Diprosone OV

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Betamethasone dipropionate 0.064 mg/g Equivalent to 0.5 mg Betamethasone dipropionate;  
Available from:
Merck Sharp & Dohme (New Zealand) Limited
INN (International Name):
Betamethasone dipropionate 0.064 mg/g (Equivalent to 0.5 mg Betamethasone dipropionate)
Dosage:
0.05% w/w
Pharmaceutical form:
Topical ointment
Composition:
Active: Betamethasone dipropionate 0.064 mg/g Equivalent to 0.5 mg Betamethasone dipropionate   Excipient: Propylene glycol Propylene glycol monostearate White beeswax White soft paraffin
Units in package:
Tube, HDPE cap, 30 g
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Crystal Pharma SA
Product summary:
Package - Contents - Shelf Life: Tube, HDPE cap - 30 g - 24 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-2441/1
Authorization date:
1981-07-28

DIPROSONE OV

Diprosone OV

(Optimised Vehicle)

Betamethasone dipropionate 0.05%

Consumer Medicine Information

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.

DIPROSONE OV

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 well-

tolerated 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

DIPROSONE OV

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

03 November 2017

S-CCDS-MK1460-DPL-MTL-

082017

S-CCDS-MK1460-DPL-MTL-082017

DATA SHEET

1.

DIPROSONE OV

DIPROSONE OV (0.05% w/w) cream

DIPROSONE OV (0.05% w/w) ointment

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Betamethasone dipropionate equivalent to betamethasone 0.5 mg/g (0.05% w/w).

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

DIPROSONE OV Cream is a white cream in an optimised vehicle.

DIPROSONE OV Ointment is a white ointment in an optimised vehicle.

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 once or twice daily to cover

completely the affected area.

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 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, DIPROSONE OV Ointment should be applied to the lesion sites previously

affected and treated.

Patients

this

pulse

dose

regimen

relapse

should

reverted

back

conventional dosing regimen.

4.3

Contraindications

Hypersensitivity to betamethasone dipropionate, other corticosteroids or any components

in DIPROSONE OV. Like other topical corticosteroids, DIPROSONE OV is contraindicated

in viral infections of the skin, such as vaccinia, varicella and Herpes simplex, also

tuberculosis, acne rosacea, fungal skin infections (moniliasis), perioral dermatitis and

ulcerative conditions.

4.4

Special warnings and precautions for use

DIPROSONE OV should not be used in or near the eyes, as there is a potential risk of

developing glaucoma and cataract.

If irritation or sensitisation develops with the use of DIPROSONE OV, treatment should be

discontinued and appropriate therapy instituted.

S-CCDS-MK1460-DPL-MTL-082017

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.

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.

DIPROSONE OV Cream has been shown to suppress the HPA axis with repeated

application of 7g/day. In patients with psoriasis, application of 14g 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 14g 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 7g per day

(applied as 3.5g twice daily), DIPROSONE OV Ointment was shown to cause minimal

inhibition of the HPA axis when applied for two to three weeks in normal patients and in

patients with psoriasis and eczematous disorders. With 6 to 7g 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,

reduce

frequency

application,

substitute

with

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.

Patients should not use more than 45g DIPROSONE OV weekly.

Routine steroid precautions must be observed if the patient is stressed, e.g. as in surgery.

Suitable precautions should be taken when using topical corticosteroids in patients with

stasis dermatitis and other skin diseases with impaired circulation.

Prolonged use on flexures and intertriginous areas is undesirable.

S-CCDS-MK1460-DPL-MTL-082017

Application to the face is undesirable except in special conditions such as discoid lupus

erythematosus.

Prolonged use of topical corticosteroid preparations may produce striae or atrophy of the

skin or subcutaneous tissue. If this occurs, treatment should be discontinued.

with

highly

active

topical

corticosteroid

preparations,

treatment

should

discontinued

when

dermatological

disorder

controlled.

According

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.

Patients who are to use the pulse dose 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.

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 Children

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.

Babies and children up to four years should not be treated with topical steroids for longer

than three weeks. The use of potent topical corticosteroids should be avoided in children,

unless strictly necessary and then only for short periods.

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.

4.5

Interaction with other medicines and other forms of interaction

No data available.

4.6

Fertility, pregnancy and lactation

Use in Pregnancy

Since safety of topical corticosteroid use in pregnant women has not been established,

drugs of this class should be used during pregnancy only if potential benefit justifies the

potential risk to the fetus. Topical corticosteroids should not be used extensively in large

amounts or for prolonged periods of time in pregnant patients.

S-CCDS-MK1460-DPL-MTL-082017

Use in Lactation

Since it is not known whether topical administration of corticosteroids can result in

sufficient systemic absorption to produce detectable quantities in breast milk, a decision

should be made to discontinue breastfeeding or to discontinue the drug, taking into

account the importance of the drug to the mother.

4.7

Effects on ability to drive and use machines

None known.

4.8

Undesirable effects

The most frequent side effects reported with DIPROSONE OV are mild to moderate

transient burning/stinging, dry skin, pruritus, irritation and folliculitis.

Systemic adverse reactions, such as vision blurred, have also been reported with the use

of topical corticosteroids.

Rarely reported adverse effects include tingling, prickly skin/tightening or cracking of skin,

warm

feeling,

laminar

scaling

perilesional

scaling,

follicular

rash,

skin

atrophy,

erythema, urticaria, vesiculation, telangiectasia, acneiform papules and hyperaesthesia.

Adverse reactions reported with the use of the DIPROSONE OV Ointment pulse dose

regimen were mild intermittent hypertension and paraesthesia.

Other

local

adverse

reactions

that

have

been

reported

with

topical

corticosteroids

include:

itching,

hypertrichosis,

hypopigmentation,

perioral

dermatitis,

allergic contact dermatitis, maceration of the skin, secondary infection, striae, miliaria and

exacerbation of untreated infections.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It

allows

continued monitoring

the benefit/risk

balance

medicine.

Healthcare

professionals are asked to report any suspected adverse reactions:

https://nzphvc.otago.ac.nz/reporting/

4.9

Overdose

Symptoms:

Excessive

prolonged

topical

corticosteroids

suppress

pituitary-adrenal

function

resulting

secondary

adrenal

insufficiency

produce

manifestations of hypercorticism, including Cushing's disease.

Treatment:

Appropriate

symptomatic

treatment

indicated.

Acute

hypercorticoid

symptoms are virtually reversible. Treat electrolyte imbalance, if necessary. In cases of

chronic toxicity, slow withdrawal of corticosteroids is advised.

For advice on the management of overdose please contact the National Poisons Centre

on 0800 POISON (0800 764766).

5.

PHARMACEUTICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: betamethasone: ATC code: D07AC01

DIPROSONE OV is a potent topically active corticosteroid, producing prompt, marked and

prolonged

anti-inflammatory,

anti-pruritic

vasoconstrictive

effects.

optimised

S-CCDS-MK1460-DPL-MTL-082017

vehicle with the propylene glycol component increases penetration and enhances the local

effectiveness of the betamethasone dipropionate.

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,

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 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

hypothalamic-pituitary adrenal (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.

5.2

Pharmacokinetic properties

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 dermatological 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.

5.3

Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that

already included in other sections of the Data Sheet.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

DIPROSONE OV Cream:

propylene glycol

carbomer 980

titanium dioxide

sodium hydroxide

purified water

S-CCDS-MK1460-DPL-MTL-082017

DIPROSONE OV Ointment:

propylene glycol

soft white paraffin

white beeswax

propylene glycol monostearate

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

6.2

Incompatabilities

None known.

6.3

Shelf life

Cream: 18 months from date of manufacture

Ointment: 24 months from date of manufacture

6.4

Special precautions for storage

Store below 25°C

6.5

Nature and contents of container

Cream: 30g tube, HDPE cap

Ointment: 30g tube, HDPE cap

6.6

Special precautions for disposal

Not applicable.

7.

MEDICINE SCHEDULE

Prescription medicine

8.

SPONSOR

Merck Sharp & Dohme (NZ) Ltd

P O Box 99 851

Newmarket

Auckland 1149

Tel: 0800 500 673

9.

DATE OF FIRST APPROVAL

DIPROSONE OV Cream: 15 January 1991

DIPROSONE OV Ointment: 28 July 1981

10.

DATE OF REVISION OF THE TEXT

03 November 2017

SUMMARY TABLE OF CHANGES

Date

Change

04-September-2017

Reformat data sheet

Addition of special warning and precaution for use: visual disturbance reported

with systemic and topical corticosteroid use

Addition of undesirable effect: systemic adverse reactions such as ‘vision blurred’

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