Betamethasone Dipropionate - Betamethasone Dipropionate gel prescribing information
INDICATIONS AND USAGE
Betamethasone dipropionate gel (augmented) is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dose should not exceed 50 g per week because of potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
This product is not recommended for use in pediatric patients under 12 years of age.
DOSAGE AND ADMINISTRATION
Apply a thin layer of betamethasone dipropionate gel (augmented) to the affected skin once or twice daily and rub it in gently and completely.
Betamethasone dipropionate gel (augmented) is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g per week should not be used.
Betamethasone dipropionate gel (augmented) should not be used with occlusive dressings.
CONTRAINDICATIONS
Betamethasone dipropionate gel (augmented) is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
ADVERSE REACTIONS
In controlled clinical trials, the total incidence of adverse events associated with the use of betamethasone dipropionate gel (augmented) was 10%. These included stinging or burning in 6% of patients, dry skin in 4% of patients, and pruritus in 2% of patients. Less frequently reported adverse reactions were irritation, skin atrophy, telangiectasia, erythema, cracking/tightening of the skin, follicular rash, and allergic contact dermatitis.
The following additional local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with super-high potency corticosteroids, such as betamethasone dipropionate gel (augmented).
These reactions are listed in approximate decreasing order of occurrence: acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, striae, and miliaria.
DESCRIPTION
Betamethasone dipropionate gel (augmented), 0.05%, contains betamethasone dipropionate, USP, a synthetic fluorinated corticosteroid for topical dermatologic use. Betamethasone dipropionate is included in a class of compounds consisting primarily of synthetic corticosteroids for use topically as anti-inflammatory and anti-pruritic agents.
Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C 28 H 37 FO 7 , 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 gel (augmented) contains: 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in an augmented gel base of carbomer homopolymer type C, propylene glycol, purified water and sodium hydroxide.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, betamethasone dipropionate has anti-inflammatory, anti-pruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation, such as prostaglandins and leukotrienes, by inhibiting the release of their common pre-cursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 .
Pharmacokinetics
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. In addition, inflammation and/or other disease processes in the skin may increase percutaneous absorption. Studies performed with betamethasone dipropionate gel (augmented) indicate that it is in the super-high range of potency as compared with other topical corticosteroids.
HOW SUPPLIED
Betamethasone Dipropionate Gel (Augmented), 0.05% is supplied as follows:
| 15 g | NDC 51672-1309-1 |
| 50 g | NDC 51672-1309-3 |
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
