AUSTRALIAN PRODUCT INFORMATION- CEFTAZIDIME KABI

(CEFTAZIDIME AS PENTAHYDRATE)

1 NAME OF MEDICINE
Ceftazidime (as pentahydrate)

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Ceftazidime Kabi powder for injection contains either 1 g or 2 g of ceftazidime (as
pentahydrate).
Ceftazidime Kabi contains approximately 52.5 mg (2.3 mq) of sodium per gram of ceftazidime.
1.164g ceftazidime pentahydrate is equivalent to 1 g ceftazidime free acid.
For the full list of excipients, see Section 6.1 List of excipients.

3 PHARMACEUTICAL FORM
Powder for injection.
Supplied as a white to pale yellow powder. On the addition of Water for Injections, Ceftazidime
Kabi dissolves with effervescence to produce a solution for injection.

4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Ceftazidime Kabi is 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 aminoglycosides 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, patients in intensive care units with specific problems, e.g. infected burns.
▪ Respiratory tract infections: for example, pneumonia, broncho-pneumonia, infected
pleurisy, infected bronchiectasis, 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), 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.

4.2 Dose and method of administration

Note: Vials of Ceftazidime Kabi are supplied under reduced pressure; a positive pressure is
produced on reconstitution due to the release of carbon dioxide.
Dosage
Ceftazidime is to be used by the parenteral route, the dosage depending upon the severity,
sensitivity and type of infection and the age, weight and renal function of the patient.
Adults
The adult dosage range for ceftazidime is 1–6 g per day: for instance, 500 mg, 1 g or
2 g given twelve or eight hours by intravenous or intramuscular injection.
In urinary tract infections and in many less serious infections, 500 mg or 1 g every twelve
hours is usually adequate.
In the majority of infections, 1 g every eight hours or 2 g every twelve hours should be given.
In very severe infections, 2 g every eight or twelve hours should be administered.
Individual doses in excess of 1 g should be administered intravenously.
Children (over 12 months)
The usual dosage range for children aged over 12 months is 25–100 mg/kg/day (up to a
maximum of 6 g/day) given as two or three divided doses. The maximum daily dosage (6 g)
may be given to children with very serious infections e.g. those who are immunocompromised
or who suffer from cystic fibrosis.
Neonates and Infants up to 12 months
25–100 mg/kg/day in two divided doses. In neonates, the serum half-life of ceftazidime can
be 3–4 times greater than that measured in adults.
Method of administration
Ceftazidime may be given intravenously or by deep intramuscular injection into a large muscle
mass such as the upper outer quadrant of the gluteus maximus or lateral part of the thigh.
Instructions for Reconstitution
Ceftazidime Kabi may be constituted with Water for Injections or, for intramuscular injection,
with 1.0% Lidocaine Injection. See table below for addition volumes and solution
concentrations.
Table 1: Preparation of Solution

Amount of Diluent Approx. Concentration

to be added
Vial Size (mg/mL)

1g Intramuscular 3 mL 260

Intravenous 10 mL 90

2g Intravenous bolus 10 mL 170

Intravenous infusion 50 mL# 40

# Note: Addition should be in two stages (see text)

All sizes of vials as supplied are under reduced pressure. As the product dissolves,
carbon dioxide is released and a positive pressure develops. Small bubbles in the

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reconstituted solution will resolve and a clear solution obtained in about 1–2 minutes. For ease
of use, it is recommended that the following techniques of reconstitution are adopted.
▪ 1 g I.M./I.V. and 2 g I.V. bolus vials
1. Insert the syringe needle through the vial closure and inject the recommended volume
of diluent. The vacuum may assist entry of the diluent. Remove the syringe needle.
2. Shake to dissolve: carbon dioxide is released and a clear solution will be obtained in
about 1–2 minutes.
3. Invert the vial. With the syringe plunger fully depressed, insert the needle through the
vial closure and withdraw the total volume of solution into the syringe (the pressure in
the vial may aid withdrawal). Ensure that the needle remains within the solution and
does not enter the headspace. The withdrawn solution may contain small bubbles of
carbon dioxide; they may be disregarded.
▪ 2 g I.V. infusion vial
This vial may be reconstituted for short intravenous infusion (i.e. 15–30 minutes) as
follows:
1. Insert the syringe needle through the vial closure and inject 10 mL of diluent. The
vacuum may assist entry of the diluent. Remove the syringe needle.
2. Shake to dissolve; carbon dioxide is released and a clear solution will be obtained in
about 1–2 minutes.
3. Insert a gas relief needle through the vial closure to relieve the internal pressure and,
with the gas relief in position, add a further 40 mL of diluent. Remove the gas relief
needle and syringe needle. Shake the vial and set up for infusion use in the normal way.
Note: To preserve product sterility, it is important that a gas relief needle is not inserted
through the vial closure before the product has dissolved.
These solutions may be given directly into the vein or introduced into the tubing of a giving set
if the patient is receiving parenteral fluids.
Solutions of Ceftazidime Kabi reconstituted in Water for Injections or 1% Lidocaine Injection
retain satisfactory potency for 4 hours if kept below 25°C or for 12 hours if refrigerated (2–
8°C).
Ceftazidime is compatible with the intravenous fluids shown below. Solutions at
concentrations up to 40 mg/mL in these infusion fluids may be stored for up to 4 hours below
25°C or 12 hours if refrigerated (2-8°C):
▪ 0.9% Sodium Chloride Infusion
▪ Compound Sodium Lactate Infusion
▪ 10% Glucose Infusion
Sodium Bicarbonate Infusion is not recommended as a diluent.
It is advisable to administer reconstituted product as soon as possible.
The dilution is to be made under aseptic conditions. The solution is to be inspected visually
for particulate matter prior to administration. The solution should only be used if it is clear and
free from particles.

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Solutions range from light yellow to amber depending on concentration, diluent and storage
conditions used. Within the stated recommendations, product potency is not adversely
affected by such colour variations.
For use in one patient on one occasion only. Discard any unused solution appropriately.
Ceftazidime and aminoglycosides should not be mixed in the same giving set or syringe.
Precipitation has been reported when vancomycin has been added to ceftazidime in solution.
Therefore, it would be prudent to flush giving sets and intravenous lines between the
administration of these two agents. Protect from light.
Dosage in Impaired Renal Function
Adults
Ceftazidime is excreted by the kidneys almost exclusively by glomerular filtration. Therefore,
in patients with impaired renal function it is recommended that the dosage of ceftazidime
should be reduced to compensate for its slower excretion, except in mild impairment i.e.
glomerular filtration rate (GFR) greater than 50 mL/min. In patients with suspected renal
insufficiency, an initial loading dose of 1 g ceftazidime may be given. An estimate of GFR
should be made to determine the appropriate maintenance dose.
Recommended maintenance doses are shown below.
Table 2: Recommended Maintenance Doses of Ceftazidime in Renal Insufficiency

Creatinine Frequency
Approx. Serum Recommended Unit
Clearance Creatinine# Dose of Ceftazidime of Dosing
(mL/min) (micromol/L) (g) (hourly)

50–31 150–200 1.0 12

30–16 200–350 1.0 24

15–6 350–500 0.5 24

≤5 500 0.5 48
# These values are guidelines and may not accurately predict renal function in all patients
especially in the elderly in whom the serum creatinine concentration may overestimate
renal function.

In patients with severe infections who would normally receive 6 g ceftazidime daily were it not
for renal insufficiency, the unit dose given in the table above may be increased by 50% or the
dosing frequency increased appropriately. In such patients, it is recommended that
ceftazidime serum levels should be monitored and trough levels should not exceed 40 mg/L.
When only serum creatinine is available, the following formula (Cockcroft's equation) may be
used to estimate creatinine clearance. The serum creatinine should represent a steady state
of renal function.
Males: Creatinine clearance (mL/min) = Weight (kg) × (140 − age in years) × 88.4

72 × serum creatinine (micromol/L)

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Females: 0.85 × above value.
In children the creatinine clearance should be adjusted for body surface area or lean body
mass and the dosing frequency reduced in cases of renal insufficiency as for adults.
The serum half-life of ceftazidime during haemodialysis is approximately 3 hours. The
appropriate maintenance dose of ceftazidime should be repeated following each
haemodialysis period. Continuous ambulatory peritoneal dialysis removed approximately 10%
of the antibiotic when the dwell time was 4–6 hours.
Children
In children, the creatinine clearance should be adjusted for body surface area or lean body
mass and the dosing frequency reduced in cases of renal insufficiency as for adults.
The serum half-life of ceftazidime during haemodialysis is approximately three hours. The
appropriate maintenance dose of ceftazidime should be repeated following each
haemodialysis period. Continuous ambulatory peritoneal dialysis (CAPD) removed
approximately 10% of the antibiotic when the dwell time was four to six hours.
Dosage adjustment in the elderly
In view of the reduced clearance of ceftazidime in elderly patients, the daily dosage should be
adjusted according to renal function.
4.3 Contraindications
Hypersensitivity to cephalosporins or major allergy to penicillin (anaphylaxis, angioneurotic
oedema, urticaria).
Lignocaine should not be used as a diluent for intramuscular injection in patients who are
hypersensitive to lignocaine.
4.4 Special warnings and precautions for use
As with other beta-lactam antibiotics, before therapy with ceftazidime is instituted, careful
inquiry should be made for a history of hypersensitivity reactions to ceftazidime,
cephalosporins, penicillins or other drugs. Ceftazidime should be given only with special
caution to patients with mild type I or immediate hypersensitivity reactions to penicillin or other
beta-lactams. If an allergic reaction to ceftazidime occurs, discontinue the drug. Serious
hypersensitivity reactions may require adrenaline, hydrocortisone, antihistamine or other
emergency measures.
Antibiotic-associated pseudomembranous colitis has been reported with many antibiotics
including ceftazidime. A toxin produced by Clostridium difficile appears to be the primary
cause. The severity of the colitis may range from mild to life threatening. It is important to
consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic
use (this may occur up to several weeks after cessation of antibiotic therapy). Mild cases
usually respond to drug discontinuation alone. However, in moderate to severe cases,
appropriate therapy with a suitable oral antibacterial agent effective against Clostridium
difficile should be considered. Fluids, electrolytes and protein replacement should be provided
when indicated. If prolonged or significant diarrhoea occurs or the patient experiences
abdominal cramps, treatment should be discontinued immediately and the patient investigated
further.

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As with other broad spectrum antibiotics, prolonged use may result in the overgrowth of non
susceptible organisms (e.g. Candida enterococci) which may require interruption of treatment
or appropriate measures. Repeated evaluation of the patient’s condition is essential.
As with other extended-spectrum cephalosporins and penicillins, some initially susceptible
strains of Enterobacter spp. and Serratia spp. may develop resistance during ceftazidime
therapy. When clinically appropriate during therapy of such infections, periodic susceptibility
testing should be considered.
Concurrent treatment with high doses of cephalosporins and nephrotoxic drugs such as
aminoglycosides or potent diuretics (e.g. frusemide) may adversely affect renal function.
Clinical experience has shown that this is not likely to be a problem with ceftazidime at the
recommended dose levels. There is no evidence that ceftazidime adversely affects renal
function at normal therapeutic doses.
Drugs which delay peristalsis e.g. opiates and diphenoxylate with atropine (Lomotil) may
prolong and/or worsen the condition and should not be used.
Clostridium difficile infection rarely manifests as diarrhoea in neonates.
Peak concentrations of ceftazidime in the CSF are considerably lower than those in the
plasma. Its use in the treatment of infections of the CNS, e.g. meningitis, brain abscess, etc.
is not advised at present.
Prescribing ceftazidime in the absence of a proven or strongly suspected bacterial infection or
a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of
the development of drug-resistant bacteria.
Inducible type I beta-lactamase resistance has been noted with some organisms (e.g.
Enterobacter spp., Pseudomonas spp., and Serratia spp.). As with other extended-spectrum
beta-lactam antibiotics, resistance can develop during therapy, leading to clinical failure in
some cases. When treating infections caused by these organisms, periodic susceptibility
testing should be performed when clinically appropriate. If patients fail to respond to
monotherapy, an aminoglycoside or similar agent should be considered.
Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include
patients with renal and hepatic impairment, or poor nutritional state, as well as patients
receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored
in patients at risk and exogenous vitamin K administered as indicated.
Ceftazidime should be prescribed with caution to individuals with a history of gastrointestinal
disease, particularly colitis.
Distal necrosis can occur after inadvertent intra-arterial administration of ceftazidime.
Neurotoxicity
There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms
of neurotoxicity include encephalopathy, seizures and/or myoclonus. Risk factors for
developing neurotoxicity with cephalosporin treatment include being elderly, renal impairment,
central nervous system disorders and intravenous administration. Withdrawal of the medicine
should be considered if there are signs of neurotoxicity.
Use in hepatic impairment
Transient rises in hepatic enzymes have been noted in some patients given ceftazidime, so
careful monitoring of hepatic function is advised when any dysfunction exists.

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Repeated use of lignocaine hydrochloride as a diluent for IM use should be avoided in patients
with severe liver disease or decreased hepatic blood flow due to the possibility of lignocaine
toxicity resulting from decreased metabolism and consequent accumulation.
As with other broad spectrum antibiotics, prolonged use of ceftazidime may result in the
overgrowth of non-susceptible organisms (e.g., Candida, Enterococci) which may require
interruption of treatment or adoption of appropriate measures. Repeated evaluation of the
patient's condition is essential.
Chloramphenicol is antagonistic in vitro with ceftazidime and other cephalosporins. The
clinical relevance of this finding is unknown, but if concurrent administration of ceftazidime
with chloramphenicol is proposed, the possibility of antagonism should be considered. There
is some evidence in the literature that concurrent use of two beta-lactam antibiotics may exhibit
antagonism.
See Section 4.2 DOSE AND METHOD OF ADMINISTRATION for recommended techniques
of reconstitution.
Ceftazidime should be prescribed with caution to individuals with a history of gastrointestinal
disease, particularly colitis.
Use in renal impairment
Ceftazidime has shown some evidence of renal toxicity in animals. Clinical studies have shown
only transient elevations in serum urea and serum creatinine. It is excreted almost entirely by
glomerular filtration and its half-life is prolonged in patients with impaired renal function. In
such patients, dosage adjustment may be required in order to avoid the clinical consequences
of elevated antibiotic levels. Neurological sequelae have occasionally been reported when the
dose has not been reduced appropriately (see 4.2 DOSE AND METHOD OF
ADMINISTRATION).
Elevated levels of ceftazidime in patients with renal insufficiency can lead to seizures,
encephalopathy, asterixis, neuromuscular excitability and myoclonia. Continued dosage
should be determined by degree of renal impairment, severity of infection and susceptibility of
the causative organism.
Use in the elderly
See Section 4.2 DOSE AND METHOD OF ADMINISTRATION.
Paediatric use
Ceftazidime is effective in the treatment of neonatal infections caused by susceptible
organisms.
Effects on laboratory tests
The development of a positive Coombs test associated with the use of ceftazidime in about
5% of patients may interfere with the cross-matching of blood.
The administration of ceftazidime may result in a false-positive reaction for glucose in the urine
when using CLINITEST® tablets1, Benedict’s solution, or Fehling’s solution. It is recommended
that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX®)1 be
used.
Ceftazidime does not interfere in the alkaline picrate assay for creatinine.
1
CLINITEST® and CLINISTIX® are registered trademarks of Siemens Healthcare
Diagnostics Inc.

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For laboratory tests associated with ceftazidime administration, ceftazidime pentahydrate
should be used.
4.5 Interactions with other medicines and other forms of interactions
Aminoglycoside antibiotics and/or diuretics
Nephrotoxicity has been reported following concomitant administration of cephalosporins with
aminoglycoside antibiotics or potent diuretics such as frusemide. Renal function should be
carefully monitored, especially if higher dosages of the aminoglycosides are to be
administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity
of aminoglycoside antibiotics. Nephrotoxicity and ototoxicity were not noted when ceftazidime
was given alone in clinical trials.
Chloramphenicol
Chloramphenicol has been shown to be antagonistic to beta-lactam antibiotics, including
ceftazidime, based on in vitro studies and time kill curves with enteric gram-negative bacilli.
Due to the possibility of antagonism in vivo, particularly when bactericidal activity is desired,
this drug combination should be avoided.
In common with other antibiotics, ceftazidime may affect the gut flora, leading to lower
oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
4.6 Fertility, pregnancy and lactation
Effects on fertility
No data available.
Use in pregnancy
Pregnancy category: B1.
The safety of ceftazidime in pregnancy has not been established, although animal studies
have not produced evidence of embryopathic or teratogenic effects attributable to ceftazidime.
Therefore, it may be administered during known or suspected pregnancy only if in the opinion
of the treating physician the expected benefits outweigh the possible risks.
Use in lactation
Ceftazidime is excreted in human breast milk in low concentrations; therefore, it is not
recommended for nursing mothers unless the expected benefits to the mother greatly
outweigh any potential risk to the infant.
4.7 Effects on ability to drive and use machines
The effects of this medicine on a person's ability to drive and use machines were not assessed
as part of its registration.
4.8 Adverse effects (Undesirable effects)
Data from large clinical trials (internal and published) were used to determine the frequency
of very common to uncommon undesirable effects. The frequencies assigned to all other
undesirable effects were mainly determined using post-marketing data and refer to a reporting
rate rather than a true frequency.

The following convention has been used for the classification of frequency:
very common ≥1/10
common ≥1/100 to <1/10
uncommon ≥1/1,000 to <1/100
rare ≥1/10,000 to <1/1,000

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very rare <1/10,000.

Infections and infestations

Uncommon: Candidiasis (including vaginitis and oral thrush).

Blood and lymphatic system disorders

Common: Eosinophilia and thrombocytosis.
Uncommon: Leucopenia, neutropenia, and thrombocytopenia.
Very rare: Lymphocytosis, haemolytic anaemia, and agranulocytosis.

Immune system disorders

Very rare: Anaphylaxis (including bronchospasm and/or hypotension).

Nervous system disorders

Uncommon: Headache and dizziness.
Very rare: Paraesthesia.

There have been reports of neurological sequelae including tremor, myoclonia, convulsions,
encephalopathy, and coma in patients with renal impairment in whom the dose of ceftazidime
has not been appropriately reduced.

Vascular disorders
Common: Phlebitis or thrombophlebitis with i.v. administration.

Gastrointestinal disorders
Common: Diarrhoea.
Uncommon: Nausea, vomiting, abdominal pain, and colitis.
Very rare: Bad taste.

As with other cephalosporins, colitis may be associated with Clostridium difficile and may
present as pseudomembranous colitis (see 4.4 SPECIAL WARNINGS AND PRECAUTIONS
FOR USE).

Hepatobiliary disorders
Common: Transient elevations in one or more of the hepatic enzymes, ALT (SGPT), AST
(SOGT), LDH, GGT and alkaline phosphatase.
Very rare: Jaundice.

Skin and subcutaneous tissue disorders

Common: Maculopapular or urticarial rash.
Uncommon: Pruritus.
Very rare: Angioedema, erythema multiforme, Stevens-Johnson syndrome and toxic
epidermal necrolysis.
Not known: DRESS syndrome#

General disorders and administration site conditions

Common: Pain and/or inflammation after i.m. injection.
Uncommon: Fever.

Investigations
Common: Positive Coombs test.
Uncommon: As with some other cephalosporins, transient elevations of blood urea, blood
urea nitrogen and/or serum creatinine have been observed.

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A positive Coombs test develops in about 5% of patients and may interfere with blood cross-
matching.
Other (frequency not known)
Hypersensitivity
Maculopapular or urticarial rash, fever, pruritus; very rarely angioedema and anaphylaxis
(including bronchospasm and hypotension), erythema multiforme, Stevens-Johnson
syndrome and toxic epidermal necrolysis.
Hot flushes, superficial desquamation around injection site.
#
DRESS syndrome (Drug Reaction/Rash with Eosinophilia and Systemic Symptoms). There
have been rare reports where DRESS has been associated with ceftazidime.
Reporting of suspected adverse effects
Reporting suspected adverse reactions after registration of the medicinal product is important.
It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions at
http://www.tga.gov.au/reporting-problems.
4.9 Overdose
Symptoms
Overdosage can lead to neurological sequelae including encephalopathy, convulsions and
coma.
Treatment
Ceftazidime can be removed by haemodialysis.
For information on the management of overdose, contact the Poison Information Centre
on 131126 (Australia) or 0800 764 766 (New Zealand).

5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Mechanism of action
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
Pseudomonas aeruginosa
Pseudomonas species (other)
Klebsiella pneumoniae
Klebsiella species (other)
Proteus mirabilis

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Proteus vulgaris
Morganella morganii (formerly Proteus morganii)
Proteus rettgeri
Providencia species
Escherichia coli
Enterobacter species
Citrobacter species
Serratia species
Acinetobacter species
Neisseria gonorrhoeae
Neisseria meningitidis
Haemophilus influenza (including ampicillin-resistant strains)
Gram-positive
Staphylococcus aureus (methicillin-sensitive strains)
Staphylococcus epidermidis (methicillin-sensitive strains)
Micrococcus species
Streptococcus pyogenes
Streptococcus Group B
Streptococcus pneumoniae
Streptococcus species (excluding Streptococcus faecalis)
Ceftazidime is not active in vitro against methicillin-resistant staphylococci, Streptococcus
faecalis and many other Enterococci, Listeria monocytogenes, Campylobacter species or
Clostridium difficile.
In vitro, the activities of ceftazidime and aminoglycoside antibiotics in combination have been
shown to be at least additive; there is evidence of synergy in some strains tested. This property
may be important in the treatment of febrile neutropenic patients.
Susceptibility Tests
Quantitative methods that require measurement of zone diameters give the most precise
estimate of antibiotic susceptibility. One such procedure has been recommended for use with
discs to test susceptibility to ceftazidime.
Reports from the laboratory giving results of the standard single-disc susceptibility test with a
30 μg ceftazidime disc should be interpreted according to the following criteria:
▪ Susceptible organisms produce zones of 18 mm or greater, indicating that the test organism
is likely to respond to therapy.
▪ Organisms that produce zones of 15–17 mm are expected to be susceptible if high dosage
is used or if the infection is confined to tissues and fluids (e.g. urine) in which high antibiotic
levels are attained.

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▪ Resistant organisms produce zones of 14 mm or less, indicating that other therapy should
be selected.
Organisms should be tested with the ceftazidime disc, since ceftazidime has been shown by
in vitro tests to be active against certain strains found resistant when other beta-lactam discs
are used.
Standardised procedures require the use of laboratory control organisms. The 30 μg
ceftazidime disc should give zone diameters between 25–32 mm for E. coli ATCC 25922. For
P. aeruginosa ATCC 27853, the zone diameters should be between 22–29 mm. For S. aureus
ATCC 25923, the zone diameters should be between 16–20 mm.
In other susceptibility testing procedures, e.g. ICS agar dilution or the equivalent, a bacterial
isolate may be considered susceptible if the MIC value for ceftazidime is ≤ 16 μg/mL.
Organisms are considered resistant to ceftazidime if the MIC is  64 μg/mL. Organisms
having an MIC value of < 64 μg/mL but > 16 μg/mL are expected to be susceptible if high
dosage is used or if the infection is confined to tissues and fluids (e.g. urine) in which high
antibiotic levels are attained.
As with the standard diffusion methods, dilution procedures require the use of laboratory
control organisms. Standard ceftazidime powder should give MIC values in the range of 4–
16 μg/mL for S. aureus ATCC 25923. For E. coli ATCC 25922, the MIC range should be
between 0.125–0.5 μg/mL. For P. aeruginosa ATCC 27853, the MIC range should be between
0.5–2 μg/mL.
Susceptibility to ceftazidime will vary with geography and time and local susceptibility data
should be consulted where available.
Clinical trials
No data available.
5.2 Pharmacokinetic properties
Absorption
Absorption of ceftazidime after oral administration is negligible; therefore, ceftazidime is
intended for parenteral use only.Distribution
In humans after a single intramuscular administration of 0.5 g 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 & 20
and 5 mg/L at 4 and 8 hours, respectively, for the two doses. Five minutes after an intravenous
bolus injection of 0.5 g, 1 g and 2 g, mean serum levels are 46, 87 and 170 mg/L respectively,
for the three doses, falling to 17, 32 and 85 mg/L at 1 hour & 6, 10 and 15 mg/L at 4 hours
respectively, for the three doses.
The mean maximum concentrations of ceftazidime in bone, heart, bile, sputum, aqueous
humour, synovial and pleural and peritoneal fluids were in excess of the in vitro minimum
inhibitory levels for susceptible organisms (see Susceptibility Tests). Transplacental transfer
of the antibiotic readily occurs. Ceftazidime penetrates the intact blood brain barrier poorly and
low levels are achieved in the CSF.
The pharmacokinetics of ceftazidime are similar whether it is administered by a single or by
repeat dosage.
Metabolism
Ceftazidime is not metabolised in the body and is excreted unchanged in the active form into
the urine by glomerular filtration.

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Excretion
The serum half-life in adults with normal renal function is about 1.8 hours (1.2–2.9 hours).
This may be prolonged to 20–35 hours in anuric patients. In neonates, the serum half-life of
ceftazidime can be 3–4 times greater than that measured in adults. The serum protein binding
of ceftazidime is low at about 10%.
In the presence of normal renal function approximately 80–90% of the dose is recovered in
the urine within 24 hours. Less than 1% is excreted via the bile.
Concurrent oral administration of probenecid did not affect the serum levels or urinary
recoveries of ceftazidime.
The pharmacokinetics of ceftazidime were not affected when administered intramuscularly
with 0.5% lignocaine.
5.3 Preclinical safety data
Genotoxicity
A mouse Micronucleus test and Ames test were both negative for mutagenic effects.
Carcinogenicity
Long-term studies in animals have not been performed to evaluate carcinogenic potential.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium carbonate.
6.2 Incompatibilities
Sodium bicarbonate injection is not recommended as a diluent.
Ceftazidime and aminoglycosides should not be mixed in the same giving set or syringe.
For information on interactions with other medicines and other forms of interactions, refer to
Section 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF
INTERACTIONS.
6.3 Shelf life
In Australia, information on the shelf life can be found on the public summary of the Australian
Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
6.4 Special precautions for storage
Store below 25°C. Protect from light.
6.5 Nature and contents of container
Each vial of unreconstituted Ceftazidime Kabi contains a white or pale yellow powder
containing 1 g or 2 g ceftazidime (as pentahydrate).
Vials (Type II colourless glass, halobutyl rubber stopper, plastic-aluminium cap): packs of 1, 5
and 10.
Not all strengths and/or pack sizes may be marketed in Australia.
6.6 Special precautions for disposal
In Australia, any unused medicine or waste material should be disposed of by taking to your
local pharmacy.

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6.7 Physicochemical properties
Chemical structure

·5H2O
Chemical Name: (6R,7R)-7-[[(2Z)-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: C22H22N6O7S2·5H2O
Molecular Weight: 636.65
CAS number
78439-06-2

7 MEDICINE SCHEDULE (POISONS STANDARD)

S4 – Prescription Only Medicine

8 SPONSOR
Fresenius Kabi Australia Pty Limited
Level 2, 2 Woodland Way
Mount Kuring-gai NSW 2080
Australia.
Telephone: 1300 732 001

9 DATE OF FIRST APPROVAL

2 July 2015

10 DATE OF REVISION OF THE TEXT

29 July 2024
SUMMARY TABLE OF CHANGES
Section Changed Summary of new information
All Minor editorial changes
4.4 Addition of safety related information including information related
to prolonged use of antibiotics, antibiotic resistance, concurrent
treatments of cephalosporins and nephrotoxic drugs. Updated
information for hepatic impairment, renal impairment, and effects on
laboratory tests.

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