Hospira™ Ceftriaxone Sodium Powder for Injection

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ceftriaxone sodium 2.39 g equivalent to ceftriaxone 2 g

Available from:

Pfizer New Zealand Limited

INN (International Name):

Ceftriaxone sodium 2.39 g (equivalent to ceftriaxone 2 g)

Dosage:

2 g

Pharmaceutical form:

Powder for injection

Composition:

Active: Ceftriaxone sodium 2.39 g equivalent to ceftriaxone 2 g

Units in package:

Vial, glass, single dose, 20 ml vial with a bromo-butyl rubber closure, 2 g

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Orchid Chemicals and Pharmaceuticals Limited

Therapeutic indications:

Ceftriaxone sodium is indicated for the treatment of lower respiratory tract infections when caused by susceptible aerobic organisms

Product summary:

Package - Contents - Shelf Life: Vial, glass, single dose, 20 ml vial with a bromo-butyl rubber closure - 2 g - 24 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2011-10-18

Summary of Product characteristics

Data Sheet – New Zealand
Version 3.0
Page 1 of 11
HOSPIRA™ CEFTRIAXONE SODIUM POWDER FOR INJECTION
NAME OF THE MEDICINE
Ceftriaxone sodium
DESCRIPTION
Hospira™
Ceftriaxone
Sodium
Powder
for
Injection
is
a
sterile,
semisynthetic,
broad
spectrum
cephalosporin antibiotic for intravenous or intramuscular
administration.
Ceftriaxone sodium is Disodium
(6R,7R)-7-[[(2Z)-(2-aminothiazol-4-yl)(methoxyimino)acetyl]amino]-3-
[[(2-methyl-6-oxido-5-oxo-2,5-dihydro-1,2,4-triazin-3-yl)sulphanyl]methyl]-8-oxo-5-thia-1-
azabicyclo[4.2.0]oct-2-ene-2-carboxylate 3.5 hydrate.
.
The chemical formula of ceftriaxone sodium is C
18
H
16
N
8
Na
2
O
7
S
3
3
½
H
2
O. It has a calculated molecular
weight of 661.59 (CAS registry number: 104376-79-6).
Ceftriaxone sodium is a white or yellowish crystalline powder which is
very soluble in water, sparingly
soluble
in
methanol
and
very
slightly soluble
in
ethanol.
The
pH
of
a
5%
aqueous
solution
is
approximately 6 to 8. Ceftriaxone sodium solutions may be light yellow
to amber coloured in colour.
Hospira™ Ceftriaxone Sodium Powder for Injection contains
approximately 83 mg (3.6 mEq) of sodium
per gram of ceftriaxone activity.
PHARMACOLOGY
PHARMACOKINETICS
Ceftriaxone
is
absorbed
poorly
from
the
gastrointestinal
tract.
Average
plasma
concentrations
of
ceftriaxone following a single 30 minute intravenous (IV) infusion of
a 0.5, 1 or 2 g dose and intramuscular
(IM) administration of a single 0.5 or 1 g dose in healthy subjects
are presented in Table 1.
N
S
NH
2
O
N
H
N
OMe
N
S
COONa
S
N
N
N
O
ONa
Me
H
H
O
3.5 H
2
O
Data Sheet – New Zealand
Version 3.0
Page 2 of 11
TABLE 1
AVERAGE CEFTRIAXONE PLASMA CONCENTRATIONS AFTER SINGLE DOSE
ADMINISTRATION
.
DOSE/
ROUTE
AVERAGE PLASMA CONCENTRATIONS (MICROGRAMS/ML)
(TIME FORM END OF ADMINISTRATION)
0.5 hour
1 hour
2 hour
4 hour
6 hour
8 hour
12 hour
16 hour
24 hour
0.5 G I.V.
82
59
48
37
29
23
15
10
5
0.5 G I.M.
30
41
43
39
31
25
16
ND
ND
1 G I.V.
151
111
88
67
53
43
28
18
9
1 G I.M.
40
68
76
68
56
44
29
ND
ND
2 G I.V.
257
192
154
117
89
74
46
31
15