Consumer medicine information

Dexamethasone Juno 8 mg/2 mL Solution for injection

Dexamethasone phosphate

BRAND INFORMATION

Brand name

Dexamethasone Juno

Active ingredient

Dexamethasone phosphate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Dexamethasone Juno 8 mg/2 mL Solution for injection.

1. Why am I using Dexamethasone Juno?


DEXAMETHASONE JUNO 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 Section 1. Why am I using Dexamethasone Juno? in the full CMI.

2. What should I know before I use Dexamethasone Juno?


Do not use if you have ever had an allergic reaction to dexamethasone sodium phosphate 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 use Dexamethasone Juno? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with dexamethasone phosphate (as sodium) 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 do I use Dexamethasone Juno?

  • Your doctor will decide the appropriate dose for you
  • A doctor or nurse will usually prepare and administer the injection, 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.
  • Follow all instructions given to you by your doctor or pharmacist.

More instructions can be found in Section 4. How do I use Dexamethasone Juno? in the full CMI.

5. What should I know while using Dexamethasone Juno?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Dexamethasone Juno
Things you should not do
  • Do not abruptly stop treatment if you have been given higher or repeated doses for more than three weeks.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how this medicine affects you. This medicine may cause dizziness in some people.
Drinking alcohol
  • If you drink alcohol, dizziness may be worse.
Looking after your medicine
  • This medicine will be stored in the pharmacy or on the ward of a hospital. The injection is kept in a cool dry place, protected from light, where the temperature stays below 25°C.

For more information, see Section 5. What should I know while using Dexamethasone Juno? in the full CMI.

6. Are there any side effects?


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. If you only receive one or two doses of Dexamethasone Juno, side effects are rare. With higher doses, or longer-term therapy, side effects become more common. 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.

BRAND INFORMATION

Brand name

Dexamethasone Juno

Active ingredient

Dexamethasone phosphate

Schedule

S4

 

1 Name of Medicine

Dexamethasone sodium phosphate.

2 Qualitative and Quantitative Composition

Each millilitre of Dexamethasone Juno contains dexamethasone sodium phosphate equivalent to 4 mg of dexamethasone phosphate. It does not contain preservatives or antioxidants.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Dexamethasone Juno is a clear colourless to light yellow solution for injection, free from visible particulate matter.

4 Clinical Particulars

4.9 Overdose

Symptoms. It is difficult to define an excessive dose of a corticosteroid as the therapeutic dose will vary according to the indication and patient requirements. High dose corticosteroids given as recommended for pulse therapy are relatively free from hazardous effects.
Reports of acute toxicity and/or deaths following overdosage with glucocorticoids are rare. Exaggeration of corticosteroid related adverse effects may occur including hypertension, oedema, peptic ulceration, hyperglycaemia and altered mental state. Anaphylactic or hypersensitivity reactions may occur.
Treatment. No antidote is available. Treatment of overdosage is symptomatic. The dosage should be reduced or the drug withdrawn. Anaphylactic and hypersensitivity reactions may be treated with adrenaline (epinephrine), positive pressure artificial respiration, and aminophylline. The patient should be kept warm and quiet.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Dexamethasone sodium phosphate is a white or slightly yellow, very hygroscopic, crystalline powder. It is odourless or has a slight odour of alcohol. Dexamethasone sodium phosphate is soluble 1 in 2 of water, slightly soluble in alcohol, practically insoluble in chloroform and ether, and very slightly soluble in dioxane.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDEXAME.gif Chemical formula: C22H28FNa2O8P.
Molecular weight: 516.4.
CAS number. 2392-39-4.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription only medicine).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/DEXJUNST.gif