIC (mcg/mL)
Interpretation
≤0.12
(S) Susceptible
MIC (mcg/mL)
Interpretation
≤4
8
≥16
(S) Susceptible
(I) Intermediate
(R) Resistant
MIC (mcg/mL)
Interpretation
≤0.5
1
≥2
(S) Susceptible
(I) Intermediate
(R) Resistant
MIC (mcg/mL)
Interpretation
≤1
2
≥4
(S) Susceptible
(I) Intermediate
(R) Resistant
MIC (mcg/mL)
Interpretation
≤0.5
(S) Susceptible
MIC ( mcg/mL)
Interpretation
≤1
2
≥4
(S) Susceptible
(I) Intermediate
(R) Resistant
 Microorganism
ATCC® #
MIC (mcg/mL)
 Escherichia coli
 Staphylococcus aureus
 Pseudomonas aeruginosa
 Haemophilus influenzae
 Neisseria gonorrhoeae
 Streptococcus pneumoniae
25922
29213
27853
49247
49226
49619
0.03 - 0.12
1 - 8*
8 – 64
0.06 - 0.25
0.004 - 0.015
0.03 - 0.12
Zone Diameter (mm)
Interpretation
≥23
20-22
≤19
(S) Susceptible
(I) Intermediate
(R) Resistant
Zone Diameter (mm)
Interpretation
≥26
(S) Susceptible
Zone Diameter (mm)
Interpretation
≥35
(S) Susceptible
Zone Diameter (mm)
Interpretation
≥34
(S) Susceptible
Zone Diameter (mm)
Interpretation
≥21
14- 20
≤13
(S) Susceptible
(I) Intermediate
(R) Resistant
Zone Diameter (mm)
Interpretation
≥24
(S) Susceptible
Zone Diameter (mm)
Interpretation
≥27
25-26
≤24
(S) Susceptible
(I) Intermediate
(R) Resistant
 Microorganism
ATCC® #
Zone Diameter Ranges (mm)
 Escherichia coli
 Staphylococcus aureus
 Pseudomonas aeruginosa
 Haemophilus influenzae
 Neisseria gonorrhoeae
 Streptococcus pneumoniae
25922
29213
27853
49247
49226
49619
29 – 35
22 – 28
17 – 23
31 – 39
39 – 51
30 - 35
MIC (mcg/mL)
Interpretation
≤16
32
≥64
(S) Susceptible
(I) Intermediate
(R) Resistant
 Method
 Microorganism
ATCC® #
MIC (mcg/mL)
 Agar
 Bacteroides fragilis
 Bacteroides thetaiotaomicron
25285
29741
32 – 128
64 - 256

Transfer individual dose to appropriate intravenous solutions as soon as possible following reconstitution of the bulk package. The stability of the solution that has been transferred into a container varies according to diluent, concentration and temperature (see COMPATIBILITY AND STABILITY). Concentrations between 10 mg/mL and 40 mg/mL are recommended; however, lower concentrations may be used if desired.

Reconstituted Bulk Solutions Should Not Be Used for Direct Infusion.
* Data available for 10 to 40 mg/mL concentrations in this diluent in PVC containers only.
 
Storage
 Diluent
Room Temp. (25°C)
Refrigerated (4°C)
 Sterile Water
2 days
10 days
 0.9% Sodium Chloride Solution
2 days
10 days
 5% Dextrose Solution
2 days
10 days
 10% Dextrose Solution
2 days
10 days
 5% Dextrose + 0.9% Sodium Chloride Solution*
2 days
Incompatible
 5% Dextrose + 0.45% Sodium Chloride Solution
2 days
Incompatible
Clinical Efficacy in Evaluable Population
Study Day
Ceftriaxone
Single Dose
Comparator – 10 Days of
Oral Therapy
95% Confidence
Interval
Statistical
Outcome
Study 1 – U.S.
14
 
28
 
 74% (220/296)

 58% (167/288)
 Amoxicillin/clavulanate
82% (247/302) 

67% (200/297)
 
(-14.4%, -0.5%)

 (-17.5%, -1.2%)
 
Ceftriaxone is lower
than control at
study day
14 and 28.
Study 2 – U.S.7
14
 
28
 
54% (113/210)

35% (73/206)
TMP-SMZ
60% (124/206) 

45% (93/205)
 
(-16.4%, 3.6%)

(-19.9%, 0%)
 
Ceftriaxone is
equivalent to
control at study day
14 and 28.

Manufacturer

Aurobindo Pharma Limited

Active Ingredients

Source

Drugs and Medications [43 Associated Drugs and Medications listed on BioPortfolio]

Ceftriaxone [LUPIN PHARMACEUTICALS INC]

Ceftriaxone for Injection USP, 10 g

Ceftriaxone [Bedford Laboratories]

CEFTRIAXONE FOR INJECTION USP

Ceftriaxone [Aurobindo Pharma Limited]

Ceftriaxone for Injection, USP

Ceftriaxone [Bedford Laboratories]

CEFTRIAXONE FOR INJECTION USP

Ceftriaxone [Pfizer Laboratories, Division of Pfizer Inc ]

ceftriaxone for injection, USP

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PubMed Articles [58 Associated PubMed Articles listed on BioPortfolio]

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Novel penA mutations identified in Neisseria gonorrhoeae with decreased susceptibility to ceftriaxone isolated between 2000 and 2014 in Japan.

We examined four clinical strains of Neisseria gonorrhoeae (GU030113, GU110095, GU110332 and GU110362) isolated between 2000 and 2014 in Japan, exhibiting ceftriaxone MICs of 0.5 mg/L, for mutations o...

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Study Day
13 to 15
Study Day
30+2
 Organism
No.
Analyzed
No. Erad.
(%)
No.
Analyzed
No. Erad. (%)
   Streptococcus pneumoniae
38
32 (84)
35
25 (71)
   Haemophilus influenzae
33
28 (85)
31
22 (71)
   Moraxella catarrhalis
15
12 (80)
15
9 (60)