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 PRECEDEX?
PRECEDEX contains the active ingredient dexmedetomidine hydrochloride. PRECEDEX can
be used as a sedative (calming agent) if adults need to be calm or sleepy in the Intensive
Care Unit whilst they are being ventilated (on a breathing machine). It can also be
given to adults prior to an operation if they are not on a ventilator (breathing machine)
if it is required for the procedure or surgery that they be sleepy and calm.
2. What should I know before treatment with PRECEDEX?
You will not be given PRECEDEX if you have ever had an allergic reaction to PRECEDEX
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 PRECEDEX and affect how it works.
4. How is PRECEDEX given?
PRECEDEX is given by a slow injection (drip) into a vein by a doctor or nurse. Your
doctor will decide what dose you will receive. This depends on your condition and
other factors such as your weight. The dose will be adjusted to keep you at the right
depth of sleep or sedation.
5. What should I know during treating with PRECEDEX?
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Things you should do
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Remind any doctor or dentist you visit that you have been given PRECEDEX.
If you are pregnant or unsure if you are pregnant, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are using this
medicine.
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Things you should not do
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You should not be given PRECEDEX if you have ever had an allergic reaction to PRECEDEX,
or any of the ingredients listed at the end of the CMI.
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Looking after your medicine
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PRECEDEX is stored in the pharmacy or kept on the hospital ward at temperature below
25°C.
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6. Are there any side effects?
Side effects of this medicine may include: headache; dizziness; light-headedness;
nausea; vomiting; high temperature; feeling chills; dry mouth; constipation; diarrhoea;
agitation; confusion; depression; anxiety; hallucination; trouble with speech / understanding
speech; fainting; tiredness; fluid retention (swelling in arms / legs); increased
sweating; vision change; dry eyes; clammy skin; reduced or increased urine output;
thirst; slowing or quickening of heart beat or palpitations; shortness of breath,
rapid breathing or breathing difficulties; wheezing; tightness or pain in chest or
arms that may spread to your neck, jaw or back; loud snoring, gasping for air during
sleep; jaundice; unusual bruising; extreme fatigue; muscle twitching or spasms; restlessness;
seizures.
dexmedetomidine hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using PRECEDEX. 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 PRECEDEX.
Where to find information in this leaflet:
1. Why am I being treated with PRECEDEX?
PRECEDEX contains the active ingredient dexmedetomidine hydrochloride. It belongs to a group of medicines called alpha-2-receptor agonists. It works by its
actions on brain chemicals.
Intensive Care Sedation
PRECEDEX can be used as a sedative (calming agent) if adults need to be calm or sleepy
in the Intensive Care Unit whilst they are being ventilated (on a breathing machine).
It may be given as an infusion (drip) up to 24 hours.
Procedural Sedation
PRECEDEX can be given to adults prior to an operation if they are not on a ventilator
(breathing machine) if it is required for the procedure or surgery that they be sleepy
and calm.
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.
2. What should I know before treatment with PRECEDEX?
Warnings
Do not use PRECEDEX if:
you are allergic to dexmedetomidine hydrochloride.
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.
Check with your doctor if you:
heart problems
high or low blood pressure
diabetes
kidney or liver problems
elderly patients greater than 65 years old may be more prone to the blood pressure
lowering effects of PRECEDEX.
An increased risk of death has been seen for patients 65 years of age and under when
using this medicine. This increased risk is seen particularly in patients admitted
to the intensive care unit for reasons other than after surgery; who have a more severe
disease condition; and who are younger than 65. Your doctor will decide if this medicine
is still suitable for you.
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
Tell your doctor if you are pregnant or unsure if you are pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
The active ingredient in PRECEDEX may affect your developing baby if you take it during
pregnancy.
It also passes into breast milk and there is a possibility that your baby may be affected.
Your doctor can discuss with you the risks and benefits involved.
Use in children
The safety and effectiveness of PRECEDEX in children younger than 18 years 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 and PRECEDEX may interfere with each other. These include:
medicines used to produce calmness or to help you sleep during surgery, such as sevoflurane,
isoflurane, propofol, alfentanil and midazolam
strong pain relievers
medicines used to control blood pressure such as beta-blockers.
These medicines may be affected by PRECEDEX or may affect how well it works. You may
need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect PRECEDEX.
4. How is PRECEDEX given?
How much to use
Your doctor will decide what dose you will receive. This depends on the reason for
use and other factors. The dose will be adjusted to keep you at the right depth of
sleep or sedation.
How PRECEDEX is given
PRECEDEX is given by a slow injection (drip) into a vein. PRECEDEX should only be
given by a doctor or nurse.
If you use too much PRECEDEX
As PRECEDEX is given to you under the supervision of your doctor, it is very unlikely
that you will receive too much.
Symptoms of an overdose may include extreme drowsiness, confusion, dizziness, weakness
or becoming unconscious.
If you think you have been given too much PRECEDEX or if you experience any side effects
tell your doctor immediately.
5. What should I know during treatment with PRECEDEX?
Things you should do
Tell your doctor if you are pregnant.
Tell any other doctors, dentists, and pharmacists who treat you that you have been
given this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you have been
given this medicine. It may affect other medicines used during surgery.
If you are about to have any blood tests, tell your doctor that you have been given
this medicine. It may interfere with the results of some tests.
Things to be careful of
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.
Standing up slowly, especially when you get up from bed or chairs, will help your
body get used to the change in position and blood pressure. If this problem continues
or gets worse, talk to your doctor.
Drinking alcohol
No information is available.
Looking after your medicine
PRECEDEX is stored in the pharmacy or kept on the hospital ward.
Getting rid of any unwanted medicine
The hospital staff will dispose of any leftover PRECEDEX.
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 PRECEDEX.
This medicine helps most people with sedation, but it may have unwanted side effects
in a few people. All medicines can have side effects. Sometimes they are serious,
most of the time they are not. You may need medical attention if you get some of the
side effects.
If you are over 65 years of age you may have an increased chance of getting side effects.
Do not be alarmed by the following lists of side effects. You may not experience any
of them.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
The above list includes the more common side effects of your medicine. They are usually
mild and short-lived.
Serious side effects
Some of these side effects (for example blood abnormalities) can only be found when
your doctor does tests to check your progress.
The above list includes serious side effects. You may need urgent medical attention
or hospitalisation, and your medicine may need to be stopped.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also 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 PRECEDEX contains
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Active ingredient
(main ingredient)
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dexmedetomidine hydrochloride
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Other ingredients
(inactive ingredients)
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sodium chloride
water for injections
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Do not take this medicine if you are allergic to dexmedetomidine hydrochloride.
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo
dyes.
What PRECEDEX looks like
PRECEDEX (100 micrograms/mL) - is a clear, colourless solution. It is available in 2 mL glass vials.
AUST R 81323
PRECEDEX READY TO USE (4 micrograms/mL) - is a clear, colourless solution. It is available in 20 mL glass vials, and 50 mL
or 100 mL glass bottles, as follows:
80 micrograms/20 mL, AUST R 234022
200 micrograms/50 mL, AUST R 234023
400 micrograms/100 mL, AUST R 234024
Who distributes PRECEDEX
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in July 2024.
® Registered trademark