Diprosalic (Betamethasone Dipropionate – Salicylic Acid)

DIPROSALIC®

Schering

Betamethasone Dipropionate – Salicylic Acid

Topical Corticosteroid – Keratolytic

Action And Clinical Pharmacology: Combines the anti-inflammatory, antipruritic and vasoconstrictive activity of betamethasone dipropionate with the keratolytic effects of salicylic acid.

Indications And Clinical Uses: Topical management of subacute and chronic hyperkeratotic and dry dermatoses responsive to corticosteroid therapy.

Contra-Indications: Viral diseases including vaccinia, varicella, herpes simplex, and fungal infections; also tuberculosis of the skin. Hypersensitivity to any one of the components.

Manufacturers’ Warnings In Clinical States: Pregnancy and Lactation: 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 fetus. 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.

Children: Any of the side effects that have been reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.

Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. Use of topical corticosteroids in children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with growth and development of children.

The drug should not be used in or near the eyes since the product is not formulated for ophthalmic use: it should also be kept away from the genital area and other orifices.

Precautions: Suitable precautions should be taken in using topical corticosteroids in patients with stasis dermatitis and other skin diseases with impaired circulation. Prolonged use of corticosteroid preparations may produce striae or atrophy of the skin or subcutaneous tissue. If this occurs, treatment should be discontinued. Patients should be advised to inform subsequent physicians of the prior use of corticosteroids. If irritation, sensitization, excessive dryness, or unwanted scaling develop treatment should be discontinued. Application over extensive lesions may result in significant systemic absorption producing hypercortisonism manifesting itself by adrenal suppression, moon facies, striae and suppression of growth. If an overt infection is present, appropriate antimicrobial treatment is indicated. If symptomatic response is not noted within a few days to a week, the local application of corticosteroids should be discontinued and the patient re-evaluated. Occlusive dressings should not be used.

Adverse Reactions: The following local adverse reactions have been reported rarely with the use of topical corticosteroids: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation.

The following may occur more frequently with occlusive dressings: maceration of the skin, secondary infection, skin atrophy, striae, miliaria. In addition, the salicylic acid component may cause local reddening of the skin, desquamation, pruritus and smarting. Hypersensitivity to salicylic acid may occur.

Symptoms And Treatment Of Overdose: Symptoms: Excessive or prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency, and produce manifestations of hypercorticism, including Cushing’s disease.

Overdosage of salicylates may cause temporary hearing or visual disturbances, drowsiness and nausea. If this occurs, discontinue use until symptoms disappear.

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.

Dosage And Administration: Lotion: Apply a thin film to cover completely the affected areas of the scalp. The usual frequency of application is twice daily.

Ointment: Apply a sufficient quantity to cover completely the affected area. The ointment should be massaged gently and thoroughly into the skin. The usual frequency of application is twice daily.

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

Diprosalic should not be used under occlusive dressing.

Availability And Storage: Lotion: Each g contains: betamethasone 0.5 (as dipropionate USP) and salicylic acid 20 mg. The pH is adjusted to approximately 5. Nonmedicinal ingredients: edetate disodium, hydroxypropyl methylcellulose, isopropyl alcohol, water and sodium hydroxide to adjust pH to approximately 5. Plastic squeeze bottles of 30 mL and 60 mL. Store under 25°C.

Ointment: Each g contains: betamethasone 0.5 mg (as dipropionate USP) and salicylic acid 30 mg in a paraben-free ointment base of white petrolatum and mineral oil. Tubes of 15 and 50 g. Store under 25°C.

DIPROSALIC®Schering Betamethasone Dipropionate – Salicylic Acid Topical Corticosteroid – Keratolytic

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