Diprosone (Betamethasone Dipropionate)

DIPROSONE®

Schering

Betamethasone Dipropionate

Topical Corticosteroid

Indications And Clinical Uses: The topical management of corticosteroid responsive dermatoses including psoriasis, contact dermatitis (dermatitis venenata), atopic dermatitis (infantile eczema, allergic dermatitis), neurodermatitis (lichen simplex chronicus), lichen planus, eczema, eczematous dermatitis, intertrigo, dyshidrosis (pompholyx), seborrheic dermatitis, exfoliative dermatitis, solar dermatitis, stasis dermatitis, anogenital and senile pruritus.

Contra-Indications: Vaccinia, varicella, acute herpes simplex, tuberculous and fungal conditions. Hypersensitivity to any of the product’s 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 lotion contains isopropyl alcohol and may cause stinging or burning upon application to abraded or sun-burned skin.

Precautions: Diprosone should not be used in or near the eyes as the vehicle is not formulated for ophthalmic use.

Although hypersensitivity reactions are rare with topically applied steroids, discontinue the drug and institute appropriate therapy if signs of sensitivity or irritation are noted.

In cases of bacterial or fungal skin infections, use appropriate antimicrobial agents as primary therapy, with betamethasone dipropionate as a topical adjunct to control inflammation, erythema and itching. If a symptomatic response is not noted within a few days to a week, discontinue betamethasone dipropionate until the infection is brought under control.

If extensive areas of the body are treated with topical corticosteroids, particularly under occlusive dressings, sufficient systemic absorption to provide adrenal suppression and systemic corticosteroid effects may occur. To minimize this possibility, when long-term therapy is anticipated, interrupt treatment periodically or treat one area of the body at a time. Occlusive dressings should not be applied if body temperature is elevated.

Take suitable precautions 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, discontinue treatment.

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.

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.

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: Apply a sufficient quantity of the cream or ointment to completely cover the affected area. Massage gently and thoroughly into the skin. Although the usual frequency of application is twice daily, some patients on maintenance therapy may require less frequent application.

Availability And Storage: Cream: Each g of cream contains: betamethasone 0.5 mg (as dipropionate USP) in a water miscible base. Nonmedicinal ingredients: cetostearyl alcohol, chlorocresol, mineral oil, monobasic sodium phosphate, phosphoric acid, polyethylene glycol 1000 monocetyl ether, sodium hydroxide, water and white petrolatum. Tubes of 15 and 50 g; jars of 450 g.

Ointment: Each g of ointment contains: betamethasone 0.5 (as dipropionate USP) in a lanolin free base. Nonmedicinal ingredients: white petrolatum USP. Tubes of 15 and 50 g; jars of 450 g.

Lotion: Each mL of lotion contains: betamethasone 0.5 mg (as dipropionate USP). Nonmedicinal ingredients: carbomer 934P, isopropyl alcohol, sodium hydroxide to adjust pH and water. Plastic squeeze bottles of 30 and 75 mL.

Store at 2 to 30°C.

DIPROSONE® Schering Betamethasone Dipropionate Topical Corticosteroid

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Dermatitis, Atopic

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Dermatitis, Contact

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