Consumer medicine information

Diprosone

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.

What is in this leaflet

This leaflet answers some common questions about DIPROSONE.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using DIPROSONE against the benefits it is expected to have for you.

If you have any concerns about this medicine, ask your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What DIPROSONE is used for

The name of your medicine is DIPROSONE. It contains the active ingredient called betamethasone dipropionate.

It is a type of cortisone and belongs to the group of medicines called corticosteroids. DIPROSONE is classified as a high potency topical corticosteroid.

There are three forms of DIPROSONE: cream, ointment and lotion.

DIPROSONE is used on the skin to relieve the redness, swelling, itching and discomfort of many skin problems such as:

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

DIPROSONE Lotion is also used on the scalp and hairy parts of the body.

Your doctor may have prescribed DIPROSONE for another reason.

Ask your doctor if you have any questions about why DIPROSONE has been prescribed for you.

This medicine is available only with a doctor's prescription.

Before you use DIPROSONE

When you must not use it

Do not use DIPROSONE if you have had an allergic reaction, such as wheezing, rash or hives, to DIPROSONE, any other corticosteroid, or any of the ingredients listed at the end of this leaflet.

Do not use DIPROSONE if you have:

  • a viral skin infection, such as cold sores, shingles or chicken pox
  • a fungal skin infection, such as thrush, tinea or ringworm
  • tuberculosis of the skin
  • acne rosacea
  • inflammation around the mouth
  • skin conditions with ulcers unless your doctor tells you.

Ask your doctor to be sure you do not have any of these conditions.

Do not use DIPROSONE just before having a bath, shower or going swimming. If you do, you may reduce the effectiveness of DIPROSONE.

Do not use DIPROSONE after the expiry date (EXP) printed on the pack has passed. If you use DIPROSONE after the expiry date has passed, it may not work as well.

Do not use DIPROSONE if the packaging shows signs of tampering.

Before you start to use it

Tell your doctor or pharmacist if you have allergies to:

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

Tell your doctor if:

  • you are pregnant or breast feeding.
    Your doctor will tell you if you can use DIPROSONE during pregnancy or while you are breast feeding.
  • you have any other medical conditions, especially if you have an infection.

Using other medicines

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

How to use DIPROSONE

How to use it

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.

It is important to use DIPROSONE 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 problem may not improve.

Using it more often than you should may not improve your skin problem any faster and may cause or increase side effects.

How long to use it

Do not use DIPROSONE for more than four weeks at a time unless your doctor tells you.

If you forget to use it

If you forget to use DIPROSONE, use it as soon as you remember and then go back to your normal time for applying DIPROSONE. Do not try to make up for the amount you missed by using more than you would normally.

If you swallow it

Telephone your doctor or Poisons Information Centre (Australia - Ph: 13 11 26; New Zealand - Ph: 0800 POISON or 0800 764766) or go to the accident and emergency centre at your nearest hospital immediately if you think that you or anyone may have swallowed DIPROSONE.

Keep the telephone numbers of these places handy.

While you are using DIPROSONE

Things you must do

Tell all doctors and pharmacists who are treating you that you are using DIPROSONE.

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

Tell your doctor if, for any reason, you have not used DIPROSONE exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

If you become pregnant while using DIPROSONE, tell your doctor.

Things you must not do

Do not use DIPROSONE under dressings or on large areas of skin unless your doctor tells you.

Do not use plastic pants or tight fitting nappies if DIPROSONE is to be used on the nappy area of young children.

Do not use DIPROSONE in or near the eyes.

Do not give DIPROSONE to anyone else even if their symptoms seem similar to yours.

Do not use DIPROSONE to treat other conditions unless your doctor tells you. Your doctor has prescribed DIPROSONE specially for you and your condition. If you use it for another condition, it may not work or make the condition worse.

Things to be careful of

Do not use large amounts for a long time. If you use large amounts for a long time, the chance of absorption through the skin and the chance of side effects increases.

Only use DIPROSONE on skin areas that rub together such as under the arm or in the groin area if your doctor tells you.

Only use DIPROSONE on the face if your doctor tells you. If improvement does not occur within one week, tell your doctor.

Children and adolescents should be followed closely by the doctor, since this medicine is absorbed through the skin and can affect growth or cause other unwanted effects.

Side Effects

Tell your doctor if you do not feel well while you are using DIPROSONE.

DIPROSONE helps most people with skin problems but it may have unwanted side effects in a few people.

DIPROSONE is generally well tolerated. However, unwanted effects that have been reported by some people using DIPROSONE include:

  • burning
  • itching
  • irritation
  • infection or dryness of skin
  • irritation or redness of the face
  • increased hair growth
  • acne
  • change in skin colour
  • thinning of skin with easy bruising
  • stretch marks
  • infection of the hair roots
  • rash around mouth area
  • contact dermatitis
  • heat rash
  • visual disturbances or blurred vision

Mild temporary stinging may be expected when DIPROSONE Lotion is applied.

DIPROSONE may cause other side effects.

Side effects that may happen with oral or injectables corticosteroids may also occur with corticosteroids used on the skin, especially in infants and children.

If you have any other side effects, check with your doctor.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using DIPROSONE

Storage

Keep DIPROSONE in a cool dry place where the temperature stays below 25°C. DIPROSONE Lotion should be protected from light.

Do not store DIPROSONE or any other medicines in the bathroom or near the sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep DIPROSONE where children cannot reach it. Keep the medicine away from pets. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using DIPROSONE or it has passed its expiry date, ask your pharmacist what to do with any that is left over.

Product Description

What it looks like

DIPROSONE Cream is a white to off-white cream. It is packed in 15 g and 50 g tubes.

DIPROSONE Ointment is a white to off-white ointment. It is packed in 15 g and 50 g tubes.

DIPROSONE Lotion is a colourless to light yellow lotion. It is packed in 30 mL bottles.

Ingredients

DIPROSONE Cream contains:

  • betamethasone as dipropionate 0.5 mg/g
  • chlorocresol (preservative)
  • white soft paraffin
  • cetostearyl alcohol
  • liquid paraffin
  • cetomacrogol 1000
  • monobasic sodium phosphate dihydrate
  • phosphoric acid
  • purified water

DIPROSONE Ointment contains:

  • betamethasone as dipropionate 0.5 mg/g
  • liquid paraffin
  • white soft paraffin

DIPROSONE Lotion contains:

  • betamethasone as dipropionate 0.5 mg/g
  • isopropyl alcohol
  • carbomer
  • sodium hydroxide
  • purified water

Supplier

In Australia:

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

Presentations:
Cream - AUST R 18818
Ointment - AUST R 144098
Lotion - AUST R 18829

In New Zealand:

Organon New Zealand Limited
PO Box 99851
Newmarket
Auckland
NEW ZEALAND

Presentations:
Cream
Ointment

Date of Preparation

14 January 2021

S-CCDS-MK1460-DPS-MTL-082017

RCN: 000017952-AU

Published by MIMS April 2021

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

4.1 Therapeutic Indications

Diprosone is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. These include atopic eczema, infantile eczema, nummular eczema, contact dermatitis, neurodermatitis, anogenital and senile pruritus, lichen planus, intertrigo and psoriasis.
Diprosone Lotion is indicated wherever hair impedes access to the skin in the treatment of corticosteroid-responsive dermatoses particularly on the scalp, chest and underarms, etc. It is also indicated in the treatment of seborrhoea and psoriasis of the scalp.

4.2 Dose and Method of Administration

Diprosone cream, ointment.

Apply a small amount to the affected area twice daily. For some patients, adequate maintenance therapy may be achieved with once daily application.

Diprosone lotion.

Apply twice daily. Part the hair with a comb, then apply with nozzle directly on the scalp. Squeeze bottle gently.
In most cases, 4 weeks continuous treatment should be considered the maximum.

Children.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen.

4.3 Contraindications

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

4.4 Special Warnings and Precautions for Use

Diprosone preparations should not be used in or near the eyes.
If irritation or sensitisation develops, 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 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. This applies particularly when using the occlusive dressing technique.
Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children.
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.
Patients applying large doses of potent topical corticosteroids over large body surface areas should be evaluated periodically for evidence of HPA axis suppression. Manifestations of Cushing's syndrome also can be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying doses of Diprosone in excess of 15 g per day should be carefully monitored.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.
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.
Suitable precautions should be taken when using topical corticosteroids in patients with stasis dermatitis and other skin diseases with impaired circulation.
Topical corticosteroid preparations may produce striae or atrophy of the skin or subcutaneous tissue. If this occurs, treatment should be discontinued.
In most cases, 4 weeks continuous treatment should be considered the maximum.
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.

Use in the elderly.

No data available.

Paediatric use.

Chronic corticosteroid therapy may interfere with the growth and development of children.
Paediatric patients may demonstrate greater susceptibility than mature patients to topical corticosteroid-induced HPA axis suppression and to exogenous corticosteroid effects because of greater absorption due to a larger skin surface area to bodyweight 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 B1)
Topical corticosteroids should not be used extensively on pregnant patients in large amounts or for prolonged periods of time.
Due to lack of data on the safety of betamethasone dipropionate in lactation, care should be exercised to ensure that the potential benefits to the lactating mother outweigh the possible hazards to the nursing infant.

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 following adverse reactions have been reported with the use of topical corticosteroids: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae and miliaria.
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 and telangiectasia.
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.

Betamethasone dipropionate is a potent topically-active corticosteroid producing prompt, marked and prolonged anti-inflammatory, anti-pruritic 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, 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.

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 cream (0.05% w/w).

Chlorocresol 1 mg/g as preservative, white soft paraffin, liquid paraffin, cetostearyl alcohol, cetomacrogol 1000, monobasic sodium phosphate dihydrate, phosphoric acid, purified water.

Diprosone ointment (0.05% w/w).

White soft paraffin, liquid paraffin.

Diprosone lotion (0.05% w/w).

Isopropyl alcohol, carbomer 934P, sodium hydroxide, purified water.

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

Diprosone Cream, Ointment, Lotion: Store below 25°C.

6.5 Nature and Contents of Container

Diprosone Cream 0.05% w/w (0.5 mg/g): 2 g, 5 g, 15 g and 50 g tubes.
Diprosone Ointment 0.05% w/w (0.5 mg/g): 5 g, 15 g and 50 g tubes.
Diprosone Lotion 0.05% w/w (0.47 mg/mL): 30 mL and 100 mL bottles.
Not all pack sizes may be available.

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 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.


CAS number.

5593-20-4.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes