Patient leaflet - Ceftazidime 500 mg powder for solution for injection
1. What Ceftazidime is and what it is used for
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.
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
Ceftazidime contains sodium (main component of cooking/table salt)
called cephalosporins.
Ceftazidime is used to treat severe bacterial infections of:
You need to take this into account if you are on a controlled sodium diet.
the lungs or chest
Ceftazidime 500 mg
the lungs and bronchi in patients suffering
This medicine contains 25 mg sodium in each vial. This is equivalent to 1.25% of the recommended maximum daily dietary intake of sodium for an adult.
from cystic fibrosis
- the brain (meningitis)
- the ear
the urinary tract
Ceftazidime 1 g
the skin and soft tissues
This medicine contains 50 mg sodium in each vial. This is equivalent to 2.5% of the recommended maximum daily dietary intake of sodium for an adult.
the abdomen and abdominal wall
(peritonitis)
- the bones and joints.
Ceftazidime can also be used:
Ceftazidime 2 g
to prevent infections during prostate surgery
This medicine contains 100 mg sodium in each vial. This is equivalent to 5% of the recommended maximum daily dietary intake of sodium for an adult.
in men
to treat patients with low white blood cell
counts (neutropenia) who have a fever due
to a bacterial infection.
Reconstitution of solution – see “Instructions for reconstitution/dilution” on the end of this leaflet. Total content of sodium should be counted including sodium from dilutant. To obtain additional information on sodium content in dilutant please see leaflet of dilutant.
2. What you need to know before you are given Ceftazidime
You must not be given Ceftazidime:
if you are allergic to ceftazidime or any
of the other ingredients of this medicine
(listed in section 6);
- if you have had a severe allergic reaction
3. How Ceftazidime is given Ceftazidime is usually given by a doctor or nurse.
to any other antibiotic (penicillins,
monobactams and carbapenems) as you
may also be allergic to Ceftazidime.
Ceftazidime 500 mg powder for solution for injection
➔ Tell your doctor before you start on
Ceftazidime if you think that this applies to
Ceftazidime is given as an injection directly into a vein or into a muscle.
you. You must not be given Ceftazidime.
Take special care with Ceftazidime
Ceftazidime 1 g powder for solution for injection/infusion
You must look out for certain symptoms
such as allergic reactions, nervous system
Ceftazidime can be given as a drip (intravenous infusion) or as an injection directly into a vein or into a muscle.
disorders and gastrointestinal disorders
such as diarrhoea while you are being
given Ceftazidime. This will reduce the risk
Ceftazidime 2 g powder for solution for injection/infusion
of possible problems. See (“Conditions you
need to look out for”) in section 4. If you have
Ceftazidime can be given as a drip (intravenous infusion) or as an injection directly into a vein.
had an allergic reaction to other antibiotics
you may also be allergic to Ceftazidime.
If you need a blood or urine test
Ceftazidime is made up by the doctor, pharmacist or nurse using water for injections or a suitable infusion fluid.
Ceftazidime can affect the results of urine
tests for sugar and a blood test known as
the Coombs test. If you are having tests:
The recommended dose
➔ Tell the person taking the sample that
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.
you have been given Ceftazidime.
Other medicines and Ceftazidime
Tell your doctor if you are taking, have
recently taken or might take any other
medicines. This includes medicines you can
Newborn babies (0-2 months)
obtain without a prescription.
For every 1 kg the baby weighs, they’ll be given 25 to 60 mg Ceftazidime per day divided in two doses.
You shouldn’t be given Ceftazidime without
talking to your doctor if you are also taking:
an antibiotic called chloramphenicol
Babies (over 2 months) and children who weigh less than 40 kg
a type of antibiotic called aminoglycosides
e.g. gentamicin, tobramycin
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.
- water tablets called furosemide
➔ Tell your doctor if this applies to you.
Pregnancy, breast-feeding and fertility
Adults and adolescents who weigh 40 kg or more
Ask your doctor for advice before you are
1 to 2 g of Ceftazidime three times daily. Maximum of 9 g per day.
given Ceftazidime:
if you are pregnant, think you might be
Patients over 65 years
pregnant or are planning to become
The daily dose should not normally exceed 3 g per day, especially if you are over 80 years of age.
pregnant
- if you are breastfeeding
Your doctor will consider the benefit of
treating you with Ceftazidime against the
risk to your baby.
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The following information is intended for healthcare professionals only:
Please refer to the Summary of Product Characteristics for further information. The reconstituted product is chemically and physically stable:
- at 2°C to 8°C for 24 hours;
- below 25°C for 3 hours.
The reconstituted product does not require protection from light. From a microbiological point of view, once opened, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Special precaution for storage
This medicine does not require any special temperature storage conditions. Store in original packaging in order to protect from light.
Special precautions for disposal and other handling
All sizes of vials of Ceftazidime are supplied under reduced pressure. As the product dissolves, carbon dioxide is released and a positive pressure develops. Small bubbles of carbon dioxide in the constituted solution may be ignored.
Instructions for reconstitution/dilution
See table for addition volumes and solution concentrations, which may be useful when fractional doses are required.
Presentation Route of
administration
Amount of
diluent to be
added [ml]
Approx. ceftazidime concentration [mg/ml]
500 mg intramuscular injection 1.5 260 intravenous bolus 5 90
1 g intramuscular injection 3 260 intravenous bolus 10 90 intravenous infusion 50* 20
2 g intravenous bolus 10 170 intravenous infusion 50* 40
* Addition should be in two stages
Note:
The resulting volume of the solution of ceftazidime in reconstitution medium is increased due to the displacement factor of the drug product resulting in the listed concentrations in mg/ml presented in the above table.
Solutions may range in colour from colorless to pale-yellow depending on concentration and storage conditions used. Within the stated recommendations, product potency is not adversely affected by such colour variations.
Recommended dilution media are:
- 0.9% sodium chloride;
- 5% glucose solution for infusion;
- 5% glucose et 0.9% sodium chloride, 1:1;
- 5% glucose et 0.9% sodium chloride, 2:1;
- Ringer solution;
- lactated Ringer’s solution;
- water for injection.
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.
Other side effects
Other side effects have occurred in a small number of people but their exact frequency is unknown:
- pins and needles
- unpleasant taste in the mouth
- yellowing of the whites of the eyes or skin.
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.
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
If you forget to use Ceftazidime
If you miss an injection, you should have it
as soon as possible. Don’t take a double
dose (two injections at the same time) to
make up for a missed dose, just take your
next dose at the usual time.
Don’t stop taking Ceftazidime
Don’t stop taking Ceftazidime unless your
doctor tells you to. If you have any further
questions on the use of this medicine, ask
your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Conditions you need to look out for
- 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 to Yellow Card Scheme via www.mhra.gov.uk/ yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Ceftazidime
Keep this medicine out of the sight and reach of children.
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).
Do not use this medicine after the expiry date which is stated on the vial and carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions. Store in original packaging in order to protect from light.
The reconstituted product is chemically and physically stable:
- at 2°C to 8°C for 24 hours;
- below 25°C for 3 hours.
The reconstituted product does not require protection from light.
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.
There have been rare reports of severe
hypersensitivity reactions with severe
rash, which may be accompanied by
fever, fatigue, swelling of the face or lymph
glands, increase of eosinophils (type of
white blood cells), effects on liver, kidney
or lung (a reaction called DRESS).
➔ 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 itchiness
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
Do not throw away any medicines via wastewater or household waste. Your doctor or nurse will throw away any medicine that is no longer required. This will help protect the environment.
6. Contents of the pack and other information
What Ceftazidime contains
- Ceftazidime is available in the following strengths: 2 g, 1 g and 500 mg. The active substance is 2 g, 1 g or 500 mg of ceftazidime (present as ceftazidime pentahydrate).
- The only other ingredient is sodium carbonate.
What Ceftazidime looks like and contents of the pack
Ceftazidime is a white or pale-yellow powder filled in glass vial (15 ml for Ceftazidime 500 mg and 20 ml for Ceftazidime 1 g, 2 g) with a bromobutyl rubber stopper, aluminium cap or aluminium cap and plastic flip-off. Pack contains 10 vials.
Your doctor, pharmacist or nurse will make the injection or infusion up with water for Injections or a suitable infusion fluid. When made up, Ceftazidime varies in colour from colorless to pale-yellow. This is perfectly normal.
Marketing Authorisation Holder hameln pharma ltd
Nexus, Gloucester Business Park Gloucester, GL3 4AG
United Kingdom
Manufacturer
hameln rds s.r.o.
Horna 36, 900 01 Modra
Slovak Republic
- dizziness
- stomach ache
feeling sick or being sick
This leaflet was last revised in March 2025
- fever and chills.
➔ Tell your doctor if you get any of these.
xxx/09/25
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.
Very rare side effects
These may affect up to 1 in 10,000 people:
inflammation or failure of the kidneys.
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Ceftazidime at concentrations between 1 mg/ml and 40 mg/ml is compatible with the listed above diluents.
Ceftazidime may be constituted for intramuscular use with 1% lidocaine hydrochloride for injections.
Preparation of solutions for bolus injection
- 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 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 intravenous fluids listed above.
Preparation of solutions for intravenous infusion
Prepare using a total of 50 ml (for 1 g and 2 g vials) of compatible diluent (listed above), added in TWO stages as described below.
- 1. Puncture the stopper with a needle and inject 10 ml of the diluent into a 1 g and 2 g vial.
- 2. Withdraw the needle and shake the vial to obtain 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 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 medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities
Ceftazidime is less stable in sodium bicarbonate solution than in other intravenous fluids. It is not recommended as a diluent.
Ceftazidime and aminoglycosides should not be mixed in the same giving set or syringe. Precipitation has been reported with vancomycin added to ceftazidime in solution. Therefore, the application kit and intravenous access should be flushed between the administration of these two drugs.