Betamethasone Dipropionate is a synthetic fluorinated corticosteroid. It is active topically and produces a rapid andsustained response in those inflammatory dermatoses that are normally responsive to topical corticosteroid therapy, andit is also effective in the less responsive conditions, such as psoriasis of the scalp, chronic plaque psoriasis of the handsand feet, but excluding widespread plaque psoriasis.

Topical salicylic acid softens keratin, loosens cornified epithelium and desquamates the epidermis.

Betasal ointment are therefore indicated for the treatment of hyperkeratotic and dry corticosteroid-responsivedermatoses where the cornified epithelium may resist the penetration of the steroid. The salicylic acid constituent of Betasal ointment, as a result of its descaling action, allow access of the dermis more rapidly than by applyingsteroid alone.

 

Adults:

Once to twice daily. In most cases, a thin film should be applied to cover the affected area twice daily.

For some patients, adequate maintenance therapy may be achieved with less frequent application.

It is recommended that Betasalointmentbe prescribed for two weeks and that treatment be reviewed at that time.The maximum weekly dose should not exceed 60 g.

Children:

Dosage in children should be limited to 5 days.

Rosacea, acne, perioral dermatitis, perianal and genital pruritus. Hypersensitivity to any of the ingredients of Betasalointment contra-indicates their use as does tuberculous and most viral lesions of the skin, particularlyherpes simplex, vaccinia, varicella. Betasal should not be used in napkin eruptions, fungal or bacterial skin infectionswithout suitable concomitant anti-infective therapy.  

Occlusion must not be used, since under these circumstances the keratolytic action of salicylic acid may lead toenhanced absorption of the steroid.

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

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

It is dangerous if Betasal ointment comes into contact with the eyes. Avoid contact with the eyes and mucousmembranes.

The systemic absorption of betamethasone dipropionate and salicylic acid may be increased if extensive body surfaceareas or skin folds are treated for prolonged periods or with excessive amounts of steroids. Suitable precautions shouldbe taken in these circumstances, particularly with infants and children.

If irritation or sensitisation develops with the use of Betasal Ointment treatment should be discontinued.

Any side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may alsooccur with topical corticosteroids, especially in infants and children.

If excessive dryness or increased skin irritation develops, discontinue use of this preparation.

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 patientshould be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances whichmay include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have beenreported after use of systemic and topical corticosteroids.

Paediatric population: Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-inducedhypothalamic-pituitary-adrenal (HPA) axis suppression and exogenous corticosteroid effects than mature patientsbecause of greater absorption due to a large skin surface area to body weight ratio.

HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertensionhave been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children includelow plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertensioninclude a bulging fontanelle, headaches and bilateral papilledema.

Instruct patients not to smoke or go near naked flames – the risk of severe burns. Fabric (clothing, bedding, dressings etc)that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and beddingmay reduce product build-up but not totally remove it.

 

None stated.

 

 

Since the safety of topical corticosteroid use in pregnant women has not been established, drugs of this class should beused during pregnancy only if the potential benefit justifies the potential risk to the foetus. Drugs of this class should notbe used extensively in large amounts or for prolonged periods in pregnant patients.

Since it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption toproduce detectable quantities in breast milk, a decision should be made to discontinue nursing or to discontinue thedrug, taking into account the importance of the drug to the mother.

None stated.

Continuous application without interruption may result in local atrophy of the skin, striae and superficial vascular dilation,particularly on the face.

Adverse reactions that have been reported with the use of topical corticosteroids include: burning, itching, irritation,dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis and allergic contactdermatitis.

The following may occur more frequently with the use of occlusive dressings: maceration of the skin, secondaryinfection, skin atrophy, striae and miliaria.

Vision blurred (see also section 4.4) has been reported with corticosteroid use (frequency not known).

In addition, prolonged use of salicylic acid preparations may cause dermatitis.

Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal functions resulting in secondaryadrenal insufficiency, and produce manifestations of hypercorticism, including Cushing's disease.

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

With topical preparations containing salicylic acid excessive prolonged use may result in symptoms of salicyclism.Treatment is symptomatic. Measures should be taken to rid the body rapidly of salicylate. Administer oral sodiumbicarbonate to alkalinise the urine and force diuresis.

The steroid content of each tube is so low as to have little or no toxic effect in the unlikely event of accidental oralingestion.

Betasal ointment contains the dipropionate ester of betamethasone which is a glucocorticoid exhibiting the generalproperties of corticosteroids and salicylic acid which has keratolytic properties.

Salicylic acid is applied topically in the treatment of hyperkeratotic and scaling conditions where its keratolytic actionfacilitates penetration of the corticosteroid.

In pharmacological doses, corticosteroids are used primarily for their anti-inflammatory and/or immune-suppressiveeffects.

Topical corticosteroids such as betamethasone dipropionate are effective in the treatment of a range of dermatosesbecause of their anti-inflammatory, anti-pruritic and vasoconstrictive actions. However, while the physiologic,pharmacologic and clinical effects of the corticosteroids are well known, the exact mechanisms of their action in eachdisease are uncertain.

Salicylic acid exerts only local action after topical application.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, integrityof the epidermal barrier and the use of occlusive dressings.

Topical corticosteroids can be absorbed through intact, normal skin. Inflammation and/or other disease processes in theskin may increase percutaneous absorption.

Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.

Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemicallyadministered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees, are metabolised primarilyin the liver and are excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted in thebile.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in othersections of the SPC.

 

 

White bee wax

Cetyl alcohol

Stearyl alcohol

White soft paraffin

Dehymuls E

Liquid paraffin.

None stated.

24 months

Do not Store above 30°C.

To be used within 6 months from the first opening of the tube

Betasal is available in an aluminium tube of  20 g inside a carton box along with a patient information leaflet.

Not applicable