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  • Diprosalic Ointment
    / MSD


    Active Ingredient *
    Betamethasone 0.5 mg/g
    Salicylic Acid 30 mg/g

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Ointment

    15 g

    full basket chart 8461 4433

    Dosage

    Adults: Once to twice daily. In most cases a thin film should be applied to the affected areas twice daily and massaged gently and thoroughly into the skin.
    For some patients adequate maintenance therapy may be achieved with less frequent application.
    It is recommended that Diprosalic preparations are prescribed for two weeks, and that treatment is reviewed at that time. The maximum weekly dose should not exceed 60g.
    Children: Dosage in children should be limited to 5 days.


    Indications

    Betamethasone Dipropionate is a synthetic fluorinated corticosteroid.
    Diprosalic Ointment provides anti inflammatory, antipruritic, anti allergic and chronic hyperkeratotic and dry keratolytic activity in the topical management of subacute dermatoses responsive to corticosteroid therapy.


    Contra-Indications

    Rosacea, acne, perioral dermatitis, perianal and genital pruritus. Hypersensitivity to any of the ingredients of the Diprosalic presentations contra-indicates their use as does tuberculous and most viral lesions of the skin, particularly herpes simplex, vacinia, varicella.
    Diprosalic should not be used in napkin eruptions, fungal or bacterial skin infections without suitable concomitant anti-infective therapy.


    Special Precautions

    Occlusion must not be used, since under these circumstances the keratolytic action of salicylic acid may lead to enhanced absorption of the steroid.
    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.
    Topical corticosteroids may be hazardous in psoriasis for a number of reasons, including rebound relapses following development of tolerance, risk of generalised pustular psoriasis and local systemic toxicity due to impaired barrier function of the skin. Careful patient supervision is important.
    It is dangerous if Diprosalic presentations come into contact with the eyes. Avoid contact with the eyes and mucous membranes.
    The systemic absorption of betamethasone dipropionate and salicylic acid may be increased if extensive body surface areas or skin folds are treated for prolonged periods or  with excessive amounts of steroids. Suitable precautions should be taken in these circumstances, particularly with infants and children.
    If irritation or sensitisation develops with the use of Diprosalic, treatment should be discontinued.
    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.Any side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
    If excessive dryness or increased skin irritation develops, discontinue use of this
    preparation.
    Paediatric population: Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituary-adrenal (HPA) axis suppression and to exogenous corticosteroid effects than mature patients because 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 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 papilledema.


    Side Effects

    Diprosalic skin preparations are generally well tolerated and side-effects are rare.
    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 contact dermatitis.
    The following may occur more frequently with the use of occlusive dressings: maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
    Vision blurred has been reported with corticosteroid use (frequency not known).
    In addition, prolonged use of salicylic acid preparations may cause dermatitis.


    Pregnancy and Lactation

    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 the potential benefit justifies the potential risk to the foetus. Drugs of this class should not be used extensively in large amounts or for prolonged periods of time in pregnant patients.
    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 nursing or to discontinue the drug, taking into account the importance of the drug to the mother.


    Overdose

    Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal functions resulting in secondary adrenal insufficiency, and produce manifestations of hypercorticism, including Cushing’s disease.
    Treatment: Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are usually reversible.
    Treat electrolyte 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 sodium bicarbonate to alkalinize 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 oral ingestion.


    Manufacturer
    Schering Plough
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