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 using AZACTAM?
AZACTAM contains the active ingredient aztreonam. AZACTAM is used to treat serious
infections caused by bacteria.
2. What should I know before I use AZACTAM?
Do not use if you have ever had an allergic reaction to AZACTAM or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions or allergies, take any
other medicines, if you have diarrhoea or usually get diarrhoea when you take antibiotics
or have ever suffered problems with your bowel, or if you are pregnant or plan to
become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with AZACTAM and affect how it works.
4. How do I use AZACTAM?
The dose of AZACTAM will be determined by your doctor.
AZACTAM will be administered as an injection or infusion in a hospital or clinic.
5. What should I know while using AZACTAM?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using AZACTAM.
Call your doctor straight away if you get severe, prolonged or bloody diarrhoea, even
if it is several weeks after AZACTAM has stopped.
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Things you should not do
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Do not take any diarrhoea medicine without checking with your doctor first
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how AZACTAM
affects you.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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Looking after your medicine
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AZACTAM will be stored in the hospital or pharmacy.
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6. Are there any side effects?
Serious side effects include signs of an allergic reaction; swelling of the face,
lips, tongue and/or throat with difficulty in swallowing or breathing; severe and
sudden onset of pinkish, itchy swelling; blistering on the skin; ulcers in the eyes
or mouth; severe persistent of bloody diarrhoea; flu-like symptoms or fever. Other
side effects include itchy skin; flushing; rash; changes to bowel habits including
diarrhoea, constipation, pain in the gut, indigestion or upset stomach; oral or vaginal
thrush; swelling or pain at the injection site; confusion; impaired consciousness;
fits or seizures; movement disorders; bleeding under the skin; dermatitis; nausea;
vomiting; bloating; altered taste.
Active ingredient(s):
Aztreonam (azz-TREE-oh-nam)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using AZACTAM. 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 AZACTAM.
Where to find information in this leaflet:
1. Why am I using AZACTAM?
AZACTAM contains the active ingredient aztreonam.
AZACTAM is used for the treatment of serious infections caused by bacteria. AZACTAM
may be used in the treatment of infections present in various parts of the body and
sometimes AZACTAM is given with other antibiotics.
Your doctor may have prescribed AZACTAM for another use. Ask your doctor if you have
any questions about why AZACTAM was prescribed for you.
AZACTAM works by killing or preventing the growth of the bacteria that is causing
your infection.
2. What should I know before I use AZACTAM?
Warnings
Do not use AZACTAM if:
you have a severe allergic reaction to AZACTAM, or any of the ingredients listed at
the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have allergies to:
any other medicines, particularly antibiotics
any of the substances, such as foods, preservatives or dyes.
have or have had any other medical conditions, especially the following:
You have diarrhoea or usually get diarrhoea when you take antibiotics or have ever
suffered problems with your bowel. If you develop severe, prolonged or bloody diarrhoea
during or after using AZACTAM. This side effect may be serious and require treatment.
Do not treat with over-the-counter diarrhoea treatments, please consult your doctor.
You have or have had liver disease.
You have renal (kidney) impairment.
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.
Check with 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.
These medicines may be affected by AZACTAM or they may affect how well AZACTAM works.
Tell your doctor if you are taking any other medicines; especially if you are taking
any of the following:
Probenecid (medicine to treat gout)
Frusemide (medicine that reduces fluid)
Know the medicines you take. Keep a list of your medicines with you to show your doctor
or pharmacist.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect AZACTAM.
If you have not told your doctor about any of the above, tell them before you take
AZACTAM.
4. How am I given AZACTAM?
How AZACTAM is given
AZACTAM will be administered as an injection or infusion in a hospital or clinic.
The AZACTAM injection will be prepared and administered by your doctor or nurse. You
will not administer AZACTAM yourself.
AZACTAM will be injected directly into your vein over 3-5 minutes or it will be administered
as an infusion over 30 minutes.
AZACTAM can also be administered as an injection into a large muscle, such as the
buttocks or thigh.
How much to take
The dose of AZACTAM will be determined by your doctor; your doctor will consider the
severity and location of your infection, your size and your medical history.
The dose of AZACTAM can range from 1.5g to 8g each day.
When to take AZACTAM
AZACTAM is given over 2, 3 or 4 injections throughout a 24-hour period.
If you miss a dose of AZACTAM
AZACTAM is administered in a hospital or clinic by a doctor or nurse. If you believe
you have missed a dose inform your doctor or nurse straight away.
If you are given to much
As your dose of AZACTAM will be determined and administered by a doctor, the chance
of receiving an overdose is most unlikely. However, if an overdose should be given
your doctor will give the appropriate treatment.
5. What should I know while using AZACTAM?
Things you should do
Tell all the doctors, dentists and pharmacists who are treating you that you are taking
AZACTAM.
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking AZACTAM.
Tell your doctor if you notice anything that is making you feel unwell. Other side
effects not listed may also occur in some patients.
Call your doctor straight away if you:
If you notice any of the following side effects, particularly if they occur several
weeks after the treatment with AZACTAM has stopped:
severe abdominal cramps or stomach cramps
watery and severe diarrhoea, which may also be bloody
fever with one or both of the above symptoms
Although these side effects are rare, you may have a serious condition affecting your
bowel and may need urgent medical attention.
become pregnant during AZACTAM treatment
Things you should not do
Do not take any diarrhoea medicine without checking with your doctor first.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how AZACTAM
affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
AZACTAM will be stored in the hospital or pharmacy under the appropriate conditions.
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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Allergic Reaction
Signs of allergic reaction, such as swelling of the face, lips, tongue and/or throat
with difficulty in swallowing or breathing.
Skin
Severe and sudden onset of pinkish, itchy swellings
blistering of the skin usually on the trunk or genital areas
Eyes and Mouth
ulcers in the eyes or mouth
Gut and Digestive System
Severe, persistent or bloody diarrhoea (which may be associated with stomach pain
or fever). This is a rare side effect which may occur after treatment with antibiotics
and can be a sign of serious bowel inflammation.
General
fever, generally feeing unwell, flu-like symptoms
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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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Other side effects
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Less serious side effects
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What to do
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Skin
Skin rash or itchiness, skin redness
Gut and Digestive System
Any change to your bowel habits - diarrhoea or constipation, pain in the gut, indigestion
or upset stomach
Mouth
Oral thrush - white, furry, sore tongue and mouth
Injection Site
Swelling, pain or inflammation at the site of the injection
Genitals
Vaginal thrush - sore and itchy vagina and/or discharge, itching or burning while
passing urine
Brain and Nervous System
confusion, impairment of consciousness, epilepsy (fits or seizures), movement disorders;
particularly in patients with renal (kidney) impairment and in association with beta-lactam
antibiotic overdose.
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Tell your doctor if you have any of these side effects.
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Common side effects
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What to do
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Skin
Allergic reaction, itchy skin, flushing
Rash, red/purple spots under the surface of the skin (bleeding under the skin), dermatitis
Blood and Liver
Changes in blood cell counts and liver function tests (these will be monitored by
your doctor)
Gut and Digestive System
Diarrhoea, nausea, vomiting, abdominal cramps/bloating
Mouth
Mouth ulcer, altered taste
Injection Site
Soreness at the injection site
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Speak to your doctor if you have any of these side effects and they worry you.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
During treatment with AZACTAM you will require close medical supervision.
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/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 AZACTAM contains
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Active ingredient
(main ingredient)
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Aztreonam
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Other ingredients
(inactive ingredients)
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L-arginine
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Do not take this medicine if you are allergic to any of these ingredients.
What AZACTAM looks like
AZACTAM for is a white powder that is prepared a solution intended for injection by
your doctor or nurse.
AZACTAM 1g vial (pack of 10 vials) (AUST R 14032)
Who distributes AZACTAM
Bristol-Myers Squibb Australia Pty Ltd
4 Nexus Court, Mulgrave,
Victoria 3170, Australia.
Toll free number: 1800 067 567
AZACTAM is a registered trademark of Bristol-Myers Squibb Company.
This leaflet was prepared in April 2024.