Skip to Content

CEFTAZIDIME 2G POWDER FOR SOLUTION FOR INJECTION AND INFUSION

Active substance(s): CEFTAZIDIME PENTAHYDRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Ceftazidime 500, 1g, Powder for solution for injection
Ceftazidime 2g, Powder for solution for injection/infusion
Ceftazidime
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor.
In this leaflet:
1. What Ceftazidime Injection is and what it is used for
2. Before you are given Ceftazidime Injection
3. How Ceftazidime Injection is given
4. Possible side effects
5. How to store Ceftazidime Injection
6. Further information
The name of your medicine is “Ceftazidime powder for solution for injection or infusion” (referred to as
Ceftazidime Injection throughout this leaflet).
1. WHAT Ceftazidime Injection IS AND WHAT IT IS USED FOR
Ceftazidime is an antibiotic used in adults and children (including newborn babies). It works by killing
bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Ceftazidime is used to treat severe bacterial infections of:
• the lungs or chest
• the lungs and bronchi in patients suffering from cystic fibrosis
• the brain (meningitis)
• the ear
• the urinary tract
• the skin and soft tissues
• the abdomen and abdominal wall (peritonitis)
• the bones and joints.
Ceftazidime can also be used:
• to prevent infections during prostate surgery in men
• to treat patients with low white blood cell counts (neutropenia) who have a fever due to a
bacterial infection.
2. BEFORE YOU ARE GIVEN Ceftazidime Injection
You must not be given Ceftazidime Injection:
• if you are allergic (hypersensitive) to ceftazidime or the other ingredients of this medicine (see section 6).
• if you have had a severe allergic reaction to any other antibiotic (penicillins, monobactams and
carbapenems) as you may also be allergic to Ceftazidime.
Tell your doctor before you start on Ceftazidime if you think that this applies to you. You must not be
given Ceftazidime Injection.
Take special care with Ceftazidime Injection
You must look out for certain symptoms such as allergic reactions, nervous system disorders and
gastrointestinal disorders such as diarrhoea while you are being given Ceftazidime. This will reduce
the risk of possible problems. See ‘Conditions you need to look out for’ in Section 4.
If you have had an allergic reaction to other antibiotics you may also be allergic to Ceftazidime.
If you need a blood or urine test
Ceftazidime can affect the results of urine tests for sugar and a blood test known as the ‘Coombs
test’. If you are having tests, tell the person taking the sample that you have been given Ceftazidime.
Taking other medicines
Tell your doctor if you are taking any other medicines, if you’ve started taking any recently or you start
taking new ones. This includes medicines you can obtain without a prescription.
You shouldn’t be given Ceftazidime without talking to your doctor if you are also taking:
• an antibiotic called chloramphenicol
• a type of antibiotic called aminoglycosides e.g. gentamicin, tobramycin
• water tablets called furosemide
Tell your doctor if this applies to you.
Pregnancy and breast-feeding
Tell your doctor before you are given Ceftazidime:
• If you are pregnant, think you might be pregnant or are planning to become pregnant
• If you are breastfeeding
Your doctor will consider the benefit of treating you with Ceftazidime against the risk to your baby.
Driving and using machines
Ceftazidime can cause side effects that affect your ability to drive, such as dizziness.
Don’t drive or use machines unless you are sure you’re not affected.
Important information about some of the ingredients of Ceftazidime Injection
Ceftazidime Injection 500 mg contains 26 mg sodium per vial; Ceftazidime Injection 1g contains
52 mg sodium per vial; Ceftazidime Injection 2g contains 104 mg sodium per vial.
You need to take this into account if you are on a controlled sodium diet.
3. HOW Ceftazidime Injection IS GIVEN
Ceftazidime Injection is usually given by a doctor or nurse. It can be given as a drip (intravenous
infusion) or as an injection directly into a vein or into a muscle.
Ceftazidime Injection is made up by the doctor, pharmacist or nurse using water for injections or a
suitable infusion fluid.
The usual dose
The correct dose of Ceftazidime for you will be decided by your doctor and depends on: the severity
and type of infection; whether you are on any other antibiotics; your weight and age; how well your
kidneys are working.
Newborn babies (0-2 months):
For every 1 kg the baby weighs, they’ll be given 25 to 60 mg Ceftazidime per day divided in two doses.
Babies (over 2 months) and children who weigh less than 40 kg
For every 1 kg the baby or child weighs, they’ll be given 100 to 150 mg of Ceftazidime per day divided
in three doses. Maximum 6 g per day.
Adults and adolescents who weigh 40 kg or more
1 to 2 g of Ceftazidime three times daily. Maximum of 9 g per day.

INFORMATION FOR THE HEALTHCARE PROFESSIONAL
The following information is intended for medical or healthcare professionals.
Please refer to the Summary of Product Characteristics for further information.
Instructions for constitution
See table for addition volumes and solution concentrations, which may be useful when fractional
doses are required.
Vial size

Route

Amount of diluent
to be added (ml)

Approximate
Approximate
available
Concentration
volume (ml)
(mg/ml)
500mg
Intramuscular
1.5 ml
1.7 ml
294
500mg
Intravenous bolus
5 ml
5.2 ml
96
1g
Intramuscular
3 ml
3.5 ml
286
1g
Intravenous bolus
10 ml
10.5 ml
95
1g
Intravenous infusion
50 ml*
20
*
2g
Intravenous bolus
10 ml
11.6 ml
172
2g
Intravenous infusion
50 ml*
40
*
*Note: addition should be in two stages. See ‘Preparation of solutions for IV infusion’
Solutions range in colour 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.
Ceftazidime at concentrations between 1 mg/ml and 40 mg/ml is compatible with:
• sodium chloride 9 mg/ml (0.9%) solution for injection
• M/6 sodium lactate injection
• compound sodium lactate injection (Hartmann’s solution)
• 5% dextrose injection
• 0.225% sodium chloride and 5% dextrose injection
• 0.45% sodium chloride and 5% dextrose injection
• 0.9% sodium chloride and 5% dextrose injection
• 0.18% sodium chloride and 4% dextrose injection
• 10% dextrose Injection
• Dextran 40 injection 10% in 0.9% sodium chloride injection
• Dextran 40 injection 10% in 5% dextrose Injection
• Dextran 70 injection 6% in 0.9% sodium chloride injection
• Dextran 70 injection 6% in 5% dextrose injection.
Ceftazidime at concentrations between 0.05 mg/ml and 0.25 mg/ml is compatible with Intraperitoneal Dialysis Fluid (Lactate).
Ceftazidime may be constituted for intramuscular use with 0.5% or 1% Lidocaine Hydrochloride Injection.
The contents of a 500 mg vial of ceftazidime for injection, constituted with 1.5 ml water for injections,
may be added to metronidazole injection (500 mg in 100 ml) and both retain their activity.
Preparation of solutions for bolus injection
1. Insert the syringe needle through the vial closure and inject the recommended volume of diluent.
Remove the syringe needle.
2. Shake to dissolve: carbon dioxide is released and a clear solution will be obtained in about 1 to
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 head
space. The withdrawn solution may contain small bubbles of carbon dioxide; they may be
disregarded.
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. Ceftazidime is compatible with the most commonly used
intravenous fluids.
Preparation of solutions for iv infusion
Prepare using a total of 50 ml of compatible diluent, added in TWO stages as below.
1. Introduce the syringe needle through the vial closure and inject 10 ml of diluent.
2. Withdraw the needle and shake the vial to give a clear solution.
3. Do not insert a gas relief needle until the product has dissolved. Insert a gas relief needle through
the vial closure to relieve the internal pressure.
4. Transfer the reconstituted solution to final delivery vehicle (e.g. mini-bag or burette-type set) making
up a total volume of at least 50 ml, and administer by intravenous infusion over 15 to 30 min.
Note: To preserve product sterility, it is important that the gas relief needle is not inserted through the
vial closure before the product has dissolved.
Any unused product or waste material should be disposed of in accordance with local requirements.
Posology
Adults and children ≥ 40 kg
Intermittent Administration
Infection

Dose to be administered

Broncho-pulmonary infections in cystic fibrosis
Febrile neutropenia

100 to 150 mg/kg/day every 8 h,
maximum 9 g per day1
2 g every 8 h

Nosocomial pneumonia
Bacterial meningitis
Bacteraemia*
Bone and joint infections

1-2 g every 8 h

Complicated skin and soft tissue infections
Complicated intra-abdominal infections
Peritonitis associated with dialysis in patients on CAPD
Complicated urinary tract infections

1-2 g every 8 h or 12 h

Peri-operative prophylaxis for transuretheral resection
of prostate (TURP)

1 g at induction of anaesthesia,
and a second dose at catheter removal

Chronic suppurative otitis media

1 g to 2 g every 8h

Malignant otitis externa
Continuous infusion
Infection

Dose to be administered

Febrile neutropenia
Nosocomial pneumonia
Broncho-pulmonary infections in cystic fibrosis

Loading dose of 2 g followed by a
continuous infusion of 4 to 6 g every 24 h1

Bacterial meningitis
Bacteraemia*
Bone and joint infections
Complicated skin and soft tissue infections
Complicated intra-abdominal infections
Peritonitis associated with dialysis in patients on CAPD
1

In adults with normal renal function 9 g/day has been used without adverse effects.

* When associated with, or suspected to be associated with, any of the infections listed in
section 4.1 of the SPC.
Children < 40 kg
Infants and toddlers > 2 months and children < 40 kg
Intermittent Administration
Infection

Usual dose

Complicated urinary tract infections

100-150 mg/kg/day in three
divided doses, maximum 6 g/day

Chronic suppurative otitis media
Malignant otitis externa
Neutropenic children
Broncho-pulmonary infections in cystic fibrosis

150 mg/kg/day in three divided doses,
maximum 6 g/day

Bacterial meningitis
Bacteraemia*

ACSI104F00
FRONT

Patients over 65
The daily dose should not normally exceed 3 g per day, especially if you are over 80 years of age.
Patients with kidney problems
You may be given a different dose to the usual dose. The doctor or nurse will decide how much
Ceftazidime you will need, depending on the severity of the kidney disease. Your doctor will check
you closely and you may have more regular kidney function tests.
If you are given more Ceftazidime than you should
If you accidentally use more than your prescribed dose, contact your doctor or nearest hospital
straight away.
If you forget to use Ceftazidime
If you miss an injection, you should have it as soon as possible. However, if it is almost time for your
next injection, skip the missed injection. Don’t take a double dose (two injections at the same time)
to make up for a missed dose.
If you stop using Ceftazidime
Don’t stop taking Ceftazidime unless your doctor tells you to.
If you have any questions ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ceftazidime can cause side effects, although not everybody gets them.
Conditions you need to look out for
The following serious side effects have occurred in a small number of people but their exact frequency
is unknown:
• severe allergic reaction. Signs include raised and itchy rash, swelling, sometimes of the face or
mouth causing difficulty in breathing.
• skin rash, which may blister, and looks like small targets (central dark spot surrounded by a paler
area, with a dark ring around the edge).
• a widespread rash with blisters and peeling skin. (These may be signs of ‘Stevens-Johnson
syndrome’ or ‘toxic epidermal necrolysis’).
• nervous system disorders: tremors, fits and, in some cases coma. These have occurred in people
when the dose they are given is too high, particularly in people with kidney disease.
Contact a doctor or nurse immediately if you get any of these symptoms.
Common side effects
These may affect up to 1 in 10 people:
• diarrhoea
• swelling and redness along a vein
• red raised skin rash which may be itchy
• pain, burning, swelling or inflammation at the injection site.
Tell your doctor if any of these are troubling you.
Common side effects that may show up in blood tests:
• an increase in a type of white blood cell (eosinophilia)
• an increase in the number of cells that help the blood to clot
• an increase in liver enzymes.
Uncommon side effects
These may affect up to 1 in 100 people:
• inflammation of the gut which can cause pain or diarrhoea which may contain blood
• thrush -fungal infections in the mouth or vagina
• headache
• dizziness
• stomach ache
• feeling sick or being sick
• fever and chills.
Tell your doctor if you get any of these.
Uncommon side effects that may show up in blood tests:
• a decrease in the number of white blood cells
• a decrease in the number of blood platelets (cells that help the blood to clot)
• an increase in the level of urea, urea nitrogen or serum creatinine in the blood.
Other side effects
Other side effects have occurred in a small number of people but their exact frequency is unknown:
• inflammation or failure of the kidneys
• pins and needles
• unpleasant taste in the mouth
• yellowing of the whites of the eyes or skin.
Other side effects that may show up in blood tests:
• red blood cells destroyed too quickly
• an increase in a certain type of white blood cells
• severe decrease in the number of white blood cells.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information
on the safety of this medicine.
5. HOW TO STORE CEFTAZIDIME INJECTION
Keep out of the reach and sight of children.
Do not use Ceftazidime Injection after the expiry date which is printed on the label and carton.
Store the vial in the outer carton to protect from light.
6. FURTHER INFORMATION
What Ceftazidime Injection contains
Each vial contains 500mg, 1g or 2g Ceftazidime (as pentahydrate).
The other ingredient is sodium carbonate anhydrous (E500)
What Ceftazidime Injection looks like and contents of the pack
Ceftazidime Injection is a white to cream-coloured powder in a glass vial.
Each carton contains 1, 5, 10, 20 or 50 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Villerton Invest SA, 40 Avenue Monterey, L-2163 Luxembourg
Manufacturer
Facta Farmaceutici SpA, 64100 Teramo, Italy
This leaflet was last revised in January 2015.

L08GBCFZ02

Infants and toddlers > 2 months and children < 40 kg (cont.)
Bone and joint infections

100-150 mg/kg/day in three
divided doses, maximum 6 g/day

Complicated skin and soft tissue infections
Complicated intra-abdominal infections
Peritonitis associated with dialysis in patients on CAPD
Continuous infusion
Febrile neutropenia

Loading dose of 60-100 mg/kg
followed by a continuous infusion
100-200 mg/kg/day, maximum 6 g/day

Nosocomial pneumonia
Broncho-pulmonary infections in cystic fibrosis
Bacterial meningitis
Bacteraemia*
Bone and joint infections
Complicated skin and soft tissue infections
Complicated intra-abdominal infections
Peritonitis associated with dialysis in patients on CAPD

* Where associated with, or suspected to be associated with, any of the infections listed in
section 4.1 of the SPC.
Neonates and infants ≤ 2 months
Intermittent Administration
Most infections
1

25-60 mg/kg/day in two divided doses1

In neonates and infants ≤ 2 months, the serum half life of ceftazidime can be three to four times
that in adults.

Elderly: The daily dose should not normally exceed 3 g in those over 80 years of age.
Hepatic impairment: Close clinical monitoring for safety and efficacy is advised.
Renal impairment: Dosage should be reduced. An initial loading dose of 1 g should be given.
Maintenance doses should be based on creatinine clearance:
Recommended maintenance doses in renal impairment – intermittent infusion
Adults and children > 40 kg
Creatinine
clearance (ml/min)

Approx. serum creatinine
μmol/l (mg/dl)

Recommended unit
dose of ceftazidime (g)

Frequency of dosing
(hourly)

50-31

150-200 (1.7-2.3)

1

12

30-16

200-350 (2.3-4.0)

1

24

15-6

350-500 (4.0-5.6)

0.5

24

>500 (>5.6)

0.5

48

<5
Children < 40 kg
Creatinine
clearance (ml/min)**

Approx. serum creatinine*
μmol/l (mg/dl)

Recommended individual
dose (mg/kg body weight)

Frequency of
dosing (hourly)

50-31

150-200 (1.7-2.3)

25

12

30-16

200-350 (2.3-4.0)

25

24

15-6

350-500 (4.0-5.6)

12.5

24

>500 (>5.6)

12.5

48

<5
* Guideline values

** Estimated based on body surface area, or measured.
Close clinical monitoring is advised.
Recommended maintenance doses in renal impairment – continuous infusion
Adults and children ≥ 40 kg
Creatinine
clearance (ml/min)**

Approx. serum creatinine
μmol/l (mg/dl)

Frequency of dosing (hourly)

50 – 31

150-200
(1.7-2.3)

Loading dose of 2g followed by 1g to 3g/24 hours

30 – 16

200-350
(2.3-4.0)

Loading dose of 2g followed by 1g /24 hours

> 350
(>4.0)

Not evaluated

≤ 15

** Estimated based on body surface area, or measured.
Caution is advised in dose selection. Close clinical monitoring is advised.
Children < 40 kg
If continuous infusion is used in children with renal impairment, the creatinine clearance should be
adjusted for body surface area or lean body mass. Close clinical monitoring is advised.
Haemodialysis
The serum half-life during haemodialysis ranges from 3 to 5 h.
Following each haemodialysis period, the maintenance dose of ceftazidime recommended in the
below table should be repeated.
Peritoneal dialysis
Ceftazidime may be used in peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD).
In addition to intravenous use, ceftazidime can be incorporated into the dialysis fluid (usually 125 to
250 mg for 2 litres of dialysis solution).
For patients in renal failure on continuous arterio-venous haemodialysis or high-flux haemofiltration in
intensive therapy units: 1 g daily either as a single dose or in divided doses. For low-flux haemofiltration,
follow the dose recommended under renal impairment.
For patients on veno-venous haemofiltration and veno-venous haemodialysis, follow the dosage
recommendations in the tables below.
Continuous veno-venous haemofiltration dose guidelines
Residual renal function
(creatinine clearance ml/min)

1

Maintenance dose (mg) for an ultrafiltration rate (ml/min) of 1:
5

16.7

33.3

50

0

250

250

500

500

5

250

250

500

500

10

250

500

500

750

15

250

500

500

750

20

500

500

500

750

Maintenance dose to be administered every 12h

Continuous veno-venous haemodialysis dose guidelines
Residual renal function
(creatinine clearance ml/min)

0

1

Maintenance dose (mg) for a dialysate in flow rate of 1
1.0 litre/h

2.0 litre/h

Ultrafiltration rate (litres/h)

Ultrafiltration rate (litres/h)

0.5

1.0

2.0

0.5

1.0

2.0

500

500

500

500

500

750

5

500

500

750

500

500

750

10

500

500

750

500

750

1000

15

500

750

750

750

750

1000

20

750

750

1000

750

750

1000

Maintenance dose to be administered every 12h

L08GBCFZ02

ACSI104F00
BACK

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide