Consumer medicine information

Celestone-M 0.02% Cream

Betamethasone valerate

BRAND INFORMATION

Brand name

Celestone-M

Active ingredient

Betamethasone valerate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Celestone-M 0.02% Cream.

1. Why am I using Celestone M?


Celestone M contains the active ingredient betamethasone valerate. Celestone M is used on the skin to relieve the redness, swelling, itching and discomfort of many skin problems.
For more information, see Section 1. Why am I using Celestone M? in the full CMI.

2. What should I know before I use Celestone M?


Do not use if you have ever had an allergic reaction to betamethasone valerate 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 Celestone M? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with Celestone M 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 Celestone M?

  • Apply a thin film of Celestone M Cream to the affected skin two to three times daily. Massage gently until it disappears

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

5. What should I know while using Celestone M?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Celestone M.
  • Discontinue Celestone M immediately and speak to your doctor if it causes irritation or sensitisation
Things you should not do
  • Do not use Celestone M under dressings, over large areas of skin, or on the face unless your doctor has told you to
  • Do not use it near the eyes
  • Do not use it under plastic pants or tightly fitting nappies in young children
Looking after your medicine
  • Keep Celestone M in a cool, dry place where the temperature stays below 25°C.

For more information, see Section 5. What should I know while using Celestone M? 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

Celestone-M

Active ingredient

Betamethasone valerate

Schedule

S4

 

1 Name of Medicine

Betamethasone valerate.

2 Qualitative and Quantitative Composition

Celestone-M Cream contains betamethasone valerate equivalent to betamethasone 0.2 mg/g.
Excipients with known effect. Celestone-M Cream contains cetostearyl alcohol and chlorocresol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cream.

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 Poison 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

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSBETVAL.gif Betamethasone valerate is 9-fluoro-11β, 21-dihydroxy-16β-methyl-3, 20-dioxopregna-1,4-dien-17-yl pentanoate. The empirical formula is C27H37FO6. MW = 476.6.
CAS number. CAS Registry number is 2152-44-5.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes

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