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DEXAMETHASONE VIATRIS
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.
DEXAMETHASONE VIATRIS contains the active ingredient dexamethasone phosphate (as sodium).
Dexamethasone phosphate (as sodium) is a glucocorticoid and belongs to a group of
medicines called corticosteroids. It may be used to treat an inactive or underactive
adrenal gland or to treat a number of different diseases such as certain immune disorders
and skin problems, asthma or arthritis. Corticosteroids reduce inflammation, one of
the body’s reactions to injury. Except for its use in the treatment of underactive
adrenal glands, dexamethasone phosphate (as sodium) does not cure disease; it treats
the symptoms. For more information, see Section1. Why am I being given DEXAMETHASONE VIATRIS? in the full CMI.
Do not use if you have ever had an allergic reaction to DEXAMETHASONE VIATRIS 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.
For more information, see Section 2. What should I know before I am given DEXAMETHASONE VIATRIS? in the full CMI.
Some medicines may interfere with DEXAMETHASONE VIATRIS 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.
DEXAMETHASONE VIATRIS is given as a slow injection or infusion (intravenous drip)
into the veins. It may also be given as an injection into an injured muscle or joint.
It may be given as a course of injections or as a single dose. DEXAMETHASONE VIATRIS
injection should only be given by a doctor or nurse who will decide the correct dose
depending upon the condition being treated, and other factors such as your weight.
More instructions can be found in Section 4. How am I given DEXAMETHASONE VIATRIS? in the full CMI.
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you have been given DEXAMETHASONE
VIATRIS if you:
plan to have surgery that requires a general anaesthetic
become pregnant while you are being treated with DEXAMETHASONE VIATRIS
get an infection while being treated with this medicine.
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Driving or using machines
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Be careful driving or operating machinery while being treated with DEXAMETHASONE VIATRIS,
as it may cause dizziness and blurred vision in some people.
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Drinking alcohol
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If you drink alcohol while being treated with DEXAMETHASONE VIATRIS, you may experience
dizziness
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Looking after your medicine
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DEXAMETHASONE VIATRIS will usually be stored in the pharmacy or on the ward, in a
cool dry place, protected from light, where the temperature stays below 25°C.
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For more information, see Section 5. What should I know while I am being given DEXAMETHASONE VIATRIS? in the full CMI.
Dexamethasone phosphate (as sodium) may cause allergic reaction such as rash, itching
or hives on the skin; swelling of the face, lips, tongue or other parts of the body;
shortness of breath, wheezing or difficulty breathing. 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.
DEXAMETHASONE VIATRIS®
Active ingredient(s): Dexamethasone Phosphate (as sodium)
Consumer Medicine Information (CMI)
This leaflet provides important information about given DEXAMETHASONE VIATRIS 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 given DEXAMETHASONE VIATRIS.
Where to find information in this leaflet:
DEXAMETHASONE VIATRIS contains the active ingredient dexamethasone phosphate (as sodium). DEXAMETHASONE VIATRIS is a glucocorticoid and belongs to a group of medicines called
corticosteroids.
DEXAMETHASONE VIATRIS is used to treat an inactive or underactive adrenal gland or
to treat a number of different diseases such as certain immune disorders, skin problems,
asthma or arthritis.
Corticosteroids reduce inflammation, one of the body's reactions to injury.
Except for its use in the treatment of an underactive adrenal gland, DEXAMETHASONE
VIATRIS does not cure disease; it treats the symptoms.
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.
This medicine is not addictive.
You should not be given DEXAMETHASONE VIATRIS if:
you are allergic to dexamethasone sodium phosphate, or any of the ingredients listed
at the end of this leaflet.
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.
an internal fungal infection or any other infection
recently been given a live vaccine unless you are being given this medicine for replacement
therapy
myasthenia gravis, a muscle wasting disease
a stomach (peptic) ulcer
osteoporosis (weak or brittle bones)
have a severe mental health condition
Check with your doctor if you:
diabetes, a condition in which the level of sugar in the blood is too high
any current or recent infections
heart failure or a recent heart attack
kidney disease
liver disease
thyroid disease
inflammation of the bowel wall or other bowel problems
high blood pressure
eye diseases, including glaucoma or a family history of glaucoma, including infections,
ulcers or allergies
muscle disease or injury
mental illness
epilepsy, seizures or convulsions, migraine
Cushing's disease, a condition where there is too much cortisol
a stomach ulcer
intestinal disease
osteoporosis (weak or brittle bones)
take any medicines for any other condition
myasthenia gravis, a muscle wasting disease
presence of bacteria in the bloodstream
unstable joints
infection at the injection site
latent tuberculosis, where you have tuberculosis bacteria in your body but do not
feel sick
chicken pox or measles, or have been exposed to these recently
suspected or identified pheochromocytoma, which are tumours growing on part of your
kidneys
suspected or identified pheochromocytoma, which are tumours growing on part of your
kidneys
been diagnosed with Acute Respiratory Disease Syndrome (ARDS) for over 2 weeks
you have suffered a head injury or stroke
pre-eclampsia or fluid retention.
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.
Like most corticosteroid medicines, dexamethasone is not generally recommended for
use during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
The active ingredient in DEXAMETHASONE VIATRIS may pass into breast milk and there
is a possibility that your baby may be affected.
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 DEXAMETHASONE VIATRIS and affect how it works.
These include:
barbiturates, carbamazepine or phenytoin, medicines used to treat epilepsy
aspirin and other non-steroidal anti-inflammatory medicines, especially phenylbutazone
insulin or other medicines for the control of blood sugar
estrogens and other oral contraceptives
anti-thyroid medicines used to treat an over active thyroid gland
fluid tablets (known as diuretics), particularly furosemide and thiazides or other
medicines affecting the kidneys
anticoagulant medicines (medicines to prevent blood clots), such as warfarin or heparin
any recent vaccinations or immunisations
ciclosporin, a medicine used to prevent transplant rejection
rifabutin, rifampicin, amphotericin or vancomycin, medicines used to treat infections
ritonavir, a medicine used in the treatment of HIV/AIDS
ketoconazole, a medicine used to treat fungal infections
digoxin, a medicine used to treat heart conditions
aminoglutethimide, a hormone used to treat breast cancer
daunorubicin or doxorubicin, a medicine used to treat cancer
salbutamol, salmeterol, medicines used to treat asthma
some medicines used in the treatment of heartburn and indigestion
doxapram, a medicine used to treat chronic obstructive pulmonary disease
glycopyrrolate, a medicine used to dry up secretions or saliva.
These medicines may be affected by DEXAMETHASONE VIATRIS or may affect how well it
works. You may need different amounts of your medicines, or you may need to take different
medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect DEXAMETHASONE VIATRIS.
How much DEXAMETHASONE VIATRIS is given
The dose of DEXAMETHASONE VIATRIS is variable, depending on the condition being treated.
It may be given as a course of injections or as a single dose.
Your doctor will determine the dose you will receive.
The dose depends on your condition and other factors, such as your weight.
As soon as an improvement in your condition is noticed, the dosage should be adjusted
to the minimum required to control your symptoms.
As your doctor will give you the injection they will determine when it is given to
you.
Your doctor will determine how long you will take this medicine for.
How is DEXAMETHASONE VIATRIS given
DEXAMETHASONE VIATRIS is given as a slow injection or infusion (intravenous drip)
into the veins. It may also be given as an injection into an injured muscle or joint.
DEXAMETHASONE VIATRIS is an injection which is given to you by a doctor or nurse.
If you are given too much DEXAMETHASONE VIATRIS
As DEXAMETHASONE VIATRIS will most likely be given to you in hospital under the supervision
of your doctor it is very unlikely that you will receive too much.
However, if you experience severe side effects tell your doctor or nurse immediately,
or if you are not already in hospital go to Accident and Emergency at the nearest
hospital or immediately contact the Poisons Information Centre for advice on overdose
(Call 13 11 26).
You should do this even if there are no signs of discomfort or poisoning.
Symptoms of an overdose may include some of the side effects listed below 6. Are there any side effects including swelling of the limbs, sore stomach or altered mental state.
You may need urgent medical attention.
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are being given DEXAMETHASONE VIATRIS.
Tell any other doctors, dentists and pharmacists who treat you that you are being
given this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are being
given this medicine.
It may affect other medicines used during surgery.
If you become pregnant while you are being given this medicine, tell your doctor immediately.
Tell your doctor immediately if you get an infection whilst you are being given this
medicine.
Like most corticosteroid medicine, dexamethasone may hide the symptoms of an infection.
Things you should not do
If you have been given DEXAMETHASONE VIATRIS for a painful or inflamed joint, you
should be careful not to overuse the joint if the inflammation is still present.
Do not abruptly stop treatment with Dexamethasone Viatris if you have been given high
doses of this medicine or repeated doses for more than three weeks. A gradual dose
reduction may be required to prevent withdrawal symptoms. These withdrawal symptoms
may include fever, aches and pains, itchy skin, weight loss, conjunctivitis or blocked
sinuses.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DEXAMETHASONE
VIATRIS affects you.
As with other corticosteroid medicines, dexamethasone may cause dizziness and blurred
vision in some people.
If you have any of these symptoms, do not drive, operate machinery or do anything
else that could be dangerous.
Drinking alcohol
Tell your doctor if you drink alcohol.
If you drink alcohol, dizziness may be worse.
Looking after your medicine
This medicine will usually be stored in the hospital pharmacy or on the ward, in a
cool, dry place protected from light where the temperature stays below 25°C.
Keep it where young children cannot reach it.
When to discard your medicine
DEXAMETHASONE VIATRIS will be opened for use on you. It will be used only once and
then it will be discarded. It will never be stored after it is opened nor used for
more than one person.
Getting rid of any unwanted medicine
Any unwanted medicine will be disposed of in safe manner by our doctor, nurse or pharmacist.
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, nurse 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.
If you only receive one or two doses of this medicine, side effects are rarer.
Less serious side effects
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Less serious side effects
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What to do
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nausea and vomiting
'gas' or abdominal bloating
bad taste in the mouth
menstrual irregularity
weight gain
fluid retention
increased body hair
bruising easily
wounds that take a long time to heal
muscular weakness
headache
dizziness
thin, fragile skin
acne
sleep disturbances
reduced growth in children
blurred vision
fungal infection and being susceptible to other kinds of infections.
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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signs of an allergic reaction such as a rash, itching or hives on the skin, swelling
of the face, lips, tongue or other parts of the body, shortness of breath, wheezing
or difficulty breathing
severe stomach pain
blood in the faeces
irregular heartbeat
changes in vision
changes in mood or sleep patterns
joint pain or broken bones
breakdown of weight-bearing joints (Charcot-like arthropathy)
tendon rupture
seizures or convulsions
signs of infection
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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 serious side effects.
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Tell your doctor or nurse if you notice anything else that may be making you feel
unwell.
Other side effects not listed here may occur in some people.
The above list includes serious side effects that may require medical attention. Serious
side effects are rare.
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 DEXAMETHASONE VIATRIS contains
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Active ingredient
(main ingredient)
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Dexamethasone phosphate (as sodium)
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Other ingredients
(inactive ingredients)
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sodium citrate
creatine
sodium hydroxide
hydrochloric acid
water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What DEXAMETHASONE VIATRIS looks like
DEXAMETHASONE VIATRIS is a clear, colourless solution, free from visible particulate
matter and packaged in a 2 mL amber vial with rubber stopper and aluminium seal.
This medicine is available in packs of 5 vials.
DEXAMETHASONE VIATRIS 4 mg/1 mL ampoule - AUST R 163200
DEXAMETHASONE VIATRIS 8 mg/2 mL ampoule - AUST R 163199
