Consumer medicine information

Ceftazidime Aspen Powder for injection

Ceftazidime

BRAND INFORMATION

Brand name

Ceftazidime Aspen Powder for injection

Active ingredient

Ceftazidime

Schedule

What is in this leaflet

This leaflet answers some common questions about CEFTAZIDIME ASPEN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking CEFTAZIDIME ASPEN against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

Keep this leaflet even after your treatment is finished.

You may need to read it again.

What CEFTAZIDIME ASPEN is used for

CEFTAZIDIME ASPEN contains ceftazidime (as pentahydrate) as the active ingredient. It belongs to a group of antibiotics called cephalosporins.

It 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.

It works by killing the bacteria that cause these infections.

Ask your doctor if you have any questions why CEFTAZIDIME ASPEN has been prescribed for you.

Your doctor may have prescribed it for another purpose.

CEFTAZIDIME ASPEN is available only with a doctor’s prescription.

There is no evidence that it is addictive.

Before you are given it

When you must not be given it

You must not be given CEFTAZIDIME ASPEN if you have or have had an allergy to:

any medicine containing ceftazidime
any other cephalosporin antibiotic
major allergy to penicillin

If you are allergic to cephalosporin or penicillin you may have an increased chance of being allergic to CEFTAZIDIME ASPEN.

any of the ingredients listed at the end of this leaflet.

Signs of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

CEFTAZIDIME ASPEN should not be mixed with lignocaine and given to you if you have had an allergic reaction to lignocaine.

Lignocaine is sometimes mixed with CEFTAZIDIME ASPEN to reduce pain when injected into muscle.

You must not be given this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If you are not sure whether you should be given CEFTAZIDIME ASPEN, talk to your doctor.

Before you are given it

Tell your doctor if you have or have had any of the following medical conditions:

a reaction to any other antibiotic (particularly a penicillin), even if it was not a serious reaction
allergy to foods, dyes, preservatives or any other medicines
you have had to stop taking another medicine for this or any other infection
kidney or liver problems
stomach or bowel illness (e.g. colitis)
blood clotting disorder
you have been taking an antibiotic for a prolonged time.

Tell your doctor if you are pregnant or plan to become pregnant.

Your doctor will discuss the benefits and possible risks of using this medicine during pregnancy.

Tell your doctor if you are breastfeeding.

It is not recommended for use while breastfeeding as it is found in breast milk.

If you have not told your doctor about any of the above, tell them before you start being given CEFTAZIDIME ASPEN.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and CEFTAZIDIME ASPEN may interfere with each other. These include:

chloramphenicol, an antibiotic used to treat bacterial infections
diuretics, a medicine which helps to reduce the amount of excess fluid in the body by increasing the amount of urine produced
aminoglycosides, an antibiotic used to treat serious bacterial infections
any other antibiotic.

These medicines may be affected by CEFTAZIDIME ASPEN or they may affect how well it works. You may need to be given different amounts of your medicine or you may need to be given different medicines.

Your doctor has more information on medicines to be careful with or avoid while being treated with this medicine.

Talk to your doctor about the need for an additional method of contraception while being on CEFTAZIDIME ASPEN.

Some antibiotics may decrease the effectiveness of some birth control pills, although this has not been shown with CEFTAZIDIME ASPEN.

How it is given

How much is given

Your doctor will decide what dose you will receive. This depends on the condition being treated and your response to the treatment. Your doctor may change the dose and frequency of your medicine as your condition changes. If you have kidney problems, your doctor may lower the dose and frequency of administration.

How it is given

CEFTAZIDIME ASPEN will be injected into a muscle or into a vein. When it is injected into a vein it may be given directly or through a 'drip'.

CEFTAZIDIME ASPEN will be prepared and given to you by a doctor or nurse. You will not be expected to give yourself this medicine.

If you are given too much (overdose)

As CEFTAZIDIME ASPEN is given to you under the supervision of your doctor, it is extremely unlikely that you will be given too much.

However, if you experience any side effects after being given this medicine, tell your doctor or nurse immediately.

Symptoms of an overdose may include fits and loss of consciousness.

While you are being given it

Things you must do

Tell your doctor if the symptoms of your infection do not improve within a few days or if they become worse.

Tell your doctor or pharmacist if you have severe diarrhoea or any diarrhoea that persists for more than a day or so.

Do this even if it occurs several weeks after stopping treatment with CEFTAZIDIME ASPEN.

Do not take any medicines for diarrhoea without first checking with your doctor.

Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care.

Tell your doctor if you get a sore white mouth or tongue or a vaginal itching or discharge during or soon after stopping treatment with CEFTAZIDIME ASPEN.

This may mean you have a fungal infection called thrush. This medicine will not kill fungi and you may need other treatment.

If you are about to have any blood tests, tell your doctor that you have been treated with CEFTAZIDIME ASPEN.

It may interfere with the results of some tests.

If you are diabetic, check with your doctor or pharmacist before using urine sugar tests.

CEFTAZIDIME ASPEN may cause false test results with some urine sugar tests.

Things to be careful of

Be careful driving or operating machinery until you know how CEFTAZIDIME ASPEN affects you.

CEFTAZIDIME ASPEN may cause dizziness in some people. If you experience symptoms such as this, do not drive, operate machinery or do anything else that could be dangerous.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well during or after treatment with CEFTAZIDIME ASPEN.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Tell your doctor if you notice any of the following and they worry you:

pain or flaking skin where you had the injection
headache
stomach pain
dizziness
numbness or tingling
nausea (feeling of sickness) or vomiting.

The above list includes the more common side effects of your medicine.

Tell your doctor as soon as possible if you notice any of the following:

sore mouth or tongue
vaginal discharge, genital itching.

The above list includes serious side effects that may require medical attention.

Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital if you notice any of the following symptoms:

allergic-type reactions such as difficulty breathing, swelling of the eyelids, face or lips, fever, itching, rash or hives
diarrhoea, particularly if bloody or watery and if you also have stomach cramps or a high temperature (even several weeks after your CEFTAZIDIME ASPEN treatment)
bruising or bleeding
shaking or muscle twitches.

These are rare but serious side effects. You may need urgent medical attention.

Tell your doctor if you notice anything else that is making you feel unwell, even if you think the problems are not connected with this medicine and are not referred to in this leaflet.

Other side effects not listed above may also occur in some people.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

After using it

Storage

CEFTAZIDIME ASPEN will be stored in the pharmacy or on the ward. It should be protected from light and kept in a cool dry place where the temperature stays below 25°C.

Product description

What it looks like

CEFTAZIDIME ASPEN is available in two strengths: 1 g or 2 g.

Both strengths are a white or almost white powder for injection in clear glass vials.

Available in packs of 1 vial.

Before use, the doctor or nurse will mix CEFTAZIDIME ASPEN powder with a sterile fluid to form a solution for injection.

Ingredients

Active ingredient:
Each vial contains either 1 g or 2 g of ceftazidime (as pentahydrate).

Inactive ingredient:

sodium carbonate.

This medicine does not contain lactose, gluten, sucrose, tartrazine or any other azo dyes.

BRAND INFORMATION

Brand name

Ceftazidime Aspen Powder for injection

Active ingredient

Ceftazidime

Schedule

Name of the medicine

Ceftazidime (as pentahydrate).

Excipients.

Sodium carbonate. Ceftazidime Aspen powder for injection contains approximately 50.5 mg (2.2 mEq) of sodium per gram of ceftazidime.

Description

Chemical name: (6R,7R)-7-[[(2Z)-2- (2-aminothiazol-4-yl)-2- [(1-carboxyl-1-methylethoxy) imino]acetyl]amino]- 8-oxo-3-[(1-pyridinio) methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2- carboxylate pentahydrate. MW: 637.0. CAS: 78439-06-2.
Ceftazidine is a cephalosporin antibiotic for use by injection only. Ceftazidime Aspen powder for injection is a white or almost white crystalline powder of ceftazidime pentahydrate (sterile and buffered with sodium carbonate) equivalent to 1 g or 2 g ceftazidime (on dried and sodium carbonate free basis). On the addition of water for injections, Ceftazidime Aspen powder for injection dissolves with effervescence to produce a solution for injection. Ceftazidime Aspen powder for injection contains approximately 50.5 mg (2.2 mEq) of sodium per gram of ceftazidime. For laboratory tests associated with ceftazidime administration, ceftazidime pentahydrate should be used.

Pharmacology

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 spp (other), Klebsiella pneumoniae, Klebsiella spp (other), Proteus mirabilis, P. vulgaris, Morganella morganii (formerly P morganii), P rettgeri, Providencia spp, Escherichia coli, Enterobacter spp, Citrobacter spp, Serratia spp, Acinetobacter spp, Neisseria gonorrhoeae, N meningitidis, Haemophilus influenzae (including ampicillin resistant strains).

Gram positive organisms.

Staphylococcus aureus (methicillin sensitive strains), Staph epidermidis (methicillin sensitive strains), Micrococcus spp, Streptococcus pyogenes, Streptococcus group B, Strep pneumoniae, Streptococcus spp (excluding Strep. faecalis).
Ceftazidime is not active in vitro against methicillin resistant Staphylococci, Streptococcus faecalis and many other Enterococci, Listeria monocytogenes, Campylobacter spp or Clostridium difficile.
In vitro, the activities of ceftazidime and aminoglycoside antibiotics in combination have been shown to be at least additive and there is evidence of synergy in some strains tested. This property may be important in the treatment of febrile neutropenic patients.

Susceptibility tests.

Dilution or diffusion techniques - either quantitative (MIC) or breakpoint, should be used following a regularly updated, recognised and standardised method (e.g. Clinical and Laboratory Standards Institute [CLSI formerly NCCLS]). Standardised susceptibility test procedures require the use of the laboratory control microorganisms to control the technical aspects of the laboratory procedures.
A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable.
A report of “Intermediate” indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone, which prevents small-uncontrolled technical factors from causing major discrepancies in interpretation.
A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Note.

The prevalence of resistance may vary geographically for selected species and local information on resistance is desirable, particularly when treating severe infections.

Pharmacokinetics.

Absorption of ceftazidime after oral administration is negligible, therefore Ceftazidime Aspen is intended for parenteral use only.
In humans, after a single intramuscular administration of 500 mg and 1 g, mean peak serum levels of 18 mg/L and 37 mg/L respectively are achieved at 1 hour, falling to 8 mg/L and 2 mg/L (500 mg) and 20 mg/L and 5 mg/L (1 g) at four hours and eight hours respectively for the two doses.
Five minutes after an intravenous bolus injection of 500 mg, 1 g and 2 g, mean serum levels are respectively 46 mg/L, 87 mg/L and 170 mg/L, falling to 17 mg/L and 6 mg/L (500 mg), 32 mg/L and 10 mg/L (1 g) and 85 mg/L and 15 mg/L (2 g) at one and four hours respectively with the three doses. 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 three to four times greater than that measured in adults. The serum protein binding of ceftazidime is low at about 10%.

Ceftazidime is not metabolised in the body and is excreted unchanged in the active form into the urine by glomerular filtration. 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.
The mean maximum concentrations of ceftazidime in bone, heart, bile, sputum, aqueous humour and synovial, 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 occurs readily. Ceftazidime penetrates the intact blood-brain barrier poorly and low levels are achieved in the cerebrospinal fluid (CSF).
The pharmacokinetics of ceftazidime are similar whether it is administered by a single or by repeat dosage.
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.

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; patients in intensive care units with specific problems, e.g. infected burns.

Respiratory tract.

For example, 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.

Contraindications

Ceftazidime Aspen powder for injection is contraindicated in patients with hypersensitivity to cephalosporins or a 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.

Precautions

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. If an allergic reaction to ceftazidime occurs, discontinue the drug. Serious hypersensitivity reactions may require adrenaline, hydrocortisone, antihistamine or other emergency measures.
Ceftazidime should be prescribed with caution to individuals with a history of gastrointestinal disease, particularly colitis.
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 Cl. difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated.
Drugs that delay peristalsis, e.g. opiates and diphenoxylate with atropine (e.g. Lomotil), may prolong and/or worsen the condition and should not be used.
Cl 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 central nervous system, e.g. meningitis or brain abscess, 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 in individuals with a history of gastrointestinal disease, particularly colitis.
Distal necrosis can occur after inadvertent intra-arterial administration of ceftazidime.
Vials of Ceftazidime Aspen powder for injection, as supplied, are under reduced pressure; a positive pressure is produced on reconstitution due to the release of carbon dioxide (see Dosage and Administration for recommended techniques of reconstitution).

Impaired renal function.

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 Dosage and Administration).

Impaired hepatic function.

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.
Repeated use of lignocaine as a diluent for intramuscular 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.

Use in pregnancy.

(Category B1)
The safety of Ceftazidime Aspen 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 doctor, 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 breastfeeding mothers unless the expected benefits to the mother greatly outweigh any potential risk to the infant.

Paediatric use.

Ceftazidime is effective in the treatment of neonatal infections caused by susceptible organisms.

Interactions

Aminoglycoside antibiotics and/or diuretics.

Nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibiotics or potent diuretics such as furosemide. 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 aminoglycosidic antibiotics. Nephrotoxicity and ototoxicity were not noted when ceftazidime was given alone in clinical trials.

Oral contraceptives.

In common with other antibiotics, ceftazidime may effect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.

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 bacterial activity is desired, this drug combination should be avoided.

Effect 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 tablets, Benedict’s solution, or Fehling’s solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix) be used.

Adverse Effects

Clinical trial experience has shown that ceftazidime is generally well tolerated. Adverse reactions are infrequent and include the following.

Local.

Phlebitis or thrombophlebitis with intravenous administration; pain and/or inflammation after intramuscular injection.

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.

Gastrointestinal.

Diarrhoea, nausea, vomiting, abdominal pain and very rarely oral thrush or colitis. Pseudomembranous colitis has been reported.

Central nervous system.

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

Genitourinary.

Candidiasis, vaginitis.

Renal.

Transient elevations of blood urea, serum urea and/or serum creatinine have been observed occasionally.

Hepatic.

Elevations in one or more of the hepatic enzymes, AST, ALT, LDH, GGT and alkaline phosphatase, may occur.

Haematological.

Eosinophilia, positive Coombs test, thrombocytosis; very rarely, transient leucopenia, haemolytic anaemia, neutropenia, thrombocytopenia and lymphocytosis have been seen.

Other.

Hot flushes, superficial desquamation around injection site.

Dosage and Administration

Note.

Vials of Ceftazidime Aspen powder for injection as supplied are under reduced pressure; a positive pressure is produced on reconstitution due to the release of carbon dioxide.
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.
Ceftazidime Aspen powder for injection is for use in one patient only. Discard any remaining contents.

Adults.

The adult dosage range for ceftazidime is 1 g to 6 g daily, for instance, 500 mg, 1 g or 2 g given every 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 exceeding 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, infants up to 12 months.

25-100 mg/kg/day in two divided doses. In neonates the serum half-life of ceftazidime can be three to four times greater than that measured in adults.

Use in the elderly.

In view of the reduced clearance of ceftazidime in elderly patients, the daily dosage should be adjusted according to renal function.

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/minute. In patients with suspected renal insufficiency, an initial loading dose of ceftazidime 1 g may be given. An estimate of GFR should be made to determine the appropriate maintenance dose.
Recommended maintenance doses are shown in Table 3.

In patients with severe infections who would normally receive ceftazidime 6 g 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.

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.

Administration.

Ceftazidime may be given intravenously, 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, or added to intraperitoneal dialysis fluids.

Reconstitution.

Ceftazidime Aspen may be reconstituted with water for injections or, for intramuscular injection, with 0.5% lignocaine. See Table 4 for additive volumes and solution concentrations.

All sizes of vials as supplied are under reduced pressure. As the product dissolves, carbon dioxide is released and a positive pressure develops. For ease of use, it is recommended that the following techniques of reconstitution are adopted.

1 g intramuscular/intravenous and 2 g intravenous bolus vials.

Insert syringe needle through vial closure and inject recommended volume of diluent. The vacuum may assist entry of the diluent. Remove syringe needle. Shake to dissolve; carbon dioxide is released and a clear solution obtained in about one to two minutes. Invert the vial. With the syringe plunger fully depressed, insert the needle through 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 intravenous infusion vial.

This vial may be reconstituted for short intravenous infusion (e.g. up to 30 minutes) as follows. Insert syringe needle through the vial closure and inject 10 mL of diluent.
The vacuum may assist entry of the diluent. Remove the syringe needle. Shake to dissolve; carbon dioxide is released and a clear solution obtained in about one to two minutes. Insert a gas relief needle through vial closure to relieve internal pressure and, with 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.
Product is for single use in one patient only. Discard any residue.
Solutions of Ceftazidime Aspen powder for injection reconstituted in water for injections are physically and chemically stable for twelve hours if kept below 25°C or for seven days if refrigerated at 2°C to 8°C. When reconstituted in 0.5% Lignocaine Hydrochloride Injection BP, the corresponding times are six hours at below 25°C or four days under refrigeration (2°C to 8°C). Some increase in the colour of prepared solutions of Ceftazidime Aspen for injection may occur on storage. To reduce microbiological hazard, the reconstituted solution should be diluted as soon as practicable after reconstitution and administered as soon as practicable after dilution. If storage is necessary, hold at 2°C to 8°C for a total time not more than 24 hours after reconstitution.
Ceftazidime Aspen is compatible with the intravenous fluids shown below. Solutions at concentrations between 1 mg/mL and 40 mg/mL in these infusion fluids are physically and chemically stable for up to twelve hours below 25°C or seven days if refrigerated (2°C to 8°C): 0.9% Sodium Chloride Injection BP, M/6 Sodium Lactate Injection BP, M/6 Compound Sodium Lactate Injection BP (Hartmann's solution), 5% Dextrose Injection BP, Dextran 40 Injection BP 10% in 0.9% Sodium Chloride Injection BP, Dextran 40 Injection BP 10% in 5% Dextrose Injection BP, Dextran 70 Injection BP 6% in 0.9% Sodium Chloride Injection BP, Dextran 70 Injection BP 6% in 5% Dextrose Injection BP. To reduce microbiological hazard, the reconstituted solution should be diluted as soon as practicable after reconstitution and administered as soon as practicable after dilution. If storage is necessary, hold at 2°C to 8°C for a total time not more than 24 hours after reconstitution. Sodium bicarbonate injection is not recommended as a diluent.
Ceftazidime Aspen powder for injection is physically and chemically stable for up to twelve hours below 25°C or seven days under refrigeration (2°C to 8°C) at concentrations between 0.05 mg/mL and 0.25 mg/mL in Intraperitoneal Dialysis Fluid (Lactate) BPC 1973. To reduce microbiological hazard, the reconstituted solution should be diluted as soon as practicable after reconstitution and administered as soon as practicable after dilution. If storage is necessary, hold at 2°C to 8°C for a total time not more than 24 hours after reconstitution.
Ceftazidime Aspen powder for injection is physically and chemically stable for twelve hours below 25°C or seven days under refrigeration (2°C to 8°C) when admixed at 4 mg/mL with potassium chloride 10 mEq/L or 40 mEq/L in 0.9% Sodium Chloride Injection BP, or heparin (10 and 50 units/mL) in 0.9% sodium chloride. To reduce microbiological hazard, the reconstituted solution should be diluted as soon as practicable after reconstitution and administered as soon as practicable after dilution. If storage is necessary, hold at 2°C to 8°C for a total time not more than 24 hours after reconstitution.
Ceftazidime Aspen powder for injection (4 mg/mL) is physically and chemically stable for 24 hours when stored below 25°C or seven days when refrigerated (2°C to 8°C, do not freeze) when admixed with cloxacillin. To reduce microbiological hazard, the reconstituted solution should be diluted as soon as practicable after reconstitution and administered as soon as practicable after dilution. If storage is necessary, hold at 2°C to 8°C for a total time not more than 24 hours after reconstitution.
Ceftazidime Aspen powder for injection (5 mg/mL) is physically and chemically stable for twelve hours when stored below 2°C or seven days when refrigerated (2°C to 8°C, do not freeze) when admixed with metronidazole. To reduce microbiological hazard, the reconstituted solution should be diluted as soon as practicable after reconstitution and administered as soon as practicable after dilution. If storage is necessary, hold at 2°C to 8°C for a total time not more than 24 hours after reconstitution.
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 administrations of these two agents.
Protect from light.
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.

Overdosage

Symptoms.

Overdosage can lead to neurological sequelae including encephalopathy, convulsions and coma.

Treatment.

Ceftazidime can be removed by haemodialysis. Contact the Poisons Information Centre for advice on management of overdosage.

Presentation

Ceftazidime Aspen powder for injection 1 g (for IM or IV use) or 2 g (for IV use).
Available in packs of 1 and 5* vials.
(* Not currently distributed in Australia).

Storage

Store below 25°C. Protect from light.

Poison Schedule

S4.

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Ceftazidime Aspen Powder for injection

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