Consumer medicine information

Diprosone 0.05% Ointment

Betamethasone dipropionate

BRAND INFORMATION

Brand name

Diprosone

Active ingredient

Betamethasone dipropionate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Diprosone 0.05% Ointment.

1. Why am I using DIPROSONE?


DIPROSONE contains the active ingredient betamethasone dipropionate. DIPROSONE is used on the skin to relieve the redness, swelling, itching and discomfort of many skin problems such as psoriasis, eczema and other types of dermatitis.
For more information, see Section 1. Why am I using DIPROSONE? in the full CMI.

2. What should I know before I use DIPROSONE?


Do not use if you have ever had an allergic reaction to betamethasone dipropionate 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 DIPROSONE? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with DIPROSONE and affect how it works.
More information can be found in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use DIPROSONE?

  • Apply a thin film of DIPROSONE Cream or Ointment or a few drops of DIPROSONE Lotion to the affected skin or scalp twice daily. Massage gently until it disappears. For some patients, once daily application may be enough for maintenance therapy

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

5. What should I know while using DIPROSONE?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using DIPROSONE.
  • If you become pregnant while using DIPROSONE, tell your doctor
Things you should not do
  • Do not use DIPROSONE under dressings, over large areas of skin, or for more than 4 weeks at a time unless your doctor has told you to.
  • Do not use DIPROSONE in or near the eyes, or under plastic pants or tightly fitting nappies in young children.
Looking after your medicine
  • Keep DIPROSONE in a cool, dry place where the temperature stays below 25°C.
  • DIPROSONE Lotion should be protected from light.

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

6. Are there any side effects?


Local, skin-related side effects such as burning, itching, irritation, infection or dryness, acne, skin thinning and discolouration have been reported with the use of topical corticosteroids, especially under occlusive dressings. 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

Diprosone

Active ingredient

Betamethasone dipropionate

Schedule

S4

 

1 Name of Medicine

Betamethasone dipropionate.

2 Qualitative and Quantitative Composition

Betamethasone dipropionate equivalent to betamethasone 0.5 mg/g (0.05% w/w).
Diprosone cream (0.05% w/w). Each g contains betamethasone dipropionate equivalent to betamethasone 0.5 mg.
Diprosone ointment (0.05% w/w). Each g contains betamethasone dipropionate equivalent to betamethasone 0.5 mg.
Diprosone lotion (0.05% w/w). Each mL contains betamethasone dipropionate equivalent to betamethasone 0.47 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Diprosone is supplied as cream, ointment, lotion 0.05% w/w.

4 Clinical Particulars

4.9 Overdose

Symptoms. Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal function resulting in secondary adrenal insufficiency and produce manifestations of hypercorticism, including Cushing's disease.
Treatment. Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are virtually reversible. Treat electrolyte imbalance, if necessary. In cases of chronic toxicity, slow withdrawal of corticosteroids is advised.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

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

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Betamethasone dipropionate is a white or almost white, crystalline powder, practically insoluble in water, freely soluble in acetone and in methylene chloride, sparingly soluble in ethanol (96 per cent). The chemical name is 9-fluoro-11β-hydroxy- 16β-methyl-3,20-dioxopregna- 1,4-diene-17,21-diyl dipropanoate. The empirical formula is C28H37FO7. Molecular Weight = 504.6.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSBETDPR.gif CAS number. 5593-20-4.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes

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