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 treated with DBL Dobutamine Hydrochloride Injection?
DBL Dobutamine Hydrochloride Injection contains the active ingredient dobutamine hydrochloride.
DBL Dobutamine Hydrochloride Injection is used in patients who require short-term
treatment of heart failure following a heart attack or heart surgery.
2. What should I know before treatment with DBL Dobutamine Hydrochloride Injection?
Do not use if you have ever had an allergic reaction to dobutamine hydrochloride,
sodium metabisulfite or any of the other ingredients listed at the end of the CMI.
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 Dobutamine Hydrochloride Injection and affect
how it works.
4. How is DBL Dobutamine Hydrochloride Injection given?
Your doctor will decide what dose of dobutamine you will receive. This depends on
your condition and other factors, such as your weight.
DBL Dobutamine Hydrochloride Injection is given to you by a doctor or nurse as a slow
injection into a vein (via a ‘drip’).
5. What should I know during treatment with DBL Dobutamine Hydrochloride Injection?
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Things you should do
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Remind any doctor, nurse, pharmacist or dentist you visit that you were or are being
treated with DBL Dobutamine Hydrochloride Injection.
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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 DBL Dobutamine
Hydrochloride Injection affects you.
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6. Are there any side effects?
Side effects include: nausea and vomiting, and headache. Serious side effects include:
pain or tenderness at the injection site, allergic reaction symptoms (which include
shortness of breath, wheezing or difficulty breathing, swelling of the face, lips,
tongue or other parts of the body, rash, itching or hives on the skin), fast or irregular
heart beat, chest pain (such as angina pain), shortness of breath, tremors or shaking,
and feeling anxious or nervous.
Active ingredient(s):
Dobutamine Hydrochloride (do-BEWT-a-meen)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL Dobutamine Hydrochloride
Injection. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about being treated with DBL Dobutamine Hydrochloride
Injection.
Where to find information in this leaflet:
1. Why am I being treated with DBL Dobutamine Hydrochloride Injection?
DBL Dobutamine Hydrochloride Injection contains the active ingredient dobutamine hydrochloride.
DBL Dobutamine Hydrochloride Injection is used in patients who require short-term
treatment of heart failure following a heart attack or heart surgery.
DBL Dobutamine Hydrochloride Injection acts directly on the heart muscle to increase
the force of each contraction.
Your doctor may have prescribed this medicine for another reason.
Ask your doctor if you have any questions about why DBL Dobutamine Hydrochloride Injection
has been prescribed for you.
There is no evidence that DBL Dobutamine Hydrochloride Injection is addictive.
2. What should I know before treatment with DBL Dobutamine Hydrochloride Injection?
Warnings
You must not be given DBL Dobutamine Hydrochloride Injection if:
1. you are allergic to dobutamine hydrochloride, sodium metabisulfite or any of the other
ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction to DBL Dobutamine Hydrochloride Injection may include:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Always check the ingredients to make sure you can use this medicine.
2. you have a heart condition called idiopathic hypertrophic subaortic stenosis (a narrowing
of an artery coming from the heart).
If you are not sure whether you should be given DBL Dobutamine Hydrochloride Injection,
talk to your doctor or pharmacist.
Check with your doctor if you:
have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
have or have had any other medical conditions, especially the following:
high blood pressure
fast or irregular heart beat
other heart problems
low potassium levels (hypokalaemia)
take any medicines for any other condition
If you have not told your doctor or pharmacist about any of the above, tell them before
you start being treated with DBL Dobutamine Hydrochloride Injection.
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 Dobutamine Hydrochloride Injection is not recommended for use during pregnancy.
If there is a need to consider dobutamine during pregnancy, your doctor will discuss
with you the benefits and risks of being given it.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
You should not breastfeed while being given DBL Dobutamine Hydrochloride Injection.
Use in Children
DBL Dobutamine Hydrochloride Injection is not recommended in children as the safety
and effectiveness of dobutamine in children have not been established.
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 Dobutamine Hydrochloride Injection and affect
how it works.
These include:
some general anaesthetics, such as halothane
beta-blockers, a type of medication used for heart and blood pressure problems.
entacapone, a medicine used for Parkinson’s disease
glyceryl trinitrate, a medicine used for angina.
These medicines may be affected by DBL Dobutamine Hydrochloride Injection, or may
affect how well it works. You may need different amounts of your medicine, or you
may need to take or use different medicines. Your doctor or pharmacist will advise
you.
Your doctor and pharmacist may have more information on medicines to be careful with
or avoid while being treated with DBL Dobutamine Hydrochloride Injection.
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 Dobutamine Hydrochloride Injection.
4. How is DBL Dobutamine Hydrochloride Injection given?
How much is given
Your doctor will decide what dose of dobutamine you will receive. This depends on
your condition and other factors, such as your weight.
How is it given
DBL Dobutamine Hydrochloride Injection is given as a slow injection into a vein (via
a ‘drip’). It must only be given by a doctor or nurse.
If you are given too much DBL Dobutamine Hydrochloride Injection
As DBL Dobutamine Hydrochloride Injection is given to you under the supervision of
your doctor, it is very unlikely that you will receive too much.
If you think that you have been given too much DBL Dobutamine Hydrochloride Injection,
you may need urgent medical attention.
You should immediately:
contact your doctor, or
phone the Poisons Information Centre
(by calling
13 11 26), or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Symptoms of a dobutamine overdose include the side effects listed below in Section
6. Are there any side effects? but are usually of a more severe nature.
5. What should I know during treatment with DBL Dobutamine Hydrochloride Injection?
Things you should do
Remind any doctor, nurse, pharmacist or dentist you visit that you were or are being
treated with DBL Dobutamine Hydrochloride Injection.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DBL Dobutamine
Hydrochloride Injection affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are being given DBL Dobutamine Hydrochloride Injection.
It helps most people with heart failure, but it may have unwanted side effects in
a few people. 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
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/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 DBL Dobutamine Hydrochloride Injection contains
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Active ingredient
(main ingredient)
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dobutamine hydrochloride
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Other ingredients
(inactive ingredients)
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sodium metabisulfite
water for injections
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Do not use this medicine if you are allergic to any of these ingredients.
DBL Dobutamine Hydrochloride Injection does not contain lactose, sucrose, gluten,
tartrazine or any other azo dyes.
What DBL Dobutamine Hydrochloride Injection looks like
DBL Dobutamine Hydrochloride Injection is a clear, colourless or slightly yellow solution.
(Aust R 46451).
DBL Dobutamine Hydrochloride Injection is supplied as 250 mg/20 mL vials.
How is DBL Dobutamine Hydrochloride Injection stored
DBL Dobutamine Hydrochloride Injection will be stored in the pharmacy or on the ward.
The injection is kept in a cool dry place, protected from light, where the temperature
stays below 25°C.
Who distributes DBL Dobutamine Hydrochloride Injection
Pfizer Australia Pty Ltd
Sydney NSW
This leaflet was prepared in August 2022.