Del-Beta
(betamethasone)Del-Beta Prescribing Information
Betamethasone Dipropionate Lotion USP, 0.05% is a medium-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.
Apply a few drops of Betamethasone Dipropionate Lotion USP, 0.05% to the affected area and massage lightly until it disappears. Apply twice daily, in the morning and at night.
Betamethasone Dipropionate Lotion USP, 0.05% is not to be used with occlusive dressings.
Betamethasone Dipropionate Lotion USP, 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in these preparations.
The following local adverse reactions are reported infrequently when betamethasone dipropionate lotion 0.05% is used as recommended in the DOSAGE AND ADMINISTRATION section. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria.
Adverse reactions reported to be possibly or probably related to treatment with betamethasone dipropionate lotion 0.05% during a pediatric study include: paresthesia (burning), erythema, erythematous rash, and dry skin. These adverse reactions each occurred in a different patient; 4% of the 25 patient population, respectively. An adverse reaction reported to be possibly or probably related to treatment in 2 different patients, 8%, of the 25 patients is puritis.
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 Lotion USP, 0.05% contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has high corticosteroid activity and slight 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 Lotion USP, 0.05% contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a lotion base of carbomer homopolymer type B, isopropyl alcohol, and purified water. Sodium hydroxide is used to adjust pH.
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).
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION).
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Twenty-five pediatric patients ages 6 to 12 years, with atopic dermatitis, were enrolled in an open-label, hypothalamic-pituitary-adrenal (HPA) axis safety study. Betamethasone dipropionate lotion 0.05% was applied twice daily for 2 to 3 weeks over a mean body surface area of 45% (range 35% to 72%). In 11 of 15 (73%) evaluable patients, adrenal suppression was indicated by either a < 5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol < 18 mcg/dL and an increase of < 7 mcg/dL from the baseline cortisol. Studies performed with betamethasone dipropionate lotion 0.05% indicate that it is in the medium range of potency as compared with other topical corticosteroids.
Betamethasone Dipropionate Lotion USP, 0.05% is available as follows:
60 mL bottle (NDC 45802-021-46)
Shake well before using.