Betamethasone Dipropionate - Betamethasone Dipropionate cream prescribing information
INDICATIONS AND USAGE
Betamethasone dipropionate cream is a medium-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 13 years and older.
DOSAGE AND ADMINISTRATION
Apply a thin film of betamethasone dipropionate cream USP, 0.05% to the affected skin areas once daily. In some cases, twice-daily dosage may be necessary.
Betamethasone dipropionate cream USP, 0.05% should not be used with occlusive dressings.
CONTRAINDICATIONS
Betamethasone dipropionate cream is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.
ADVERSE REACTIONS
The following local adverse reactions are reported infrequently when betamethasone dipropionate cream USP, 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 infections, skin atrophy, striae and miliaria. Adverse reactions reported to be possibly or probably related to treatment with betamethasone dipropionate cream during a pedatric clinical study include signs of skin atrophy (brusing, shininess). Skin atrophy occurred in 3 of 63 (5%) patients, a 3-year old, a 5-year old, and a 7-year old.
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.
DESCRIPTION
Betamethasone Dipropionate Cream USP, 0.05% contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight mineralocorticoid activity.
Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone.
Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.
Chemically, it is 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. The structural formula is:
Each gram of Betamethasone Dipropionate Cream USP, 0.05% contains: 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone), in a hydrophilic emollient cream consisting of cetomacrogol 1000, cetostearyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, white petrolatum, chlorocresol as preservative, and phosphoric acid and/or sodium hydroxide for pH adjustment.
CLINICAL PHARMACOLOGY
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 through 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.
Sixty-three 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 was applied twice daily for 2 to 3 weeks over a mean body surface area of 40% (range 35% to 90%). In 10 of 43 (23%) 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/or an increase of < 7 mcg/dL from the baseline cortisol. Studies performed with betamethasone dipropionate cream indicate that it is in the medium range of potency as compared with other topical corticosteroids.
HOW SUPPLIED
Betamethasone Dipropionate Cream USP, 0.05% is supplied in 15 gram (NDC 51672-1274-1) and 45 gram (NDC 51672-1274-6) tubes.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
