Hospira™ Ceftazidime

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ceftazidime pentahydrate 2.329 g equivalent to ceftazidime 2.0 g

Available from:

Pfizer New Zealand Limited

INN (International Name):

Ceftazidime pentahydrate 2.329 g (equivalent to ceftazidime 2.0 g)

Dosage:

2 g

Pharmaceutical form:

Powder for injection

Composition:

Active: Ceftazidime pentahydrate 2.329 g equivalent to ceftazidime 2.0 g Excipient: Sodium carbonate

Units in package:

Vial, glass, Type 1, clear 100 mL with bromobutyl rubber stopper, 2 g

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Hospira Healthcare India Pvt. Ltd

Therapeutic indications:

Indicated for the treatment of single and mixed infections caused by susceptible aerobic organisms with suspected or documented resistance to other antimicrobials, but not to ceftazidime, and as an alternative to aminoglycoside in pseudomonal infection in patients in whom aminoglycoside toxicity is a cause for concern and other pseudomonal antibiotics cannot be used. Indications include: - Severe infections in general: for example septicaemia, including neonatal sepsis, bacteraemia, and in patients in intensive care units with specific problems, for example infected burns. - Respiratory tract infections: for example, pneumonia, broncho-pneumonia, infected pleurisy, infected bronchiectasis and bronchitis. - Severe ear, nose and throat infections: for example, otitis media, mastoiditis. - Urinary tract infections: for example, acute and chronic pyelonephritis, pyelitis, cystitis, urethritis (bacterial only), and infections associated with bladder and renal stones. - Skin and soft tissue infections: for example, erysipelas, abscesses, cellulitis, infected burns and wounds, mastitis. - Gastrointestinal and abdominal infections: for example, intra-abdominal abscesses, enterocolitis. - Bone and joint infections: for example, osteitis, osteomyelitis, septic arthritis, infected bursitis. - Infections associted with haemo- and peritoneal dialysis and with continuous ambulatory peritoneal dialysis (CAPD)

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type 1, clear 100 mL with bromobutyl rubber stopper - 2 g - 24 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2012-05-08

Summary of Product characteristics

Data Sheet – New Zealand
Version 3.0 Page 1
HOSPIRA™ CEFTAZIDIME, POWDER FOR INJECTION
NAME OF THE MEDICINE
Ceftazidime (as ceftazidime pentahydrate)
CAS No. 78439-06-2
Molecular Weight: 636.6
Molecular formula: C
22
H
22
N
6
O
7
S
2
, 5H
2
O
Chemical name:
(6_R_,7_R_)-7-[[(2_Z_)-2-(2-Aminothiazol-4-yl)-2-[(1-carboxy-1
methylethoxy)imino]acetyl]amino]-8-oxo-3-[(1-pyridinio)methyl]-5-thia-1-azabicyclo
[4.2.0]oct-2-ene-2-carboxylate pentahydrate.
DESCRIPTION
Hospira™ Ceftazidime Powder for Injection is a cephalosporin
antibiotic for use by injection
only. It is supplied as a white to cream coloured crystalline powder
in vials containing 1 g
and 2 g ceftazidime (as pentahydrate) with sodium carbonate anhydrous
(117 mg per gram of
ceftazidime). On the addition of Water for Injections, Hospira™
Ceftazidime Powder for
Injection dissolves with effervescence to produce a light yellow to
amber coloured solution
for injection.
Ceftazidime pentahydrate is slightly soluble in water and in methanol,
practically insoluble in
acetone and in ethanol (96 per cent).
It dissolves in acid and alkali solutions.
Ceftazidime
pentahydrate decomposes at about 150 °C
.
Ceftazidime
penthahydrate
is
hygroscopic
and
crystalline
in
nature
.
No
potential
polymorphism is reported.
Hospira™ Ceftazidime Powder for Injection contains approximately 51
mg (2.17 mEq) of
sodium per gram of ceftazidime. 116 mg ceftazidime pentahydrate is
equivalent to 100 mg
ceftazidime
anhydrous.
For
laboratory
tests
associated
with
ceftazidime
administration,
ceftazidime pentahydrate should be used.
PHARMACOLOGY
PHARMACOKINETICS
Absorption
of
ceftazidime
after
oral
administration
is
negligible,
therefore
Hospira™
Ceftazidime Powder for Injection is intended for parenteral use only.
Data Sheet – New Zealand
Version 3.0 Page 2
In humans, after a single intramuscular administration of 500 mg and 1
g, mean peak serum
levels of 18 and 37 mg/L respectively are achieved at 1 hour, falling
to 8 and 2 mg/L and 20
and 5 mg/L at four and eight hours respectively