DYNASTAT®
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.
Dynastat contains the active ingredient parecoxib sodium. Dynastat is used to relieve
pain and reduce swelling and soreness which may occur after surgery. For more information,
see Section 1. Why am I being treated with Dynastat? in the full CMI.
You must not be given Dynastat if you: have ever had an allergic reaction to parecoxib
or any ingredients listed at the end of the CMI, take other medicines to relieve pain,
reduce swelling and soreness or sulfonamides antibiotics; are about to have heart
or blood vessel surgery, have had heart or other blood vessel disease, stroke, severe
liver problems or in the third trimester of pregnancy or are breastfeeding. Tell your
doctor if you have or ever had kidney or liver problems, heart diseases, other blood
vessel diseases or taking medicines for these conditions, stroke, diabetes, high cholesterol,
high or low blood pressure, water retention or taking “water” tablets, dehydrated,
asthma, blood clots or taking medicine for blood clots, swelling, blistering, peeling,
itching, reddening or some other skin problems after taking similar medicines, stomach
ulcers or bloody or black stools, smoke, have a fever or an infection. For more information,
see Section 2. What should I know before I treatment with Dynastat? in the full CMI.
Some medicines may interfere with Dynastat and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Dynastat is given by a doctor or nurse. Your doctor will decide how much Dynastat
you will need. More instructions can be found in Section 4. How Dynastat will be given to me? in the full CMI.
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Things you should do
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Tell your doctor if you are pregnant, intend to become pregnant, breastfeeding or
intend to breastfeed. Tell your doctor if you develop allergic reactions such as extensive
skin rashes, severe blisters and bleeding in lips, eyes, mouth, nose and genitals.
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Things you should not do
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Do not withhold your medical history including current medicines or supplements used
from your doctor. Do not take any other medicines unless your doctor is aware of it.
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Driving or using machines
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This medicine may cause dizziness or light-headedness in some people. If you have
any of these symptoms, do not drive, operate machinery or do anything else that could
be dangerous.
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Drinking alcohol
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Tell your doctor or nurse if you drink alcohol.
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For more information, see Section 5. What should I know during treatment with Dynastat? in the full CMI.
Side effects: allergic reaction, e.g., wheezing, swollen face, lips, mouth, tongue
or throat which may cause difficulty in swallowing or breathing; skin rash, swelling/blistering/peeling;
bruises; red, purple blotches; blisters/bleeding lips, eyes, mouth, nose, genitals;
swollen armpit, neck or limbs; injection site pain/reaction; fever; chills; delayed
wound healing; wound discharges; pain after tooth extraction; yellow skin/eyes; back,
joint pain; weak muscle; earache; tiredness; pale looking skin; slow or irregular
heartbeat; low/high blood pressure; dizziness; fainting; shortness of breath; chest,
neck or shoulder pain; swollen, sore leg veins; severe, persistent headache, stiff
neck, light sensitivity; weight gain; appetite loss; diarrhoea; unusual stomach sounds;
severe stomach pain; sore throat; vomiting; bloody/black stool; heartburn; constipation;
wind, bloating; dry mouth, feeling thirsty; urinate often; pass less urine; trouble
sleeping; irritability; agitation; skin becomes numb or painful to touch; increased
sweating; liver, kidney or heart problems; and blood sugar, calcium or potassium changes. For
more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
DYNASTAT® (die-na-stat)
Active ingredient(s):
parecoxib
sodium
Consumer Medicine Information (CMI)
This leaflet provides important information about using Dynastat. 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 Dynastat.
Where to find information in this leaflet:
Dynastat contains the active ingredient
parecoxib
sodium. Dynastat is a type of non-steroidal anti-inflammatory drug (NSAID) and belongs to
a group of medicines called Coxibs. Dynastat is used to relieve pain and reduce swelling
and soreness, which may occur after surgery.
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.
You must not be given Dynastat if you are allergic to or have experienced allergic reactions to:
parecoxib or any of the ingredients listed at the end of this leaflet
other Coxib medicines, such as valdecoxib, celecoxib
aspirin, ibuprofen or other NSAIDs used to treat pain, swelling and soreness
sulfonamides, a type of antibiotic.
You must not be given Dynastat if you have or had any of the following medical conditions:
heart or blood vessel surgery
heart problems, heart failure, heart attack or other blood vessel disease
a stroke
severe liver problems.
in the third trimester of your pregnancy or are breastfeeding
Tell your doctor if you have ever had any of the following:
kidney or liver problems
heart or blood vessel surgery, heart problems, heart failure, heart attack or other
blood vessel disease or taking medicines for any of these conditions
stroke
diabetes
high cholesterol
high or low blood pressure
blood clots or taking medicine to prevent blood clots
smoke
water retention or taking “water” tablets
feeling dehydrated
asthma or other allergic conditions
skin problems such as swelling, blistering, peeling, itching or redness that can occur
with fever chills, headache, joint pain or generally feeling unwell, or some other
skin abnormality after taking NSAIDs or other Coxib medicines
stomach ulcers or bloody or black stools
fever or an infection. If you are given Dynastat when you have an infection, it may
hide a fever (a sign of an infection).
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 and nurse if you are pregnant or intend to become pregnant.
You should not be treated with Dynastat if you are in the third trimester of your
pregnancy.
Use of Dynastat during the first two trimesters of your pregnancy is not recommended
as it may affect your developing baby. It may also affect labour. Your doctor will
discuss with you the benefits and risks of using it.
Related medicines, NSAIDs, have been associated with reversible infertility in some
women.
Use of NSAIDs in early pregnancy can increase the risk of spontaneous abortion and
may affect your developing baby.
Use of NSAIDs in the second or third trimester of your pregnancy may cause kidney
problems in your developing baby.
Tell your doctor and nurse if you are breastfeeding or intend to breastfeed.
You should not be treated with Dynastat if you are breastfeeding.
Dynastat passes into breast milk, therefore, you need to stop breastfeeding during
treatment with Dynastat.
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 Dynastat and affect how it works. These include
medicines for:
high blood pressure (e.g., losartan, olmersartan), other heart diseases (e.g., captopril,
enalapril, monopril, lisinopril, accupril, ramipril, fluid or “water” tablets, (e.g.,
hydrochlorothiazide, indapamide), pain, fever and inflammation (e.g., aspirin or other
NSAIDs) or combinations of these medicines
severe allergies, swelling or inflammation such as corticosteroids (e.g., prednisolone)
preventing or stopping blood clots, e.g., warfarin or apixaban, rivaroxaban, dabigatran
anxiety, depression or prevent mood swings, e.g., lithium salts, fluoxetine or sertraline
diabetes, e.g., glibenclamide.
arthritis and cancer, such as methotrexate
preventing the body from rejecting the new organ after transplants, e.g., ciclosporin,
tacrolimus
fungal infections, e.g., fluconazole and ketoconazole.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Dynastat.
How much is given and how it is given
Dynastat will be given to you in the hospital. Your doctor will decide how much Dynastat
you need. It may depend on whether you have liver or kidney problems, your age, weight
or other medicines you may be taking.
If too much Dynastat is given
As Dynastat is most likely to be given to you in hospital under the supervision of
your doctor, it is very unlikely that you will receive an overdose. However, if you
experience any side effects tell your doctor or nurse immediately.
If you are given too much Dynastat, you may feel tired, drowsy, feel sick, have stomach
pains or other abdominal problems.
If you are concerned that you may have been given too much Dynastat, you may need
urgent medical attention.
You should immediately:
tell your doctor or nurse, or
phone the Poisons Information Centre
(by calling 13 11 26), or
(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.
Things you should do
Tell your doctor if you:
are pregnant, intend to become pregnant, breast feeding or intend to breastfeed.
develop sudden potentially life-threatening allergic reactions such as extensive skin
rashes, severe blisters and bleeding in lips, eyes, mouth, nose and genitals.
Things you should not do
Do not take any other medication unless your doctor is aware of it.
Do not withhold your medical history including current medicines or supplements used
from your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Dynastat
affects you.
This medicine may cause dizziness or light-headedness in some people. If you have
any of these symptoms, do not drive, operate machinery or do anything else that could
be dangerous.
Looking after your medicine
Dynastat is stored in a hospital and it is responsible for storing and disposing of
any unused product correctly.
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.
Side effects
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Side effects
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What to do
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vomiting
heartburn
constipation
diarrhoea
stomach pain, wind, bloating, feeling uncomfortably full
dry mouth, feeling thirsty and needing to urinate more often
back pain
earache
pain after a tooth extraction
sore throat
low or high blood pressure
dizziness or light-headedness
trouble sleeping
irritability, agitation
feeling numb (your skin may lose sensitivity to pain and touch)
increased sweating
passing less urine than normal
loss of appetite
problems with your liver, kidneys or heart*
changes in your blood sugar, calcium or potassium level*
*These side effects may show up when you have a blood test.
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Speak to your doctor if you have any of these side effects and they worry you
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Side effects
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Side effects
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What to do
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signs of allergic reaction such as wheezing, swelling of the face, lips, mouth, tongue
or throat which may cause difficulty in swallowing or breathing
skin rash including hives, raised red, itchy spots
swelling, blistering or peeling of skin, fever, chills, headache, sore throat, diarrhoea,
aching joints and muscles
bleeding or bruising more easily than normal, reddish or purplish blotches under the
skin
complications with skin healing after operations
yellowing of the skin or eyes (jaundice)
slow heartbeat
irregular heartbeat
unusual weight gain or loss of appetite
unusual stomach sounds
severe stomach or throat pain
vomiting blood or bloody/black sticky bowel motions
blistering and bleeding in the lips, eyes, mouth, nose and genitals
swelling under the armpit or neck
injection site pain or reaction
joint pain, muscle weakness
tiredness, short of breath, looking pale
discharge from wounds
feeling faint or collapse, shortness of breath
chest pain or discomfort spreading to neck or shoulders, swollen or sore leg veins
a severe or persistent headache, fever, stiff neck, sensitivity to light and vomiting
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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 side effects.
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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.
This medicine is only available with a doctor's prescription.
What Dynastat contains
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Active ingredient
(main ingredient)
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parecoxib sodium
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Other ingredients
(inactive ingredients)
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dibasic sodium phosphate, phosphoric acid and sodium hydroxide
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Do not take this medicine if you are allergic to any of these ingredients.
What Dynastat looks like
Dynastat is a white to off-white powder. When diluted, Dynastat is a clear and colourless
solution.
Dynastat 40 mg powder for injection - AUST R 82525.
