BETAMETHASONE DIPROPIONATE
CREAM USP (AUGMENTED*), 0.05%
(potency expressed as betamethasone)
* Vehicle augments the penetration of the steroid.

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE

Rx Only

Betamethasone dipropionate cream (augmented) contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use in an emollient base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of 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 Cream USP (Augmented*), 0.05% contains: 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in an emollient cream base of purified water, USP; chlorocresol NF; white petrolatum, USP; white wax, NF; cyclomethicone; sorbitol solution, USP; glyceryl monooleate; propylene glycol, USP; ceteareth-30; carbomer 940, NF; and sodium hydroxide NF.

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, anti-pruritic, 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.

Betamethasone dipropionate cream (augmented) is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.

Betamethasone dipropionate cream (augmented), is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

The only local adverse reaction reported to be possibly or probably related to treatment with betamethasone dipropionate cream (augmented) during adult, controlled clinical studies was stinging. It occurred in 1 patient, 0.4%, of the 242 patients or subjects involved in the studies.

Adverse reactions reported to be possibly or probably related to treatment with betamethasone dipropionate cream (augmented) during a pediatric clinical study include signs of skin atrophy (telangiectasia, bruising, shininess). Skin atrophy occurred in 7 of 67 (10%) patients, involving all age groups from 3 months - 12 years of age.

The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions are uled 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.

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.

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (SeePRECAUTIONS .)

Apply a thin film of betamethasone dipropionate cream (augmented) to the affected skin areas once or twice daily.Treatment with betamethasone dipropionate cream (augmented) should be limited to 45 g per week.

Betamethasone dipropionate cream (augmented) is not to be used with occlusive dressings.

Betamethasone Dipropionate Cream USP (Augmented*), 0.05%, is supplied as follows:

•  NDC 0168-0265-15 15 gram tube
•  NDC 0168-0265-50 50 gram tube

Store between 2° and 30°C (36° and 86°F).

E. FOUGERA & CO.
a division of Altana Inc.
MELVILLE, NEW YORK 11747

I2265
R7/03
#59