Consumer medicine information

Diprosone OV (Optimised Vehicle) [8678]

Betamethasone dipropionate

BRAND INFORMATION

Brand name

Diprosone OV Ointment

Active ingredient

Betamethasone dipropionate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Diprosone OV (Optimised Vehicle) [8678].

What is in this leaflet

This leaflet answers some common questions about Diprosone OV Cream and Ointment.

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 OV against the benefits they expect it will have for you.

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

Keep this leaflet with the medicine.

You may need to read it again.

What Diprosone OV is used for

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)

Your doctor may have prescribed Diprosone OV for another reason.

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

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

Before you use Diprosone OV

When you must not use it

Do not use Diprosone OV if you have had an allergic reaction to:

  • other medicines containing betamethasone dipropionate
  • any other corticosteroid(s)
  • any of the ingredients listed at the end of this leaflet.

Some symptoms of an allergic reaction include wheezing, skin rash and hives.

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.

Do not use Diprosone OV in children under 12 years of age unless your doctor tells you to.

Long-term use may affect their growth and development.

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.

Do not use Diprosone OV if the expiry date (EXP) printed on the pack has passed.

If you use Diprosone OV after the expiry date has passed, it may not work as well.

Do not use Diprosone OV if the packaging is torn or 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 OV 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 or ointments or taking any other medicines. This includes medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.

How to use Diprosone OV

How to use it

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

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.

How long to use it

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 it

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 it

Telephone your doctor or Poisons Information Centre (Phone 13 11 26), or go to the accident and emergency centre at your nearest hospital immediately if you think that you or anyone may have swallowed Diprosone OV. Do this even if there are no signs of discomfort or poisoning.

Keep the telephone numbers of these places handy.

While you are using Diprosone OV

Things you must 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.

Things you must 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.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Diprosone OV.

Diprosone OV is generally welltolerated but may have unwanted side effects in a few people. These side effects mainly involve the skin and include:

  • 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

Other less common side effects include:

  • tingling, prickly skin
  • tightening or cracking of skin
  • scaling of skin
  • thinning of the skin
  • sensation of warmth
  • rash
  • redness
  • hives
  • visual disturbances or blurred vision

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 above may occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

Ask your doctor or pharmacist if you don't understand anything in this list.

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

After using Diprosone OV

Storage

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

Do not store Diprosone OV or any other medicines in the bathroom or near the sink. Do not leave it in the car or on the window sill.

Heat and dampness can destroy some medicines.

Keep Diprosone OV where children cannot reach it.

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 OV, 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 OV Cream is a smooth white cream. It is packed in 30g tubes.

Diprosone OV Ointment is a smooth white ointment. It is packed in 30g tubes.

Ingredients

Diprosone OV Cream contains:

  • betamethasone as dipropionate 0.5 mg/g
  • carbomer 980
  • propylene glycol
  • sodium hydroxide
  • titanium dioxide
  • purified water

Diprosone OV Ointment contains:

  • betamethasone as dipropionate 0.5 mg/g
  • propylene glycol
  • white beeswax
  • propylene glycol monostearate
  • soft white paraffin

Diprosone OV Cream and Ointment do not contain preservatives, parabens or lanolin.

Supplier

Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A, 26 Talavera Road, Macquarie Park, NSW 2113
AUSTRALIA

Australian Registration Numbers

Cream - AUST R 18825

Ointment - AUST R 18823

Date of Preparation

15 November 2017

S-CCDS-MK1460-DPL-MTL-082017

BRAND INFORMATION

Brand name

Diprosone OV Ointment

Active ingredient

Betamethasone dipropionate

Schedule

S4

 

Name of the medicine

Betamethasone (as dipropionate).

Excipients.

Cream.

Optimised vehicle consisting of propylene glycol, carbomer 980, titanium dioxide, sodium hydroxide, purified water.

Ointment.

Optimised vehicle consisting of propylene glycol, soft white paraffin, white beeswax, propylene glycol monostearate.

Description

Chemical name: 9α-fluoro-11β,17, 21-trihydroxy-16β-methylpregna-1, 4-diene-3,20- dione-17,21-dipropionate. CAS: 5593-20-4. 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 alcohol.

Actions

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.

Pharmacokinetics.

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.
After dermal absorption, topical corticosteroids enter pharmacokinetic pathways similar to those of systemically administered corticosteroids. In varying degrees, corticosteroids are bound to plasma proteins. They are metabolised primarily in the liver and excreted by the kidneys. Some topical corticosteroids and their metabolites undergo biliary excretion.

Indications

Diprosone OV cream, ointment and lotion 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.

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.

Precautions

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 pregnancy.

(Category A)
Topical corticosteroids should not be used extensively on pregnant patients in large amounts or for prolonged periods of time.

Use in lactation.

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.

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 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.

Adverse 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.

Dosage and Administration

Diprosone OV cream and ointment.

Apply a thin film once or twice daily 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.

Overdosage

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.

Treatement.

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.

Presentation

Cream, 0.5 mg/g (0.05%): 5 g*, 30 g (tube, AUST R 18825).
Ointment, 0.5 mg/g (0.05%): 5 g*, 30 g (tube, AUST R 18823).
* Not currently marketed in Australia.

Storage

Store below 25°C.

Poison Schedule

S4.