2. What should I know before treatment with DBL Dexamethasone Sodium Phosphate Injection?
Do not use if you have ever had an allergic reaction to DBL Dexamethasone Sodium Phosphate
Injection, sulfites 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 DBL Dexamethasone Sodium Phosphate Injection 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.
4. How is DBL Dexamethasone Sodium Phosphate Injection given?
Your doctor will decide how much DBL Dexamethasone Sodium Phosphate Injection you
will receive. DBL Dexamethasone Sodium Phosphate Injection should only be given by
a doctor, nurse, or other trained person. More instructions can be found in Section
4. How do I use DBL Dexamethasone Sodium Phosphate Injection? in the full CMI.
5. What should I know during treatment DBL Dexamethasone Sodium Phosphate Injection?
|
Things you should do
|
Call your doctor straight away if you become pregnant and/or get an infection.
Remind any doctor, dentist or pharmacist you visit that you are being treated with
this injection.
|
|
Things you should not do
|
Do not abruptly stop treatment with this injection if you have been given high doses
of this medicine or repeated doses for more than three weeks.
If you have been given DBL Dexamethasone Sodium Phosphate Injection for a painful
or inflamed joint, you should be careful not to overuse the joint as long as the inflammation
is still present.
|
|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how DBL Dexamethasone
Sodium Phosphate Injection affects you.
|
|
Drinking alcohol
|
Tell your doctor if you drink alcohol. Alcohol may make dizziness worse increase the
risk of stomach-related side effects.
|
6. Are there any side effects?
Side effects include: nausea, vomiting; gas, abdominal bloating; bad taste in mouth;
diarrhoea, nose bleeds; burning/tingling; menstrual irregularity; increased appetite,
weight gain, fluid retention; increased body hair; sweating; bruising; slow wound
healing; thin, fragile skin acne painful or tender bumps under the skin; dermatitis;
redness or spots under skin; altered pigmentation; fatigue, feeling unwell; hiccups;
fungal infection; muscle weakness, pain, cramps, stiffness or rigidity; headache;
dizziness, spinning; fainting; carbohydrate intolerance,. If you experience the following
serious side effects tell your doctor immediately or go to Accident and Emergency
at your nearest hospital: allergic reaction; infection; severe muscle pain/weakness,
dark wee; joint, tendon or bone degeneration or fracture; severe stomach pain, blood
in poo; rapid/ irregular heartbeat; changes in vision; changes in mood/thinking/behaviour/sleep
patterns; seizures/convulsions; reduced growth in children; Cushing syndrome; heart
rupture, heart failure; blood clot; numbness/weakness of arms or legs; release of
immune cells; increased blood sugar, diabetes. 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.
Active ingredient(s): dexamethasone sodium phosphate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL Dexamethasone Sodium Phosphate
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 using DBL Dexamethasone Sodium Phosphate
Injection.
Where to find information in this leaflet:
1. Why am I being treated with DBL Dexamethasone Sodium Phosphate Injection?
DBL Dexamethasone Sodium Phosphate Injection contains the active ingredient dexamethasone
sodium phosphate. DBL Dexamethasone Sodium Phosphate Injection is a glucocorticoid and belongs to a
group of medicines called corticosteroids.
DBL Dexamethasone Sodium Phosphate Injection
may be used to treat an inactive or underactive adrenal gland or to treat a number
of different conditions such as certain immune disorders; skin, lung, gastrointestinal,
eye and blood problems; asthma; arthritis; or certain cancers or conditions associated
with cancers. It may also be used to treat a buildup of fluid and before or after
surgery to assist with the treatment of shock.
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 the condition, it treats the symptoms.
Your doctor may have prescribed DBL Dexamethasone Sodium Phosphate Injection for another
reason. Ask your doctor if you have any questions about why DBL Dexamethasone Sodium
Phosphate Injection has been prescribed for you.
DBL Dexamethasone Sodium Phosphate Injection is not addictive.
2. What should I know before treatment with DBL Dexamethasone Sodium Phosphate Injection?
Warnings
You should not be given DBL Dexamethasone Sodium Phosphate Injection if:
you are allergic to dexamethasone sodium phosphate, or any of the ingredients listed
at the end of this leaflet.
You should not be given DBL Dexamethasone Sodium Phosphate Injection (8mg/2mL vial)
if you have a known allergy to sulfites or 'sulfur' products. Tell your doctor or
nurse if you have this type of allergy.
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.
you have:
an internal fungal infection or an internal infection that is not being treated
recently been given a live vaccine such as polio/sabin, unless you are being given
the dexamethasone phosphate (as sodium) for replacement therapy
a stomach ulcer
weak or brittle bones
myasthenia gravis, a muscle wasting disease
a severe mental health illness
You should not be given DBL Dexamethasone Sodium Phosphate Injection in a local area
of the body if you have:
a bloodstream infection
unstable joints
infection at the injection site
Check with your doctor if you:
have or have had any other medical conditions, especially the following:
diabetes, a disorder of sugar metabolism or control or family history of diabetes
current or recent infections
heart failure or a recent heart attack
kidney problems
liver problems
adrenal gland problems
thyroid problems
herpes infection in the eye
inflammation of the bowel wall or other bowel problems or diarrhoea
stomach ulcer(s)
high blood pressure
eye diseases, including glaucoma, infections, ulcers or allergies
epilepsy, seizures or convulsions, migraine
weak or brittle bones
myasthenia gravis, a muscle wasting disease
severe mental health illness
blood cancers
take any medicines for any other condition
have been given any vaccines recently
have allergies to:
any other medicines
any other substances, such as foods, latex 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?
Use in children
Long term treatment with corticosteroids can affect growth and development in children.
Your doctor will monitor your child closely if your child needs long term treatment
with DBL Dexamethasone Sodium Phosphate Injection.
Thickening of the heart muscle may develop if dexamethasone is given to a prematurely
born baby. Your doctor will monitor your baby's heart function and structure.
Use in the elderly
Long term treatment with corticosteroids in the elderly can result in a greater chance
of osteoporosis, diabetes, high blood pressure, lack of potassium in the blood, a
greater chance of infection and thinning of the skin. Your doctor will monitor for
these closely if you need long term treatment with DBL Dexamethasone Sodium Phosphate
Injection.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
DBL Dexamethasone Sodium Phosphate Injection is not generally recommended for use
during pregnancy. Your doctor will discuss with you the possible benefits and risks
of using DBL Dexamethasone Sodium Phosphate Injection during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
DBL Dexamethasone Sodium Phosphate Injection may pass into breast milk, and there
is a possibility that the breast-fed baby may be affected. Therefore, DBL Dexamethasone
Sodium Phosphate Injection is not recommended for use during breast-feeding.
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 DBL Dexamethasone Sodium Phosphate Injection and
affect how it works. These include:
barbiturates or phenytoin, medicines used to treat epilepsy
aspirin, and other non-steroidal anti-inflammatory medicines
insulin or other medicines for the control of sugar in the blood
oestrogens and other oral contraceptives
anti-thyroid medicines used to treat an overactive thyroid gland
fluid tablets, particularly frusemide 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
rifampicin or amphotericin, medicines used to treat infections
digoxin, a medicine used to treat heart condition
anticholinergics such as glycopyrrolate, used to dry up secretions or saliva.
pancuronium bromide and vercuronium bromide used to relax muscles
These medicines may be affected by DBL Dexamethasone Sodium Phosphate Injection or
may affect how well it works. You may need different amounts of your medicine, or
you may need to take or use 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 DBL Dexamethasone Sodium Phosphate
Injection.
4. How is DBL Dexamethasone Sodium Phosphate Injection given?
How much is given
The dose of DBL Dexamethasone Sodium Phosphate Injection is variable, depending upon
the condition being treated. It may be given as a course of injections or as a single
dose. Your doctor will decide what dose will receive. This 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 the symptoms.
How it is given
DBL Dexamethasone Sodium Phosphate Injection is given as a slow injection or infusion
(slow drip) into a vein. It may also be given as an injection into an muscle or injured
joint.
DBL Dexamethasone Sodium Phosphate Injection should only be given by a doctor or nurse.
If you are given too much DBL Dexamethasone Sodium Phosphate Injection (Overdose)
As DBL Dexamethasone Sodium Phosphate Injection is most likely to 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.
If you are not already in hospital, you should immediately:
phone the Poisons Information Centre
(by calling
13 11 26),
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Symptoms of a DBL Dexamethasone Sodium Phosphate Injection overdose may include the
side effects listed below in 6. Are there any side effects? section but are usually
of a more severe nature.
Ask your doctor or pharmacist if you have any concerns.
5. What should I know during treatment with DBL Dexamethasone Sodium Phosphate Injection?
Things you should do
Remind any doctor, surgeon, dentist or pharmacist you visit that you are being given
DBL Dexamethasone Sodium Phosphate Injection. In particular if you:
are about to start on any new medicine
plan to have surgery that needs a general anaesthetic
Call your doctor straight away if you:
become pregnant
get an infection. DBL Dexamethasone Sodium Phosphate Injection may mask or hide the
symptoms of an infection.
Things you should not do
Do not abruptly stop treatment with DBL Dexamethasone Sodium Phosphate Injection 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.
If you have been given DBL Dexamethasone Sodium Phosphate Injection for a painful
or inflamed joint, you should be careful not to overuse the joint as long as the inflammation
is still present.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DBL Dexamethasone
Sodium Phosphate Injection affects you.
DBL Dexamethasone Sodium Phosphate Injection may cause dizziness, spinning sensation,
inability to sleep or convulsions (fits) in some people. Make sure you know how you
react to DBL Dexamethasone Sodium Phosphate Injection before you drive a car, operate
machinery, or do anything else that could be dangerous if these occur.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may make dizziness worse and increase the risk of stomach-related side effects
such as stomach ulcers and bleeding.
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.
If you are over 65 years of age you may have an increased chance of getting side effects.
Thickening of the heart muscle may develop if dexamethasone is given to a prematurely
born baby. Your doctor will monitor your baby's heart function and structure.
If you only receive one or two doses of DBL Dexamethasone Sodium Phosphate Injection,
side effects are rare. With higher doses, or longer-term therapy, side effects become
more common.
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
Serious side effects
|
Serious side effects
|
What to do
|
|
Signs of an allergic reaction
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
Signs of infection
fever or chills
unexplained fatigue or weakness
increased susceptibility to infections and recurrence of tuberculosis if you have
had it previously
Muscle and bone-related
severe muscle pain or weakness often along with passing of dark red or brown urine
(wee), or only passing small amounts of wee
joint pain, ruptured tendons, collapsed vertebrae, degeneration of the jaw bone or
broken bones
Stomach-related
severe stomach pain
blood in the faeces (poo)
Heart-related
rapid and/or irregular heartbeat
Eye-related
changes in vision
Head and brain-related
changes in mood, thinking or behaviour, for example:
irritability, over-excitement, depression, suicidal thoughts, mania, delusions, hallucinations,
anxiety, confusion, memory loss, and aggravation of schizophrenia
changes in sleep patterns
seizures or convulsions; aggravation of epilepsy
Other
reduced growth in children
Cushing syndrome (weight gain, rounded (moon-shaped) face and high blood pressure)
heart rupture (trouble breathing, chest pain, cold extremities, confusion or change
in thinking)
congestive heart failure (shortness of breath, swelling of the feet or legs due to
fluid build-up)
blood clot (sudden severe headache, loss of vision, loss of coordination, slurred
speech, shortness of breath, chest pain, numbness heat or swelling in the arms and
legs)
numbness or weakness of the arms or legs
release of immune cells (fever, fatigue, pain, difficulty breathing, night sweats,
weight loss and rash)
high blood sugar; development of diabetes; increase in need of medicine to control
diabetes
|
Call your doctor or nurse straight away. If you are not already in hospital, go straight
to the Emergency Department at your nearest hospital if you notice any of these serious
side effects.
You may need urgent medical attention. Serious side effects are rare.
|
A ‘withdrawal syndrome’ may also occur including fever, aching, sore muscles; swollen,
painful joints; runny or blocked nose; itchy runny eyes; painful itchy skin nodules;
and loss of weight. Too fast a reduction in treatment after prolonged treatment may
result in adrenal insufficiency, low blood pressure and death.
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/safety/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 DBL Dexamethasone Sodium Phosphate Injection contains
|
Active ingredient
(main ingredient)
|
dexamethasone sodium phosphate
|
|
Other ingredients
(inactive ingredients)
|
sodium citrate dihydrate
disodium edetate
hydrochloric acid
sodium hydroxide
sodium sulfite
water for injections
|
Do not take this medicine if you are allergic to any of these ingredients.
DBL Dexamethasone Sodium Phosphate Injection does not contain lactose, sucrose, gluten,
tartrazine or any other azo dyes.
What DBL Dexamethasone Sodium Phosphate Injection looks like
DBL Dexamethasone Sodium Phosphate Injection is a clear, colourless solution in a
vial, available in the strength 8 mg/2 mL (AUST R 178774).
How is DBL Dexamethasone Sodium Phosphate stored
DBL Dexamethasone Sodium Phosphate Injection will be stored correctly in the pharmacy
or on the ward.
Who distributes DBL Dexamethasone Sodium Phosphate Injection
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in December 2025.
™ = Trademark
© Pfizer Australia Pty Ltd 2025