BETAMETHASONE VALERATE

Betamethasone Valerate Foam, 0.12% contains betamethasone valerate, USP, a synthetic corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory agents. Betamethasone valerate is 9-fluoro11ß,17, 21-trihydroxy-16ß-methylpregna-1, 4-diene-3, 20-dione 17-valerate, with the empirical formula C 27 H 37 FO 6 , a molecular weight of 476.58. The following is the chemical structure: Betamethasone valerate is a white to practically white, odorless crystalline powder, and is practically insoluble in water, freely soluble in acetone and in chloroform, soluble in alcohol, and slightly soluble in benzene and in ether. Betamethasone Valerate Foam, 0.12% contains 1.2 mg betamethasone valerate, USP, per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant. betamethasone valerate chemical structure

Betamethasone Valerate Foam, 0.12% is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.

Note: For proper dispensing of foam, can must be inverted. For application to the scalp invert can and dispense a small amount of Betamethasone Valerate Foam, 0.12% onto a saucer or other cool surface. Do not dispense directly onto hands as foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of foam with fingers and gently massage into affected area until foam disappears. Repeat until entire affected scalp area is treated. Apply twice daily, once in the morning and once at night. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Betamethasone Valerate Foam, 0.12% should not be used with occlusive dressings unless directed by a physician.

Betamethasone Valerate Foam, 0.12% is contraindicated in patients who are hypersensitive to betamethasone valerate, to other corticosteroids, or to any ingredient in this preparation.

The most frequent adverse event was burning/itching/ stinging at the application site; the incidence and severity of this event were as follows: Incidence and severity of burning/itching/stinging Product Total incidence Maximum severity Mild Moderate Severe Betamethasone Valerate Foam, 0.12% n=63 34 (54%) 28 (44%) 5 (8%) 1 (2%) Betamethasone Valerate Lotion n=63 33 (52%) 26 (41%) 6 (10%) 1 (2%) Placebo Foam n=32 24 (75%) 13 (41%) 7 (22%) 4 (12%) Placebo Lotion n=30 20 (67%) 12 (40%) 5 (17%) 3 (10%) Other adverse events which were considered to be possibly, probably, or definitely related to Betamethasone Valerate Foam, 0.12% occurred in one patient each; these were paresthesia, pruritus, acne, alopecia, and conjunctivitis. The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximately decreasing order of occurrence: irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and 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.