CEFTAZIDIME SXP ceftazidime 2g powder for injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ceftazidime pentahydrate, Quantity: 2329.3 mg (Equivalent: ceftazidime, Qty 2 g)

Available from:

Southern XP IP Pty Ltd

INN (International Name):

ceftazidime pentahydrate

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium carbonate; carbon dioxide

Administration route:

Intravenous

Units in package:

5 bottles

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: White to cream coloured crystalline powder; Container Type: Bottle; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-10-14

Patient Information leaflet

________________________________________________________________________________
C:Products/Cefs/Ceftazidime/CMI 30oct08
30/10/08
Page
1 of 2
CEFTAZIDIME SXP
_Ceftazidime _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
Please read this leaflet carefully before
you use Ceftazidime SXP.
This leaflet answers some common
questions about Ceftazidime SXP. It
does not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits.
Sometimes new risks are found even
when a medicine has been used for
many years. Your doctor has weighed
the expected benefits of you taking
Ceftazidime SXP against the risks this
medicine could have for you.
If you have any concerns about taking
this medicine, ask your doctor or
pharmacist.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
What Ceftazidime SXP is
used for
Ceftazidime SXP belongs to a group of
medicines called cephalosporins.
Ceftazidime SXP is used to treat a
wide range of infections caused by
bacteria. These infections may affect
the chest (bronchitis or pneumonia),
ears, nose, throat, bladder and urinary
tract, skin and soft tissue, stomach or
bones.
Ceftazidime SXP works by killing the
bacteria that cause these infections.
Your doctor may have prescribed
Ceftazidime SXP for another reason.
There is no evidence that Ceftazidime
SXP injection is addictive.
Before you are given
Ceftazidime SXP
_When you must not be given it: _
_ _
YOU MUST NOT BE GIVEN CEFTAZIDIME
SXP IF:
_ _

you have ever had an allergic
reaction to cephalosporins,
penicillins or any of the
ingredients listed toward the
end of this leaflet. (See
"Ingredients")

the expiry date (EXP) printed
on the pack has passed.

the packaging is torn or shows
signs of tampering
_Tell your doctor if: _
_ _
YOU MUST TELL YOUR DOCTOR IF:_ _

you are allergic to foods,
dyes, preservatives or any
other medicines (in particular
cephalosporins, penicillins,
chloramphenicol or
lignocaine).

you are taking

Summary of Product characteristics

C:Products/Cefs/Ceftazidime/PI 1sep08
1/9/08
Page 1 of 12
PRODUCT INFORMATION
CEFTAZIDIME SXP
NAME OF THE MEDICINE
PROPRIETARY NAMES: Ceftazidime SXP 1g
Ceftazidime SXP 2g
NON PROPRIETARY NAMES: Ceftazidime (as pentahydrate) powder for
injection 1 g
Ceftazidime (as pentahydrate) powder for injection 2 g
CHEMICAL NAME:_ _
(6_R_,7_R_)-7-[[(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
MOLECULAR FORMULA: C
22
H
22
N
6
O
7
S
2
.5H
2
O
MOLECULAR WEIGHT: 636.6
STRUCTURE:
_ _
The chemical structure of ceftazidime pentahydrate is:
CAS NUMBER: 78439-06-2_ _
C:Products/Cefs/Ceftazidime/PI 1sep08
1/9/08
Page 2 of 12
DESCRIPTION
Ceftazidime is a cephalosporin antibiotic for use by injection only.
It is a white or almost
white crystalline powder in vials containing ceftazidime as
pentahydrate, with sodium
carbonate anhydrous. On the addition of water for injections,
Ceftazidime SXP injection
dissolves with effervescence to produce a solution for injection.
Ceftazidime SXP injection contains approximately 52 mg (2.3 mEq) of
sodium per g of
ceftazidime. Ceftazidime pentahydrate 116 mg is equivalent to
ceftazidime anhydrous 100
mg.
For laboratory tests associated with ceftazidime administration,
ceftazidime pentahydrate
should be used.
PHARMACOLOGY
ACTIONS: Antibiotic
MICROBIOLOGY: Ceftazidime is bactericidal in action, exerting its
effect on target cell wall
proteins and causing inhibition of cell wall synthesis. It is stable
to most beta-lactamases
produced by Gram positive and Gram negative organisms and consequently
is active against
many ampicillin and cephalothin resistant strains (but not methicillin
resistant strains).
Ceftazidime has been shown to have in vitro activity against the
following organisms.
_ _
_GRAM NEGATIVE ORGANISMS._ _Pseudomonas aeruginosa_, Pseudomonas sp.
(other), _Klebsiella _
_pneumoniae_, Klebsiella sp. (other), _Proteus mirabilis, P. vulgaris,
Morganella morganii_
(formerly