Diprolene
(betamethasone)Diprolene Prescribing Information
Betamethasone dipropionate cream, 0.05% (augmented) is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.
Apply a thin film of betamethasone dipropionate cream, 0.05% (augmented) to the affected skin areas once or twice daily. Treatment with betamethasone dipropionate cream, 0.05% (augmented) should be limited to 45 g per week.
Betamethasone dipropionate cream, 0.05% (augmented) is not to be used with occlusive dressings.
Betamethasone dipropionate cream, 0.05% (augmented) is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.
The only local adverse reaction reported to be possibly or probably related to treatment with betamethasone dipropionate cream, 0.05% (augmented) during adult controlled clinical studies was stinging. It occurred in 1 patient, 0.4%, of the 242 patients or subjects involved in the studies.
Adverse reactions reported to be possibly or probably related to treatment with betamethasone dipropionate cream, 0.05% (augmented) during a pediatric clinical study include signs of skin atrophy (telangiectasia, bruising, shininess). Skin atrophy occurred in 7 of 67 (10%) patients, involving all age groups from 3 months - 12 years of age.
The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.
Betamethasone dipropionate cream, 0.05% (augmented) contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use in an emollient base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone.
Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula :
Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.
Each gram of betamethasone dipropionate cream, 0.05% (augmented) contains: 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in an emollient cream base of purified water USP; chlorocresol NF; propylene glycol USP; white petrolatum USP; white wax NF; cyclomethicone NF; sorbitol solution USP; glyceryl oleate/propylene glycol; ceteareth-30; carbomer homopolymer NF; and sodium hydroxide NF.
The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects.
Topical corticosteroids, such as betamethasone dipropionate, are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.
Pharmacokinetics:
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. (See DOSAGE AND ADMINISTRATION section.)
Topical corticosteroids can be absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. (See DOSAGE AND ADMINISTRATION section.)
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 metabolized primarily in the liver and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Betamethasone dipropionate cream, 0.05% (augmented) was applied once daily at 7 grams per day for 1 week to diseased skin, in adult patients with psoriasis or atopic dermatitis, to study its effects on the hypothalamic-pituitary-adrenal (HPA) axis. The results suggested that the drug caused a slight lowering of adrenal corticosteroid secretion, although in no case did plasma cortisol levels go below the lower limit of the normal range.
Sixty-seven pediatric patients ages 1 to 12 years, with atopic dermatitis, were enrolled in an open-label, hypothalamic-pituitary-adrenal (HPA) axis safety study.Betamethasone dipropionate cream, 0.05% (augmented) was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 95%). In 19 of 60 (32%) evaluable patients, adrenal suppression was indicated by either a ≤ 5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤ 8 mcg/dL and/or an increase of < 7 mcg/dL from the baseline cortisol. Studies performed with betamethasone dipropionate cream, 0.05% (augmented) indicate that it is in the high range of potency as compared with other topical corticosteroids.
Betamethasone dipropionate cream, 0.05% (augmented) is supplied in 15 g (NDC 68462-290-17) and 50 g (NDC 68462-290-52); boxes of one.