Consumer medicine information

Diprosone OV

Betamethasone dipropionate

BRAND INFORMATION

Brand name

Diprosone OV

Active ingredient

Betamethasone dipropionate

Schedule

SUMMARY CMI

DIPROSONE OV^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

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 medicine	Keep 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.

FULL CMI

DIPROSONE OV^®

Active ingredient(s): Betamethasone dipropionate

Consumer Medicine Information (CMI)

This leaflet provides important information about using DIPROSONE OV. 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 DIPROSONE OV.

Where to find information in this leaflet:

1. Why am I using DIPROSONE OV?
2. What should I know before I use DIPROSONE OV?
3. What if I am taking other medicines?
4. How do I use DIPROSONE OV?
5. What should I know while using DIPROSONE OV?
6. Are there any side effects?
7. Product details

1. Why am I using DIPROSONE OV?

DIPROSONE OV contains the active ingredient betamethasone dipropionate. Betamethasone dipropionate is a very strong corticosteroid used to decrease inflammation, redness, itchiness and discomfort of some skin conditions.

DIPROSONE OV Cream and Ointment are used to treat persistent or severe:

dermatitis
eczema (an often itchy skin condition with redness, swelling, oozing of fluid, crusting which may lead to scaling)
acute or chronic psoriasis (a stubborn skin disorder with raised, rough, reddened areas covered with dry, fine silvery scales)

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

Warnings

Do not use DIPROSONE OV if:

you have had an allergic reaction to other medicines containing betamethasone dipropionate, any other corticosteroid(s), or any of the ingredients listed at the end of this leaflet.
Some symptoms of an allergic reaction include wheezing, skin rash and hives.
Always check the ingredients to make sure you can use this medicine.

Do not use DIPROSONE OV if you have:

a viral infection (such as cold sores, shingles or chicken pox)
a fungal infection (such as thrush, ringworm or tinea)
tuberculosis of the skin
acne rosacea
inflammation around the mouth
skin conditions with ulcers.

Unless your doctor tells you, do not use DIPROSONE OV:

in children under 12 years of age. Long-term use may affect their growth and development.

Tell your doctor or pharmacist if you have allergies to:

any other medicines
any other substances, such as foods, dyes or preservatives.

Check with your doctor if you:

have any other medical conditions, especially if you have an infection.
take any medicines for any other condition

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?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor will tell you if you can use DIPROSONE OV during pregnancy or while you are breast-feeding.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are using other creams or ointments or taking any other medicines. This includes medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect DIPROSONE OV.

4. How do I use DIPROSONE OV?

How much to use

Apply a thin layer of DIPROSONE OV Cream or Ointment to completely cover the affected area once or twice daily.

How to use DIPROSONE OV

It is important to use DIPROSONE OV exactly as your doctor has told you. If you use it less often than you should, it may not work as well and your skin condition may not improve.
Using it more often than you should may not improve your skin condition faster and may cause or increase side effects.
Do not use DIPROSONE OV just before having a bath, shower or a swim. If you do, you may reduce the effectiveness of DIPROSONE OV.

How long to use DIPROSONE OV

Your doctor will advise you how long to use DIPROSONE OV. Duration of treatment might take from a few days to a longer period of time.

Do not use DIPROSONE OV for more than 4 weeks without seeing your doctor.

Do not use DIPROSONE OV once the skin condition has cleared.

If you forget to use DIPROSONE OV

If you forget to use DIPROSONE OV, use it as soon as you remember and then use again at the normal time.

Do not apply twice the amount to make up for the application that you missed.

If you swallow DIPROSONE OV

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or
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.

5. What should I know while using DIPROSONE OV?

Things you should do

If you are about to start taking any new medicine, tell your doctor, dentist and pharmacist who are treating you that you are using DIPROSONE OV.

Tell your doctor if you feel that DIPROSONE OV is not helping your skin problem or if your skin problem worsens or seems infected.

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.

Remind any doctor, dentist or pharmacist you visit that you are using DIPROSONE OV.

Things you should not do

Do not use DIPROSONE OV in or near the eyes.
Do not use DIPROSONE OV on the face unless your doctor tells you. Use only a small amount and stop when the condition has cleared.
Do not use DIPROSONE OV 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).
Do not give DIPROSONE OV to anyone else, even if they have similar symptoms as you.
Do not use DIPROSONE OV to treat any other complaint(s) unless your doctor tells you to.

Things to be careful of

Do not use large amounts for a long time.
DIPROSONE OV is absorbed through the skin and side effects may increase with extended use.
Do not continue to use DIPROSONE OV if skin begins to thin or stretch marks appear.
Do not use DIPROSONE OV between skin folds or between fingers or toes for a long period without seeing your doctor.
DIPROSONE OV does not take the place of antibiotics if there is an infection.

Looking after your medicine

Keep DIPROSONE OV in a cool dry place where the temperature stays below 25°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

in the bathroom or near a sink, or
in the car or on window sills.

Do not use DIPROSONE OV if the packaging is torn or shows signs of tampering.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

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.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects

What to do

Skin-related:

burning
stinging sensation
itchiness
irritation
dry skin, softening of the skin
acne
lightening in skin colour
contact dermatitis
dermatitis around the mouth
inflamed follicles
increased hair growth
skin infection
stretch marks
tingling, prickly skin
tightening or cracking of skin
scaling of skin
thinning of the skin
sensation of warmth
rash
redness
hives

Eye-related:

visual disturbances or blurred vision

Speak to your doctor if you have any of these less serious side effects and they worry you.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Long-term use over large areas may suppress cortisol production in the body or cause side effects similar to those from oral corticosteroids, especially in infants and children.

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/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 DIPROSONE OV Ointment contains

Active ingredient (main ingredient)	betamethasone as dipropionate 0.5 mg/g
Other ingredients (inactive ingredients)	propylene glycol white beeswax propylene glycol monostearate white soft paraffin
Potential allergens	Does not contain preservatives, parabens or lanolin

What DIPROSONE OV Cream contains

Active ingredient (main ingredient)	betamethasone as dipropionate 0.5 mg/g
Other ingredients (inactive ingredients)	carbomer 980 propylene glycol sodium hydroxide titanium dioxide purified water
Potential allergens	Does not contain preservatives, parabens or lanolin

Do not take this medicine if you are allergic to any of these ingredients.

What DIPROSONE OV looks like

DIPROSONE OV Ointment is a smooth white ointment. It is packed in 30g tubes. (Aust R 18823).

DIPROSONE OV Cream is a smooth white cream. It is packed in 30g tubes. (Aust R 18825).

Who distributes DIPROSONE OV

Organon Pharma Pty Limited
Building A, 26 Talavera Road,
Macquarie Park, NSW 2113
AUSTRALIA

This leaflet was prepared in March 2022.

Published by MIMS September 2024

BRAND INFORMATION

Brand name

Diprosone OV

Active ingredient

Betamethasone dipropionate

Schedule

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

4.1 Therapeutic Indications

Diprosone OV cream and ointment are indicated for the relief of the inflammatory and pruritic manifestations of resistant or severe corticosteroid-responsive dermatoses. These include atopic eczema, nummular eczema, contact dermatitis, neurodermatitis, anogenital and senile pruritus, lichen planus and psoriasis.
Diprosone OV ointment is also indicated for the maintenance of remission in chronic psoriasis.

4.2 Dose and Method of Administration

Diprosone OV cream and ointment.

Apply a thin film to cover completely the affected area once or twice daily.
Patients with chronic psoriasis who have achieved at least a marked improvement in their psoriatic lesion(s) (i.e. approximately ≥ 80% improvement) with Diprosone OV ointment may be maintained in remission with a pulse dosing regimen consisting of three consecutive applications of up to 3.5 g each of Diprosone OV ointment, twelve hours apart (e.g. morning, evening, following morning) to the previously affected areas once each week. For this purpose, the Diprosone OV ointment should be applied to the lesion sites previously affected and treated.
Patients on this pulse dose regimen who relapse should be reverted back to the conventional dosing regimen.

4.3 Contraindications

Hypersensitivity to betamethasone dipropionate, other corticosteroids or any of the components in Diprosone OV. Like other topical corticosteroids, Diprosone OV is contraindicated in most viral infections of the skin, such as vaccinia, varicella and Herpes simplex, also tuberculosis and acne rosacea.

4.4 Special Warnings and Precautions for Use

Diprosone OV should not be used in or near the eyes.
If irritation or sensitisation develops with the use of Diprosone OV, treatment should be discontinued and appropriate therapy instituted.
In the presence of an infection, an appropriate antifungal or antibacterial agent should be administered. If a favourable response does not occur promptly, Diprosone OV should be discontinued until the infection has been controlled adequately.
Corticosteroids are known to be absorbed percutaneously, therefore in patients under prolonged and extensive topical treatment, the possibility of systemic effects should be kept in mind.
Diprosone OV cream has been shown to suppress the hypothalamic-pituitary adrenal (HPA) axis with repeated application of 7 g/day. In patients with psoriasis, application of 14 g per day of Diprosone OV cream for eight days produced a depression of adrenocortical hormonal levels in plasma. Shortly after treatment cessation, adrenal output returned to normal.
At 14 g per day for nine days, Diprosone OV ointment was shown to depress the plasma cortisol levels following repeated applications to diseased skin in patients with psoriasis. These effects were reversible upon discontinuation of treatment.
At 7 g per day (applied as 3.5 g twice daily), Diprosone OV ointment was shown to cause minimal inhibition of the hypothalamic-pituitary-adrenal (HPA) axis when applied for two to three weeks in normal patients and in patients with psoriasis and eczematous disorders. With 6 to 7 g of Diprosone OV ointment applied once daily for three weeks, no significant inhibition of the HPA axis was observed in patients with psoriasis and atopic dermatitis, as measured by plasma cortisol and 24-hour urinary 17-hydroxy-corticosteroid levels.
Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated. Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children as adrenal suppression may occur. Therefore, patients applying large doses of potent topical corticosteroids over large body surface areas should be evaluated periodically for evidence of HPA axis suppression. If HPA axis suppression occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute with a less potent corticosteroid agent.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of corticosteroid withdrawal may occur, requiring supplemental systemic corticosteroid therapy.
Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
Diprosone OV is not intended for use under occlusive dressings since this will also increase systemic absorption of the corticosteroid. In infants the napkin may act as an occlusive dressing and increase absorption.
Patients should not use more than 45 g Diprosone OV weekly.
Suitable precautions should be taken when using topical corticosteroids in patients with stasis dermatitis and other skin diseases with impaired circulation.
Unless specifically indicated, application to the face is undesirable, as is prolonged use on flexures and intertriginous areas.
Prolonged use of topical corticosteroid preparations may produce striae or atrophy of the skin or subcutaneous tissue. If this occurs, treatment should be discontinued.
As with all highly active topical corticosteroid preparations, treatment should be discontinued when the dermatologic disorder is controlled. According to clinical response, duration of therapy may vary from a few days to a longer period of time. However, treatment should not be continued for more than four weeks without patient re-evaluation.
Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and intraocular) corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Diprosone OV ointment.

Patients who are to use the pulse dosing regimen to maintain remission in chronic psoriasis should be instructed specifically as to where the medication should be applied.
Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.

Use in the elderly.

No data available.

Paediatric use.

Diprosone OV is not recommended for use in children under 12 years of age.
Chronic corticosteroid therapy may interfere with the growth and development of children.
Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and to exogenous corticosteroid effects than mature patients because of greater absorption due to a larger skin surface area to body weight ratio.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include a bulging fontanelle, headaches and bilateral papilloedema.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B3)
Topical corticosteroids should not be used extensively on pregnant patients in large amounts or for prolonged periods of time.
Since it is not known whether the components of Diprosone OV are excreted in the milk of nursing mothers, caution should be exercised when Diprosone OV is administered to nursing women.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The most frequent side effects reported with Diprosone OV are mild to moderate transient burning/ stinging, dry skin, pruritus, irritation and folliculitis.
Rarely reported adverse effects include tingling, prickly skin, tightening or cracking of skin, warm feeling, laminar scaling and perilesional scaling, follicular rash, skin atrophy, erythema, urticaria, vesiculation and telangiectasia.
Adverse reactions reported with the use of the Diprosone OV ointment pulse dose regimen were mild intermittent hypertension (one case) and paraesthesia (two cases).
Other local adverse reactions that have been reported with the use of topical corticosteroids include: itching, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae and miliaria.
Systemic adverse reactions, such as vision blurred, have also been reported with the use of topical corticosteroids.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.

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

5.1 Pharmacodynamic Properties

Mechanism of action.

Topical corticosteroid.

Diprosone OV is effective because of its anti-inflammatory, antipruritic and vasoconstrictive actions. The optimised vehicle with the propylene glycol component increases penetration and enhances the local effectiveness of the betamethasone dipropionate.

Pharmacology.

Betamethasone dipropionate is a potent topically-active corticosteroid, producing prompt, marked and prolonged anti-inflammatory, antipruritic and vasoconstrictive effects.
According to the McKenzie-Stoughton Vasoconstrictor Test, betamethasone dipropionate was demonstrated to be significantly more active (p < 0.05) than betamethasone valerate, fluocinolone acetonide, fluocortolone caproate plus fluocortolone, and flumethasone pivalate. While the direct applicability of this vasoconstrictor test to clinical situations has not been demonstrated conclusively, the results showed betamethasone dipropionate to be active in a concentration of 0.000016%, the lowest concentration tested which showed activity. To enhance the skin penetration of betamethasone dipropionate, various vehicles were evaluated based on the McKenzie Vasoconstrictor Test. Propylene glycol was determined to be an excellent solvent. The vasoconstrictor potency of the betamethasone dipropionate with propylene glycol (Diprosone OV) was demonstrated to be significantly greater than for Diprosone as measured by the McKenzie Test.
In controlled clinical trials, patients with moderate to severe chronic psoriasis who had at least a marked improvement in their symptoms (i.e. approximately ≥ 80% improvement) following 3 to 4 weeks of treatment with Diprosone OV ointment, were entered into a pulse dose regimen (three consecutive applications applied twelve hours apart once each week) for the maintenance of remission. Of these patients, 65% were kept in remission with this regimen of Diprosone OV ointment for a period of 6 months and no significant HPA axis suppression or skin atrophy was observed. Effectiveness and safety of this regimen have been clinically determined for a period of 6 months use.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including vehicle, integrity of the epidermal barrier and the use of occlusive dressings. While topical corticosteroids can be absorbed from normal intact skin, dermal inflammation and/or other dermatologic disease processes may increase percutaneous absorption. Occlusive dressings also substantially increase percutaneous absorption.

Distribution.

After dermal absorption, topical corticosteroids enter pharmacokinetic pathways similar to those of systemically administered corticosteroids. In varying degrees, corticosteroids are bound to plasma proteins.

Metabolism.

Corticosteroids are metabolised primarily in the liver.

Excretion.

Corticosteroids are excreted by the kidneys. Some topical corticosteroids and their metabolites undergo biliary excretion.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Diprosone OV cream (0.05%): is in an optimised vehicle consisting of propylene glycol, carbomer 980, titanium dioxide, sodium hydroxide and purified water.
Diprosone OV ointment (0.05%): is in an optimised vehicle consisting of propylene glycol, white soft paraffin, white beeswax and propylene glycol.
Diprosone OV cream and ointment do not contain preservatives, parabens or lanolin.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

The expiry date can be found on the packaging. In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG).

6.4 Special Precautions for Storage

Cream and ointment.

Store below 25°C.

6.5 Nature and Contents of Container

Diprosone OV 0.5 mg/g cream (AUST R 18825) and ointment (AUST R 18823): 5 g* and 30 g tube.
* Not available in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

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.

CAS number.

5593-20-4.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

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Consumer medicine information

Diprosone OV

Betamethasone dipropionate

Keep track of your medicines

BRAND INFORMATION