Luxiq

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.

The most frequent adverse event was burning/itching/ stinging at the application site; the incidence and severity of this event were as follows:

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.

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 C27H37FO6, a molecular weight of 476.58. The following is the chemical structure:

Betamethasone valerate

Betamethasone valerate

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.

Like other topical corticosteroids, betamethasone valerate foam has anti-inflammatory, antipruritic, 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 A2 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 precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

The safety and efficacy of Betamethasone Valerate Foam, 0.12% has been demonstrated in a four-week trial. An adequate and well-controlled clinical trial was conducted in 190 patients with moderate to severe scalp psoriasis. Patients were treated twice daily for four weeks with Betamethasone Valerate Foam, 0.12%, Placebo foam, a commercially available betamethasone valerate lotion 0.12% (formerly expressed as 0.1% betamethasone), or Placebo lotion. At four weeks of treatment, study results of 159 patients demonstrated that the efficacy of Betamethasone Valerate Foam, 0.12% in treating scalp psoriasis is superior to that of placebo foam, and is comparable to that of a currently marketed BMV lotion (see Table below).

Betamethasone Valerate Foam, 0.12% is available as follows:

50 g aluminum can (NDC 45802-053-01)

100 g aluminum can (NDC 45802-053-02)

Store at 20 - 25°C (68 - 77°F) [see USP Controlled Room Temperature].

FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION.

KEEP OUT OF REACH OF CHILDREN.

Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).