Betamethasone Dipropionate is a synthetic fluorinated corticosteroid. It is active topically and produces a rapid and sustained response in eczema and dermatitis of all types, including atopic eczema, photodermatitis., lichen planus, lichen simplex, prurigo nodularis, discoid lupus erythematosus, necrobiosis lipoidica, pretibial myxodemea and erythroderma. It is also effective in the less responsive conditions such as psoriasis of the scalp and chronic plaque psoriasis of the hands and feet, but excluding widespread plaque psoriasis.

As a general rule, corticosteroids should not be used in the treatment of banal conditions; their potency limits

their use to serious cases in children.

Posology

Application once or twice daily, in the morning and at night.

Paediatric population

The use of Diprolene in pediatric patients under 12 years of age is not recommended. Children are more

likely to experience systemic undesirable effects linked to the use of topically applied corticosteroids and, in

general, require shorter treatments with less powerful agents than adults. It is advisable to only apply the

minimum amount necessary to gain a therapeutic effect. Corticoids may affect growth hormone secretion in

children; therefore, the evolution of their weight and height should be monitored.

Method of administration

Apply a thin film of Diprolene ointment to cover completely the affected skin areas once or twice daily, in the morning and at night.

In most cases, application once a day is as effective as twice-daily application. Then, massage gently to enable penetration of the medicinal product.

It is recommended to wash one's hands after application of Diprolene.

Duration of treatment will depend on the results. After a few days, it is recommended to check cutaneous lesions.

Treatment will be discontinued as soon as lesions cure and will not be prolonged more than two weeks without medical advice.

The maximum daily dose should correspond to the lowest amount of ointment that has a therapeutic activity, i.e. apply a thin film of ointment on the affected areas.

Local and systemic toxicity is common, especially following long continuous use on large areas of damaged skin, in flexures or with polythene occlusion. If used in children or on the face courses should be limited to 5 days. Long term continuous therapy should be avoided in all patients irrespective of age.

Occlusion must not be used.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons, including rebound relapses following development of tolerance, risk of generalized pustular psoriasis and local systemic toxicity due to impaired barrier function of the skin. Careful patient supervision is important.

Diprolene ointment should not be applied on or near the eyes or on mucosae; they are not intended for use under occlusive dressing in any way. They can be applied on the face only for short periods of time.

The use of Diprolene on damaged or atrophic skin, on extensive skin surfaces, under occlusive dressing and in children (because of a large surface area to body weight ratio) may increase systemic absorption.

Please bear in mind that local corticosteroids may give a distorted clinical picture.

Caution is advised when Diprolene is applied on atrophic skin.

A rebound effect may occur upon discontinuation of treatment. Infectious exacerbation may occur and healing may be slower.

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.

Paediatric population

Children may absorb larger amounts of corticoids (due to the high body surface area/body weight ratio); therefore, they demonstrate greater susceptibility to systemic effects (see section 4.8. "Undesirable effects"). Corticoids may affect growth hormone secretion in children; therefore, the evolution of their weight and height should be monitored.

The use of Diprolene in paediatric patients under 12 years of age is not recommended.

In the presence of irritation or hypersensitivity treatment with Diprolene should be discontinued.

In the presence of bacterial infection, a specific antimicrobial treatment should be initiated. If a favorable response to treatment does not occur promptly, topical administration of the corticoid should be discontinued until the infection has been controlled adequately.

Visual disturbance

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.

There are no known interactions.

Pregnancy

There are no relevant and well-controlled clinical studies on the teratogenic potential of corticosteroids

administered topically in pregnant women. Therefore, topical corticosteroids should only be used during

pregnancy if the potential benefit justifies the potential risk to the fetus.

Use of topical corticosteroids may suppress hypothalamic-pituitary-adrenal axis, resulting in secondary

adrenal function.

Lactation

It is not known whether a topical administration of corticosteroids would result in sufficient systemic

absorption for detectable amounts to pass into the breast milk. You should decide to either discontinue

nursing or abstain from treatment with Diprolene by taking into account the benefit of breastfeeding for the

child in relation to the treatment benefit for the woman.

Not relevant.

In the presence of a bacterial infection, a specific antimicrobial therapy will be instituted.

Percutaneous absorption of corticosteroids is known to occur. Possible systemic effects should be considered in patients receiving prolonged treatment or corticosteroids applied on extensive skin surface.

Systemic effects occur on the one hand in the form of inhibition of the hypothalamic-pituitary-adrenal (HPA) axis and on the other hand in the form of the Cushing-type activity of the medicinal product itself.

In children, the absorption capacity of corticosteroids is greater; therefore, they demonstrate greater susceptibility to systemic effects, even if they only receive 30 g weekly.

Patients with serious hepatic disorders also demonstrate greater susceptibility to these effects.

Local and systemic effects are more likely to occur if the skin is thin and damaged.

Since corticosteroids may affect growth hormone secretion in children, their weight and height should be monitored.

The following adverse events have been reported during treatment with corticosteroids: burning feeling, pruritus, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infections, skin atrophy, striae and miliary.

As with any product applied on the skin, allergic reaction to Dirpolene ointment is not impossible.

The following undesirable effects have been reported in children: suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, growth retardation and increased intracranial pressure.

Diprolene ointment is colorless and does not stain clothes.

Vision blurred (see also section 4.4) has been reported with corticosteroid use (unknown frequency: cannot be

estimated from available data).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization 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 via the National Pharmacovigilance and Drug Safety Centre (NPC).

To report any side effect(s):

·            Saudi Arabia:

The National Pharmacovigilance and Drug Safety Centre (NPC). SFDA

o Fax: +966-11-205-7662

o Call NPC at +966-11-20382222, Exts: 2317-2356-2353-2354-2334-2340.

o Toll free phone: 8002490000

o E-mail: npc.drug@sfda.gov.sa

o Website: www.sfda.gov.sa/npc

·            Other GCC States:

Please contact the relevant competent authority.

Use of topical corticosteroids may suppress hypothalamic-pituitary-adrenal axis, resulting in secondary adrenal function.

Treatment: treatment is symptomatic. Acute hypercorticoid symptoms are reversible. Treat electrolyte imbalance, if necessary. In case of chronic toxicity, slow withdrawal of corticosteroids is advised.

In case of accidental oral intake, treatment is the same as for an oral overdosage with corticosteroids.

Pharmacotherapeutic group: Corticosteroids, dermatological preparations - corticosteroids, potent (group III), ATC code: D07A C01 (European standard).

Betamethasone dipropionate:

Betamethasone dipropionate belongs to class I of the corticosteroids (very potent) (American standard).

In local application it provides rapid and prolonged anti-inflammatory, antipruritic and vasoconstrictive properties.

A local treatment with corticosteroids is never a causal treatment. A possible recurrence of the disorder should be taken into account upon discontinuation of treatment.

Excipients:

The formulation of Diprolene ointment, with a propylene glycol base, enables betamethasone dipropionate to remain a solution and facilitates skin penetration of the stratum corneum, enhancing its local activity without any significant increase in its systemic action.

Systemic resorption of betamethasone dipropionate is possible, especially after prolonged treatment or when it is applied on extensive body surfaces.

Due to the self-occlusive effect the ointment has a higher penetration than the cream.

Not relevant

Diprolene ointment:

propylene glycol monostearate, propylene glycol, white wax, petrolatum.

Dithranol is not compatible with Diprolene ointment.

Store below 30°C.

Diprolene, ointment: aluminium tubes of  10, 15, 20, 30, 50, 100 and 500g.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.