Consumer medicine information

Diprosone OV 0.05% Ointment

Betamethasone dipropionate

BRAND INFORMATION

Brand name

Diprosone OV

Active ingredient

Betamethasone dipropionate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

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

1. Why am I using DIPROSONE OV?


DIPROSONE OV contains the active ingredient betamethasone dipropionate. DIPROSONE OV is used to treat persistent or severe dermatitis, eczema, or acute or chronic psoriasis.
For more information, see Section 1. Why am I using DIPROSONE OV? in the full CMI.

2. What should I know before I use DIPROSONE OV?


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 OV? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with DIPROSONE OV 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 DIPROSONE OV?


Apply a thin layer of DIPROSONE OV Cream or Ointment to completely cover the affected area once or twice daily. More instructions can be found in Section 4. How do I use DIPROSONE OV? in the full CMI.

5. What should I know while using DIPROSONE OV?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using DIPROSONE OV.
  • Go to your doctor regularly for a check-up if you are on long-term DIPROSONE OV therapy.
  • Tell your doctor if you become pregnant while using DIPROSONE OV.
Things you should not do
  • Do not use DIPROSONE OV on the face unless your doctor tells you.
  • Do not use DIPROSONE OV in or near the eyes, under an air-tight dressing such as a plastic wrap or a tight nappy.
  • Do not use more than 45g of DIPROSONE OV Cream or Ointment per week (one and a half tubes).
Looking after your medicineKeep DIPROSONE OV in a cool dry place where the temperature stays below 25°C.

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

6. Are there any side effects?


The most common side effects are local, skin-related side effects including a temporary burning or stinging sensation, dry skin, itchiness, irritation and inflamed follicles. Other local side effects such as increased hair growth, acne, changes in skin colour or texture, dermatitis, and skin infection have been reported with the use of topical corticosteroids.
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 OV

Active ingredient

Betamethasone dipropionate

Schedule

S4

 

1 Name of Medicine

Betamethasone dipropionate.

2 Qualitative and Quantitative Composition

Diprosone OV cream (0.05%). Each g contains 0.64 mg betamethasone dipropionate, equivalent to betamethasone 0.5 mg.
Diprosone OV ointment (0.05%). Each g contains 0.64 mg betamethasone dipropionate, equivalent to betamethasone 0.5 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Diprosone OV 0.5 mg/g is supplied as cream and ointment.

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 percent).
Chemically betamethasone dipropionate is a synthetic corticosteroid which has the chemical name: 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/CSBETADI.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/DIPROVST.gif