Active ingredient(s):
Dantrolene sodium hemiheptahydrate
Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about treatment with this medicine,
speak to your doctor or pharmacist.
1. Why am I being treated with Dantrium powder for injection?
Dantrium powder for Injection contains the active ingredient dantrolene sodium hemiheptahydrate.
It is a muscle relaxant used to treat a condition known as malignant hyperthermia.
2. What should I know before treatment with Dantrium powder for injection?
Talk to your doctor if you have ever had an allergic reaction to dantrolene or mannitol
which are ingredients contained in this medicine.
Talk to your doctor if you have any 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 Dantrium powder for injection and affect how it
works.
4. How is Dantrium powder for injection given?
Dantrium powder for Injection is made into a solution, which is given by injection
into a vein by your doctor.
5. What should I know during treatment with Dantrium powder for injection?
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Things you should do
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Tell your doctor if you are taking any other medicines including medicines for heart
conditions, or tranquilisers.
Take care when getting out of bed or walking downstairs.
Be careful when eating or drinking on the day you have been treated with Dantrium.
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Driving or using machines
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For 2 days after treatment, do not operate machinery or do anything else that could
be dangerous when not fully alert.
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Drinking alcohol
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No information.
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Looking after your medicine
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Dantrium powder for Injection is stored in the pharmacy or on the hospital ward under
the correct conditions.
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6. Are there any side effects?
Side effects of this medicine may include swelling or tenderness around a vein; itchy
skin rash or reddening of the skin; breathlessness; chest tightness or pain; gasping
for air; wheezing; drowsiness; dizziness; weakness in the legs or loss of grip strength;
difficulty in swallowing.
Active ingredient(s):
Dantrolene sodium hemiheptahydrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about treatment with Dantrium powder for
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 treatment with Dantrium powder for
injection.
Where to find information in this leaflet:
1. Why am I being treated Dantrium powder for injection?
Dantrium powder for injection contains the active ingredient dantrolene sodium hemiheptahydrate.
It is a muscle relaxant used to treat a condition known as malignant hyperthermia.
This condition occurs rarely during or after surgery or anaesthesia. The tendency
to develop malignant hyperthermia may be inherited.
Some of the symptoms of malignant hyperthermia are very high fever, fast and irregular
heart-beat, difficulty breathing and rigid muscles.
Malignant hyperthemia may be fatal if not treated.
Your doctor may have prescribed Dantrium powder for injection for a purpose other
than that listed above.
Ask your doctor if you have any questions about why Dantrium was prescribed for you.
2. What should I know before treatment with Dantrium powder for injection?
Warnings
Tell your doctor if you have ever had an allergic reaction to dantrolene sodium hemiheptahydrate
or mannitol.
Some of the symptoms of an allergic reaction may include rash, itching or hives on
the skin, swelling of the face, lips, tongue or other parts of the body, shortness
of breath, wheezing or troubled breathing.
Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes.
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.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
3. What if I am taking other medicines?
Some medicines may interfere with Dantrium powder for injection and affect how it
works.
Tell your doctor if you are taking any heart medicines or tranquillisers (medicines
to reduce anxiety or help you sleep).
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Dantrium powder for injection.
4. How is Dantrium powder for injection given?
How much Dantrium powder for injection is given
The dose of Dantrium is calculated by your doctor according to your body weight.
How is Dantrium powder for injection given
Dantrium is given to you by your doctor as soon as malignant hyperthermia is recognised.
It will be given by injection into a vein.
How long will I receive Dantrium powder for injection
Treatment must continue until all symptoms of malignant hyperthermia are gone.
Treatment may be repeated if symptoms return after initial recovery.
If you receive too much Dantrium powder for injection
As Dantrium powder for injection is given under the close supervision of your doctor,
it is very unlikely that you will receive too much.
If you experience any side effects tell your doctor or nurse immediately.
Tell your doctor or nurse immediately if you are concerned that you may have been
given too much Dantrium powder for injection.
5. What should I know during or after treatment with Dantrium powder for injection?
Things you should do
Driving or using machines
For 2 days after treatment, do not operate machinery or do anything else that could
be dangerous when not fully alert.
Weakness, dizziness and drowsiness can continue for up to 48 hours after treatment.
Things to be careful of
Take care when getting out of bed or walking downstairs.
You may experience light-headedness, leg weakness or loss in grip strength after treatment
with Dantrium.
Be careful when eating or drinking on the day you have been treated with Dantrium.
Some people have difficulty swallowing after treatment with Dantrium. Choking has
been reported.
Drinking alcohol
Caution should be taken when drinking alcohol.
Looking after your medicine
Dantrium powder for injection is stored in the pharmacy or on the hospital ward under
the correct conditions.
Disposal of the medicine
The hospital staff will dispose of any leftover Dantrium powder for injection.
6. Are there any side effects?
Tell your doctor as soon as possible if you have any concerns about being treated
with Dantrium powder for injection.
All medicines can have side effects. You may need medical treatment if you get some
of the side effects.
Tell your doctor, nurse 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.
7. Product details
This medicine is only available with a doctor's prescription.
What Dantrium powder for injection contains
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Active ingredient
(main ingredient)
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dantrolene sodium hemiheptahydrate
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Other ingredients
(inactive ingredients)
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mannitol
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sodium hydroxide
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What Dantrium powder for injection looks like
Dantrium powder for injection is a powder which must be diluted with sterile water
for injections before use.
Dantrium powder for injection: Aust R 14435.
Who distributes Dantrium powder for injection
Pfizer Australia Pty Ltd
Sydney NSW
This leaflet was prepared in November 2024.