DIPROMET -Dermal Cream

Betamethasone (dipropionate) 0.05 %

COMPOSITION:

DIPROMET- Dermal Cream: Each 4 g of cream 0.05 % contains: 0.643 mg Betamethasone Dipropionate (equivalent to 0.5mg betamethasone).

Excipients:

Chlorocresol, Sodium dihydrogen phosphate dehydrate, Phosphoric acid, White soft paraffin, Liquid paraffin, Cetomacrogol 1000, Cetostearyl alcohol, Sodium hydroxide, Purified water.

PHARMACODYNAMIC PROPERTIES:

BETAMETHASONE preparations contain the dipropionate ester of betamethasone which is a glucocorticoid exhibiting the general properties of corticosteroids.

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

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.

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.

Topical corticosteroids can be absorbed through intact, normal skin. Inflammation and/or other disease processes in the skin 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 systemically administered corticosteroids. Corticosteroids are bound to plasma proteins

in varying degrees, are metabolised primarily in the liver and excreted by the kidnays. Some of the topical corticosteroids and their metabolites are also excreted in the bile.

THERAPEUTIC INDICATIONS:

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, prurigonodularis , discoid lupus erythematosus , necrobiosislipiodica , 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.

CONTRAINDICATIONS:

Rosacea, acne, perioral dermatitis, perianal and genital pruritus. Hypersensitivity to any of the ingredients of the BETAMETHASONE presentations contra-indicates their use as does.

tuberculous and most viral lesions of the skin, particularly herpes simplex, vacinia, varicella. BETAMETHASONE should not be used in napkin eruptions, fungal or bacterial skin infections

without suitable concomitant anti-infective therapy.

POSOLOGY and METHOD of ADMINISTRATION:

Adults and Children:

Once to twice daily. In most cases, a thin film of BETAMETHASONE should be applied to cover the affected area twice daily. For some patients adequate maintenance therapy may be

achieved with less frequent application.

BETAMETHASONE Cream is especially appropriate for moist or weeping surfaces and the ointment for dry, lichenifield or scaly lesions but this is not invariably so Control over the dosage

regimen may be achieved during intermittent and maintenance therapy by using BETAMETHASONE Cream or Ointment, the base vehicles of BETAMETHASONE Cream and Ointment.

Such control may be necessary in mild and improving dry skin conditions requiring low dose steroid treatment.

SPECIAL WARNINGS and PRECAUTIONS for USE:

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.

General: Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insuffciency after withdrawal of treatment.

Manifestations of Cushing's syndrome also can be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients receiving a large dose of a potent

topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression. If HPA axis suppression is noted, an attempt should be made to

withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.

Recovery of HPAaxis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental

systemic corticosteroids.

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 patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios.

If irritation develops, treatment should be discontinued and appropriate therapy instituted.

BETAMETHASONE is not for ophthalmic use.

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 HPA axis suppression and to exogenous corticosteroid-induced HPA axis suppression and to

exogenous corticosteroid effects than adult patients because of greater absorption due to a larger skin surface area to body weight ratio. HPA axis suppression, Cushing's syndrome and

intracranial hypertension have been reported in paediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in paediatric patients include linear growth

retardation, delayed weight gain, low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include a bulging fontanelle,

headaches and bilateral papilledema.

INTERACTION WITH OTHER MEDICINAL PRODUCTS and OTHER FORMS of INTERACTION:

None stated.

PREGNANCY and LACTATION:

There are no adequate and well-controlled studies of the teratogenic potential of topically applied corticosteroids in pregnant women. Therefore, topical steroids should be used during

Pregnancy only if the potential benefit justifies the potential risk to the foetus.

It is not known whether topical administration of corticosteroids would result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered

corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, a decision should be made whether to discontinue the drug, taking

into account the importance of the drug to the mother.

EFFECT ON ABILITY TO DRIVE AND USE MACHINES :

None stated.

UNDESIRABLE EFFECTS:

BETAMETHASONE skin preparations are generally well tolerated and side-effects are rare. The systemic absorption of betamethasone dipropionate 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.

The following local adverse reactions that have been reported with the use of BETAMETHASONE include: burning, itching, and irritation, dryness, folliculitis, hypertrichosis, acneiform

eruptions, hypopigmentation, perioral dermatitis, and allergic contact dermatitis, maceration of the skin, secondary infection, striae and miliaria.

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

Vision blurred has been reported with corticosteroid use.

OVERDOSE:

Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal functions resulting in sacondary adrenal insufficiency, which is usually reversible. In such cases,

appropriate: symptomatic treatment is indicated. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, reduce the frequency of application, or to substitute a less potent steroid.

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.

PACKAGING:

DIPROMET-Dermal Cream: Carton package of aluminium tube of 20 or 40g.

STORAGE CONDITIONS:

Store DIPROMET- Dermal Cream at temperature below 25°C.