Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I being given DBL Cefotaxime Sodium?
DBL Cefotaxime Sodium contains the active ingredient Cefotaxime Sodium.
DBL Cefotaxime Sodium is an antibiotic used to treat infections of the kidneys and
bladder, blood, skin and flesh immediately under the skin, bones, heart valves, brain,
abdomen and some sexually transmitted infections (gonorrhoea).
2. What should I know before I am given DBL Cefotaxime Sodium?
Do not use if you have ever had an allergic reaction to DBL Cefotaxime Sodium or any
similar medicines known as cephalosporins or if you have had a major allergic reaction
to penicillin. Cefotaxime should not be mixed with lignocaine and given if you have
had an allergic reaction to lignocaine or other local anaesthetics, if you have heart
failure or heart block or to infants less than 30 months old.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with DBL Cefotaxime Sodium and affect how it works.
4. How will I be given DBL Cefotaxime Sodium?
DBL Cefotaxime Sodium should only be given by a doctor or nurse. It may be given by
direct injection into a vein or as a slow injection or infusion (intravenous drip)
into a vein or as a deep injection into a large muscle. Your doctor will decide what
dose you will receive and how long you will receive DBL Cefotaxime Sodium for. This
depends on your infection and other factors, such as your weight. More instructions
can be found in Section
4. How will I be given DBL Cefotaxime Sodium? in the full CMI.
5. What should I know while being given DBL Cefotaxime Sodium ?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are being given DBL Cefotaxime
Sodium.
If your symptoms of your infection do not improve within a few days, or if they become
worse, tell your doctor. If you get severe diarrhoea, tell your doctor or nurse immediately.
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Things you should not do
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Do not use if you have ever had an allergic reaction to DBL Cefotaxime Sodium or any
similar medicines known as cephalosporins or if you had a major allergic reaction
to penicillin or to lignocaine. DBL Cefotaxime Sodium should not be given if you are
pregnant or breastfeeding.
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Driving or using machines
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DBL Cefotaxime Sodium may affect your ability to drive a car or operate machinery.
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Looking after your medicine
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DBL Cefotaxime Sodium will be stored in the hospital pharmacy or on the ward in a
cool, dry place, protected from heat and light, where the temperature stays below
25°C.
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6. Are there any side effects?
Side effects include white, furry, sore tongue and mouth, a sore and itchy vagina
and/or discharge, signs of frequent infections such as fever, sore throat, swollen
glands or mouth ulcers, nausea or diarrhoea, pain, swelling, redness or tenderness
near the injection site, skin rash and itchiness. Some serious side effects include
signs of an allergic reaction, such as rash, itching or hives, swelling of the face
and lips, shortness of breath, wheezing or difficulty breathing, severe blisters and
bleeding, ulcerations or lesions of the skin or in the mouth, severe stomach cramps,
watery and severe diarrhoea, fever in combination with cramps/ diarrhoea. For more
information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
Cefotaxime sodium.
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL Cefotaxime Sodium. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using
DBL Cefotaxime Sodium.
Where to find information in this leaflet:
1. Why am I being given DBL Cefotaxime Sodium?
DBL Cefotaxime Sodium contains the active ingredient Cefotaxime Sodium. DBL Cefotaxime Sodium is an antibiotic. Cefotaxime belongs to a group of antibiotics
called cephalosporins. These antibiotics work by killing the bacteria that are causing
your infection. DBL Cefotaxime Sodium is used to treat infections of the:
kidneys and bladder
blood (septicaemia)
skin and flesh immediately under the skin
bones
heart valves
brain (meningitis)
abdomen (peritonitis)
some sexually transmitted infections (gonorrhoea).
It is also used to prevent infections before, during and after surgery.
Cefotaxime will not work against infections caused by viruses such as colds or the
flu.
Your doctor may have prescribed cefotaxime for another reason.
2. What should I know before I am given DBL Cefotaxime Sodium?
Warnings
Do not use DBL Cefotaxime Sodium if:
you are allergic to cefotaxime or any similar medicines known as cephalosporins
you have had a major allergic reaction to penicillins
if you are pregnant or breastfeeding
Cefotaxime should not be mixed with lignocaine and given:
if you have had an allergic reaction to lignocaine or other local anaesthetics
if you have heart failure or heart block
to infants less than 30 months old
Sometimes DBL Cefotaxime Sodium is mixed with lignocaine hydrochloride so that the
injection into the muscle is less painful.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have of the following medical conditions: kidney disease, liver disease, stomach or
bowel problems or asthma.
Have a low white blood cell count (neutropenia)
are on a low salt diet
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
DBL Cefotaxime Sodium
should not be given if you are pregnant or breastfeeding.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with DBL Cefotaxime Sodium and affect how it works. These
include:
aminoglycoside antibiotics (such as gentamicin)
other antibiotic medicines (such as tetracyclines, erythromycin and chloramphenicol)
probenecid, a medicine used to treat gout
"water" tablets or diuretics (such as furosemide).
Talk to your doctor about the need for an additional method of contraception while
being given DBL Cefotaxime Sodium.
Some antibiotics may decrease the effectiveness of some birth control pills, although
this has not been shown with cefotaxime.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect DBL Cefotaxime Sodium.
4. How will I be given DBL Cefotaxime Sodium?
How much will be given
DBL Cefotaxime Sodium may be given by:
direct injection into a vein or as a slow injection or infusion (intravenous drip)
into a vein
as a deep injection into a large muscle.
DBL Cefotaxime Sodium
should only be given by a doctor or nurse.
Your doctor will decide what dose of DBL Cefotaxime Sodium you will receive and for
how long you will receive it. This depends on your infection and other factors, such
as your weight. For most infections, it is usually given in divided doses throughout
the day.
Sometimes only a single dose of DBL Cefotaxime Sodium is required for the treatment
of certain infections.
If you are given too much DBL Cefotaxime Sodium
As DBL Cefotaxime Sodium is given under medical supervision; it is very unlikely that
you will receive too much. If you think that you have been given too much, you may
need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while being given DBL Cefotaxime Sodium?
Things you should do
Call your doctor straight away if:
the symptoms of your infection do not improve within a few days, or if they become
worse
you get severe diarrhoea. Do this even if it occurs several weeks after cefotaxime
has been stopped. Do not take any diarrhoea medicine without first checking with your
doctor. Diarrhoea may mean that you have a serious condition affecting your bowel.
You may need urgent medical care.
you get a sore white mouth or tongue while being given or soon after stopping cefotaxime.
Also tell your doctor if you get vaginal itching or discharge. This may mean you have
a fungal infection called thrush. Sometimes the use of DBL Cefotaxime Sodium allows
fungi to grow and the above symptoms to occur. Cefotaxime does not work against fungi.
you become pregnant while you are being treated with cefotaxime.
If you have to test your urine for sugar while you are being given DBL Cefotaxime
Sodium, make sure your doctor knows which type of test you use. This medicine may
affect the results of some of these tests.
If you have to have any blood tests, tell your doctor you are being given DBL Cefotaxime
Sodium. This medicine may affect the results of some blood tests.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how
DBL Cefotaxime Sodium
affects you.
DBL Cefotaxime Sodium may cause dizziness, drowsiness, seizures or unusual body movements
in some people. If you have any of these symptoms, do not drive, operate machinery
or do anything else that could be dangerous.
Drinking alcohol
No information available.
Looking after your medicine
DBL Cefotaxime Sodium will be stored in the hospital pharmacy or on the ward.
DBL Cefotaxime Sodium should be kept in a cool, dry place, protected from heat and
light, where the temperature stays below 25°C.
The reconstituted solution must be used immediately and any unused solution should
be discarded.
Keep it where young children cannot reach it.
When to discard your medicine
Discard any medicine that has passed the expiry date.
This medicine should only be used in one patient and any unused medicine should be
discarded.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Serious side effects
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Serious side effects
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What to do
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a white, furry, sore tongue and mouth (oral thrush)
a sore and itchy vagina and/or discharge (vaginal thrush)
severe blisters and bleeding in the lips, eyes, mouth, nose or genitals
itchy spots accompanied by fever and feeling unwell
ulceration or lesions on the skin or in the mouth
loss of appetite
signs of an allergic reaction, such as rash, itching or hives on the skin; swelling
of the face, lips, tongue or other parts of the body; shortness of breath, wheezing
or difficulty breathing
severe abdominal cramps, severe persistent diarrhoea which may be bloody, fever (with
or without cramps/diarrhoea). It may develop during treatment or several weeks after
you stop cefotaxime
fast or irregular heartbeat
changes in the rhythm or rate of the heartbeat
chest pain
blood in the urine or decreased urine output or fluid retention with swelling of the
legs, ankles or feet
unusual bleeding or bruising under the skin
signs of anaemia, such as tiredness, headache, dizziness being short of breath when
exercising or looking pale
yellowing of the skin or eyes, also known as jaundice
seizures or abnormal movements.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/safety/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Cefotaxime Sodium contains
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Active ingredient
(main ingredient)
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Cefotaxime Sodium (equivalent to 1 g of Cefotaxime)
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Other ingredients
(inactive ingredients)
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Sodium (each gram of Cefotaxime contains 48.2 mg of sodium)
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Do not take this medicine if you are allergic to any of these ingredients.
DBL Cefotaxime Sodium does not contain gluten, lactose, sucrose, tartrazine or any
other azo dyes.
What DBL Cefotaxime Sodium looks like
DBL Cefotaxime Sodium is a white to pale yellow crystalline powder. It is supplied
in a glass vial with a rubber stopper in packs of 1 vial (AUST R 78702).
Who distributes DBL Cefotaxime Sodium
Pfizer Australia Pty Ltd
Sydney NSW
This leaflet was prepared in February 2025.