BETADIP-S

  • Therapeutic Category
    • DERMATOLOGICAL DRUGS
    • Medications for the stratum corneum and reddish
  • Pharmaceutical Form : Dermal solution
  • Composition : Each gram contains: Betamethasone dipropionate 0.64 mg, equivalent to betamethasone 0.5 mg Salicylic acid 20 mg
  • Active Substance : Betamethasone dipropionate, Salicylic acid

PHARMACODYNAMICS:

This preparation contains the dipropionate ester of betamethasone which is a glucocorticoid exhibiting the general properties 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 action facilitates penetration of the corticosteroid.

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

Topical corticosteroids such as betamethasone dipropionate are effective in the treatment of a range of dermatoses because 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 each disease are uncertain.

PHARMACOKINETICS:

Salicylic acid exerts only local action after topical application.

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.

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

INDICATIONS:

Betamethasone Dipropionate is a synthetic fluorinated corticosteroid. It is active topically and produces a rapid and sustained response in those inflammatory dermatoses that are normally responsive to topical corticosteroid therapy, and it is also effective in the less responsive conditions, such as psoriasis of the scalp.

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

THIS presentation is therefore indicated for the treatment of hyperkeratotic and dry corticosteroid-responsive dermatoses where the cornified epithelium may resist penetration of the steroid. The salicylic acid constituent of THIS preparations, as a result of its descaling action, allows access of the dermis more rapidly than by applying steroid alone.

CONTRAINDICATIONS:

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

WARNINGS:

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 THIS presentation 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 this product, treatment should be discontinued.

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.

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.

Pediatric population:

Pediatric 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.

pregnancy and lactation:

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.

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.

UNDESIRABLE EFFECTS:

THIS 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.

DOSAGE& ADMINISTRATON:

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 THESE 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.

 

STORAGE CONDITIONS: Do not store above 25°C.

PACKAGING: 30 mL