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 LEVOPHED?
LEVOPHED contains the active ingredient noradrenaline (norepinephrine). LEVOPHED is
used by a doctor in an emergency to restore blood pressure back to normal.
2. What should I know before treatment with LEVOPHED?
Do not start treatment if you have ever had an allergic reaction to LEVOPHED or any
of the 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 LEVOPHED and affect how it works.
4. How is LEVOPHED given?
Your doctor will decide what dose you will receive. This depends on your condition
and how you respond to LEVOPHED. Often, the dose is adjusted according to how the
medicine is affecting your blood pressure.
5. What should I know during and after treatment with LEVOPHED?
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Things you should do
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Remind any doctor, nurse, dentist or pharmacist who is treating you that you have
been given or are being given LEVOPHED.
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Driving or using machines
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Do not drive or use any machines or tools until you know how LEVOPHED affects you.
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6. Are there any side effects?
Side effects include: skin and tissue damage close to the site of injection, anxiety,
headache, dizziness, low or irregular heart-beat, tingling or numbness in the feet,
and, coldness, numbness or discolouration of your limbs.
Serious side effects include: allergic reaction symptoms (shortness of breath, wheezing
or difficulty breathing, swelling of the face, lips, mouth, throat or tongue or other
parts of the body and, rash, itching or hives on the skin), Very high blood pressure
symptoms (headache, dizziness, sensitivity to light, chest pain, slow heart-beat,
sweating and pale skin, vomiting, and trouble breathing and shortness of breath).
Active ingredient(s):
noradrenaline (norepinephrine) acid tartrate monohydrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using LEVOPHED. 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 LEVOPHED.
Where to find information in this leaflet:
1. Why am I being treated with LEVOPHED?
LEVOPHED contains the active ingredient noradrenaline (norepinephrine).
LEVOPHED belongs to a group of medicines called sympathomimetic amines.
It works by making the heart beat more forcefully and constricting blood vessels.
This results in a higher blood pressure and greater blood flow to the heart and other
organs of the body.
LEVOPHED is used to restore blood pressure back to normal. LEVOPHED is only given by a doctor in emergency situations, usually in hospital,
as a result of serious conditions which cause a dramatic drop in blood pressure.
Such conditions could be:
a heart attack
infection in the blood
severe reaction to a medicine
severe reaction to a blood transfusion
allergic reactions
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
There is no evidence that LEVOPHED is addictive.
2. What should I know before treatment with LEVOPHED?
Warnings
You must not be given LEVOPHED if:
noradrenaline (norepinephrine), or any of the ingredients listed at the end of this
leaflet.
any other similar medicines such as adrenaline (epinephrine), phenylephrine, pseudoephedrine.
sodium metabisulfite or sulfites.
Some of the symptoms of an allergic reaction 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.
low blood pressure due to low blood volume
blood clots in certain vessels.
If given in these cases, it can further reduce blood supply to important organs.
Check with your doctor if you:
have allergies to any other medicines and/or substances, such as foods, preservatives
or dyes.
have or have had any other medical conditions, especially the following:
asthma
heart problems
diabetes
high blood pressure
an overactive thyroid gland
take any medicines for any other condition.
If you have not told your doctor about any of the above, tell them before you start
receiving LEVOPHED.
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.
Your doctor will discuss the possible risks and benefits of you being given LEVOPHED
during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor will discuss the possible risks and benefits of using LEVOPHED during
breast-feeding. It is not known whether LEVOPHED passes into breast milk.
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 LEVOPHED and affect how it works.
Medicines that may increase the effect of LEVOPHED include:
antidepressants including moclobemide, imipramine and amitriptyline.
guanethidine
You may need different amounts of LEVOPHED, or you may need to take different medicines.
Your doctor or pharmacist will advise you.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect LEVOPHED.
Your doctor and pharmacist may have more information on medicines to be careful with
or avoid while being given LEVOPHED.
4. How is LEVOPHED given?
How much is given
Your doctor will decide what dose you will receive. This depends on your condition
and how you respond to LEVOPHED. Often, the dose is adjusted according to how the
medicine is affecting your blood pressure.
How LEVOPHED is given
LEVOPHED is diluted and given slowly as an infusion (a drip) into a large vein. It
will usually be given to you by a doctor.
How long LEVOPHED is given for
This medicine is given until blood pressure and blood circulation to all organs is
back to normal and remains normal even when the medicine is no longer given.
If you are given too much LEVOPHED
As LEVOPHED is given to you in hospital under the supervision of your doctor, it is
very unlikely that you will receive too much.
Symptoms of an overdose may include:
headache
dizziness
sensitivity to light
chest pain
slow heart-beat
sweating and pale skin
vomiting
trouble breathing and shortness of breath.
If you think that you have been given too much LEVOPHED, 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.
5. What should I know during and after treatment with LEVOPHED?
Things you should do
Remind any doctor, nurse, dentist or pharmacist who is treating you that you have
been given or are being given LEVOPHED.
Driving or using machines
Do not drive or use any machines or tools until you know how LEVOPHED affects you.
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.
If you are over 65 years of age you may have an increased chance of getting 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
treatment with any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What LEVOPHED contains
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Active ingredient
(main ingredient)
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noradrenaline (norepinephrine) acid tartrate monohydrate
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Other ingredients
(inactive ingredients)
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sodium chloride
sodium metabisulfite
water for injections
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Each 4mL vial contains 4mg of noradrenaline (norepinephrine).
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo
dyes.
Do not use this medicine if you are allergic to any of these ingredients.
What LEVOPHED looks like
LEVOPHED is a clear liquid in a glass vial (Aust R 183622).
It is available in packs of 10 vials.
How is LEVOPHED stored
LEVOPHED injection will be stored in the pharmacy or on the ward. The injection is
kept in a cool dry place, protected from light. Store below 25°C. Do not freeze.
Who distributes LEVOPHED
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free number: 1800 675 229
This leaflet was prepared in August 2022.
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© Pfizer Australia Pty Ltd 2022